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AM22-42-O - AM22-42-O: (On-Demand) Ask the FDA and CMS/CLIA (Enduring)


‐ Nov 7, 2022 6:00pm

Expiration Date: Dec 31, 2024


Credits: None available.

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.

All relevant financial relationships have been mitigated.


Learning Objectives:

  • Evaluate existing practices to establish alignment with current regulatory requirements and recommendations.
  • Apply FDA's recommendations in recently issued guidance to industry.
  • Describe FDA's approach for blood and HCT/P policies, regulations and inspection programs.

Moderator(s):

Moderator & Speaker(s):

Speaker(s):

Disclosures

  • Karen Palmer, MT(ASCP) CQA(ASQ):
    Nothing to Disclose
  • Arnold McKinnon:
    Nothing to Disclose

Tags:

quality donor testing collections and product manufacturing donor apheresis patient safety component processing

By completing the evaluation, you are attesting to watching the presentation in its entirety. A certificate will be immediately provided after submission.

Credits Available


AM22-42-O: (On-Demand) Ask the FDA and CMS/CLIA (Enduring) Evaluation