Life Sciences and Healthcare


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 Webinar Id:  LSHCDD009
 10:00 AM PT | 01:00 PM ET
 05/24/2018
 Duration: 60 mins

Applying Quality Risk Management

This webinar is intended to help you better understand and get familiar with best practices for FDA approval process for quality risk management (QRM) applicable for pharmaceutical industry. This webinar is further intended to discuss how risk management plans can be effectively integrated into a quality system (QS) in the pharmaceutical industry.


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPBLT2505
 10:00 AM PT | 01:00 PM ET
 05/25/2018
 Duration: 90 mins

HIPAA Compliance Officer Training | HIPAA Professional 2018

This webinar will be addressing how to practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educat........


View Details

        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPHJ2905
 10:00 AM PT | 01:00 PM ET
 05/29/2018
 Duration: 60 mins

The Roles and Responsibilities of a HIPAA Security/Privacy Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facilit........


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJH3105
 10:00 AM PT | 01:00 PM ET
 05/31/2018
 Duration: 90 mins

HIPAA, HITECH and Omnibus Rule Compliance - 3 Steps to Meeting the Requirements

Does your organization understand modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act (HITECH)? Are you meeting the requirements of the HIPAA Omnibus Rule? This webinar will look at each Act and Rule to spell what 3 steps must be in place to meet organizational requirements. The changes in the final rulemaking provide the pu........


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJW0531
 10:00 AM PT | 01:00 PM  ET
 05/31/2018
 Duration: 60 mins

How to Prepare a HIPAA Compliant Disaster Recovery Plan

This webinar focuses on an area often missed in performing HIPAA assessments: the business continuation and disaster recovery planning. This session takes the participants through the process of considering what can/may happen that could put the healthcare organization out of business and how to develop methods for mitigating those risks.


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCWK0606
 10:00 AM PT | 01:00 PM ET
 06/06/2018
 Duration: 60 mins

Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do Course Duration

Because the Anti-Kickback Statute is so broad it what it proscribes, healthcare organizations, conducting what would be normal marketing activities in other industries, have run afoul of the Statute on numerous occasions. The Statute and the regulations only tell part of the story. This program will review not only the Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with ........


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCCP0606
 10:00 AM PT | 1:00 PM ET
 06/06/2018
 Duration: 60 mins

Writing & Delivering Effective Training in the Life Sciences

Training is the process by which individuals acquire skill and knowledge. There are a variety of approaches and techniques that should be applied to specific situations to achieve maximum effectiveness. Uninitiated training personnel often apply training techniques that are totally inappropriate for the situations for which they are utilized resulting in very ineffective training. Read and Understand is a technique that is and has been ........


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCJA0013
 10:00 AM PT | 1:00 PM ET
 06/08/2018
 Duration: 60 mins

Auditing Medical Director Contracts for Compliance

This webinar will discuss auditing your medical director contacts for compliance. More specifically, it will discuss the regulatory framework governing medical director contracts, key compliance issues, and what to look for when auditing your contracts for compliance. It will also discuss recent government enforcement trends relating to medical director agreements.


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHSW611
 10:00 AM PT | 01:00 PM ET
 06/11/2018
 Duration: 75 mins

10 Keys for Maximizing the Benefits of your SPC Program

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified. However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combine technical competencies, such as us........


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPBLT1106
 10:00 AM PT | 01:00 PM ET
 06/11/2018
 Duration: 180 mins

3-Hr Virtual Seminar on What to Expect in a Federal HIPAA Audit & How to Avoid a Federal Audit

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received This lesson will be addressing how to ........


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        $378
  Single Attendee
(Only for one Participant)
      $699
Multiple Attendee
( 2 - 5 Participants)
     $1522
Corporate Attendee
( 6 - 10 Participants)
        $447
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCP618
 10:00 AM PT | 01:00 PM ET
 06/18/2018
 Duration: 60 mins

Understanding Design Controls

Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation, however, the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed. Knowing how the FDA both views and examines design controls is crucial to achieving compliance thr........


View Details

        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPBT0626
 10:00 AM PT | 01:00 PM  ET
 06/26/2018
 Duration: 60 mins

GDPR - How to Comply as an American Business or Healthcare Entity

This lesson will be addressing the specifics on how American businesses and healthcare organizations need to quickly get on the task of compliance with the European Union's (EU) new General Data Protection Regulation (GDPR).  In addition, this webinar will address how to best accomplish compliance with GDPR and also understand how to assess risks and exposure specifically to American organizations and healthcare.  We will be going throu........


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJW0630
 10:00 AM PT | 01:00 PM ET
 06/29/2018
 Duration: 60 mins

How to Prepare HIPAA Compliant Policies And Procedures

The HIPAA Privacy and Security regulations particularly specify that the covered entity and business associates must implement policies and procedures that promote the compliance with the HIPAA regulations. HIPAA Policies and Procedures are the basis for a health care organization's HIPAA compliance program. The policies and procedures describe how the organization complies with HIPAA. This is used as a basis for performing your HIPAA R........


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        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPBT0712
 10:00 AM PT | 01:00 PM  ET
 07/12/2018
 Duration: 60 mins

SAMHSA 42 CFR Part 2 vs HIPAA

This lesson will be addressing how practice/business managers (or compliance offers) need to ensure their organization is complying with the Federal Substance Abuse and Mental Health Administration (SAMHSA) regulations (42 CFR Part 2) and how this differs from the HIPAA (Health Insurance Portability and Accountability Act) Privacy and Security Regulations. Both regulations carry significant civil and even criminal penalties if not compl........


View Details

        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHSW716
 10:00 AM PT | 01:00 PM ET
 07/16/2018
 Duration: 75 mins

Process Capability for Normal and Non-Normal Data

This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for estimating process capability (e.g. establishing process stability) are discussed first. Distributions are briefly described and methods for estimating ppm levels are presented. The use and limitations of common process capability indices (e.g. Cpk and Ppk) are discussed. It is vital that appropriate methods are used ........


View Details

        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPBT0726
 10:00 AM PT | 01:00 PM  ET
 07/26/2018
 Duration: 60 mins

HIPAA - Emailing, Texting, and Personal Devices (myths vs realities)

This lesson will be going into great detail regarding your practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. I will uncover myths versus ........


View Details

        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCJB011
 10:00 AM PT | 1:00 PM ET
 08/10/2018
 Duration: 60 mins

Beyond the Allegation: How to Effectively Conduct Compliance Investigations.

This webinar will give attendees a blueprint for conducting effective compliance investigations, from A-Z. Given that responding to detected offenses are included in the Seven Elements of an Effective Compliance Program as deemed by the Office of Inspector General (?OIG?), this presentation is intended to provide strategies and tips for conducting and documenting investigations in a manner that can be defended should a complaint be made........


View Details

        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHSW813
 10:00 AM PT | 01:00 PM ET
 08/13/2018
 Duration: 75 mins

Stability Studies and Estimating Shelf Life

Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Many approaches are available to quantify the "shelf life" and the method(s) chosen often depend on the testing time available. This webinar discusses the steps to set-up a stability study and analyze the results to estimate the product's shelf l........


View Details

        $179
  Single Attendee
(Only for one Participant)
      $368
Multiple Attendee
( 2 - 5 Participants)
     $741
Corporate Attendee
( 6 - 10 Participants)
        $167
    Recorded
(6 months unlimited access)
 Webinar Id: HIPBLT3HR01
 6 months unlimited
 Duration: 180 mins

3-hour virtual seminar: New Finalized Amendments to HIPAA - Many Changes to the Rules, Many Changes Needed for Compliance

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated ........

$393 Recorded (6 months unlimited access)
 Webinar Id: LSHCJR005
 6 months unlimited
 Duration: 60 mins

Transportation Food Safety Standards for Shippers, Carriers and Receivers

While the FDA Food Safety Modernization Act (FSMA) rules for the sanitary transportation of human and animal foods require training for rail and road carrier transportation personnel, training is only the tip of the iceberg and does not certify carriers or shippers in food safety. The company?s responsibility under FSMA is to assure that there are transportation standards established, a plan is in place to document and meet the plan, th........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJW0503
 6 months unlimited
 Duration: 60 mins

Role of IT in Hipaa Compliance

This webinar provides the participants with an orientation of the role the IT services in the healthcare organization in addressing the organization's HIPAA compliance. This encompasses understanding what role IT hardware and software plays in the HIPAA compliance process, what responsibilities IT vendors should have and how to work with vendors. The materials will discuss IT security in the context of an overall organization security p........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMDF001
 6 months unlimited
 Duration: 75 mins

FDA/EU MDSAP Inspections - Getting Prepared

Inspections are critical to the success of the business on several levels. Therefore, being appropriately prepared and management of the inspection process is a critical activity. The consequences if a company does not pass an inspection are time consuming, delayed product approvals, and could lead to civil or even criminal litigation by the FDA and EU inspection agencies.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT2404
 6 months unlimited
 Duration: 90 mins

New Amendments to HIPAA Regulations - New Final Amendments Create New Challenges

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated ........

$243 Recorded (6 months unlimited access)
 Webinar Id: HIPDMH001
 6 months unlimited
 Duration: 90 mins

HIPAA Compliant Messaging Platforms, Including Advanced Capabilities that Provide Technology-Driven Improvements to Operational Efficiencies and Clinical Care

HIPAA compliant messaging platforms provide encryption services which are 100% complaint with HIPAA regulations regarding private healthcare information being communicated via smartphones and computers between physicians, hospitals, clinics and other healthcare facilities. A few of the more advanced platforms also include additional capabilities which result in significant improvements to operational efficiencies and clinical care. 

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCEM001
 6 months unlimited
 Duration: 60 mins

Mobile Medical Apps (Is It an FDA Regulated Device?) and Cybersecurity

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than just testing performance. Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app design will be explained.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHPH003
 6 months unlimited
 Duration: 60 mins

Business Associates Come in From the Cold! 5 Steps to HIPAA Compliance.

HIPAA law applies to Business Associates (BAs) in healthcare - BAs are organizations that create, receive, maintain or transmit Protected Health Information (PHI) - on behalf of a Covered Entity or to provide a service or function involving PHI for a covered Entity - and are directly liable for compliance with HIPAA law protecting the privacy and security of PHI.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP413
 6 months unlimited
 Duration: 60 mins

Achieving your CE Mark in the EU for your Medical Devices

The letters 'CE' appear on many products that are traded on the single market in the European Economic Area (EEA). CE marking is required for many products. CE marks: Show that the manufacturer has checked that their products meet EU safety, health or environmental requirements Is an indicator of a product's compliance with EU legislation: Allow the free movement of products within the European marketBy placing the CE mark on a product,........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP003R
 6 months unlimited
 Duration: 60 mins

Writing Effective Compliance Documentation

Compliance documentation to include Standard Operating Procedures - the documentation required by regulation - is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regu........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCWK001
 6 months unlimited
 Duration: 90 mins

Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

This webinar will provide an in-depth understanding of the Federal False Claims Act, Federal Anti-Kickback and Stark laws, and discuss how marketing activities can trigger either or both.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJPTH002
 6 months unlimited
 Duration: 60 mins

HIPAA Compliance Through Policies

The webinar will explain the process for covered entities and business associates to use to draft, adopt, and implement HIPAA compliance policies. Writing a policy is easier than one may think. It is a three-step process: researching, drafting and revising. This webinar will teach you to ask questions, solicit help, collect samples, keep the principles of substance, organization, coherence, style, and correctness in mind while you are d........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCAB005
 6 months unlimited
 Duration: 90 mins

Current Concepts & Challenges in Cloud Compliance

The evolution of computerized technologies has been both amazing and challenging. Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements. Cloud computing is a current example of this evolution. This presentation will provide a discussion of Cloud concepts, terminology, definitions, architecture, and services; review t........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHJ007
 6 months unlimited
 Duration: 60 mins

The Roles and Responsibilities of a HIPAA Security/Privacy Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facilit........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJPTH005
 6 months unlimited
 Duration: 60 mins

The HIPAA Breach Notification Rule: What it Really Means and How to Comply?

