MODERATOR
:
SPEAKER
(S):
Michele Sugrue, MS, MT(ASCP)SBB, Coordinator, Research Programs, University of Florida
Salem Akel, PhD, Saint Louis Cord blood bank @ SSM Cardinal Glennon Children Hospital
Tao Wang, MS, Validation & Quality Systems Manager, National Cord Blood Program, New York Blood Center
Description
Using a case study-based format, this session will address validation and qualification studies specifically in the cellular therapy laboratory. Following a brief overview of the subject, three case studies will be presented to describe approaches to the validation and qualification of equipment, processes and facilities. The speakers will discuss current regulatory requirements and accrediting agencies as well as the challenges that laboratories of all sizes face when developing validation and qualification protocols.
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Describe the current requirements of regulatory and accreditation agencies.
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Illustrate the applications of validation, verification and qualification studies through case studies addressing equipment, processes and facilities.
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Review the differences between validation, verification and qualification as they apply to cellular therapy laboratory practices.
CE Category | CE Value |
---|
California Clinical Laboratory Personnel |
1.5 |
California Nurse |
1.8 |
Florida Laboratory Personnel |
1.8 |
General Attendee |
1.5 |
Physician |
1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.