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Wednesday, February 9, 2011
2:00 PM to 3:30 PM (ET)
MODERATOR
J. Wade Atkins, CQA(ASQ), MS, MT(ASCP)SBB, National Institutes of Health
SPEAKERSElizabeth Burns, Progenitor Cell Therapy
Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ), Dana Farber Cancer Institute
Paul W. Eldridge, Ph.D.
DESCRIPTION
This session will review the experience encountered by three facilities during their Food and Drug Administration (FDA) inspection for cellular therapy manufacturing. The presentations will cover the basics as well as how the inspection focus might be different based on the product types (361, 351, Facility / BLA) manufactured. Each presenters will also provide insight on how to manage the process, who should be present, what their inspectors focused on, what to do if the inspection is not moving in the right direction and ultimately how to respond to any 483s issued.
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