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This is a new section with Video Clips with FDA officials. They make statements and answer questions related to FDA compliance topics. The video clips are available in MS .
Windows Video File forma. For viewing you need the MS Media View, which can be downloaded for free from the Microsoft Website website

Video Clips

User friendly wmv format

 

Part 11 Update 2009

John Murray - Part 11 Update 2009

John Murray, FDA's Computer Validation expert gives an update on the current staus and outlook for Part 11. He also gives adivce on what to do until the new revision will be released.

V-221

 

Vendor Compliance

Paul Motise - An author of 21 CFR Part 11

Motise  answers the question what vendors should do to help users of equipment to comply with regulations, e.g., Part11

V-115

 

FDA 21st Century GMP Initiative helps to optimize resources

Douglas Ellsworth, Director of the FDA's New Jersey District Office

Explains why the risk assessment as part of the cGMP initiative is so important to optimize resources for the FDA and for the industry

V-111

 

FDA's Dispute Resolution Program

David Horowitz, Director of CDER's Office of Compliance

Gives FDA's perspective for a more formal dispute resolution process.

V-101

 

 

GMP training records don't need to comply with Part 11

At the FDA's CDER Life Video Conference on the New Scope of Part 11 FDA officials have been asked for examples where part 11 does not apply. The question has been answered by Scott MacIntire, Director of the Division of Compliance Information and Quality Assurance of ORA and Joseph Famulare, Director of the Division of Manufacturing and Product Quality, CDER Office of Compliance.

V-102

 

Other examples where part 11 does not apply

John F. Murray, Jr., Software and Part 11 Compliance Expert, Office of Compliance, CDRH

Murray gives more examples where part does not apply. Examples that have been mentioned are 'Records maintained in medical device' and 'Hospital information systems (patient records).

V-105

 

 

Warning Letters Will Speak Louder

David Horowitz, Director of CDER's Office of Compliance

 makes a clear statement that FDA warning letters will speak louder than ever now. Mr. Horowitz explained why and about the consequences for the industry.

V-108

 

What does it mean 'to narrow the scope of Part 11'?

Joseph Famulare, Deputy Director, Div. of Manufacturing & Product Quality Office of Compliance

explains the steps to decide whether part 11 control should be implemented. Recommendations are the same as presented in may conference talks.

The picture at the right has been used many times to explain FDA's new approach for Part 11. In the video clip Mr. Famulare goes through each step. Key points are:

  • The record is required by a predicate rule
  • The record is used for a regulated activity
  • The record has medium on high impact on product quality

John F. Murray, Jr., Software and Part 11 Compliance Expert, Office of Compliance, CDRH

Murray said as clear as possible: "According to the old interpretation the mere existence of electronic data in or around a product or plant was considered to be an electronic record of the rule." Mr. Murray talked about how this is changing.

 

V-103

 

Definition of a record with FDA's new scope of Part11

John F. Murray, Jr., Software and Part 11 Compliance Expert, Office of Compliance, CDRH

Murray said as clear as possible: "According to the old interpretation the mere existence of electronic data in or around a product or plant was considered to be an electronic record of the rule.".  Mr. Murray talked about how this is changing.

V-114

 

FDA names examples for facilities that are at high risks

Douglas Ellsworth, Director of the FDA's New Jersey District Office,

Ellsworth gives three examples

V-116

 

Facilities defined as 'low risk' will still be inspected

Douglas Ellsworth, Director of the FDA's New Jersey District Office,

Ellsworth made it clear that fact that a company does not fall in one of FDA's 'high risk' facility does not mean that the company is out of the hook. He also explained what type of inspections these facilities should expect

V-112

 

GMP initiative not a deregulation

David Horowitz, Director of CDER's Office of Compliance

Horowitz makes a clear statement that FDA's GMP initiative is not an initiative for deregulation. The main purpose is to put FDA's resources towards high risk facilities and systems, in other words to optimize FDA's limited resources.

V-107

 

FDA's GMP initiative not only for GMP's

David Horowitz, Director of CDER's Office of Compliance
Ajaz S. Hussain, PhD, Deputy Director, Office of Pharmaceutical Science, CDER

Both make statements about the scope of FDA's GMP initiative. The initiative covers all part of a quality system..

V-104