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2019 AABB Annual Meeting On-Demand


MN2-11: Ask the FDA and CMS


Oct 21, 2019 10:30am ‐ Oct 21, 2019 12:00pm

Expiration Date: Dec 31, 2021


Credits: None available.

Standard: Free
Members: $0.00

Description

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.

At the completion of this session, participants should be able to:

  • 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 & Speaker(s):

Speaker(s):

Disclosures

  • Sharon Carayiannis, MT(ASCP)HP :

    Nothing to Disclose

  • Anne Elder, MD, PhD :

    Nothing to Disclose

  • Carlos Villa, MD PhD :

    Nothing to Disclose

  • Hanh Khuu, MD :

    Nothing to disclose

  • Judy Ciaraldi, BS, MT(ASCP)SBB, CQA(ASQ) :

    Nothing to disclose

  • Miriam Montes, MS, MT(ASCP)SBB :

    Nothing to disclose

  • Tricia Martinez :

    Nothing to disclose

  • Karen Palmer, MT(ASCP) CQA(ASQ) :

    Nothing to disclose

  • Mary Hasan :

    Nothing to disclose

Credits Available


MN2-11: Ask the FDA and CMS Evaluation

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