SHARING SITE SECRETS: OUR EXPERIENCE WITH MORE THAN 15 FDA INSPECTIONS
The most stressful moment in a site’s research experience just might be the first time you learn that you’ve been selected for an FDA inspection. Panic from not knowing what to expect may hinder an organized and thoughtful approach to preparing for and hosting that inspection. But, what if an institution that has 4-6 inspections every year shared their experiences, and how, in response to those experiences, they now plan and prepare for, host, and manage post-inspection responsibilities? This session will do just that. This session will demystify the inspection process from a site perspective and give your site a confident and organized plan to manage your first – or next – FDA inspection.
- Evaluate potential process gaps for hosting an FDA inspection.
- Implement processes to streamline site preparation upon notice of inspection.
- Execute an organized and collaborative team approach to hosting and responding to an inspection.
Please click here to purchase contact hours.
- Neala Lane, MS, CCRC - Associate Director, Quality Improvement Office, Indiana University