Many
of our recently held briefings are available on audiocassette files.
Visit our Tapes Library for our highly regarded series
on:
|
 Audio
Library
FDA
Enforcement: Root Cause Analysis and
Risk Assessment: Stay abreast (and ahead)
of FDA expectations |
|
|
Speaker: |
Paula
Shadle, Ph.D., President Shadle Consulting
|
| Date
of Briefing: |
January
19, 2005 |
| Approximate
length: |
One
hour |
|
Description: |
This
audio briefing will focus on RCA and its affect
on Risk Assessment, for example if a root
cause is not detected, the chance is high
that the problem will recur. Risk Assessment
then entails: Is the problem easy to detect?
What is the chance that unsafe product is
released into use? What is the chance that
harm is done? |
| Price: |
$225
CD |
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|
Go
to the
Order Form
Click
here for previous Expert Briefings on
FDA Enforcement. |
 |
Audio
Library
FDA
Enforcement: Root Cause Analysis
-- How to Benefit from Failures |
| Speaker: |
Lee
N. Vanden Heuval, ABS Consulting |
| Date
of Briefing: |
August
11, 2004 |
| Approximate
length: |
One
hour |
| Description: |
A
root cause analysis should identify why things
go wrong…then make sure they don't happen
again. Learn how to conduct an effective root
cause analysis, learn the fundamentals from
a veteran of hundreds of failure investigations,
Lee N. Vanden Heuvel of ABS Consulting. |
| Price: |
$195
Tape |
|
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|
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to the
Order Form
|
Audio
Library
FDA
Enforcement: New
USSC Sentencing Guidelines adn Corporate Compliance
& Ethnics Programs |
|
| Speakers: |
John
Fleder, Douglas Farquhar, Molly C. Andersen, Hyman,
Phelps & McNamara
|
| Date
of Briefing: |
June
15, 2004 |
| Approximate
length: |
90
minutes |
|
Description: |
This
information packed, one-hour audio-video briefing featuring
John Fleder and Douglas Farquhar from Hyman, Phelps &
McNamara – specialists on corporate compliance with
FDA regs -- will provide practical information on how
to set up effective compliance programs that include voluntary
disclosure protocols and training to help staff implement
the programs. |
| Price: |
$275
Tape |
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|
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to the
Order Form |
Audio
Library
FDA
Enforcement: Protocols
and Strategies for Hosting FDA Investigations |
|
|
Speaker: |
Barbara
Unger, Principal Consultant, Don Hill & Associates,
Inc. |
|
Date
of Briefing: |
May
18, 2004 |
|
Approximate
length: |
One
hour |
|
Description: |
Barbara
Unger, Principal Consultant with Don Hill &
Associates, Inc., explains how to develop and implement
a comprehensive flexible plan for hosting an FDA
inspector. This plan ensures that all key functions
are identified and staffed, team members are trained
to work together, both directly with the inspector
and behind-the-scenes. The plan describes activities
to conduct while the inspector(s) are on site as
well as follow up activities after the inspection. |
|
Price: |
$195
Tape |
|
ptovvvvv |
Go
to the
Order Form |
|
|
Audio
Library
FDA
Enforcement: Root Cause Analysis |
|
|
Speaker: |
Paula
Shadle, Ph.D., President Shadle Consulting
|
| Date
of Briefing: |
January
22, 2004 |
| Approximate
length: |
One
hour |
|
Description: |
To
help you understand RCA and how it can help you is Paula
Shadle, Ph.D., consultant on biopharma-ceutical quality.
Dr. Shadle -- who late last year conducted a highly popular
briefing on CAPAs -- is a leading authority on RCA and
a former executive with major biopharmaceutical firms.
She returns to provide first hand expertise on time and
money saving production techniques via this audio advisory.
|
| Price: |
$195
CD |
| ttttttttttttt
|
Go
to the
Order Form |
|
|
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last updated
October 16, 2006
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