CHARLES H. PAUL


Writing Effective Standard Operating Procedures and Work Instructions
Writing Effective Standard Operating Procedures and Work Instructions
: Charles H. Paul
Recorded Webinar

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
De Novo Classification Process
: Charles H. Paul
Recorded Webinar

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.....

$200.00
Combination Product Updates for Filing Reviews for Post Market Safety Reporting
Combination Product Updates for Filing Reviews for Post Market Safety Reporting
: Charles H. Paul
: 07 January 2019
: 01 : 00 PM EST
: 60 Minutes

This webinar is essential to understanding how your PMA is evaluated and precisely those key points that are the focus of the FDA during their review.This webinar addresses the Final Guidance published by the FDA entitled Acceptance and Filing Reviews for Premarket Approval Applications (PMAs). The PMA regulation (21 CFR 814.42(e)) to which this guidance pertains, identifies the criteria that, if not met, m.....

$179.00
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