 How
to Prepare for FDA Clinical Research
Audits
Feb. 7, 2006, 2:30-3.30 pm (EST):*
Jerri Perkins, M.D., FDA Consultant,
Perkins & Perkins
CROs and clinical research personnel
are often intimidated by the
prospect of an FDA inspection. There
is much mystique surrounding this
process. This interactive session
will relieve your anxieties by
explaining how companies and sites
can prepare for FDA inspections.
A
former FDA medical officer
and conductor of pre-FDA audits,
Jerri Perkins, M.D., of Perkins &
Perkins
will reveal what to expect during an
FDA audit by describing what agency
inspectors are actually looking for
during a BiMo inspection…and why
these audits are crucial to the
drug/device approval process.
In other words, Perkins will help
you take the anxiety out of a
pending FDA BiMo audit. If you are
responsible for ensuring that your
firm is complying with FDA
regulations, this is a must
attend event.
*Please note special time.
What
You Will Learn From This
ExpertBriefing by Dr. Jerri Perkins:
-
How to de-mystify the process of
an FDA inspection
-
The importance of pre-FDA audits
-
Techniques for sponsors and
sites to prepare for inspections
-
How to respond to the FDA after
the audit
What
You Will Receive:
-
Speaker outline in PowerPoint
format
-
Free CD recording of the
briefing
-
Free
trial subscription to
BioResearch Compliance Report
— our new publication
focusing on GCP and GLP
compliance issues
-
Certificate of attendance
(pending completion of
evaluation form)
Registration Fees:
-
Audioconference (includes
slides, free trial subscription
to BioResearch Compliance Report
and CD of the conference):
$399
-
CD only (includes slides and
free trial subscription): $325
-
Additional sites per company:
$225
-
Non-profit/Govt./Academic: $299
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