Session Information
AABB Annual Meeting and CTTXPO 2012
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Ask the FDA and CMS/CLIA
Track
:
QE - Quality Education
Program Code:
9328-QE
Date:
Monday, October 8, 2012
Time:
4:00 PM to 5:30 PM
EST
Location:
Ballroom East
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):
Sharon O'Callaghan, MT(ASCP), Consumer Safety Officer, FDA/CBER
Dr. Orieji Illoh, MD, Deputy Director, Division of Blood Applications, Food and Drug Administration
Paul Mintz, MD, Director, Division of Hematology Clinical Review, CBER FDA
Paul Mied, PhD, Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, CBER
Dr. Hira Nakhasi, PhD, Director, Division of Emerging and Transfusion Transmitted Diseases (DETTD)
Lore Fields, MT(ASCP)SBB, Consumer Safety Officer, FDA/OBRR/DBA/BPB
Judy Ellen Ciaraldi, BS, MT(ASCP)SBB, CQA(ASQ), Consumer Safety Officer, Food and Drug Administration
Ms. Teresita Mercado, MS, Chief, Devices Review Branch, FDA/CBER/OBRR
Ellen Lazarus, MD, CAPT, Director, Division of Human Tissues, FDA/CBER
Jaroslav Vostal, MD, PhD, Chief Laboratory of Cellular Hematology
Diane Maloney, JD
Dr. Jay Epstein, MD, Director, Office of Blood Research and Review, Food and Drug Administration
Alan Williams, PhD, Associate Director for Regulatory Affairs, Office of Blood Research and Review, CBER
Description
This event provides an opportunity for discussion of FDA and CLIA policies, regulations, guidance documents and inspection programs that are relevant to the oversight of blood and cellular therapy programs. Questions for the discussion are submitted before the scheduled session via the AABB website and at kiosks in the Cyber Connection, located in the Boston Convention & Exhibition Center.
- Interpret and describe Clinical Laboratory Improvement Act (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.
Online Access
(Code: 9328-QE/9328-QEA/9328-QE)
Annual Meeting Attendee/AABB Member:$25 USD
Non-Attendee/AABB Member:$40 USD
Annual Meeting Attendee/Non AABB Member:$40 USD
Non-Attendee/Non AABB Member $50 USD - Your Price
This session is a part of:
This session is a part of:
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