With the Enactment of the Modifications to HIPAA contained in the so-called HI-TECH Act and its implementing regulation, the Omnibus Rule, the law and DHHS have greatly expanded the importance of handling breaches properly. How covered entities handle security incidents, breaches, and complaints is one of the key areas that DHS audits for. In addition, it has imposed civil money penalties as high as $5.5 million for failure to handle HI........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA0011
 6 months unlimited
 Duration: 60 mins

How to Draft a Memorandum Analyzing Any Regulatory Issue

This presentation provides a blueprint for how to draft a written opinion analyzing any regulatory compliance issue. Since analyzing issues is central to what a compliance officer does on a daily basis, this webinar is intended to aid compliance professionals with how to analyze an issue and communicate their analysis in a way that is accurate and complete, but not overly detailed, causing one to lose the reader. In addition to covering........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT2703
 6 months unlimited
 Duration: 90 mins

HIPAA Changes 2018 and How to Comply

This lesson will be addressing how to practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates t........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBP2003
 6 months unlimited
 Duration: 60 mins

HIPAA 101 - The basics of HIPAA Compliance

What HIPAA is and what are the key MUST do's to be in compliance and avoid "willful neglect" in an audit.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJPTW006
 6 months unlimited
 Duration: 60 mins

What Does the Term "Reasonable and Appropriate" Mean under HIPAA? And How Do You Achieve It?

The HIPAA Security Rule requires covered entities and business associates to implement "reasonable and appropriate" security measures to protect against improper access, use, or disclosure of Protected Health Information ("PHI"). The Rule, however, gives very little guidance as to what constitutes reasonable and appropriate security measures. This is probably a good thing because what is reasonable and appropriate for a small town denta........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJL004
 6 months unlimited
 Duration: 60 mins

LYOPHILIZATION TECHNOLOGY

Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained. During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so th........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPPH1403
 6 months unlimited
 Duration: 60 mins

Top Targets of Fed HIPAA Enforcers & Simple Steps to Take Control

This webinar for HIPAA Covered Entities and Business Associates will identify the top OCR HIPAA enforcement priorities for 2018 and explain simply how you can master HIPAA compliance requirements for each enforcement priority. HIPAA Compliance is in crisis throughout the United States. The Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services has just announced results of its recen........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT1203
 6 months unlimited
 Duration: 90 mins

Patients Suing under HIPAA - Beware of new Laws and Risks

This lesson will be addressing how law firms who work with protected health information need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days as it relates........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP39
 6 months unlimited
 Duration: 60 mins

Leverage Regulatory Documentation: Write Sops That Actually Work and Have Value

Compliance documentation to include Standard Operating Procedures _ the documentation required by regulation _ is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regu........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJBW001
 6 months unlimited
 Duration: 60 mins

How to Respond to a HIPAA Breach

It has become clear that health care organizations no longer have to worry about "if" a HIPAA Breach will occur; but, they have to worry about what to do when a HIPAA breach "does" occur. Even the most ardent HIPAA compliance followers have breaches occur. The biggest concern now is for a healthcare organization to know what to do when a breach occurs. This encompasses being able to know what a breach is when a breach occurred, what to ........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJPTW007
 6 months unlimited
 Duration: 60 mins

What Is a HIPAA Security Incident and What Should You Do about It?

With the Enactment of the Modifications to HIPAA contained in the so-called HI-TECH Act and its implementing regulation, the Omnibus Rule, the law and DHHS have greatly expanded the importance of handling breaches properly. How covered entities handle security incidents, breaches, and complaints is one of the key areas that DHS audits for. In addition, it has imposed civil money penalties as high as $5.5 million for failure to handle HI........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCST003
 6 months unlimited
 Duration: 60 mins

Understanding and Implementing a Technology Transfer Process

Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, management, and transfer of tec........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJT001
 6 months unlimited
 Duration: 60 mins

Total Quality Control (TQC) and Management (TQM)

Infighting, slow delivery, high returns, high rework, customer complaints and other similar problems are symptomatic of a lack of a coherent and agreed-upon approach to business. Total Quality Controls (TQC) or Total Quality Management (TQM) systems have proven themselves successful in just about every industry from electronics manufacturers through food processors. TQC systems are also form the basis of OSHA programs. Developing a step........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJK003
 6 months unlimited
 Duration: 60 mins

Is Your Material Compliance Program Due for an Update

The Product Substance Regulations (RoHS, REACH, etc.) present an international complex and changing landscape that is getting harder to support. Your Compliance Team and related processes that were implemented previously may no longer be adequate or effective. Several case studies are presented to show examples of possible current status and suggestions for updates.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHPH002
 6 months unlimited
 Duration: 60 mins

HIPAA and Patient Engagement - Easy-to-Follow Rules for Email & Text Messaging.

Patient Engagement is a cornerstone of effective patient care. Communication technology offers indispensable patient engagement tools. Secure patient portals are available. So are encrypted text message and email products. But patients overwhelmingly choose non-secure communication tools like text messaging and email. Appointment reminders, healthcare instructions, patient satisfaction surveys, health and wellness newsletters and recall........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA005
 6 months unlimited
 Duration: 60 mins

Your First 100 Days as a Compliance Officer: Strategies to Prioritize Your Workload.

This webinar is designed to provide a realistic overview of what your first 100 days on the job as new compliance officer should look for any healthcare organization. It will discuss how to effectively on board to the organization and prioritize your workload for the first 100 days and beyond.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHJPT002
 6 months unlimited
 Duration: 60 mins

How to do a HIPAA and HITECH Risk Analysis

After explaining the need for conducting a HIPAA risk analysis and the penalties for not doing so, this Webinar will provide attendees a methodology for doing so. HIPAA does not specify a particular way of conducting such an analysis. But the author has taken hundreds of covered entities and business associates through the process and his way of doing must work because none of them have had a security breach.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT1602
 6 months unlimited
 Duration: 90 mins

Surviving the Imminent Federal HIPAA Audits

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received This lesson will be addressing how pra........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHPH001
 6 months unlimited
 Duration: 60 mins

HIPAA and Patient Engagement - Easy-to-Follow Rules for Web Sites & Social Media.

Patient Engagement is a cornerstone of quality patient care and Web Sites and Social Media are widely used to communicate with patients. HIPAA law still applies but is misunderstood by most health care providers and business associates in relation to patient communications. This webinar provides the guidance needed to use Web Sites and Social Media in healthcare.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJPTR001
 6 months unlimited
 Duration: 60 mins

Road to HIPAA Compliance: How to Handle HIPAA and HITECH Security Breaches, Complaints, and Investigations

With the Enactment of the Modifications to HIPAA contained in the so called HI-TECH Act and its implementing regulation, the Omnibus Rule, the law and DHHS have greatly expanded the importance of handling breaches properly. How covered entities handle security incidents, breaches, and complaints is one of the key areas that DHS audits for. In addition, it has imposed civil money penalties as high as $5.5 million for failure to handle HI........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCT0001
 6 months unlimited
 Duration: 90 mins

Data Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organisations in the pharmaceutical, biologic, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a step further, we are now looking ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCDD006
 6 months unlimited
 Duration: 60 mins

Understanding Aseptic Technique and Cleanroom Behavior

Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT0602
 6 months unlimited
 Duration: 90 mins

Changes under the HIPAA Omnibus Rule - What's new for 2018

This lesson will be addressing how to practice/business managers (or compliance officers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP0010
 6 months unlimited
 Duration: 90 mins

Project Management in the Life Sciences - Some Tips and Approaches

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant. You are half listening to the presentation while thinking about some of the other work you need to complete on different matters. The installation will take a year to execute and will require the coordination with several fun........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCWR001
 6 months unlimited
 Duration: 60 mins

Reduce Inspection Costs with Sequential Sampling

ANSI/ASQ Z1.4 (formerly MIL-STD 105) is a generally accepted standard for acceptance sampling by attribute (pass/fail) data. Sampling plans are defined by a sample size of n and an acceptance number c, and lots are accepted if the sample contains c or fewer nonconformances or defects. Double sampling and multiple sampling plans seek to reduce the amount of inspection by accepting very good lots quickly, and rejecting very bad lots just ........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHPH010
 6 months unlimited
 Duration: 60 mins

HIPAA Breach - or Not? How to Find Out & What to Do

More than 170 million Americans have been affected by Breaches of Unsecured Protected Health Information (PHI) since 2009. A Ransomware attack that encrypts PHI is now presumed to be a HIPAA Breach by Federal regulators. HIPAA Breach Notification Content and Timeliness are 2 of the top Enforcement priorities of the Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJP007
 6 months unlimited
 Duration: 60 mins

How to Handle HIPAA Security Incidents, Breaches, Complaints, and Investigations

With the Enactment of the Modifications to HIPAA contained in the so called HI-TECH Act and its implementing regulation, the Omnibus Rule, the law and DHHS have greatly expanded the importance of handling breaches properly. How covered entities handle security incidents, breaches, and complaints is one of the key areas that DHS audits for. In addition, it has imposed civil money penalties as high as $5.5 million for failure to handle HI........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCDD0001
 6 months unlimited
 Duration: 60 mins

How to properly investigate OOS/OOT Results

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHJT006
 6 months unlimited
 Duration: 60 mins

The Roles And Responsibilities of a HIPAA Privacy and Security Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspectiv -from a personal perspective - from the perspective of the person in charge of moving an organization or facility ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJL001
 6 months unlimited
 Duration: 90 mins

Lean Manufacturing Systems

Lean manufacturing has been around for many years and helps companies go through the point in their growth cycle when the initial fly-by-night system they struggled to put in place as a young company no longer satisfies demand or schedules. The changes required to move from batch processing and other manufacturing models to a more efficient customer oriented model are generally established when companies hit the wall in terms of continu........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCM001
 6 months unlimited
 Duration: 60 mins

CMS Phase 2 Requirements - Are you ready?

Phase 2 of the new CMS requirements were to be in place by Nov. 28, 2017. We will look at most Phase 2 requirements in detail. Let this be a moment for your team to solidly know what is required and together assess your home's compliance. Proven culture change best practices that contribute to compliance will be highlighted.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHBLT001
 6 months unlimited
 Duration: 90 mins

HIPAA Changes 2018 and How to comply?

