FDA's Five Layers of Safety: Maintaining Compliance
Program Code: 5318-QE
Monday, October 22, 2007
2:00 PM to 3:30 PM (ET)

MODERATOR
Mary Beth Bassett, BS, MT(ASCP), Blood Systems, Inc

SPEAKERS
Kathleen Hopping, BS, CQA(ASQ), Blood Systems, Inc.
Sharon O'Callaghan, MT(ASCP), FDA/CBER

DESCRIPTION
This presentation will help participants understand the FDA's 5 layer of safety and how it is used in inspections. It will also help the industry understand how they can use these layers along with the elements of the Quality System to maintain compliance.