Abstract
Functional quality systems are essential to a successful cellular therapy program. A major driver to implementation of a quality management system in the United States is the federal law outlined in the Code of Federal Regulations (CFR) Title 21 parts 211 and 1271. Almost every accrediting agency now requires the implementation of a quality program including the AABB, Centers for Medicare and Medicaid Services (CMS), The Joint Commission (TJC), the College of American Pathologists (CAP), the Foundation for the Accreditation of Cellular Therapy (FACT), the International Standards Organization (ISO), the American Association of Tissue Banks (AATB), and the Clinical Laboratory Standards Institute (CLSI).
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Atkins, J. (2009). Quality. In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_16
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DOI: https://doi.org/10.1007/b102110_16
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