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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.


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$179.00
Risk Assessment tools and Techniques in the Medical Device Industry

 Charles H. Paul
 October 07 2022
 01 : 00 PM EST    
 60 Minutes
Risk Assessment tools and Techniques in the Medical Device Industry

Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.21 CFR Section 820 requires that comprehensive risk analysis be performed as part of the medical device regulatory ..

$179.00
FDA Inspection Readiness Dos and Don’ts

 Charles H. Paul
 November 04 2022
 01 : 00 PM EST    
 60 Minutes
FDA Inspection Readiness Dos and Don’ts

The Food, Drug and Cosmetic (FD&C) Act gives FDA the authority to conduct inspections at drug and medical device manufacturing facilities as well as other regulated industries. Those companies manufacturing drugs and higher risk medical devices, are prime candidates for inspections. Facilities having historical significant violations, are also FDA inspected. Areas Covered The inspection process – what t..

Showing 1 to 4 of 4 (1 Pages)
$200.00
De Novo Classification Process

 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 ..

$200.00
Writing Effective Standard Operating Procedures and Work Instructions

 Charles H. Paul
 Recorded Webinar
 60 Minutes
 Download Catalog
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..

Showing 1 to 4 of 4 (1 Pages)