This lesson will be addressing how to practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates t........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCST001
 6 months unlimited
 Duration: 60 mins

Pharmaceutical Quality Risk Management (QRM) Overview

Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and Controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. There is much confusion on how to define risk and individuals often think of quality risk manageme........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJB002
 6 months unlimited
 Duration: 60 mins

Batch Production Record and Device History Record Review and Quality Assessment to ensure compliance with DMF and DMR specifications

Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product with established specifications before a batch can be released for distribution BPRs, DHRs and laboratory control records for critical process steps a........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCU008
 6 months unlimited
 Duration: 60 mins

Understanding Medical Device Design Controls

Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation however the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed. Knowing how the FDA both views and examines design controls is crucial to achieving compliance throu........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHJPT001
 6 months unlimited
 Duration: 60 mins

HIPAA Compliance with the New Omnibus Rule: How to Pass an Audit to Avoid Penalties and Criminal Convictions

Before the HITECH Act, DHHS could audit covered entities for HIPAA compliance, but did not have to. With that Act, now the must audit those entities and business associates as well. In the first audits, the Phase I audits, DHHS came on site. The subsequent Phase II audits, however, were paper audits in which those audited had to provide documentation of their compliance. As yet, we do not know what form Phase III will take, but the nece........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPNBLT001
 6 months unlimited
 Duration: 90 mins

New HIPAA Updates for 2018 Covering 2017 Changes

This HIPAA 2018 changes and updates session will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA has become fully enforced and the government is not using kid gloves anymore. It will even handle key updates under the Omnibus Principle, Trump administration and every other appropriate changes for 2018 and beyond. You will find an enormous level of dilemmas and risks for ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCN002
 6 months unlimited
 Duration: 60 mins

New CMS Requirements - Culture Change Links and Leverages

CMS issued the Reform of Requirements for LTC Facilities: Final Rule in 2016 with some requirements due at that time known as Phase I. Phase 2 is in effect as of Nov. 28, 2017 and Phase 3 comes in 2019. Knowing regulations is foundational; homes are held accountable to them. Learn the new requirements (last regulation changes were in 1991) -what's new and what remains, as well as some culture change wins. Many culture change practices h........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPOJPT001
 6 months unlimited
 Duration: 60 mins

Omnibus (Mega) Rule Changes to HIPAA & the HITECH Act and What They Mean to Covered Entities and Business Associates

The Omnibus or Mega Rule, implementing the HITECH Act of 2009 significantly changed HIPAA compliance. Although it has been in effect for some time now, some of the drastic changes are still causing covered entities and business associates significant difficulties.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHP001
 6 months unlimited
 Duration: 60 mins

Perspectives on Proactive Internal Auditing-for Compliance, Quality System Effectiveness and Product & Process Improvement

Senior Management has the responsibility to be involved in design and implementation of the quality system and this responsibility continues to include participation in quality activities. The most productive activity of this continued participation is to ensure that periodic internal audits are conducted to the term the effectiveness of the quality system established and that when deficiencies occur, solutions are effectively implement........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPTPH001
 6 months unlimited
 Duration: 60 mins

Take the Fear out of HIPAA , Step-by-Step Compliance Guidelines

The HIPAA Rules are frequently misunderstood and inadvertently violated. However, HIPAA Rules are easy to follow, step-by-step, when you know the steps. This session will explain exactly how a health care provider's designated HIPAA Compliance Official can find the right steps for each HIPAA compliance topic and how the health care provider can review and be assured the practice is up to date and in compliance with the HIPAA Rules.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBPH003
 6 months unlimited
 Duration: 60 mins

HIPAA Awareness and Security Training for Covered Entities & Business Associates

This webinar will explain the importance of HIPAA, outlines the requirements related to protecting personal health information (PHI), and specifies best practices for the handling of such information. It focuses on Businesses associates (and their sub-contractors) and their responsibilities under HIPAA as well as the Covered Entity responsibilities to monitor their BAs Business associates and their subcontractors face potential liabilit........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCPF001
 6 months unlimited
 Duration: 90 mins

Fighting butterflies & presenting with finesse

This webinar will help you bring the visual element to your presentations, along with the ease of presentation. Learn how to captivate your audience, communicate your message, and have fun!

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBP002
 6 months unlimited
 Duration: 60 mins

Produce Safety: The Enigma of a Healthy Diet (Popeye Would Turn Over in his Grave)

In the United States, more illnesses have been attributed to leafy vegetables (22%) than to any other commodity: illnesses associated with leafy vegetables are the second most frequent cause of hospitalizations (14%) and the fifth most frequent cause of death (6%). This situation is probably reflected globally. Should we stop eating all raw fruit and vegetables? Does washing make it safer? Are we putting ourselves at risk by eating our ........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJPTH001
 6 months unlimited
 Duration: 60 mins

HIPAA Privacy Rule Use and Disclosure Misconceptions

With the complexity of the Privacy Rule and the frequent changes to it, healthcare covered entities and their business associates often do not know what uses and disclosures the Privacy Rule permits. Not knowing when you can disclose health information This can result in can result in bad outcomes, including the death of the patient/client, lawsuits for breach of confidentiality, HIPAA civil money penalties, and bad publicity, as well a........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRC007
 6 months unlimited
 Duration: 60 mins

CMO Supplier Quality Agreements :- How to Comply with new FDA and EU Guidelines for Contract Drug Manufacturer

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts: EU GMP Chapter 7 "Outsourced Activities" (Revised) Draft Guidance for Industry -"Contract Manufacturing A........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCWLP001
 6 months unlimited
 Duration: 60 mins

Paying for Referrals: Risky Behavior

The session will provide an overview of the Anti-Kickback Statute (AKS) and review what it prohibits, as well as review the Statute's available safe harbors. It will also show how violation of the AKS can raise FCA concerns, and it will provide an assessment of enforcement activities, showing how participants may be at risk. In addition, the session will review recent cases and show how they potentially impact participants. We will prov........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPNAK002
 6 months unlimited
 Duration: 60 mins

HIPAA Compliance in Light of Recent Enforcement Actions.

This webinar will examine recent HIPAA enforcement actions and trends and will discuss practical insights on HIPAA from such enforcement activities. The webinar will cover HIPAA hot topics, as reflected in enforcement actions, and will provide guidance on avoiding enforcement actions.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCUJA021
 6 months unlimited
 Duration: 60 mins

Understanding the Decision Points of Self-Disclosures and Repayment Obligations.

Historically, providers and suppliers enrolled in federal government healthcare programs have reconciled and returned overpayments through various post-payment audits. Additionally, these same entities have voluntarily returned self-identified overpayment through various self-disclosure methods made available to them. When Congress passed the Fraud Enforcement Recovery Act of 2009 ("FERA"), these self-identified disclosures went from st........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJSF001
 6 months unlimited
 Duration: 60 mins

Fund Raising for Organizations Governed by HIPAA

Organizations that are covered by HIPAA are also governed by special rules when fundraising for that organization. Any health care institution that fund raises or clinical providers who assist in fund raising are affected by these federal regulations.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCWP001
 6 months unlimited
 Duration: 60 mins

Process Capability Analysis, and What to Do if it's Not a Bell Curve

The process capability index, and related process performance index, reflect the ability of a manufacturing process to meet specifications. A Six Sigma process has six process standard deviations between the specification limits and the nominal. The traditional process capability indices, however, rely on the assumption that the process follows a normal (bell curve) distribution. When this is not the case, special but off the shelf meth........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHPH008
 6 months unlimited
 Duration: 60 mins

HIPAA Risk Analysis - Risk Management - Explained & Demonstrated

The Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS) has just announced alarming results of the Phase 2 Covered Entity HIPAA Compliance Audits. 94% failed the Risk Management Audit and 87% failed the Risk Analysis Audit! Every audited Covered Entity knew well in advance that it was on the short list to be audited, had completed pre-audit questionnaires and knew the exact........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMEW007
 6 months unlimited
 Duration: 90 mins

Conducting a Software Validation of Medical Device to Meet FDA Requirements

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Software validation is much more than testing.We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHWMC003
 6 months unlimited
 Duration: 60 mins

Healthcare Quality Improvement Act - Achieving Immunity in Your Peer Review Process

This webinar will discuss the Health Care Quality Improvement Act (HCQIA) in detail, including the standards that must be met to achieve immunity under the act. The HCQIA itself will be reviewed, including a detailed look at the Congressional purpose for the act. The legislative history of the act will be reviewed to gain an understanding of the intent of Congress in passing the act. Next will be a review of the standards under the act.........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCFP001
 6 months unlimited
 Duration: 90min mins

FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

This webinar will review the current regulations, guidance documents for GMP Documentation in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling,and documentation requirements will also be reviewed and explored.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMC001
 6 months unlimited
 Duration: 60min mins

CAPA: Corrective and Preventative Actions and Addressing Non-Conformances

CAPA is both a precursor to and component of RCA that helps people prevent non-conformances from occurring and if all else fails; answer the question of why the non-conformance occurred in the first place. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem. What is a non-conformance? When you have a non-conformance in the laboratory, how do you approach it? Do you jum........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBPH007
 6 months unlimited
 Duration: 60 mins

Business Associates 2018 - Top 5 HIPAA Compliance Priorities

Business Associates - organizations that create, receive, maintain or transmit Protected Health Information (PHI) - on behalf of a Covered Entity or to provide a service or function involving PHI for a covered Entity - are directly liable for compliance with HIPAA law protecting the privacy and security of PHI. If you are a Business Associate you must know exactly what you have to do to comply with HIPAA. But you have two hurdles. 

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPNAK003
 6 months unlimited
 Duration: 60 mins

HIPAA Basics for Non - Healthcare People

This webinar will provide a broad overview of HIPAA, including its applicability, its general rules, and requirements for compliance.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRC005
 6 months unlimited
 Duration: 60 mins

Pharmaceutical Compressed Air :- Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCTJA014
 6 months unlimited
 Duration: 60 mins

Tis the Season: Navigating the Compliance Challenges with Holiday Gifts

This webinar is designed to help attendees navigate through the compliance challenges related to holiday gift giving and receiving with physicians, vendors, patients, and co-workers. More specifically, it will discuss the regulatory framework surrounding gifts, common gifting scenarios, the pitfalls to avoid, and strategies for drafting organizational gift policies.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCCB003
 6 months unlimited
 Duration: 90 mins

Regulatory Compliance and Culture Change

CMS regulations have always supported the principles and practices of culture change and now even more so. See how the new CMS regulations support culture change practices and how the national culture change movement affected the new requirements .Learn how a transformed culture centered around resident autonomy and regard, naturally meets regulations. It is our time to now only link culture change to the new CMS requirements but levera........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMEW006
 6 months unlimited
 Duration: 90 mins

MDR Program conforming to New FDA Guidance

This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include death, injury and malfunction reporting requirements, record keeping requirements, report timing, clarification of the term "becoming aware" and clarification of reporting using electronic form 3500A.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCGCP005
 6 months unlimited
 Duration: 60 mins

GMP Auditing for Pharmaceutical Manufacturing.

Auditing involves a comprehensive review of vendors that will provide resources and/or services. The ICH Q10 document provides an outline on the pharmaceutical drug product life-cycle. Through the review of ICH Q8, Q9, and Q10, the participant will be able to audit the various activities associated with the different stages of the product lifecycle. By using a scientific risk-based approach, as outlined in ICH Q9, the participant will b........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMEW005
 6 months unlimited
 Duration: 90 mins

Medical Device Premarket and Post market Cyber security following the new FDA Guidances

Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks, and to other medical devices. All medical devices carry a certain amount of risk. The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBPH001
 6 months unlimited
 Duration: 75 mins

HIPAA - The Do's and Don'ts of Social Media and HIPAA Compliance

Hundreds of hospitals and other healthcare institutions across the nation are embracing social media. But how risky is this from a HIPAA and HITECH compliance stand point is this practice? Are you doing all you can/should to be compliant and manage/reduce the risk of a breach of PHI in your institution? By federal law PHI must be secured and its privacy insured. How do open, very public forums like Facebook, Twitter, LinkedIn mesh with ........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPMPH004
 6 months unlimited
 Duration: 60 mins

MACRA & MIPS - Patient Engagement Part 1 - HIPAA Rules for Web Sites & Social Media

There are widespread violations of the HIPAA Rules for communicating with patients by unencrypted email and text message - largely because Providers and Business Associates just don't know the rules - and don't understand what PHI really is - as defined by HIPAA. The HIPAA Rules and HHS/OCR guidance provide a simple, easy to use 3 Step Safe Harbor for using unencrypted email and text messaging to engage patients. This session will expla........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCWA001
 6 months unlimited
 Duration: 90 mins

Writing Effective SOP?s

Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCTK002
 6 months unlimited
 Duration: 60 mins

Human Factors Engineering in New Product Development

This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCPBA001
 6 months unlimited
 Duration: 90 mins

Advertising and Promotional material compliance and review process

This webinar will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal assurances that compliance of materials is appropriately assessed, evaluated, and documented. Ensure that your company has a program in place that will ensure full understanding and communication of potential risks associated with materials and ability to mitigate risk through subtle but important modifica........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPNAK001
 6 months unlimited
 Duration: 60 mins

HIPAA And Litigation - Getting and Producing Records Through Discovery

This webinar will examine the interplay between HIPAA and state law when it comes to requesting and producing health records in the context of litigation. The webinar will address how attorneys should properly request health records and how covered entities and business associates should properly respond to such requests.

