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AM23-ST-19-O

AM23-ST-19-O: Ask the FDA and CMS/CLIA (Enduring)

Credits
1 General Continuing Education (GEN) | 1 Florida Lab Personnel (FLP) | 1 California Nurse (CN) | 1 California Lab Personnel (CLP) | 1 Physician (PHY)
$3000
Standard Price
Members save $5

This popular session consistently draws a large audience and provides an opportunity for the regulatory experts with the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services/Clinical Laboratory Improvement Amendments representatives to respond to member questions about new rules, regulations, and guidance. The session also allows the FDA to present their current thinking on policies, regulations, guidance documents, and inspection programs relevant to their oversight of blood and human cells, tissues, and tissue-based products (HCT/P) programs. Questions for the session are submitted in advance to regulatory@aabb.org.

Learning Objectives

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

Moderator

Speaker Image for Karen Palmer
Karen Palmer, MT(ASCP), CQA(ASQ)
Director, Regulatory Affairs, AABB

Speakers

Speaker Image for Hanh Khuu
NIH CT Lab
Speaker Image for Carlos Villa
Carlos Villa, MD, PhD
Center for Biologics Evaluation and Research (CBER), Food & Drug Administration
Speaker Image for Susan Turcovski
Deputy Director, FDA Office of Regulatory Affairs Office of Biological Prdts Operations
Speaker Image for Anne Eder
Anne Eder, MD, PhD
Center for Biologics Evaluation and Research (CBER), Food & Drug Administration
Speaker Image for Carmelita Bibby
FDA, CBER, OBRR

Tracks

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