Session Information
AABB Audioconference Series 2011
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Ancillary Materials
Track
:
Cellular Therapy
Program Code:
114658
Date:
Wednesday, April 27, 2011
Time:
2:00 PM to 3:30 PM
EST
DIRECTOR
:
Elizabeth Read, MD, Professor, University of California, San Francisco
MODERATOR
:
Elizabeth Read, MD, Professor, University of California, San Francisco
SPEAKER
(S):
Elizabeth Read, MD, Professor, University of California, San Francisco
Fouad Atouf, PhD, Senior Scientific Liaison, US Pharmacopeia
Description
Manufacture of cellular therapy products incorporates the use of a broad range of ancillary materials, including culture media, human and animal serum, and cytokines. This program will review the regulatory requirements for ancillary materials, present USP's risk-based approach for their qualification, and provide examples of commonly used reagents and appropriate qualification activities.
- Define the term ancillary material in the context of cellular therapy product manufacturing.
- For 3 different ancillary materials, list 1-2 examples of qualification activities.
- Review regulatory requirements for description and qualification of ancillary materials.
- Summarize USP's risk-based approach to qualification of ancillary materials.
| 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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