$167 Recorded (6 months unlimited access)
 Webinar Id: LHSCDRD002
 6 months unlimited
 Duration: 60 mins

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

The session will provide an understanding and overview of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Gain experience and learn more about detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites. The issue of fraud is again a focus within the clinical research industry. Although high-profile cases tend to periodically........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHJ005
 6 months unlimited
 Duration: 60 mins

The Roles and Responsibilities of a HIPAA Security/Privacy Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance.  This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facili........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP006
 6 months unlimited
 Duration: 60 mins

Preventing Medical Device Recalls ? A Prevention Strategy

In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2016 attributable to a variety of reasons. Whatever the reason, medical device recalls are expensive and most importantly carry significant risk to the health and safety of patients. The increase indicates serious failures in the processes and controls designed to ensure reliability, safety, and effectiveness of the recalle........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHJA019
 6 months unlimited
 Duration: 60 mins

Healthcare Fraud: Current Legislative and Regulatory Update.

This presentation will provide a general overview of the key legislative and regulatory developments in the area of healthcare fraud and abuse. For the key regulatory developments, Mr. Anstine will walk through notable cases to highlight key takeaways attendees should be aware of relative to help safeguard the operations of their own organizations.  

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT008
 6 months unlimited
 Duration: 90 mins

HIPAA - New Risks for the Business Associate

The objectives of this course will be to go over the specific risks associated with business associates as it relates to HIPAA compliance.  I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.  Times have changed and unfortunately many businesses are losing clients or un........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMEW004
 6 months unlimited
 Duration: 60 mins

Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than just testing performance. Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app design will be explained.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSDD005
 6 months unlimited
 Duration: 60 mins

Course Description - How to Write and Manage a Change Control System

This webinar will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCAWL002
 6 months unlimited
 Duration: 60 mins

Acceptance Sampling for Variables (ANSI/ASQ Z1.9)

ANSI/ASQ Z1.9 (formerly MIL-STD 414) is a generally accepted standard for acceptance sampling by variables (real number) data. The sampling plans work by (1) calculating the sample's average along with a measurement of dispersion (standard deviation or range) and (2) comparing these results against tabulated criteria to determine whether the lot should be accepted or rejected. Switching rules similar to those of ANSI/ASQ Z1.4 (formerly ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCPJA018
 6 months unlimited
 Duration: 60 mins

Protecting Your Organization Against Sanctions for Ineffective Exclusion Screening.

Under certain circumstances (such as convictions for patient abuse and violations of the anti-kickback statute), the Department of Health and Human Services, Office of Inspector General ("OIG") is required to exclude persons from federal healthcare programs (e.g. Medicare, Medicaid). In other circumstances,(such as civil and criminal violations of healthcare laws), the OIG has the discretion to exclude an individual from a federal healt........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRG001
 6 months unlimited
 Duration: 60 mins

Import FDA in the Automated Commercial Environment (ACE) Authorized Electronic Data Interchange (EDI) System

It focuses on the role of the import managers when shipping goods under the FDA and Customs Regulations. It also addresses what regulations can be used to help the importer in understanding Automated Commercial Environment (ACE)as the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Certain Electronic Entry and Entry Summary Filings Accompanied by Food and Drug Administration (FDA) Data. This review FDA report........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCACP003
 6 months unlimited
 Duration: 60 mins

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing.

The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBPH002
 6 months unlimited
 Duration: 60 mins

HIPAA 101 - The basics of HIPAA Compliance

What HIPAA is and what are the key MUST do's to be in compliance and avoid "willful neglect" in an audit.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCLJA013
 6 months unlimited
 Duration: 60 mins

Looking Inward: Assessing the Effectiveness of Your Compliance Program.

This webinar is designed to walk attendees through a self-assessment of the effectiveness of his/her compliance program to determine if the program is meeting the Federal government's standards (e.g. The Office of Inspector General's "Seven Elements of an Effective Compliance Program"). More specifically, this presentation will walk through a checklist of questions directed at each of the seven elements and offer strategies and tips for........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT009
 6 months unlimited
 Duration: 90 mins

What to Expect in a Federal HIPAA Audit and How to be Prepared

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received.This lesson will be addressing how to p........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJHT001
 6 months unlimited
 Duration: 90 mins

How to Handle HIPAA and HITECH Act Breaches, Complaints and Investigations: Everything You Need to Know

This webinar will inform covered entities and business associates how to handle security incidents. Almost every one of those entities will have one or more security incidents a year but they may or may not be a breach that they must take further action on. The webinar will spell out what actions must be taken in the event of an incident or breach and also how to handle complaints by patients/clients and what to do if investigated to av........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSDD004
 6 months unlimited
 Duration: 60 mins

Steam Sterilization Microbiology and Autoclave Performance Qualification

Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPSKH003
 6 months unlimited
 Duration: 60 mins

How to survive a HIPAA audit by HHS/OCR

The OCR HIPAA Audit is a mandate under the Health Information Technology for Economic and Clinical Health (HITECH) Act. The HIPAA audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate. The entire audit protocol is organized around modules, representing separate elements of privacy, security, and breach notification. Privacy Rule requirements for  Notice of privacy ........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT010
 6 months unlimited
 Duration: 90 mins

HIPAA & the Compliance Officer

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017.  Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.  The primary goal is to ensure everyone is well educate........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCCB001
 6 months unlimited
 Duration: 90 mins

CMS Reform of LTC Requirements: Final Rule

CMS issued the Reform of Requirements for LTC Facilities: Final Rule in Sept. 28, 2016. Phase I implementation was already required by Nov. 28, 2016. Phase 2 is to be implemented by Nov. 28, 2017. Is your home ready? Learn the new requirements (last regulation changes were in 1991) - what's new and what remains, as well as some culture change wins. Together we'll brainstorm ways to comply that don't cost a lot of money; many culture cha........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCTK001
 6 months unlimited
 Duration: 60 mins

How Home Healthcare is Changing the Medical Device Game

This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPAB001
 6 months unlimited
 Duration: 180 mins

3-Hour Virtual Seminar on HIPAA Compliance Certification

HIPAA, which stands for Health Insurance Portability & Accountability Act, does not just apply to health insurance. The rules apply to all companies with Personal Health Information (PHI) in electronic formats -doctors, health plans, pharma organizations, government programs, research organizations, testing organizations, pharmacies, clinics, IT services for regulated organizations, and more. In March of 2013, the HIPAA Omnibus Final Ru........

$447 Recorded (6 months unlimited access)
 Webinar Id: HIPJMB001
 6 months unlimited
 Duration: 60 mins

HIPAA Issues in Mental and Behavioral Health

This webinar is not a total guide to HIPAA compliance. Total HIPAA compliance includes information on the standard transactions and code sets, identifiers, how to handle breaches, and the like. This webinar focuses on HIPAA's Security Rule and Privacy Rule compliance to enable mental and behavioral health professionals to effectively treat their clients without violating HIPAA's complex individual rights standards and disclosure standar........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT011
 6 months unlimited
 Duration: 90 mins

HIPAA Audits - an Insiders Perspective.

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received This lesson will be addressing how pra........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT012
 6 months unlimited
 Duration: 90 mins

Do's and Don'ts Regarding HIPAA Texting and Emailing

This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as ........

$243 Recorded (6 months unlimited access)
 Webinar Id: LHSCMJA014
 6 months unlimited
 Duration: 60 mins

Medical Director Contracting: Key Pitfalls to Avoid.

This webinar will discuss key compliance issues with respect to medical director contracts. More specifically, it will discuss the regulatory framework governing medical director contracts, key compliance issues, how to audit for medical director contract compliance, and recent government enforcement trends relating to medical director agreements.  

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT013
 6 months unlimited
 Duration: 90 mins

Managing Risks Under HIPAA - HITECH

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak o........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHHSK003
 6 months unlimited
 Duration: 60 mins

HIPAA-HITECH Assessment of your Cloud Service Providers

The primary objective of this 60 minute webinar is to help organization identify the key vulnerabilities with cloud service providers by reviewing the best practices to evaluate, engage and monitor online service providers to protect ePHI handled on behalf of the Covered Entity. Have you identified the e-PHI with your cloud service providers? This includes e-PHI that you create, receive, maintain or transmit. What are the external sourc........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCAB003
 6 months unlimited
 Duration: 90 mins

Sharps Safety Program: Risks, Prevention & Management of Sharps Injuries

Occupational exposure to blood borne pathogens from needle sticks and other sharps injuries is a serious problem, but it is often preventable. The Centers for Disease Control and Prevention (CDC) estimates that each year 385,000 needle sticks and other sharps related injuries are sustained by hospital-based healthcare personnel. Similar injuries occur in other healthcare settings, such as nursing homes, clinics, emergency care services,........

$277 Recorded (6 months unlimited access)
 Webinar Id: HIPKO001
 6 months unlimited
 Duration: 60 mins

We Had a HIPAA Breach - Now What Do We Do?

This webinar will explain what a HIPAA breach is, who can be involved, how to resolve it, and what must be done. 

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCJA017
 6 months unlimited
 Duration: 60 mins

Conducting Effective Compliance Investigation Interviews.

This presentation will give attendees a blueprint for conducting effective compliance investigation interviews.  Given that responding to detected offenses are included in the Seven Elements of an Effective Compliance Program as deemed by the Office of Inspector General ("OIG"), this webinar is intended to provide helpful strategies for conducting and documenting investigation interviews.  To help guide the discussion, Mr. Anstine will ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP009
 6 months unlimited
 Duration: 60 mins

Writing Effective Compliance Documentation.

Compliance documentation to include Standard Operating Procedures - the documentation required by regulation - is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regu........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCTG001
 6 months unlimited
 Duration: 60 mins

Assay Validation for Clinical Diagnostics

This webinar will cover what is necessary for the validation of an assay in a clinical diagnostics setting

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCTMBI004
 6 months unlimited
 Duration: 60 mins

The Revised Total Coliform Rule (RTCR)

Total coliforms are a group of related bacteria that are (with few exceptions) not harmful to humans, but are found in human waste (sewage). A variety of microbial pathogens in sewage can potentially cause health problems if humans ingest them. EPA no longer considers enumeration of total coliforms a useful indicator of other pathogens for drinking water. Total coliforms are used to determine the adequacy of water treatment and the inte........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPMRB002
 6 months unlimited
 Duration: 60 mins

HIPAA and the administrative subpoena ? how HIPAA does or does not protect you when the government comes calling for your patient records and you are in trouble

This webinar reviews core privacy requirements of HIPAA then covers in detail the ways state licensure boards and agencies use the authority of state law to cover HIPAA exceptions and gain access to your patient records. What authority exists in state law to do so? How does that mesh with the federal law requirements and privacy mandates of HIPAA? What do you do when the government comes calling for protected health information on your ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCDLT001
 6 months unlimited
 Duration: 90 mins

Why your Organization Needs ISO 45001 and Understanding the Updated Concepts as Compared to Other Safety & Health Management Systems

Workplace incidents impact not only your employees but also result in a significant drain on the bottom line. Most companies today have turned to homegrown programs or standard frameworks like OHSAS 18001 to deal with these issues. Today, gain an understanding of how the new and updated concepts in ISO 45001 can have an impact on legal requirements, operational controls, risks, opportunities & performance and progress towards your compa........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBJA015
 6 months unlimited
 Duration: 60 mins

Breach Notification Rule: A Blueprint for Conducting Consistent Risk Assessments.

