Session Information
AABB Annual Meeting and CTTXPO 2012
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Mysteries of a Quality Control Unit (QCU)
Track
:
QE - Quality Education
Program Code:
9313-QE-CT
Date:
Monday, October 8, 2012
Time:
10:30 AM to 12:00 PM
EST
Location:
205C
DIRECTOR
:
Laura Gindy, MT(ASCP)SBB, CQA(ASQ), Compliance and Quality Director, StemCyte
MODERATOR
:
Laura Gindy, MT(ASCP)SBB, CQA(ASQ), Compliance and Quality Director, StemCyte
SPEAKER
(S):
Laura Gindy, MT(ASCP)SBB, CQA(ASQ), Compliance and Quality Director, StemCyte
Christianna Henderson, BSc(MT), Senior Clinical Sceintist, SSM Cardinal Glennon Children's Medical Center
Bernadette Keane, BSc, VP Quality, bluebird bio
Eva Quinley, MS, MT(ASCP)SBB, CQA(ASQ), Chief Operating Officer/Regional Executive Director, MEDIC Regional Blood Center/ITxM
Description
QCU is not a new concept and has been used by the pharmaceutical industry for many years. However, it is a new concept for the cellular therapy field and especially for cord blood facilities. The FDA guidance for industry for obtaining a BLA license for cord blood specifies the need for a QCU and outlines the QCU responsibilities. This session will discuss the regulations concerning QCU responsibilities found in the guidance. Several examples of QCUs in different-sized facilities will be presented, including a large and small cord blood bank facility and a pharmaceutical company.
Bernadette Keane did not consent to presentation capturing and recording.
Bernadette Keane did not consent to presentation capturing and recording.
LEARNER OUTCOMES:
- Define a (QCU) in a good manufacturing (GMP) cellular therapy facility (currently cord blood facilities) and discuss the FDA regulations concerning it.
- Discuss how QCUs fulfill the FDA requirements and still fit into the laboratory workflow.
- Illustrate how pharmaceutical QCUs may be similar to or different from cellular therapy (cord blood) QCUs.
- Present three different examples of setting up a QCU, including one from a large cord blood facility, one from a small cord blood facility and one from a pharmaceutical company.
| 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: 9313-QE-CTAM/9313-QE-CT/9313-QE-CTA/9313-QE-CT)
Annual Meeting Attendee/AABB Member:$25 USD
Non-Attendee/AABB Member:$40 USD
Annual Meeting Attendee/Non AABB Member:$40 USD
Non-Attendee/Non AABB Member $50 USD - Your Price
This session is a part of:
This session is a part of:
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