MODERATOR
:
M. Victor Lemas, PhD, Laboratory Director, Cell Therapy Lab, Johns Hopkins Medicine
SPEAKER
(S):
M. Victor Lemas, PhD, Laboratory Director, Cell Therapy Lab, Johns Hopkins Medicine
Mr. F. Enrique Alvarez, BS, MLS(ASCP)CM, CQA(ASQ), Assistant Director, Cell Therapy Laboratory, UT MD Anderson Cancer Center
9304-QE-CT: Product Testing 101 - Are The Cells Safe To Use?
Ellen Areman, MS, SBB(ASCP), Regulatory Consultant, Ellen Areman Consulting, LLC
Testing the CT Product - Regulatory Considerations
Michael Creer, MD, Director, Clinical Laboratories and Chief, Clinical Pathology, Penn State Hershey Medical Center
HCT Product Testing 101: What's in the Bag?
Description
Every cell therapy (CT) product must be tested prior to release and distribution to ensure that specified requirements for safety, purity and potency have been met. Speakers will review the most common test methods for routine CT products, such as hematopoietic progenitor cells (HPC) from blood, marrow and cord blood, as well as a few investigational CT products. Bringing a new or modified test method online presents special challenges to ensure that reported results are accurate and robust, that technologists are both competent and proficient and that clinicians understand the clinical implications of new or modified tests. Approaches to meet these challenges will also be presented.
LEARNER OUTCOMES:
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Describe test methods for manipulated, cultured and other products that might require tests such as mycoplasma, endotoxin or functional evaluations.
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Discuss strategies for implementation of common CT test methods.
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Review regulations and accreditation standards related to CT product testing.
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Review test methods, kits, tools and other resources for common, established CT product tests such as cell counts, viability, flow cytometry and CFU assays.
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.