This presentation will provide a blueprint for consistently conducting risk assessments under the HIPAA Breach Notification Rule. More specifically, it will address topics such as what constitutes a breach, what to include in a Breach Notification policy, how to conduct a risk assessment analysing any issue, and how to document your risk assessment. This presentation will use a situational examples that attendees can relate to in order ........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPSFD001
 6 months unlimited
 Duration: 90 mins

FMLA, ADA, USERRA, Workers Compensation, and HIPAA: Navigating the Bermuda Triangle of Medical Leaves

Understanding the basics of, as well as the similarities, the distinctions, and the interrelationships among the Family Medical Leave Act (FMLA), the Americans with Disability Act (ADA), workers' compensation laws, the Uniformed Services Employment and Reemployment Rights Act (USERRA), and the Health Insurance Portability and Accountability Act (HIPAA) is critical to your business.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPUAP001
 6 months unlimited
 Duration: 60 mins

Encryption & HIPAA Mandates

Firewall systems are the first line of defense. Encryption and HIPAA mandates are the last line of defense. In between the two lines of defense, businesses deploy a multitude of security controls to prevent unauthorized access and tenacious attacks. Firewall systems are the first line of defense. Encryption is the last line of defense. In between the two lines of defense, businesses deploy a multitude of security controls to prevent una........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPJPT001
 6 months unlimited
 Duration: 60 mins

How to do a HIPAA risk analysis

After explaining the need for conducting a HIPAA risk analysis and the penalties for not doing so, this Webinar will provide attendees a methodology for doing so. HIPAA does not specify a particular way of conducting such an analysis. But the author has taken hundreds of covered entities and business associates through the process and his way of doing must work because none of them have had a security breach.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCWJL002
 6 months unlimited
 Duration: 90 mins

What Employers Need to Know about Medical Marijuana In the Workplace

Most recent laws legalizing marijuana use have been geared towards removing criminal penalties for users, and do not fully address workplace issues posed by medical marijuana. Some state laws explicitly prohibit employers from discriminating against employees because of their status of medical marijuana cardholders. Some may only addresses the impact of a positive drug test for a limited set of job duties, such as public utility workers........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP005
 6 months unlimited
 Duration: 60 mins

Classifying Medical Devices

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The determination process, how you apply the classification pr........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCIMBI004
 6 months unlimited
 Duration: 60 mins

Is it Method Verification or Validation, or Just Semantics?

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses. Although method validation and method verification are related terms, they have very different analytical and statistical req........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHTS001
 6 months unlimited
 Duration: 60 mins

HIPAA: HIGHLIGHTS HOOPLA and HOOEY

Buying a fill-in- the-blank template does not equal HIPAA compliance, and doing nothing, or saying "I didn't know" can result in willful negligence. Translation: Fines that start at $10,000 and go up exponentially for each violation. I teach healthcare practices who want to be HIPAA compliant, but don't want the time consuming frustration or risk that comes with not knowing the process.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMPH005
 6 months unlimited
 Duration: 60 mins

MACRA & MIPS - Patient Engagement - HIPAA Rules for Text Messaging & Email

There are widespread violations of the HIPAA Rules for communicating with patients by unencrypted email and text message - largely because Providers and Business Associates just don't know the rules - and don't understand what PHI really is - as defined by HIPAA. The HIPAA Rules and HHS/OCR guidance provide a simple, easy to use 3 Step Safe Harbor for using unencrypted email and text messaging to engage patients. This session will expla........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCNJA020
 6 months unlimited
 Duration: 60 mins

Navigating the Politics of Healthcare from the Compliance Role

This presentation will cover four main strategies the compliance professional can use to navigate the politics of healthcare to obtain buy-in to the compliance program. Additionally, the presentation will include strategies for improved communications with physicians and healthcare leaders.  

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT006
 6 months unlimited
 Duration: 60 mins

New HIPAA Regulations Affect Business Associates: That was then, this is now.

The objectives of this course will be to go over the specific risks associated with business associates as it relates to HIPAA compliance. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. Times have changed and unfortunately many businesses are losing clients or unab........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPMRB001
 6 months unlimited
 Duration: 60 mins

HIPAA privacy exceptions for law enforcement purposes as applied to health care professionals

This webinar starts with a review of the core requirements of HIPAA then covers in detail the many exceptions that apply to law enforcement purposes as applied to health care professionals. What do you do when the police come calling for protected health information on your patient? And because the patient is in trouble? Or because you are in trouble? Gain a firm understanding of the HIPAA exceptions for law enforcement purposes.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCGRG002
 6 months unlimited
 Duration: 60 mins

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: "In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a giv........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCJA016
 6 months unlimited
 Duration: 60 mins

Compliance with the CMS Physician Open Payments Rule.

Open Payments is a federal program under the Centers for Medicare and Medicaid Services ("CMS") that collects certain information relating to payments and other items of value provided to physicians from drug and device companies. Examples include: speaking fees, gifts, meals, and covering the cost of travel expenses to name a few. The Open Payments program also includes information on ownership interests a physician may have in a drug ........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHSSK001
 6 months unlimited
 Duration: 60 mins

Navigating HIPAA/HITECH Regulatory Compliance Strategies.

As the compliance deadline for new HIPAA-HITECH rule approaches, it becomes imperative for healthcare business associate organizations to develop strategies to protect electronic health information, and comply with HIPAA-HITECH regulations. This instructor-led one-day training will teach you how to design, implement, and administer comprehensive healthcare IT compliance and security protection programs as a business associate. During th........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCTG002
 6 months unlimited
 Duration: 60 mins

Translating Academic and Discovery Assays Into GLP Compliant Assays

This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP007
 6 months unlimited
 Duration: 60 mins

Training in Regulated Environments

Training is the process by which individuals acquire skill and knowledge. There are a variety of approaches and techniques that should be applied to specific situations to achieve maximum effectiveness. Uninitiated training personnel often apply training techniques that are totally inappropriate for the situations for which they are utilized resulting in very ineffective training. Read and Understand is a technique that is and has been ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCUJR001
 6 months unlimited
 Duration: 90 mins

Using Your Food Safety Data to Drive Cost Reductions and Process Improvements

In today's world of food safety, everyone in the supply chain is challenged to document what they are doing. This seemingly expensive documentation yields data that is valuable to cutting costs, improving food safety, meeting legal requirements and improving business processes. But most companies do not yet know how to use the data they spend so much time and money collecting. Yet, there are some relatively easy, quick to implement anal........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT007
 6 months unlimited
 Duration: 60 mins

Understanding The New HIPAA Risk Audit - Are You Fully Prepared?

HIPAA NOW HAS TEETH! It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for covered entities. This once relatively benign legislation is being fully enforced and the news is not good for covered entities or business associates! Be prepared! Protect your practice or business! What factors might spurn a HIPAA audit? ...are you doing these things? Why are the Feds enfor........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHJA023
 6 months unlimited
 Duration: 60 mins

Preparing the front office staff to carry out HIPAA privacy procedures.

HIPAA audits are on the rise, and you'll probably be surprised to learn that you are most likely to be targeted for a HIPAA audit based on a patient compliant. And your front desk could be a target area. And not always for the reasons you'd think. HIPAA compliance makes your front-desk staff more important than ever. How they handle their everyday tasks and interact with your patients can not only cause you to get audited, but can also ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJAT001
 6 months unlimited
 Duration: 60 mins

Transition to ISO 13485:2016

This course will provide an overview of the differences between the 2016 version of ISO 13485 compared to the existing version, and how to transition to the standard. 

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT001
 6 months unlimited
 Duration: 180 mins

3-Hour Virtual Seminar on HIPAA Audits - An Insiders Perspective

Brian will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (Brian been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received This lesson will be addressing ho........

$447 Recorded (6 months unlimited access)
 Webinar Id: LHSCDRD001
 6 months unlimited
 Duration: 60 mins

Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHJ004
 6 months unlimited
 Duration: 60 mins

The Requirements & Responsibilities of a HIPAA Security/Privacy Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance.  This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facili........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMRB001
 6 months unlimited
 Duration: 60 mins

Health Care Investigations by the Government - How They Do It.

State government agencies tasked with investigating alleged misconduct in health care generally follow proscribed steps in investigating the misconduct. This can include agencies with authority over individually licensed health care practitioners or with authority over the administration of government health care programs - whose budgets are in the hundreds of millions of dollars. Gathering (and even seizing) evidence and interviewing w........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCJA012
 6 months unlimited
 Duration: 60 mins

Clear, Complete, and Concise: Strategies for Writing an Investigation Report

This webinar provides a blueprint for how to effectively draft a compliance investigation report. Given the frequent occurrence that compliance officers find themselves in with having to respond to identified issues through an investigation, this presentation is intended to help attendees apply a consistent approach for drafting an investigation report that can be defended. Mr. Anstine will walk attendees through a sample fact pattern t........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCLSH005
 6 months unlimited
 Duration: 75 mins

Best Practices in Nursing Documentation: Writing Effective and Legal Proof Notes

This healthcare documentation webinar will discuss how to create a lawsuit-proof, auditable nursing documentation and how to maintain compliance over the course of the document life-time. You will learn how to de-risk your documentation so as to withstand legal scrutiny. Documentation is the backbone of Medical Necessity and support for services provided. Understanding what is required for documentation is essential. Inappropriate docum........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSCP003
 6 months unlimited
 Duration: 60 mins

Sterilization of Pharmaceutical Products and Medical Devices

This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide with method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considere........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHPH003
 6 months unlimited
 Duration: 60 mins

HIPAA - 7 Deadly Sins - 7 Simple Solutions

Top 7 HIPAA Violation Concerns revealed by Federal HIPAA Compliance Audits ordered by Congress. The U. S. Department of Health and Human Services (HHS) is conducting mandatory HIPAA Compliance Audits of covered entities and business associates to ensure they comply with HIPAA Privacy and Security Law. HHS's HIPAA Compliance Audit has more than 170 detailed sections - but picked only 7 for the first round! Why? Those 7 are responsible fo........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHEW003
 6 months unlimited
 Duration: 60 mins

How to Conduct a Human Factors/ Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCGJS002
 6 months unlimited
 Duration: 60 mins

Strategies for billing medicare for durable medical equipment -from getting DME PTAN# to full accreditation

Learn how to provide your Medicare patients with Durable Medical Equipment to maximize patient clinical outcomes while developing a great revenue stream. The key is how to be legally compliant. Understand the process in how to get the proper licensure called DME PAN # and know the Federal & State Guidelines. Then learn how to get fully Accredited that can grow your business dramatically!!  Key strategies of a successful program Understa........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSJM003
 6 months unlimited
 Duration: 90 mins

Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.  Utilizing suppliers as an extension of an organization's design and manufacturing capabilities presents unique challenges.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT003
 6 months unlimited
 Duration: 60 mins

Preparing for Imminent Federal HIPAA Audits.

