When is Enough, Enough? Vendor Qualification for Cellular Therapy
Program Code: 5431-TC-CT
Tuesday, October 23, 2007
4:00 PM to 5:30 PM (ET)

MODERATOR
Kathy Loper, MHS, MT(ASCP), AABB

SPEAKERS
Mary Beth Fisk, MT, CTBS, CQA, South Texas Blood & Tissue Center
Donna Regan, MT(ASCP)SBB, St. Louis Cord Blood Bank
Mark Kaniewski, MT(ASCP), SBB, City of Hope

DESCRIPTION
Targeted for HCT/P facilities but applicable to everyone, vendor qualification is an integral component of any Quality System. The collections of HPCs by remote collection sites present unique challenges for compliance, particularly with imported products. The NAT pooling issue, an example of a hard lesson learned, could have been avoided had more extensive vendor qualification been performed. This interactive session will provide a discussion of these unique challenges and models of how facilities comply in the real world. It will focus on FDA Requirements and standards as they apply to laboratories that perform infectious disease and microbial testing and also internal service providers in the hospital setting.