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2021 AABB Annual Meeting On-Demand

AM21-82: Ask the FDA and CMS/CLIA

Oct 19, 2021 9:00pm ‐ Oct 19, 2021 10:00pm

Credits: None available.

Standard: Free
Members: $0.00


This annual event provides an opportunity for FDA and CMS/CLIA representatives to respond to member questions and present the agency's current thinking on policies, regulations, guidance documents and inspection programs that are relevant to the oversight of blood and HCT/P programs. Questions for the session are submitted in advance to regulatory@aabb.org. Identify the regulation or recommendation of interest, the specific issue or concern, and any background information, suggestions or proposed solutions to best illustrate your perspective.

Learning Objectives:
  • Apply FDA's recommendations in recently issued guidance to industry.
  • Describe FDA's approach to policies, regulations and inspection programs related to products regulated by the Center for Biologics Evaluation and Research.
  • Evaluate existing practices to establish alignment with current regulatory requirements and recommendations.




  • Karen Palmer, MT(ASCP) CQA(ASQ) : Nothing to Disclose
  • Sharon Carayiannis, MT(ASCP)HP : Nothing to Disclose
  • Michelle Gutierrez, BS, MT (AMT) : Nothing to Disclose
  • Sharon O'Callaghan, MT(ASCP) : Nothing to Disclose
  • Christopher Cox : Nothing to Disclose

Credits Available

AM21-82: Ask the FDA and CMS/CLIA Evaluation

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