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMRB003
 6 months unlimited
 Duration: 60 mins

Beyond HIPAA: Patient Medical Records and Client Confidentiality in Mental Health

State law and contractual requirements mandate medical record keeping compliance. Then, compliance with HIPAA for protected health information in those records intersects with state laws and codes of ethics which mandate confidentiality, but there are many state law exceptions recognized by HIPAA. The exceptions sometimes allow and sometimes mandate what would otherwise be a confidentiality breach. The sanctity of the doctor-patient rel........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMBI003
 6 months unlimited
 Duration: 60 mins

ISO/ IEC 17025:2017 Update: Everything Old is New Again

Many laboratories have successfully developed and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Some are still struggling to get accredited and even those already accredited still have issues as evidenced by the number of non-conformances cited during the subsequent biannual audits. Have the rules changed? What a........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRD001
 6 months unlimited
 Duration: 60 mins

Use of Electronic Health Record Data (EHR) in FDA-regulated clinical investigations

This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHGJS001
 6 months unlimited
 Duration: 60 mins

How To Bill Medicare for Durable Medical Equipment and Stay Legal Compliant

Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines. This webinar will walk you through the process of how to do the following: How to get a Medicare DME PTAN # Understanding the Anti-Kickba........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT005
 6 months unlimited
 Duration: 90 mins

HIPAA for Dummies (HIPAA Boot Camp)

This lesson is going to get back to the basics using multiple real life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member. I will uncover myths versus reality as it relates to this enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will al........

$167 Recorded (6 months unlimited access)
 Webinar Id:  LSHCJA011
 6 months unlimited
 Duration: 90 mins

Monitoring and Investigating Drug Diversion

This webinar will walk attendees through monitoring against drug diversion and investigating alleged diversions. More specifically, it will discuss the warning signs of diversion, common methods used to carry out diversion, potential organizational vulnerabilities, investigating a diversion case from beginning to end, and offer tips for safeguarding against diversion. To help highlight certain discussion points, Mr. Anstine will additio........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHEW002
 6 months unlimited
 Duration: 60 mins

Human Factors/ Usability following ISO 62366 and new FDA Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCGCP002
 6 months unlimited
 Duration: 60 mins

GMP Auditing for Pharmaceutical Manufacturing

Auditing involves a comprehensive review of vendors that will provide resources and/or services. The ICH Q10 document provides an outline on the pharmaceutical drug product life-cycle. Through the review of ICH Q8, Q9, and Q10, the participant will be able to audit the various activities associated with the different stages of the product lifecycle. By using a scientific risk-based approach, as outlined in ICH Q9, the participant will b........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCIPH002
 6 months unlimited
 Duration: 60 mins

New HIPAA Rules for Communicating with Patients by Unencrypted Email and Text Messages

Communicating with patients by unencrypted email and text message (SMS) about a variety of topics (appointment reminders, patient satisfaction, etc.) is growing dramatically. The HIPAA Rules for sending Protected Health Information (PHI) by electronic messages have been clarified. But most Providers and Business Associates are not following the HIPAA Rules. Email and text message are subject to the HIPAA Security Rule transmission stand........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT004
 6 months unlimited
 Duration: 60 mins

HIPAA Audits - An Insiders Perspective

Speaker will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (He has been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received. This lesson will be addressin........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMRB002
 6 months unlimited
 Duration: 60 mins

Evidence-Based Dentistry - A New Standard for Disciplinary Actions.

Learn to identify, understand, and defend against new legal standards in dentistry that may apply to state licensure disciplinary actions and to civil claims for malpractice. Either claim may result in ruinous practice and career consequences for the health care professional held to an objective standard of care for dentists. "Unprofessional conduct" and "negligence" are legal standards applicable to the standard of care to be met by a ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHJK004
 6 months unlimited
 Duration: 60 mins

How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Al........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRD002
 6 months unlimited
 Duration: 90 mins

FDA Regulation, 3D Printing and Medical Devices

This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCAWMC002
 6 months unlimited
 Duration: 120 mins

Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

This webinar will provide an in-depth understanding of the Federal False Claims Act, Federal Anti-Kickback and Stark laws, and discuss how marketing activities can trigger either or both.

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPBLT002
 6 months unlimited
 Duration: 60 mins

HIPAA and Personal Devices (myths vs realities)

This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LHSCTJA016
 6 months unlimited
 Duration: 60 mins

Tracking Physician Gifts Under The Stark Non-Monetary Compensation Rule.

The Stark law generally prohibits physicians from referring Medicare patients for designated health services ("DHS") to an entity the physician or immediate family member has a financial relationship with, unless an exception applies. Under Stark, there is an exception known as the Non-Monetary Compensation ("NMC")exception (42 C.F.R. 411.357(k) that allows DHS entities that are the recipient of Medicare DHS referrals to provide certain........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCEW002
 6 months unlimited
 Duration: 60 mins

How to Prepare a FDA 510(k) submission

we will explain what a 510(k) is and the procedure to prepare the submission. the several types of 510(k) will be explained.Each part of the submission will be explained. The very confusing concepts of predicate device and substantial equivalence will be discussed. How to find an acceptable predicate device will be taught. FDA places special emphasis on device software. we will cover the requirements for software.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCACP001
 6 months unlimited
 Duration: 60 mins

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCFJM003
 6 months unlimited
 Duration: 90 mins

FDA Inspections : What Regulations Expect

In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required do........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCTJM001
 6 months unlimited
 Duration: 90 mins

Technical Writing for the Pharma, Biologics, and Medical Device Industry

This course addresses how to write effective correspondence ,reports, SOPs, and protocols in support of your company's activities.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP004
 6 months unlimited
 Duration: 60 mins

Building a Compliant Documentation & Training System

This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation. Training is one of the most underrated and least respected of all the disciplines found within modern manufacturing within regulated industries - foods, cosmetics, beverages, medical devices, pharmaceuticals, biologics, etc. Yet, training is equally as important as any compliance discipline. The maj........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRPH001
 6 months unlimited
 Duration: 60 mins

Ransomware and HIPAA - How to Prevent, Prepare, Respond, Recover

This course explains treacherous Ransomware threats attacking the Healthcare Industry and how to prevent, prepare for, respond to and recover from a Ransomware attack. It covers HIPAA Rules that apply to Ransomware, compliance with the HIPAA Rules and how to conduct a HIPAA Breach Risk Assessment to prove a Ransomware attack did not result in a Breach of Unsecured Protected Health Information (PHI) - a violation of the HIPAA Privacy Rul........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBT008
 6 months unlimited
 Duration: 90 mins

HIPAA Enforcement - A Myths or Reality?

This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as ........

$167 Recorded (6 months unlimited access)
 Webinar Id: HIPHLH001
 6 months unlimited
 Duration: 75 mins

HIPAA Internal Audit Process & Policies: Your 1st Line of Defence

This course covers the components of an internal Audit process for HIPAA compliance. Why the audit is needed to support HIPAA compliance.What records are needed to ensure that your audit is replicable and supports your findings. Audits aspects which are crucial to ensure compliance,but can be part of your daily activities ; reducing time and man hours needed. Why auditing needs to be ongoing and not just occurring "when needed" or prior........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCENK005
 6 months unlimited
 Duration: 60 mins

Emergency Medical Treatment and Active Labour Act (EMTALA)

This webinar will examine the complexities and simplicities of EMTALA, the Emergency Medical Treatment and Active Labor Act. The webinar will distill the requirements of law, including its non-intuitive, highly-detailed definitions. The webinar will also discuss best practices for compliance and practical tips for compliance with the challenging situation of managing patients with psychiatric emergency medical conditions.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCEJK003
 6 months unlimited
 Duration: 60 mins

Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well a........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHJ003
 6 months unlimited
 Duration: 60 mins

The Roles And Responsibilities of a HIPAA Privacy and Security Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facilit........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMBI002
 6 months unlimited
 Duration: 60 mins

Is it Method Verification or Validation, or Just Semantics

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses. Although method validation and method verification are related terms, they have very different analytical and statistical req........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCEW001
 6 months unlimited
 Duration: 60 mins

21 CFR part 11 Compliance - electronic records & electronic signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records f........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHNK004
 6 months unlimited
 Duration: 60 mins

HIPAA And Litigation-Getting and Producing Records Through Discovery

This webinar will examine the interplay between HIPAA and state law when it comes to requesting and producing health records in the context of litigation. The webinar will address how attorneys should properly request health records and how covered entities and business associates should properly respond to such requests.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSRC001
 6 months unlimited
 Duration: 60 mins

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a sterile filtration system is essential for assuring the quality and safety of the pharmaceutical product.  Proper understanding and testing of the sterile filtration system accordin........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBT003
 6 months unlimited
 Duration: 180 mins

3-Hour Virtual Seminar on HIPAA Phase 2 Audits: How to be Prepared - An Insider's Perspective

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).  It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received  This lesson will be addressing how p........

$447 Recorded (6 months unlimited access)
 Webinar Id: LSHCHTS002
 6 months unlimited
 Duration: 60 mins

HIPAA: HIGHLIGHTS HOOPLA & HOOEY

Putting together a comprehensive HIPAA protocol and policyprogram can be a daunting task. In his course, learn the required changes to the Notice of Privacy Practices Form, the financial implications for willful neglect, why a daily data backup is no longer enough, and the communications that must not be sent via email or text. Gain a better understanding of the steps required to achieve compliance and protect both patients and the prac........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMBI001
 6 months unlimited
 Duration: 60 mins

ISO/IEC 17025:2017 Update: Everything Old is New Again

Many laboratories have successfully developed and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Some are still struggling to get accredited and even those already accredited still have issues as evidenced by the number of non-conformances cited during the subsequent biannual audits. Have the rules changed? What a........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHNK003
 6 months unlimited
 Duration: 60 mins

HIPAA Compliance in Light of Recent Enforcement Actions

This webinar will examine recent HIPAA enforcement actions and trends and will discuss practical insights on HIPAA from such enforcement activities. The webinar will cover HIPAA hot topics, as reflected in enforcement actions, and will provide guidance on avoiding enforcement actions.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJPT004
 6 months unlimited
 Duration: 60 mins

What are Reasonable and Appropriate HIPAA Security Measures?

Often healthcare and related businesses do not understand that HIPAA is far more about policies and procedures than it is about technical security measures. The HIPAA Security Rule, for example, does not specify whether an entity must have a password system and, if it does, how many characters it must have and whether it has to be alphanumerical with one or more special characters or whether it must have some type of biometric identific........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBT007
 6 months unlimited
 Duration: 90 mins

Why Should be Worried About HIPAA? All You Need to Know.

The objectives of this course will be to go over the specific risks associated with business associates as it relates to HIPAA compliance. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. Times have changed and unfortunately many businesses are losing clients or unab........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBT006
 6 months unlimited
 Duration: 90 mins

How to conduct a HIPAA Security Risk Assessment and Write Policies?

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA010
 6 months unlimited
 Duration: 60 mins

Auditing for EMTALA Compliance

This webinar is designed to walk attendees through a process for auditing your organization's compliance with The Emergency Medical Treatment And Labor Act ("EMTALA"). More specifically, it will provide an overview of EMTALA, discuss key compliance challenges facing organizations who must comply, and discuss a step-by-step approach for routine and periodic auditing.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBJK002
 6 months unlimited
 Duration: 60 mins

Best Practices in Supplier Management: How to meet FDA QSR and ISO 13485 requirements in a Lean, Cost-effective Manner

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.  Most medical device manufacturers have acceptable systems in place to assure component quality. B........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSBT001
 6 months unlimited
 Duration: 90 mins

Spotting a Weasel: The Personality of Dental Embezzler - 18 RED FLAGS!

