Session Information
AABB Annual Meeting and TXPO 2009
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Ask the FDA and CLIA
Track
:
QE- Quality/Education
Program Code:
9330-QE
Date:
Monday, October 26, 2009
Time:
4:00 PM to 5:30 PM
EST
Location:
294-296
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
Hira L. Nakhasi, PhD, Director/DETTD/OBRR/CBER, Food and Drug Administration
Jaroslav Vostal, MD, PhD, Chief Laboratory of Cellular Hematology
Daralyn Hassan, MS, MT(ASCP), Medical Technologist, Centers for Medicare & Medicaid Services
Alan E. Williams, PhD, Director, Division of Blood Application, Food and Drug Administration
Sharon O'Callaghan, MT(ASCP), Consumer Safety Officer, FDA/CBER
Sheryl A. Kochman, MT(ASCP), Supervisory Biologist, FDA
Ms. Judy Ellen Ciaraldi, BS, MT(ASCP)SBB, CQA(ASQ), Consumer Safety Officer, Food and Drug Administration
Description
This event provides an opportunity for discussion of FDA and CLIA policies, regulations, guidance documents and inspection programs that are relevant to their oversight of blood and cellular therapy programs. Questions for the discussion are submitted before the scheduled session via the AABB web site beginning in September.
- 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: 9330MA/9330NA/9330MN/9330NN)
Attendee/Member:$25 USD
Attendee:$40 USD
Member:$40 USD
$50 USD - Your Price
This session is a part of:
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