Speaker Profile
CHARLES H. PAUL
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance problems.
Charles H. Paul
January 22 2025
01 : 00 PM EST
90 Minutes
Writing Investigations that Meet Regulatory Requirements
In this immersive 90-minute seminar, participants will embark on a comprehensive exploration of the critical landscape surrounding the creation of investigations that meet stringent regulatory requirements within the life sciences. The journey begins with a foundational understanding of the regulatory environment, delving into the vital role that compliance plays in shaping the integrity of scient..
Charles H. Paul
February 11 2025
01 : 00 PM EST
90 Minutes
GCP Risk Management and Risk-Based Monitoring
This webinar offers a comprehensive exploration of the critical elements involved in ensuring the ethical conduct, integrity, and success of clinical trials. Participants will delve into the foundational principles of Good Clinical Practice (GCP), gaining a deep understanding of its significance in maintaining the highest standards throughout the clinical trial lifecycle. The training will navigate the comp..
Charles H. Paul
March 25 2025
01 : 00 PM EST
90 Minutes
Role of Cognitive Load in Medical Device Design and Human Error
The webinar delves into the critical nexus between healthcare technology and user performance. The 90-minute session begins with an exploration of cognitive load, dissecting its intrinsic, extraneous, and germane components. By unraveling the complexities of cognitive load, participants gain a profound understanding of how the mental burden associated with interacting with medical devices can impact decisio..
Charles H. Paul
Recorded Webinar
De Novo Classification Process
Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace, the classification process is quite straightforward. A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device that has been reclassified from Class III to Class ..
Writing Effective Standard Operating Procedures and Work Instructions
Standard Operating Procedures and work instructions – the documentation required by regulation – are 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 th..