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Session Details

(9327) Ask the FDA & CMS/CLIA

Director/Moderator: M. Allene Carr-Greer, MT(ASCP)SBB

Speakers: Ellen Lazarus, MD, CAPT; Gilliam Conley, MA; Orieji Illoh, MD; Richard Davey, MD; Judy Ellen Ciaraldi; Jennifer Scharpf

Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs/CFOs

 

Objectives:

·      Describe FDA blood and HCT/P policies, regulations and inspection programs with an emphasis on the new rule for requirements for blood and blood components .

·      Describe Clinical Laboratory Improvement Amendments (CLIA) regulations that are applicable to blood and cellular therapy programs.


Event Description: This event provides an opportunity for discussion of FDA and CMS/CLIA policies, regulations, guidance documents and inspection programs that are relevant to the oversight of blood and HCT/P programs. FDA participants will provide an oversight of the new rule for requirements for blood and blood components. Questions for the discussion are submitted in advance via the AABB website.

Event Level: Intermediate