Preparing for FDA GCP Inspections – Essentials for Sponsor Companies

This webinar on FDA GCP inspections, by a former FDA investigator, will provide practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.

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.

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.
• 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
• Study Managers
• Site Staff/ Study Coordinators
• Clinical Investigators