Many
of our recently held briefings are available on audiocassette files.
Visit our Tapes Library for our highly regarded series
on:
|
 Tapes
Library
Branded/Generic
Drug Policy: Anser-based-Submission (AbS): An Industry
Companion Approach to FDA's QUestion-based-Review
(QbR) |
| Speaker: |
Dr.
Dhiren Shah , head of Regularity Affairs
at Martec USA, LLC |
| Date
of Briefing: |
May
16, 2006 |
| Approximate
length: |
One
hour |
| Description: |
Join
in on a discussion of alternative and
potentially more appropriate ways to
provide data/information in QOS and
in CTD Module 3 to optimize the utility
and efficiency of QbR. |
| Price: |
$325
CD |
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|
Tapes
Library
Branded/Generic
Drug Policy: The ImPossible Dream: Improving Clinical
Quality, Cutting Timelines AND Reducing Costs in
Regulatory Submissions |
| Speaker: |
Kit
Howard, MS, Principal, Kestrel Consultants,
Inc. and Associate Director, DQRI |
| Date
of Briefing: |
February
17, 2005 |
| Approximate
length: |
One
hour |
| Description: |
Kit
Howard presents a model on creating
data and process standards that build
in quality early in drug development
while minimizing cost and time components. |
| Price: |
$250
CD |
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Tapes
Library
Branded/Generic
Drug Policy: Issues with QT Interval Prolongation/Survey
Pharmacology |
|
| Speaker: |
Michael
Gralinski, Ph.D., CorDynamics |
| Date
of Briefing: |
July
20, 2004 |
| Approximate
length: |
One
hour |
|
Description: |
In
this presentation with Michael Gralinski, Ph.D., CEO of
CorDynamics, we will examine the process for using QT
interval as a surrogate marker of cardiovascular risk,
using case studies and literature data to judge the rationale
for such a decision tree. |
| Price: |
$195
Tape |
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Click
here to see briefings from 2002. |
Tapes
Library
Branded/Generic
Drug Policy:: The
Impact of On-Line QC on Manufacturing |
|
|
Speaker: |
Parrish
M. Galliher, Xcellenix |
|
Date
of Briefing: |
July
6, 2004 |
|
Approximate
length: |
One
hour |
|
Description: |
In
this presention, Galliher will discuss the impact
of on-line QC on manufacturing - how it can improve
product quality; reduce batch release time, increase
plant capacity; lower manufacturing, QC risk and
COGS; and can be a very cost effective investment. |
|
Price: |
$195
Tape |
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|
Tapes
Library
Branded/Generic
Drug Policy:: Overcoming
Regulatory Issues |
|
|
Speaker: |
Michael
L. Longmire, Ph.D., Research Director, SSCI,
Inc. |
|
Date
of Briefing: |
May
26, 2004 |
|
Approximate
length: |
One
hour |
|
Description: |
Our
Speaker, Michael L. Longmire, Ph.D., Research
Director for SSCI, Inc., explains how addressing
issues of concern with an emphasis on quality
by design can result in classifications
of the manufacturing process as low risk.
Although these procedural changes will not
occur immediately, as they are adopted they
should provide more rapid regulatory approval
and reduced time to market. Make sure you’re
ready for the changes that evolve from PAT.
|
|
Price: |
$195
Tape |
|
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|
Archive
Library
Branded/Generic
Drug Policy: Process Analytical Technology |
|
| Speaker: |
Jean-Marie
Geoffroy, Ph.D., Abbott Technologies |
| Date
of Briefing: |
January
15, 2004 |
| Approximate
length: |
One
hour |
|
Description: |
In charge
of Abbott’s PAT is Jean-Marie Geoffroy. He notes that
a major advantage of PAT-assisted batch information is the “ability
to analyze time series and trending in a manner that is more
holistic than looking at isolated bits of batch data.”
If you or your clients are responsible for PAT and/or managing
data on APIs or raw materials, you must order this CD today! |
| Price: |
$195
Tape |
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Archive
Library
Branded/Generic
Drug Policy: Who's
Afraid of CAPAs? |
|
| Speaker: |
Paula
Shadle, Ph.D. President, Shadle Consulting |
| Date
of Briefing: |
November
19, 2003 |
| Approximate
length: |
One
hour |
|
Description: |
How
can you make your program work and be confident that it
meets current standards and requirements? Can you program
survive an FDA inspection? Using case studies,* tips and
suggestions, and discussion of your issues, Dr. Paula
J. Shadle, President, Shadle Consulting -- whose firm
specializes in QA and QC support for bio-pharmaceutical
firms – will help you wend your way through CAPA
complexities. |
| Price: |
$195
Tape |
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|
Archive
Library
Branded/Generic
Drug Policy: How the RX Industry
Can Fight Counterfeit Drugs |
|
| Speaker: |
Lews Kontnik,
Author, Protecting Medicines |
| Date
of Briefing: |
October
23, 2003 |
| Approximate
length: |
One
hour |
|
Description: |
Lewis
Kontnik, noted counterfeiting expert, co-author
of Protecting Medicine and Pharmaceuticals: A
Manual of Anticounterfeiting Solutions*, and drug
analyst for the FDA-sponsored Product Surety (anti-counterfeiting)
project, reveals how Rx companies can protect
their brand name and fight back against doctored
drugs.
|
| Price: |
$315
CD |
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Page
last updated
October 16, 2006
Washington Information
Source © Copyright 2006
208 South King Street, Leesburg, VA 20175
Tel: (703) 779-8777 . Fax: (703) 779-2508
service@fdainfo.com .
www.fdainfo.com/expertbriefings/
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