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.


$179.00

 August 13 2021

 01 : 00 PM EST    

 60 Minutes

 Download Catalog
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..

De Novo Classification Process

Charles H. Paul

$179.00

 September 10 2021

 01 : 00 PM EST    

 60 Minutes

 Download Catalog
Classifying Medical Devices in the US and the EU

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The determination pr..

Classifying Medical Devices in the US and the EU

Charles H. Paul

$179.00

 November 19 2021

 01 : 00 PM EST    

 60 Minutes

 Download Catalog
GMPs for Cannabis Operations

This webinar will provide a basic foundation for Good Manufacturing Practices essentially for any medical marijuana production operation. Medical marijuana growing and production is a regulated industry and is becoming more regulated every day. GMPs pertain to medical marijuana just as they do to pharmaceutical, medical device biologics, foods, etc. Unfortunately, there is no unified standard as..

GMPs for Cannabis Operations

Charles H. Paul

$179.00

 December 09 2021

 01 : 00 PM EST    

 60 Minutes

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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 ..

510 (K) and PMA Refuse to Accept Policy

Charles H. Paul

$179.00

 March 26 2021

 01 : 00 PM EST    

 60 Minutes

 Download Catalog
FDA Best Audit Practices

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors. A key component of this webinar is the discussion of the..

FDA Best Audit Practices

Charles H. Paul

Showing 1 to 6 of 6 (1 Pages)
$200.00

 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..

Writing Effective Standard Operating Procedures and Work Instructions

Charles H. Paul

Showing 1 to 6 of 6 (1 Pages)