Clinical Compliance 2011 - Preparing for FDA GCP Inspections ? Essentials for Sponsors and Clinical Sites

Why Should You Attend:
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.

In this webinar, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.

Areas Covered in the Seminar:

The most common FDA inspection deficiencies noted among sites and sponsors.
Overview of GCP regulations and FDA guidelines used for inspections.
Strategies used in FDA’s inspection planning.
The areas that are reviewed during GCP inspections.
Inspection documentation and proper follow-up procedures.
Effective techniques and tools that can used to prepare for GCP inspections.

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