Disaster Recovery and Business Continuity for Computer Systems Regulated by FDA


Carolyn Troiano is Keynote Speaker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. Carolyn has participated in industry conf........

Overview

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco, and other regulated industries.
Disaster recovery activities often include efforts to deal with both system functionality, and data integrity, quality, accessibility, and accuracy.
Business continuity activities often include efforts to deal with system functionality and data integrity, quality, accessibility, and accuracy, but the focus is on getting the business processes running in the absence of a sound system or data.
The specific tasks and deliverables for both disaster recovery and business continuity must be completed with care toward maintaining a compliant environment.
There are best practices used in the FDA-regulated arena, and these can be leveraged to develop a standard and consistent approach within a company. This course is designed to provide the information needed to develop solid Disaster Recovery (DR) and Business Continuity Planning (BCP) plans. The DR plan focuses on recovering the system in the event of a major event or disaster. The plan includes the people involved, steps that must be taken, and categorizes these in a way that will simplify execution and documentation.
The BCP focuses on continuing the critical business operations in the absence of a computer system that has been taken down by a major event or disaster. The business must decide what operations are critical, how long they can be sustained without the use of a computer system, if at all, and what steps should be taken to ensure continuity. If the business chooses to manually record data in the absence of the system or to record it using some other system (Excel, other application, etc.), then they will need to plan for how they will load that data into the system once it is again operational.
There are many facets of these two plans that work in tandem with each other and require coordination, planning, testing, and documentation. The common issues and challenges will be discussed, along with industry best practices.
Data is a key asset for any company, and for those regulated by FDA, extra care must be taken to ensure data integrity is maintained. This can help avoid a loss of data in the event of a disaster, as well as continuity of operations to keep the company on track.

Why should you attend this webinar?

The attendee will learn how to develop a standard approach to planning, executing and documenting efforts that involve the recovery of systems and data in a manner that complies with FDA guidelines. Some people may be new to the concept of validation and FDA regulation and will have to be coached on how to follow any necessary procedures required for compliance. This is often true for IT staff and is likely to be the case in companies in the Tobacco industry, where regulations are emerging. It's important to look at what are some of the threats and challenges, and what methods you can use to mitigate these.
The attendee will also learn how to develop a standard approach to planning, executing and documenting efforts that involve the recovery of day-to-day business operations and data in a manner that complies with FDA guidelines. Some people may be new to the concept of validation and FDA regulation and will have to be coached on how to follow any necessary procedures required for compliance. This is often true for IT staff and is likely to be the case in companies in the Tobacco industry, where regulations are emerging. It's important to look at what are some of the threats and challenges, and what methods you can use to mitigate these.

Areas Covered in the Session:

Who can Benefit:

Within FDA-regulated companies, people in the following roles will benefit from this presentation:
  • Computer System Validation Specialists
  • Information Technology Professionals (development, support, security)
  • Automation Analysts and Managers
  • QC/QA Analysts and Managers
  • Laboratory Analysts and Managers
  • Manufacturing Analysts and Supervisors
  • Supply Chain Managers and Analysts
  • Compliance and Audit Managers
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers



Webinar Id: LSHCCT0017

Training Options:

Duration: 90 mins

 07/16/2019

 10:00 A.M PT | 01:00 PM ET

 Single Attendee: [Only for one participant]

$149 (Live)                    $220 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$308 (Live)                    $529 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$616 (Live)                    $887 (Live + Recorded)

 Recorded: [Six month unlimited access]

$171 (Single Attendee) $399 (Unlimited Attendee)

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