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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
Writing World Class Compliance Documentation

 Charles H. Paul
 September 20 2019
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Writing World Class Compliance Documentation

Standard operating procedures and work instructions can be an effective tool in the control and standardization of operations, the conduct of training, the meeting of all regulatory requirements, and as user support tools to guide individual performance and to manage the execution of that performance.  The key is in knowing how to apply the proper techniques to their creation.Standard Operating Procedu..

$179.00
Complaint Handling and Adverse Event Reporting, CAPA, Recalls, and Product Life Cycle Management

 Charles H. Paul
 August 16 2019
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Complaint Handling and Adverse Event Reporting, CAPA, Recalls, and Product Life Cycle Management

Complaint handling is essentially the beginning of the process if not one crucial aspect of the process of collecting data concerning the product that is in the marketplace. It is your first “tip-off” that something might not be going as intended. Complaints are ignored at your peril and ignoring them results in a significant risk to the organization and to the patients that use your products.Complaint hand..

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)