Session Information
AABB Annual Meeting & CTTXPO 2011
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Ask the FDA and CLIA
Track
:
QE - Quality Education
Program Code:
9326-QE
Date:
Monday, October 24, 2011
Time:
4:00 PM to 5:30 PM
PST
Location:
Ballroom 20A
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):
M. Allene Carr-Greer, MT(ASCP)SBB, Director, Regulatory Affairs, AABB
Jaroslav Vostal, MD, PhD, Chief Laboratory of Cellular Hematology
Paul Mied, PhD, Deputy Director, DETTD/OBRR/CBER, FDA
Sheryl Kochman, MT(ASCP)
Ellen Lazarus, MD, CAPT, Director, Division of Human Tissues, FDA/CBER
Richard Davey, MD, Director, Division of Blood Applications, Food and Drug Administration
Diane Maloney, JD
Alan Williams, PhD, Associate Director for Regulatory Affairs, Office of Blood Research and Review, CBER
Dr. Jay Epstein, MD, Director, Office of Blood Research and Review, Food and Drug Administration
Ms. Judy Ellen Ciaraldi, BS, MT(ASCP)SBB, CQA(ASQ), Consumer Safety Officer, Food and Drug Administration
Stephany Wesley
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 were submitted before the scheduled session via the AABB website beginning in September, 2011.
- 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.
Online Access
(Code: 9326-QE)
Attendee/Member:$25 USD
Attendee/Non-Member:$40 USD
Non-Attendee/Member:$40 USD
Non-Attendee/Non-Member $50 USD - Your Price
This session is a part of:
This session is a part of:
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