Many
of our recently held briefings are available on audiocassette files.
Visit our Tapes Library for our highly regarded series
on:
|
 Tapes
Library
21
CFR Part 11: Electronic Records & cGMP Initiative |
|
| Speaker: |
Robert
W. Stotz, Ph.D., Validation Technologies |
| Date
of Briefing: |
October
16, 2003 |
| Approximate
length: |
One
hour |
|
Description: |
According to FDA, the withdrawal
was precipitated by its new initiative (announced August
21, 2002) to enhance FDA’s current good manufacturing
practice program to focus regulatory attention on those
aspects of manufacturing that pose the greatest risk,
ensure that FDA’s work does not impede innovation,
and enhance the consistency of FDA’s regulatory
approach. Robert W. Stotz, Ph.D. of Validation Technologies,
Inc will provide an exclusive update on both of these
developments. |
| Price: |
$195
Tape |
| ttttttttttttt
|
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to the
Order Form |
Tapes
Library
21
CFR Part 11: Risk-Based Plans for Part-11 Compliance |
|
|
Speaker: |
Robert
W. Stotz, Ph.D., Validation Technologies |
|
Date
of Briefing: |
June
17 , 2003 |
|
Approximate
length: |
One
hour |
|
Description: |
After
hearing Dr. Stotz’ briefing, you will learn:
how to assess the impact of FDA’s “full
circle” approach on enforcement activities;
what elements of Part 11 are affected by enforcement
discretion; which systems implemented prior to the
effective date of Part 11 still have to comply;
how these developments will change the validation
of computer systems; and how to implement a risk-based
approach to Part 11 compliance. |
|
Price: |
$195
Tape |
|
|
Go
to the
Order Form
Click
here to visit Expert Briefings from 2002. |
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October 16, 2006
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