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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
Medical Device Single Audit Program – An Overview

 Charles H. Paul
 12 April 2019
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Medical Device Single Audit Program – An Overview

The Medical Device Single Audit Program (MDSAP) is a process that allows a single audit to occur of a medical device manufacturer's Quality Management System to determine if it satisfies the requirements of multiple regulatory jurisdictions. The MDSAP Audit is a one-time audit for compliance with the regulatory requirements of five current participant countries: Australia, Brazil, Canada, Japan and the Unit..

$179.00
Understanding the FDA’s Revised Medical Device Product Guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

 Charles H. Paul
 12 February 2019
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Understanding the FDA’s Revised Medical Device Product Guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

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 FDA to cond..

Showing 1 to 4 of 4 (1 Pages)
$200.00
Writing Effective Standard Operating Procedures and Work Instructions

 Charles H. Paul
 Recorded Webinar
 60 MINUTES
 Refer a Friend
 Download Catalog
Writing Effective Standard Operating Procedures and Work Instructions

Standard Operating Procedures and work instructions – 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 tha..

$200.00
De Novo Classification Process

 Charles H. Paul
 Recorded Webinar
 60 MINUTES
 Refer a Friend
 Download Catalog
De Novo Classification Process

Today, any new medical device that is found not substantially equivalent for a reason other than performance data not previously classified based on risk is “automatically” or “statutorily” classified as a Class III device. This occurs because, by definition, a new device type would not be equivalent to a device type on the market before the 1976 Medical Device Amendments were placed in force or that has si..

Showing 1 to 4 of 4 (1 Pages)