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US BLOOD DIRECTIVES

US BLOOD DIRECTIVES. REGULATIONS FOR BLOOD and BLOOD PRODUCTS. JILL HOAG BS, SBB(ASCP) CQA(ASQ ) AABB STAFF LEAD ASSESSOR. BLOOD DIRECTIVES. DONOR and RECIPIENT SAFETY FROM COLLECTION TO TRANSFUSION PRODUCTS TESTING RECORDS STAFF. BLOOD DIRECTIVES. HEALTH and HUMAN SERVICES FDCA

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US BLOOD DIRECTIVES

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

  2. BLOOD DIRECTIVES • DONOR and RECIPIENT SAFETY • FROM COLLECTION TO TRANSFUSION • PRODUCTS • TESTING • RECORDS • STAFF

  3. BLOOD DIRECTIVES • HEALTH and HUMAN SERVICES • FDCA • FDA • SAFETY • QUALITY • PURITY • POTENCY

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

  5. BLOOD DIRECTIVES • BLA • BIOLOGICS LICENSE APPLICATION • ELA- ESTABLISHMENT • PLA- PRODUCT

  6. BLOOD DIRECTIVES • GUIDANCE DOCUMENTS • CODE OF FEDERAL REGUALTIONS • TITLE 42CFR • 493

  7. BLOOD DIRECTIVES • CODE OF FEDERAL REGUALTIONS • TITLE 21CFR • 600-680

  8. BLOOD DIRECTIVES • cGMP (606) • ORGANIZATION & PERSONNEL • FACILITY • EQUIPMENT • PRODUCTION & PROCESS CONTROLS • FINISHED PRODUCT CONTROLS • LAB CONTROLS • RECORDS & REPORTS

  9. BLOOD DIRECTIVES • ESTABLISHMENT REGISTRATION • PRODUCT LISTING • DOMESTIC • FOREIGN • EXEMPTIONS:

  10. BLOOD DIRECTIVES • BIOLOGIC PRODUCT STANDARDS • BLOOD REQUIREMENTS- GENERAL

  11. BLOOD DIRECTIVES • ADDITIONAL REQUIREMENTS for BLOOD BY PRODUCT TYPE • WHOLE BLOOD • RED CELLS • FFP • PLATELETS

  12. BLOOD DIRECTIVES • DONORS • DONOR SUITABILITY • HEALTH & HISTORY • COLLECTION • METHODS • TECHNIQUES

  13. BLOOD DIRECTIVES • PRODUCTS: • MODIFYING • PROCESSING • LABELING

  14. BLOOD DIRECTIVES • PRODUCT QC • STORING • SHIPPING

  15. BLOOD DIRECTIVES • TESTING STANDARDS • SAMPLES • REAGENTS • TEST METHODS

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

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

  18. BLOOD DIRECTIVES • BLA EXAMPLES: • RED BLOOD CELLS • PLATELETS

  19. BLOOD DIRECTIVES

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