Key Topics
- Overview of GCP regulations and FDA guidelines used for inspections
- The most common FDA inspection deficiencies noted among sites and sponsors
- Inspection documentation and proper follow-up procedures
- The areas that are reviewed during GCP inspections
- Effective techniques and tools that can used to prepare for GCP inspections
Who should Attend
Attendees from Pharma, Biotech and Medical Device companies including Compliance/GCP Quality Assurance staff, Clinical Research Associates, Site Staff/ Study Coordinators, Study Managers and Clinical Investigators.
