Session Information
AABB Audioconference Series 2011
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In the Trenches: Surviving FDA Inspection
Track
:
Cellular Therapy
Program Code:
114649
Date:
Wednesday, February 9, 2011
Time:
2:00 PM to 3:30 PM
EST
DIRECTOR
:
Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ), Administrative Director of Connell & O'Reilly Families, Dana Farber Cancer Institute
MODERATOR
:
J. Wade Atkins, CQA(ASQ), MS, MT(ASCP)SBB, Quality Assurance Specialist, National Institutes of Health
SPEAKER
(S):
Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ), Administrative Director of Connell & O'Reilly Families, Dana Farber Cancer Institute
Paul W. Eldridge, Ph.D.
Elizabeth Burns, Associate Director, Corporate Quality Assurance, Progenitor Cell Therapy
Description
This session will review the experience encountered by three facilities during their Food and Drug Administration (FDA) inspection for cellular therapy manufacturing. The presentations will cover the basics as well as how the inspection focus might be different based on the product types (361, 351, Facility / BLA) manufactured. Each presenters will also provide insight on how to manage the process, who should be present, what their inspectors focused on, what to do if the inspection is not moving in the right direction and ultimately how to respond to any 483s issued.
- Identify the difference between targeted vs general inspections
- Review the basic objectives of auditors during an inspection
- Review the preparation process for unannounced inspections
| CE Category | CE Value |
|---|---|
| California Clinical Laboratory Personnel | 1.5 |
| California Nurse | 1.9 |
| 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.
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