Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...

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FDA Guideline � Intended to be used in conjunction with applicable federal standards in 21 CFR � P Parts 6 600 through h h 68 680 � Parts 210 and 211 �� Establishments performing laboratory testing must also comply with 42 CFR Part 493 (CLIA requirements) � Standards for laboratory personnel, quality control, proficiency f testing, patient test management and d QA
Quality Assurance � Term “quality assurance” is not in the CFR � Regulations clearly require a program of activities to control the manufacturing process to prevent the release of unsuitable products
Page 1 and 2: Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQ
Page 3 and 4: A Horse named Jim � In 1901 a ser
Page 5 and 6: Early Regulations ‐ 1903 � Issu
Page 7 and 8: World at War � American Red Cross
Page 9 and 10: Court Cases 1960‐1970 � Violati
Page 11 and 12: National Blood Policy � 1972 Pres
Page 13 and 14: Bureau of Biologics Regulation �
Page 15 and 16: HIV and the Blood Supply � 1980
Page 20 and 21: Quality Control � Several dimensi
Page 22 and 23: Quality System Essentials � 1997
Page 24 and 25: AABB Accreditation � 1998 AABB In
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Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...

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