"Let’s get together for live webinar" Live Webinar: Surviving an FDA Sponsor Inspection - Training for Success When: Wednesday September 29, 2021 - 03:00 PM Duration: 100 Minutes. This ..
training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits. The sponsor clinical operations staff guided the sponsor and investigator site staff through the FDA inspection/audit process. The result was a passed FDA sponsor inspection and approved NDA. There were no FDA warning letters issued to any investigators.
Areas Covered in the Webinar: FDA sponsor inspection objectives and perspectives
FDA inspectional procedures; What sponsor staff are audit targets
Typical and common FDA questions and how not to respond