Session Information
AABB Annual Meeting & CTTXPO 2011
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Biologic License Application Submissions for Cord Blood Licensure: The Real Story(ies)!
Track
:
QE - Quality Education
Program Code:
9122-QE-CT
Date:
Saturday, October 22, 2011
Time:
2:00 PM to 3:30 PM
PST
Location:
29 C/D
DIRECTOR
:
Rebecca Haley, MD, MT(ASCP)SBB, Medical director, Cord Blood Services, NMDP Donor and Apheresis Centers, Puget Sound Blood Center
MODERATOR
:
Donna Regan, MT(ASCP)SBB, Executive Director, St. Louis Cord Blood Bank
SPEAKER
(S):
Rebecca Haley, MD, MT(ASCP)SBB, Medical director, Cord Blood Services, NMDP Donor and Apheresis Centers, Puget Sound Blood Center
Joanne Kurtzberg, MD, Director, PBMT Director, CCBB at Duke, Duke University Medical Center
Dr. Salem Akel, PhD, Scientific/Laboratory Director, St. Louis Cord Blood Bank @SSM Cardinal Glennon Hospital
Description
The session will provide important insight into activities related to the application for licensure of those cord blood banks that meet the requirements of the guidance document issued by the FDA in October, 2009. The speakers will discuss their success as well as their re-dos on the way to licensure.
Joanne Kurtzberg did not give consent to being recorded or making presentation available
Joanne Kurtzberg did not give consent to being recorded or making presentation available
LEARNER OUTCOMES:
- Compare the processes of certifying classification air quality or not officially certifying air quality, what is required and necessary.
- Describe the specific accommodations that cord blood banks have made to qualify their operations for FDA licensure.
- Present several approaches to validation of rapid microbiological methods for cord blood banks.
- Show a dataset acceptable for an updated approach to expiration dating in cryopreserved products where the expiration has not yet been reached.
| 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: 9122-QE-CT)
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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