Process Validation/Qualification for Cell Therapy Procedures
Program Code: 054572
Wednesday, February 23, 2005
2:00 PM to 3:30 PM (ET)

MODERATOR
Janice Davis-Sproul, MAS, MT(ASCP)SBB, Johns Hopkins Medicine

SPEAKERS
Safa Karandish, BS, MT(ASCP), Division of Human Tissues, FDA
Lisa Fox, MS, MT(ASCP), StemCells, Inc
J. Wade Atkins, CQA(ASQ), MS, MT(ASCP)SBB, National Institutes of Health

DESCRIPTION
Process validation is a requirement of both AABB and the Foundation for the Accreditation of Cellular Therapy (FACT) Standards. However, what does this mean and how is validation performed in a cell therapy facility? The speakers will define validation and qualification and discuss the types of qualifications. Using examples, the speakers will focus on two aspects of validation within the cell therapy facility: validating a new procedure and making a change to an existing procedure.