Preparation for FDA Inspection Training

Description:

This is a Research Coordinator Series Workshop that we are now pleased to offer to the entire Penn State research community! This training will help research groups stay prepared for FDA inspections by helping participants understand what to expect in the event of an inspection, who to contact, and what to do in order to prepare for an inspection. Common inspection findings are also discussed along with appropriate ways to respond to findings and/or questions from the FDA inspector.
Objectives:

• Describe the purpose of FDA inspection of clinical research
• Describe the processes in place to prepare for an FDA site inspection
• Describe investigator responsibilities and conduct during the FDA inspection process
• Describe the approach to responding to verbal and written findings

Credit Offered: PSNA

Registration is required. The Zoom link will be provided upon registration and you will receive an email reminder the day prior to the session.

Please register via this link.