REGULATIONS FOR BLOOD and BLOOD PRODUCTS JILL HOAG BS, SBB(ASCP) CQA(ASQ) AABB STAFF LEAD ASSESSOR 1

 DONOR and RECIPIENT SAFETY  FROM COLLECTION TO TRANSFUSION  PRODUCTS  TESTING  RECORDS  STAFF 2

 HEALTH and HUMAN SERVICES  FDCA  FDA  SAFETY  QUALITY  PURITY  POTENCY 3

 CENTER for BIOLOGICS EVALUATION and RESEARCH ( CBER)  LICENSING for BIOLOGICS  BLOOD AS A BIOLOGIC 4

 BLA  BIOLOGICS LICENSE APPLICATION  ELA- ESTABLISHMENT  PLA- PRODUCT 5

 GUIDANCE DOCUMENTS  CODE OF FEDERAL REGUALTIONS  TITLE 42CFR  493 6

 CODE OF FEDERAL REGUALTIONS  TITLE 21CFR 

 cGMP (606)  ORGANIZATION & PERSONNEL  FACILITY  EQUIPMENT  PRODUCTION & PROCESS CONTROLS  FINISHED PRODUCT CONTROLS  LAB CONTROLS  RECORDS & REPORTS 8

 ESTABLISHMENT REGISTRATION  PRODUCT LISTING  DOMESTIC  FOREIGN  EXEMPTIONS: 9

 BIOLOGIC PRODUCT STANDARDS  BLOOD REQUIREMENTS- GENERAL 10

 ADDITIONAL REQUIREMENTS for BLOOD BY PRODUCT TYPE  WHOLE BLOOD  RED CELLS  FFP  PLATELETS 11

 DONORS  DONOR SUITABILITY  HEALTH & HISTORY  COLLECTION  METHODS  TECHNIQUES 12

 PRODUCTS:  MODIFYING  PROCESSING  LABELING 13

 PRODUCT QC  STORING  SHIPPING 14

 TESTING STANDARDS  SAMPLES  REAGENTS  TEST METHODS 15

 VARIANCES  EXAMPLE:  THAWED FFP EXPIRATION  21 CFR (m)(3  6 HOURS POST THAW  24 HOURS POST THAW 16

 THE COALITION FOR BLOOD SAFETY AABB AMERICA’S BLOOD CENTERS AMERICAN RED CROSS ARMED SERVICES BLOOD PROGRAM 17

 BLA EXAMPLES:  RED BLOOD CELLS  PLATELETS 18

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