• Your shopping cart is empty!

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.


Product Compare (0)
$179.00
510 (K) and PMA Refuse to Accept Policy

 Charles H. Paul
 December 09 2021
 01 : 00 PM EST    
 60 Minutes
510 (K) and PMA Refuse to Accept Policy

This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) – Traditional, Abbreviated, and Special. The checklists clarify the content needed in traditional, special, and abbreviated 510(k) submissions to allow the FDA to condu..

Showing 1 to 3 of 3 (1 Pages)
$179.00
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 3 of 3 (1 Pages)