Preparing for FDA GCP Inspections - Webinar By ComplianceOnline (Clinical)
Venue: Online Event
|Event Date/Time: Jan 27, 2012||End Date/Time: Jan 27, 2012|
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 FDAâ€™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.
Who Will Benefit:
This webinar will provide valuable information to personnel in Sponsor Companies (i.e., Pharmaceutical, Biotechnology, Medical Device, etc.) as well as CROs and investigator sites conducting clinical trials including:
Clinical Research Associates
Compliance/GCP Quality Assurance staff
Site Staff/ Study Coordinators
Note: Use this promocode(117660) for 10% discount.