Embezzler's view dental practices as "easy pickings" and have more time to work their schemes than doctors do to provide the management oversight they must today! After all, embezzlement is deception of exploiting vulnerabilities and coming up with schemes only limited by the weasel's imagination.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHJ002
 6 months unlimited
 Duration: 60 mins

The Roles And Responsibilities of a HIPAA Privacy & Security Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facilit........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBT009
 6 months unlimited
 Duration: 90 mins

HIPAA Changes 2017

I will be speaking to real life situations I have personally dealt with on multiple occasions as part of HIPAA investigations relating to ransomware breaches. These can be absolutely devastating to your practice or business and can cause a major financial burden as well as embarrassment. I will give specific information regarding multiple incidents and what they practice/business did wrong and how these situations occurred - there are m........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJPT003
 6 months unlimited
 Duration: 60 mins

How to Perform a HIPAA Risk Analysis

Risk analysis is the key to implementing reasonable cost-effective security measures. And failure to conduct and update risk analyses are the single biggest cause of Health and Human Services imposed civil money penalties of up to several million dollars. And failure to conduct one has other affects as well-remediation and mitigation (lessening the harm of) costs, bad publicity, lost business and the like.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA009
 6 months unlimited
 Duration: 60 mins

Telemedicine: Navigating Through Key Compliance Challenges

This webinar is designed to provide an overview of the common compliance challenges to delivering healthcare through telemedicine and offer strategies to ensure compliance. More specifically, Mr. Anstine will discuss issues such as state licensure, credentialing & privileging, liability insurance, reimbursement, establishing a physician-patient relationship, patient confidentiality, and online prescribing. In addition to walking through........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCLSH004
 6 months unlimited
 Duration: 90 mins

HIPAA Audits - Phase 2 What does this mean for you ?

The OCR HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate. Will look at the process and whom it applies to. What the audits will focus on. Risk assessment will be reviewed and why this is important for your organization. Need to identify Key personnel for oversight of the focus areas. Information related to your business associates that is needed and can ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJPT002
 6 months unlimited
 Duration: 60 mins

How to Write and Adopt HIPAA Policies and Procedures

Often healthcare and related businesses do not understand that HIPAA is far more about policies and procedures than it is about technical security measures. The HIPAA Security Rule, for example, does not specify whether an entity must have a password system and, if it does, how many characters it must have and whether it has to be alphanumerical with one or more special characters or whether it must have some type of biometric identific........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHNK002
 6 months unlimited
 Duration: 60 mins

HIPAA For Employee Benefits Teams

This webinar will provide practical insights on HIPAA, including its applicability, its general rules, and requirements for compliance as it relates to employee benefits plans for companies, regardless of specific industry.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA013
 6 months unlimited
 Duration: 180 mins

3-HR VIRTUAL SEMINAR ON Beyond the Allegation: How to Effectively Conduct Compliance Investigations.

This webinar will give attendees a blueprint for conducting effective compliance investigations, from A-Z. Given that responding to detected offenses are included in the Seven Elements of an Effective Compliance Program as deemed by the Office of Inspector General ("OIG"), this presentation is intended to provide strategies and tips for conducting and documenting investigations in a manner that can be defended should a complaint be made........

$447 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP001
 6 months unlimited
 Duration: 60 mins

Managing for Compliance Effectiveness

Conforming to regulatory requirements, following all of the rules, and ensuring regulatory compliance is in no small part within the ability of the workforce to execute but in order to do this, the workforce must know what to do, how to do it, have the personal capacity to do it, have the tools to do it, and must be motivated to do it. Performance management is not about conducting yearly performance reviews - it is about knowing how pe........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJPT001
 6 months unlimited
 Duration: 60 mins

How to Handle HIPAA and HITECH Act Breaches, Complaints, and Investigations: Everything You Need to Know

This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also consti........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCML002
 6 months unlimited
 Duration: 75 mins

FDA GMP Requirements for API (Active Pharmaceutical Ingredients) - Just what do YOU need to do?

While this topic may appear easily addressed, appearances can be deceiving. This program will examine some history, real life experiences and discuss the real facts about GMP for Active Pharmaceutical ingredients. Just what is important to firms, producers of API and consumers of API. Discussed will be what regulations apply and what guidance is important. Also examined are various ICH and FDA guidance that enter the everyday business o........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJME003
 6 months unlimited
 Duration: 90 mins

Validation and Part 11 Compliance

This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Many companies o........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHNK001
 6 months unlimited
 Duration: 60 mins

HIPAA Basics for Non-Healthcare People

This webinar will provide a broad overview of HIPAA, including its applicability, its general rules, and requirements for compliance.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBJK001
 6 months unlimited
 Duration: 60 mins

Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quali........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJM0001
 6 months unlimited
 Duration: 90 mins

FDA Inspections: What Regulations Expect

In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required do........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBT004
 6 months unlimited
 Duration: 180 mins

3-HOUR VIRTUAL SEMINAR ON How to conduct a HIPAA Security Risk Assessment

This course will cover the proper methodologies on conducting a HIPAA Risk Assessment based on the formula used by Federal auditors and via the guidelines of the NIST (National Institute of Standard for Technologies). The course will also cover the most important aspects to be aware of in terms of the Federal auditing process as well as the new risks regarding patients suing for wrongful disclosures.

$447 Recorded (6 months unlimited access)
 Webinar Id: LSHCLSH003
 6 months unlimited
 Duration: 180 mins

3-hour Virtual Seminar on OIG Work Plan 2017: Trends, Reports and Issues

Every year the OIG updates what it's focus is for the upcoming year. During this session we will look at the focus for OIG audits and oversight for 2017. These work plans often drive the audits that then occur within our work sites. They provided information that is beneficial for organizations in their striving to be compliant with new regulations.

$447 Recorded (6 months unlimited access)
 Webinar Id: LSHCBT001
 6 months unlimited
 Duration: 180 mins

3-hour Virtual Seminar On HIPAA Changes Under Omnibus

I will be speaking to real life situations I have personally dealt with on multiple occasions as part of HIPAA investigations relating to ransomware breaches. These can be absolutely devastating to your practice or business and can cause a major financial burden as well as embarrassment. I will give specific information regarding multiple incidents and what they practice/business did wrong and how these situations occurred - there are m........

$447 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA014
 6 months unlimited
 Duration: 180 mins

3-hr Virtual Seminar on Compliance 101: Tackling the Common Realities You Will Encounter in the Profession.

This webinar will walk attendees through the most common political dilemmas facing any healthcare compliance professional on a daily basis no matter where they work in healthcare. In addition to identifying these common realities, Mr. Anstine will provide strategies, insights, and tips for how to overcome each reality in order to succeed in the role.  

$447 Recorded (6 months unlimited access)
 Webinar Id: LSHCDD001
 6 months unlimited
 Duration: 60 mins

Achieving Success and Compliance in the Supply Chain

supply chain is a system of organizations, people, activities, information, and resources involved in moving a product or service from supplier to customer. Supply chain activities involve the transformation of natural resources, raw materials, and components into a finished product that is delivered to the end customer.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJMAA002
 6 months unlimited
 Duration: 90 mins

An Advanced Course on Lean Documents, Lean Configuration and Document Control

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBT005
 6 months unlimited
 Duration: 180 mins

3-HOUR VIRTUAL SEMINAR ON Ransomware and HIPAA - Be very careful here!

I will be speaking to real life situations I have personally dealt with on multiple occasions as part of HIPAA investigations relating to ransomware breaches. These can be absolutely devastating to your practice or business and can cause a major financial burden as well as embarrassment. I will give specific information regarding multiple incidents and what they practice/business did wrong and how these situations occurred - there are m........

$447 Recorded (6 months unlimited access)
 Webinar Id: LSHCKO001
 6 months unlimited
 Duration: 60 mins

HIPAA for Medical and Dental Practices

This webinar covers privacy and security training for employees of private medical and dental practices and their business associates. The primary purpose is to fulfill HPAA's requirement for employee training and to improve HIPAA compliance.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCKO002
 6 months unlimited
 Duration: 60 mins

OSHA for Medical and Dental Practices

This webinar covers safety and health hazards typically found in private medical and dental practices. The primary purpose is to fulfill OSHA's requirement for employee training.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHC003
 6 months unlimited
 Duration: 60 mins

Workplace Shootings: What You Need to Know Before, During, and After

In this online session, Joe Rosner, a nationally recognized expert on workplace violence and personal safety, you will gain insights in assessing and mitigating the risks of violence in the workplace. You'll learn the Who, What, Where and Why of workplace shooters. You will also learn why having plans, policies and procedures can greatly reduce the chances of an active shooter at your facility.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJM004
 6 months unlimited
 Duration: 90 mins

ISO 13485 2016 utilizing Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2015 revision changes. They will have the additional responsibility to ensure that each and every step of the manufacturing proce........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCNP001
 6 months unlimited
 Duration: 60 mins

Investigator initiated trials- What are we doing to ensure human subject protection?

This 1-hr virtual seminar will help you understand the key issues and challenges associated with investigator initiated trials. Investigator initiated trials are very important as they are important connection for the translation of research from bench to bedside. I will discuss the role of sponsor-investigator and ways we can ensure the protection of human subjects in an investigator initiated trials. 

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA007
 6 months unlimited
 Duration: 60 mins

Looking Inward: Assessing the Effectiveness of Your Compliance Program

This webinar is designed to walk attendees through a self-assessment of the effectiveness of his/her compliance program to determine if the program is meeting the Federal government's standards (e.g. The Office of Inspector General's "Seven Elements of an Effective Compliance Program"). More specifically, this presentation will walk through a checklist of questions directed at each of the seven elements and offer strategies and tips for........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHJ001
 6 months unlimited
 Duration: 60 mins

The Requirements and Responsibilities of a HIPAA Security/Privacy Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facilit........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJM002
 6 months unlimited
 Duration: 90 mins

Process Validation for Pharma and Biologics Industries

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management. Participants will learn how to develop rigorous protocols and reports, as ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA006
 6 months unlimited
 Duration: 60 mins

Compliance Program Infrastructure: The Basics Needed to Launch Your Compliance Program

This webinar is designed to provide an overview of the core infrastructure needed to launch a healthcare compliance program. More specifically, it will provide an overview of the Seven Elements of an Effective Compliance Program as deemed by the Federal government, and interpret what each element means to your program on a daily basis. Additionally, this presentation will offer strategies and tips for getting your infrastructure in plac........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSS002
 6 months unlimited
 Duration: 90 mins

Inclusion of LGBT Employees in Healthcare: Navigating Policies, Procedures, and Practices

Healthcare is a unique culture dealing with vulnerable patients and employees committed to quality patient care. However, research states that LGBT patients are treated in a more abusive manner than straight patients. How does the misconduct to LGBT patients impact your LGBT employees? We know that healthcare does employ LGBT people. How does your organization ensure they are welcome? Do you intentionally recruit the LGBT community as e........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCML001
 6 months unlimited
 Duration: 75 mins

Outsourcing and/or Purchasing API or Excipients - An Examination of Quality/Business Issues you should consider!

This program examines considerations that are important to firms that are considering if they should produce, outsource, or purchase API. The steps discussed during this program also have application to Excipients that are used by drug product producers. The subject has both Quality and Business implications which are important to a corporate plan's success. It discusses risks and benefits associated with these decisions and what a plan........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSK0012
 6 months unlimited
 Duration: 60 mins

HOW TO MANAGE OCR/HHS HIPAA/HITECH AUDIT

Among other things, the HITECH Act significantly strengthened HIPAA enforcement activities. In addition to increasing penalties, allowing enforcement by state attorneys general, requiring notices of breaches, and making business associates directly subject to penalties, the HITECH Act mandated that Office for Civil Rights of HHS conduct HIPAA audits. This one-hour webinar will focus on preparation required by healthcare organizations to........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBT002
 6 months unlimited
 Duration: 180 mins

3-HOUR VIRTUAL SEMINAR ON HIPAA: Upcoming Changes for 2017

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak o........

