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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
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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
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
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
David Horowitz, Director of CDER's Office of Compliance
Gives FDA's perspective for a more formal dispute resolution process.
V-101
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
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
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
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
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
Douglas Ellsworth, Director of the FDA's New Jersey District Office,
Ellsworth gives three examples
V-116
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
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
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