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AM22-45-O - AM22-45-O: (On-Demand) Cellular Therapy Service Quality System Considerations from a Standards Development and Application Perspective (Enduring)
Quality systems provide a critical framework in which cellular therapy services optimize quality in daily operations. The Association for the Advancement of Blood and Biotherapies (AABB) has established standards for quality systems, adherence to which helps ensure compliance with regulations. AABB Standards for Cellular Therapy Services must consider national and international regulations, variations among institutional practices, and advances in the field when developing new and updating existing standards. Application of standards pertinent to quality systems must be updated with each iteration. Since every quality system’s ongoing application of standards to their program is unique, inspections allow for evaluation of how quality systems are implemented, maintained and updated in cellular therapy services. This session, supported by the Quality, Regulatory and Management Topics (QRM) subsection of the Cellular Therapies Section Coordinating Committee (CTSCC), will highlight the importance of quality system considerations from the perspective of standards during development and application by inspections.
Learning Objectives:
Describe important considerations during development of new standards in AABB Standards for Cellular Therapy Services that could impact quality system initiatives in the cellular therapy laboratory.
Explain important considerations during updates of already existing standards in AABB Standards for Cellular Therapy Services that could impact quality system initiatives in the cellular therapy laboratory.
Discuss aspects of cellular therapy laboratory quality systems important to consider during inspections evaluating application of new standards in AABB Standards for Cellular Therapy Services.
Review aspects of cellular therapy laboratory quality systems important to consider during inspections evaluating application of updated standards in AABB Standards for Cellular Therapy Services.
Speaker(s):
Wade
Atkins,
MS, MT(ASCP)SBB, CQA, ASQ,
Dept. of Transfusion Medicine
Kate
Brown,
PhD,
Generate Life Sciences, a CooperSurgical company
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AM22-45-O: (On-Demand) Cellular Therapy Service Quality System Considerations from a Standards Development and Application Perspective (Enduring) Evaluation