Lee Truax Bellows 2012 - Preparing for FDA Inspection and Handling the Consequences

We will review the latest inspection statistics released from FDA, discuss how to prepare for an FDA Inspection, discuss how to repsond to an FDA Inspection and discuss the possible outcomes of an FDA Inspection that has resulted in significant findings and/or citations.

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 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 as "Voluntary Action Indicated" being required. Because FDA Inspections are part of doing business and getting products to market, Clinical Investigators, Sponsors and IRBs should not only be prepared to handle an FDA Inspection but also be prepared to follow-up on findings, following the inpsection.

Areas Covered in the Session:

- Preparing for an FDA Inspection.

- Discussion on receiving and responding to 483s and warning letters.

- Discussion on what actions the FDA can take over and beyond issuing a 483 or Warning Letter.

Who will benefit:

Clinical Research managers

Project Managers

Clinical Research Associates

Monitors

Quality Assurance Professionals

Research coordinators
Clinical investigators

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