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2020 AABB Annual Meeting On-Demand

AM20-66: Ask the FDA


Oct 5, 2020 9:00pm ‐ Oct 5, 2020 9:00pm


Expiration Date: Dec 31, 2022


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.

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.

Speaker(s):

Disclosures

  • Kip Hanks : Nothing to disclose
  • Lisa Harlan : Nothing to disclose
  • Sharon O'Callaghan, MT(ASCP) : Nothing to disclose
  • Kanaeko Ravenell : Nothing to disclose
  • Emily Storch, MD : Nothing to disclose

Credits Available


AM20-66: Ask the FDA Evaluation

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