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AM21-82: Ask the FDA and CMS/CLIA


‐ Oct 19, 2021 9:00pm

Expiration Date: Dec 31, 2023


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. 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.

Speaker(s):

Moderator(s):

Disclosures

  • 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

Tags:

quality collections and product manufacturing patient safety public health and policy standards regulations and accreditation collections processing and storage

All relevant financial relationships have been mitigated. By completing the evaluation, you are attesting to watching the presentation in its entirety. A certificate will be immediately provided after submission.

Credits Available


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