Session Information
AABB Annual Meeting and CTTXPO 2012
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The What, Where, When, Why and How of HCT/P Deviation Reportable Events
Track
:
QE - Quality Education
Program Code:
9303-QE-CT
Date:
Monday, October 8, 2012
Time:
8:30 AM to 10:00 AM
EST
Location:
Ballroom West
DIRECTOR
:
Lizette Caballero, MLS (ASCP)CM, Senior Supervisor, UCSF BMT Laboratory
MODERATOR
:
Lizette Caballero, MLS (ASCP)CM, Senior Supervisor, UCSF BMT Laboratory
SPEAKER
(S):
Sharon O'Callaghan, MT(ASCP), Consumer Safety Officer, FDA/CBER
Mrs. Lisa Phillips Johnson, MT(ASCP)SBB, CQA, CMQ/OE, RAC, Quality and Regulatory Affairs Director, Cleveland Cord Blood Center
Description
Reporting of events to regulatory agencies is an intimidating task. A recent article in the Journal of Blood Services Management, illustrated the common misconceptions of when and what to report to the FDA. This session will introduce scenarios to assess knowledge before and after the session. We will cover the five W's of event reporting Who, What, When, Where and Why. The scenarios will cover all aspects of cellular therapy IND and BLA products, apheresis, NMDP and international units.
- Determine how to report, when to report and who is responsible for reporting these events.
- Explain the rationale behind the HCT/P Deviation reportable events.
- Identify which events are reportable to the FDA or other agencies and which are not.
| 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: 9303-QE-CTAM/9303-QE-CT/9303-QE-CTA/9303-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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