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Charles Paul

Charles H. Paul is Keynote Speaker at Compliance key Inc. He is President of C. H. Paul Consulting, Inc. - a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.


 Webinar Id: LSHCP618
 6 months unlimited
 Duration 60 mins
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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........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCCP003R
 6 months unlimited
 Duration 60 mins
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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: LSHCCP39
 6 months unlimited
 Duration 60 mins
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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: LSHCCP0010
 6 months unlimited
 Duration 90 mins
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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: LSHCCU008
 6 months unlimited
 Duration 60 mins
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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: LSHCCP006
 6 months unlimited
 Duration 60 mins
Ratings:
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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: LSHCCP009
 6 months unlimited
 Duration 60 mins
Ratings:
No reviews yet!!

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: LSHCCP005
 6 months unlimited
 Duration 60 mins
Ratings:
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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: LSHCCP007
 6 months unlimited
 Duration 60 mins
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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: LSHCCP004
 6 months unlimited
 Duration 60 mins
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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: LSHCCP001
 6 months unlimited
 Duration 60 mins
Ratings:
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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)


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