$447 Recorded (6 months unlimited access)
 Webinar Id: LSHCSK001
 6 months unlimited
 Duration: 60 mins

HIPAA/HITECH ASSESSMENT FOR HEALTHCARE BUSINESS ASSOCIATES

As the compliance deadline for new HIPAA-HITECH rule approaches, it becomes imperative for healthcare business associate organizations to develop strategies to protect electronic health information, and comply with HIPAA-HITECH regulations. This instructor-led one-day training will teach you how to design, implement, and administer comprehensive healthcare IT compliance and security protection programs as a business associate. During th........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSS001
 6 months unlimited
 Duration: 90 mins

A New Civil Rights Law for Health Providers, Employees of Health Programs, and Health Insurance Companies: Section 1557 of the Affordable Care Act

Healthcare providers such as hospitals, clinics, physicians, community health centers, nursing homes, home care agencies, health insurance companies (including those found in the Health Insurance Marketplaces), and any other "covered entities" which operate a "health program or activity" have a new civil rights law to incorporate into their operations. The Department of Health and Human Services (HHS) recently issued its final rule to d........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJM001
 6 months unlimited
 Duration: 60 mins

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCPJB001
 6 months unlimited
 Duration: 90 mins

Preparing Compliant eCTD Submissions: Are you prepared for upcoming FDA mandate on e-submissions?

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes a........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCLSH002
 6 months unlimited
 Duration: 75 mins

HIPAA Internal Audit Process and Policies: Your 1st Line of Defence

This course covers the components of an internal Audit process for HIPAA compliance. Why the audit is needed to support HIPAA compliance.What records are needed to ensure that your audit is replicable and supports your findings. Audits aspects which are crucial to ensure compliance,but can be part of your daily activities ; reducing time and man hours needed. Why auditing needs to be ongoing and not just occurring "when needed" or prior........

$167 Recorded (6 months unlimited access)
 Webinar Id: FSPV003
 6 months unlimited
 Duration: 90 mins

Writing High-Profile Project Evaluation Reports

The reality of any professional discipline is this: If it is not in writing, it never happened. All the professional observation and objective review that a clinician puts into an analysis are meaningless unless the work appears in a complete, objective clear, and concise evaluation report. Knowing this truth is obvious; getting there is the challenge.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCPA001
 6 months unlimited
 Duration: 60 mins

Environmental Monitoring - Knowing your Cleanroom

This webinar will provide the proper methods and techniques required to maintain a clean room per FDA and ISO regulations. By the use of viable and non-viable testing, a cleanroom can be maintained. The results collected can determine the state of control the cleanroom operates on a continuous basis. In order to maintain a cleanroom, a proper cleaning agent rotation needs to be implemented. The webinar will provide a discussion of the m........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCWMC001
 6 months unlimited
 Duration: 60 mins

The Health Care Quality Improvement Act: How to Achieve Immunity

This webinar will discuss the Health Care Quality Improvement Act (HCQIA or the Act) in detail, including the standards that must be met to achieve immunity under the act. The HCQIA itself will be reviewed, including a detailed look at the Congressional purpose for the Act. The legislative history of the act will be reviewed to gain an understanding of the intent of Congress in passing the Act. Next will be a review of the standards und........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCPJB002
 6 months unlimited
 Duration: 90 mins

SOP compliance management: A must for the pharmaceutical industry.

This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCNP002
 6 months unlimited
 Duration: 60 mins

Ethical Requirements & Development of Guidelines for Pediatric Trials in Developing Countries

This 1-hr virtual seminar will help you understand the key ethical issues and challenges associated with pediatric studies in developing countries. Pediatric populations in developing countries are extremely vulnerable participants in clinical research. I will discuss some of the key ethical issues and challenges associated with pediatric studies in developing countries and suggest how these can be addressed.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA004
 6 months unlimited
 Duration: 60 mins

Compliance Challenges with Legalized Marijuana

This webinar is designed to provide an overview of the common challenges healthcare compliance officers must face in a world of legalized marijuana. More specifically, this presentation will begin with a brief summary of the regulatory history of marijuana in the United States and a survey of the states that have currently legalized marijuana for recreational purposes. The remainder of the presentation will focus on common compliance ch........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJM00113
 6 months unlimited
 Duration: 60 mins

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principl........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCEW001
 6 months unlimited
 Duration: 60 mins

Hazard Analysis following ISO 14971

Designing a medical device and testing it to prove that it works is not sufficient in the eyes of the FDA to provide a safe product for users. The FDA has determined, through analysis of product recall data that the majority of recalls were due to a faulty design process. These recalled products were tested before release and later found to fail in unanticipated ways that were not considered in the testing process. FDA also concluded th........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA012
 6 months unlimited
 Duration: 60 mins

Navigating the Compliance Challenges with Holiday Gifts

This webinar is designed to help attendees navigate through the compliance challenges related to holiday gift giving and receiving with physicians, vendors, patients, and co-workers. More specifically, it will discuss the regulatory framework surrounding gifts, common gifting scenarios, the pitfalls to avoid, and strategies for drafting organizational gift policies.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCGS002
 6 months unlimited
 Duration: 60 mins

A Legal Compliance Program When Billing Durable Medical Equipment

Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines. This webinar will walk you through the process of how to do the following: How to get a Medicare DME PTAN # Understanding the Anti-Kickba........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCT003
 6 months unlimited
 Duration: 90 mins

FDA Compliance and Laboratory Computer System Validation

You should attend this seminar if you are responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed that, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regul........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP001L
 6 months unlimited
 Duration: 90 mins

New Technologies Affecting Healthcare

This course covers the new technologies affecting healthcare. During this discussion, we will look at how IoT, data analysis and advanced AI is enhancing the outcomes of individuals as well as driving new engagement models outside of the traditional care environments. As the shifting payment models are driving from fee-for-service to paying for quality outcomes, the new technologies offer continuous engagement with those in most need of........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCLSH001
 6 months unlimited
 Duration: 60 mins

2017 Proposed Home Health PPS Rule: Pre-Payment Review and Other - Regulatory Developments

The HH PPS proposed rule is one of the several rules for calendar year 2017 that reflect a broader Administration-wide strategy to create a health care system that results in better care, smarter spending, and healthier people. Provisions in these rules are helping to move our health-care system to one that values quality over quantity and focuses on reforms such as achieving better health outcomes, preventing disease, helping patients ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHRC003
 6 months unlimited
 Duration: 60 mins

HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.  Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safet........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRC004
 6 months unlimited
 Duration: 60 mins

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a sterile filtration system is essential for assuring the quality and safety of the pharmaceutical product. Proper understanding and testing of the sterile filtration system according........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCTF001
 6 months unlimited
 Duration: 60 mins

Federal Case Law that Out-of-Network Providers Need to Know

This presentation will explore the lawsuits brought by and against health plans and health insurers against and by out-of-network Ambulatory Surgery Centers, Hospitals and other healthcare providers affecting revenue. Cases explored will include those involving balance billing issues, recoupments, assignment of benefits (legal standing) and other issues affecting the out-of-network provider. 

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCMB001
 6 months unlimited
 Duration: 90 mins

Understanding and implementing an effective laboratory Quality Management System to comply with ISO/IEC 17025

QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. Accreditation to international standards is being becoming the norm in the global analytical community. Although essentially voluntary, there are many jurisdictions that now require food and environmental laboratories to be accredited to ISO/IEC 17025 in order to participate in regulatory programs. Many laboratories struggle with developing and........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJW003
 6 months unlimited
 Duration: 60 mins

Structuring Physician Recruitment and Non-Physician Practitioner Support Arrangements Under the New 2016 Stark Rules.

In this session Mr. Wolfe will provide a general Stark Law overview. He will also discuss best practices for auditing existing recruitment arrangements and for implementing new NPP support arrangements under the new 2016 Stark rules.CMS recently finalized a number of significant changes to the Stark Law for the 2016 calendar year, including a new Stark exception that allows hospitals to provide financial support to physician practices l........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA002
 6 months unlimited
 Duration: 60 mins

Clear, Complete, and Concise: Strategies for Writing an Investigation Report

This webinar provides a blueprint for how to effectively draft a compliance investigation report. Given the frequent occurrence that compliance officers find themselves in with having to respond to identified issues through an investigation, this presentation is intended to help attendees apply a consistent approach for drafting an investigation report that can be defended. Mr. Anstine will walk attendees through a sample fact pattern t........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJF001
 6 months unlimited
 Duration: 90 mins

Making Sense of the FMLA, ADA and Workers Comp Overlap

Few employers can say they have never had challenges with leave of absence issues. Virtually every employer in every sector of the American (and global) economy has. The Family Medical Leave Act (FMLA) requires covered employers to allow eligible employees up to 12 weeks of unpaid job-protected leave and benefits to care for their own or a family member's serious health condition. The Americans with Disabilities Act (ADA) and the Americ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHRC002
 6 months unlimited
 Duration: 60 mins

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.  Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJA001
 6 months unlimited
 Duration: 75 mins

Compliance with Section 1557 of the Affordable Care Act: Non-discrimination

Section 1557 of the Affordable Care Act ("ACA") is the civil rights provision prohibiting discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. This new federal rule became effective on October 17, 2016. Many of the provisions in Section 1557 already exist in other longstanding federal non-discrimination rules such as the Civil Rights Act of 1964, the Age Discrimi........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCT002
 6 months unlimited
 Duration: 90 mins

Organizational Change Management (OCM) Best Practices for Computer Systems Regulated by FDA

This course is intended to provide specific guidelines for coaching attendees on the best practices for creating organizational change as it relates to computer systems regulated by FDA. These include, but are not limited to system implementation, testing, validation, migration, integration, upgrade and retirement.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCGS001
 6 months unlimited
 Duration: 60 mins

A Durable Medical Equipment Revenue Program Every Practice Should Have

Increased Revenue & Profit For Your Practice! Better Service & Outcomes For Your Patients! From Your Existing Patient Base! Increase Profits $3,000-$15,000 Per Month, Per Doctor 100% Legal Compliance with Stark-Act & Anti-Kickback Statue Immediate Positive Cash-Flow Convenient One-Stop Medical Shopping For Patients Improved Compliance and Clinical Outcomes  Reduce Healthcare Costs 12%-14% All Providers Are Confronting 3 Critical Issues:........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCDD004
 6 months unlimited
 Duration: 60 mins

Managing SOP Compliance per FDA Regulations

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCESVM001
 6 months unlimited
 Duration: 60 mins

What will happen to your practice if you continue using unspecified codes?

Short-term and long-term consequences of using unspecified codes.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHC002
 6 months unlimited
 Duration: 180 mins

3-hr Virtual Seminar on An overview of the pharmaceutical manufacturing cycle: ICH Q7A, GMP for pharmaceutical active ingredients (PAI) and Part 210-211 Current Good Manufacturing Practices for Finished Pharmaceuticals

This webinar focuses on the GMP quality system of the drug manufacturing cycle beginning with ICH Q7A, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients then focusing on 21 CFR Part 210-211 Current Good Manufacturing Practices for Finished Pharmaceuticals. As you are aware, the very detailed Part 210-211 GMP is the gold standard for GMP quality systems. ICH Q7A is a very good example because the structure and te........

$447 Recorded (6 months unlimited access)
 Webinar Id: HCLS010
 6 months unlimited
 Duration: 90 mins

CGMP Application for Design & Operation

GMP was established back in the 60's and 70's to help Drug and Medical Device companies set up systems and related employee activities to help minimize patient risks.cGMP (current Good Manufacturing Practices needed to minimize patient risk and increase the probability of profitability) regulations require a quality related operations system that establishes and maintains a manufacturing system and related monitoring and testing specifi........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHC0020
 6 months unlimited
 Duration: 90 mins

HIPAA Phase 2: Keys to Surviving an Audit

HIPAA NOW HAS TEETH! Phase 2 Audits and personal patient remedies have changed the landscape! This once relatively benign legislation is being fully enforced and the news is not good for covered entities or business associates! Be prepared! Protect your practice or business! What factors might spurn a HIPAA audit? ...are you doing these things? Why are the Feds enforcing after all these years?  We will be discussing some of the changes ........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHC0016