FDA Inspections for Cell Therapy Products from the Perspective of Hospitals and Industry
Sponsored by the ISCT North American Legal and Regulatory Affairs Committee
- Karen Edward, BS, MT(ASCP), Advanced Cell & Gene Therapy
- Mary Coon, BS, CQA, Dendreon Corporation
- Elizabeth Konecki, MS, MT(ASCP), SBB, Wilford Hall Medical Center
An FDA inspection can be a nightmare costing your organization money, time and reputation, or it can be an opportunity to make a positive impression with regulators and improve your quality systems. Webinar attendees will learn how to prepare, manage and successfully complete GMP/GTP regulatory inspections. The speakers will present their real-life experiences in handling FDA inspections in their own facilities.
This product is a downloadable zipped folder containing an mp3 audio recording of the presentation and a PDF copy (or copies) of the Power Point slides.