Live Webinar on : Preparing for FDA Inspection and Handling the Consequences
Thursday, May 31, 2012 duration : 12:00 to 13:30 PM EST
We will review the latest inspection statistics
released from FDA, discuss how to prepare for
Get 15 % Discount as a early bird
registrations. Use Promo Key : an FDA Inspection, discuss how to repsond to
CGO15 an FDA Inspection and discuss the possible
outcomes of an FDA Inspection that has
resulted in significant findings and/or
Who will benefit citations.
Clinical Research managers
Areas Covered in the Session:
- Preparing for an FDA Inspection.
Clinical Research Associates
- Discussion on receiving and responding to 483s
and warning letters.
Quality Assurance Professionals
- Discussion on what actions the FDA can take over
and beyond issuing a 483 or Warning Letter.
Why should you attend
In 2010 under CDRH, CDER and CBER divisions alone,
FDA classified 1,097 Sponsor, Site and IRB Inspections.
Of those Inspections 9% or ~ 66 of the Clinical
Investigator Inspections, 6% or ~ 15 of the IRB
Pricing Inspections and 12% or ~ 15 of the Sponsor/Monitor
Inspections were categorized as "Official Action
Indicated". 45% of Clinical Investigator, 50% of IRB and
38% of Sponsor/Monitor Inspections were categorized
Live ( Single registration ) : $189.00 as "Voluntary Action Indicated" being required.
Group ( Max 10 Attendee): $249.00 Because FDA Inspections are part of doing business and
On Demand (Recording available):$289
getting products to market, Clinical Investigators,
Get Training CD : $499 Sponsors and IRBs should not only be prepared to
handle an FDA Inspection but also be prepared to
follow-up on findings, following the inspection.
More Trainings Lee Truax-Bellows has an extensive background in
the pharmaceutical and medical device industries,
having worked for both industry and a CRO as a
Regulatory Consultant Monitor, Medical
Communications Associate, Senior Quality
Auditor, Senior Trainer and Project Manager. Lee
has been involved in regulated research for over 20
plus years and specializes in product development,
GCP auditing, and training on regulated research
and Good Clinical Practice.
Lee is a founder, President and CEO of Norwich
Clinical Research Associates Ltd. (NCRA). NCRA
is a clinical contract research organization (CRO)
based in upstate NY. NCRA has been providing
clinical research expertise in medical device,
pharmaceutical, and nutraceutical development
since 1994. NCRA provides full service CRO
services such as monitoring, auditing, technical
writing, data management, biometrics and product
Lee is active in the Association of Clinical
Research Professionals (ACRP) and Society of
Quality Assurance (SQA)
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