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Session Information
AABB Annual Meeting and TXPO 2009
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Validation Rules and Regulations: How Do They Apply to Me?
Track : QE- Quality/Education
Program Code: 9123-QE-CT
Date: Saturday, October 24, 2009
Time: 2:00 PM to 3:30 PM  EST
Location: 388-390
DIRECTOR :
Ellen Areman, MS, SBB(ASCP), Regulatory Consultant, Ellen Areman Consulting, LLC
MODERATOR :
Ellen Areman, MS, SBB(ASCP), Regulatory Consultant, Ellen Areman Consulting, LLC
SPEAKER (S):
Lynn O'Donnell, PhD, Director, Cell Therapy Laboratory, The Ohio State University, James Cancer Hospital
Michele Sugrue, MS, MT(ASCP)SBB, Coordinator, Research Programs, University of Florida
Lizabeth Cardwell, MBA, MT(ASCP), Consultant, Compliance Consulting
Description
This session will describe the requirements for validation, verification and qualification of cell therapy processes, test methods and equipment. Speakers will describe approaches to validation based on the applicable regulatory requirements for different types of cell therapy products.

  • Describe the standards and FDA regulations related to validation.
  • Discuss approaches to validating release assays for cell therapy products subject to cGMP and/or cGTP regulations.
  • Explain how to design a validation protocol for a cell therapy procedure.


CE CategoryCE 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.

Handout Online
(Code: 9123-QE-CT)
Attendee: Free
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This session is a part of:
Online Offering(attendee only)
PURCHASE CON SET AABB Annual Meeting & CTTXPO 2009 Sync-to-slide Online Set - Full Meeting
Online Access
(Code: 9123MA/9123NA/9123MN/9123NN)
Attendee/Member:$25 USD
Attendee:$40 USD
Member:$40 USD
$50 USD - Your Price
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This session is a part of:
Online Offering(attendee only)
PURCHASE CON SET AABB Annual Meeting & CTTXPO 2009 Sync-to-slide Online Set - Full Meeting
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