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

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Quality Control � Several dimensions of QA include quality control (QC) procedures and current good manufacturing practices (cGMP) � Adequate QC procedures are an element of conformity with cGMP � On‐line or in‐process monitoring of manufacturing procedures
Quality Control/ Assurance Unit � Required by 21 CFR 211.22(a) � Should report to management or designee � Responsibilities include: � Standard Operating Procedures � Training and Education � Competency Evaluation � PProficiency fi i TTesting i � Validation � Equipment �� Error/Accident Reports Reports, Complaints, Complaints Adverse Reactions � Records Management � Lot Release � Quality Assurance Audits
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 18 and 19: FDA Guideline � Intended to be us
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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