10times
logo
29 Sep 2021Ended

Live Webinar- " Surviving an FDA Sponsor Inspection - Training for Success"

About1SessionSpeakersExhibitorsReviewsPhotos

Estimated Turnout

100
Delegates

100 Exhibitors

Editions

Sep 2021

Frequency

One-time
Claim event to edit details

"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 .. Read more 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.

Highlights

  • 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
Registration
Registration
199 USD Attendee
  • Share your Experience
  • Organizer
Logo Follow Company

Compliance.world

USA89 Total Events / 8 Upcoming Events

More Events From The Organizer