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

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

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

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

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

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

7.  CODE OF FEDERAL REGUALTIONS  TITLE 21CFR  600-680 7

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

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

10.  BIOLOGIC PRODUCT STANDARDS  BLOOD REQUIREMENTS- GENERAL 10

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

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

13.  PRODUCTS:  MODIFYING  PROCESSING  LABELING 13

14.  PRODUCT QC  STORING  SHIPPING 14

15.  TESTING STANDARDS  SAMPLES  REAGENTS  TEST METHODS 15

16.  VARIANCES  EXAMPLE:  THAWED FFP EXPIRATION  21 CFR 640.120 -606.122(m)(3  6 HOURS POST THAW  24 HOURS POST THAW 16

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

18.  BLA EXAMPLES:  RED BLOOD CELLS  PLATELETS 18

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