Session Information
AABB Audioconference Series 2014
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Deviation Reporting: Hematopoietic Progenitor Cells
Track
:
Cellular Therapy
Program Code:
144825
Date:
Wednesday, September 17, 2014
Time:
2:00 PM to 3:30 PM
EST
DIRECTOR
:
Ms. Fran Rabe, MS, CQM(ASQ), Director of Quality Assurance, University of Minnesota
SPEAKER
(S):
Sharon O'Callaghan, MT(ASCP), Consumer Safety Officer, FDA
Angie Ondo, MT(ASCP), BMT/CTL Quality Assurance Manager, Johns Hopkins Hospital
Description
Cellular therapy product deviation reporting to the U.S. Food and Drug Administration (FDA) is dependent on the regulatory categorization of the product. This presentation breaks down the regulatory requirements specific to 361 and 351 products and provides information related to when and how to report to the FDA. Real life deviation case studies provide practical examples of the application of the correct product deviation code.
- Differentiate and use of the FDA Product Deviation codes.
- Discuss the FDA regulatory requirements for reporting of 361 and 351 HCT/P product deviations to the agency.
- Provide real-life case study application of Product Deviation Codes.
| 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.
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