Session Information
AABB Annual Meeting and CTTXPO 2010
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Ask the FDA and CMS/CLIA
Track
:
QE- Quality Education
Program Code:
9330-QE
Date:
Monday, October 11, 2010
Time:
4:00 PM to 5:30 PM
EST
Location:
Ballroom II
DIRECTOR
:
M. Allene Carr-Greer, MT(ASCP)SBB, Director, Regulatory Affairs, AABB
MODERATOR
:
M. Allene Carr-Greer, MT(ASCP)SBB, Director, Regulatory Affairs, AABB
SPEAKER
(S):
Dr. Jay Epstein, MD, Director, Office of Blood Research and Review, Food and Drug Administration
Paul Mied, PhD, Deputy Director, DETTD/OBRR/CBER, FDA
Alan Williams, PhD, Associate Director for Regulatory Affairs, Office of Blood Research and Review, CBER
Daralyn Hassan, MS, MT(ASCP), Medical Technologist, Centers for Medicare & Medicaid Services
Jaroslav Vostal, MD, PhD, Chief Laboratory of Cellular Hematology
Sharon O'Callaghan, MT(ASCP), Consumer Safety Officer, FDA/CBER
Hira L. Nakhasi, PhD, Director/DETTD/OBRR/CBER, Food and Drug Administration
Lore Fields, MT(ASCP)SBB, Consumer Safety Officer, FDA/OBRR/DBA/BPB
Ms. Judy Ellen Ciaraldi, BS, MT(ASCP)SBB, CQA(ASQ), Consumer Safety Officer, Food and Drug Administration
Richard Davey, MD, Director, Division of Blood Applications, Food and Drug Administration
Linda Weir, BS, MT(ASCP), Consumer Safety Officer
Ellen F. Lazarus, MD, CAPT, USPHS, Medical Officer, Food and Drug Adminstration
Diane Maloney, JD
Ms. Penelope Meyers, MA, MT(ASCP)SBB, Medical Technologist, Division of Laboratory Services, Centers for Medicare & Medicaid Services
TENTATIVE DIRECTOR
:
M. Allene Carr-Greer, MT(ASCP)SBB, Director, Regulatory Affairs, AABB
Description
This event provides an opportunity for discussion of FDA and CLIA policies, regulations, guidance documents, and inspection programs that are relevant to oversight of blood and cellular therapy programs. Questions for the discussion are submitted before the scheduled session via the AABB Web site.
- Interpret and describe CLIA regulations that are applicable to blood and cellular therapy programs.
- Interpret and describe FDA blood and cellular therapy policies, regulations and inspection programs.
| CE Category | CE Value |
|---|---|
| California Clinical Laboratory Personnel | 1.5 |
| California Nurse | 1.8 |
| Florida Laboratory Personnel | 1.8 |
| General Attendee | 1.5 |
| Physician | 1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.
This session is a part of:
Online Access
(Code: 9330-QE)
Attendee/Member:$25 USD
Attendee:$40 USD
Member:$40 USD
Non-Attendee/Non-Member $50 USD - Your Price
This session is a part of:
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