DIRECTOR
:
SPEAKER
(S):
Elina Linetsky, MT, PhD, Director , Quality Assurance/Regulatory Affairs, cGMP Cell Transplant Center, DRI, UM
Challenges of Real Time Cellular Therapy Product Evaluation
Janice Davis-Sproul, MAS, MT(ASCP)SBB, Manager, Cell Therapy Laboratory, Johns Hopkins Medicine
Challenges of Real-Time Cell Therapy Product Evaluation
Sharon Tindle, MS, CQA (ASQ), QA Project Manager, BMT Tissue Services, Mount Sinai Hospital
Challenges of Real Time Product Evaluation: Testing of Hematopoietic Progenitor Cell Products
Description
Cell therapy (CT) products must be tested and then released for distribution to ensure that products that do not meet specified requirements are either not distributed or are handled appropriately to ensure the safety of patients. A challenge is testing and release of novel cell therapy products. These seemingly simple issues actually present many significant challenges for CT Laboratories. How many replicates should be performed? When is repeat testing permitted and how is it handled? How do you release a product from overseas in the middle of the night? Who needs to approve and be notified of exceptional release of products that do not pass all testing and how is that handled? What type of testing is applicable to novel cell therapy products? These challenges and how they are met will vary depending on the size of the laboratory and the complexity of the manufacturing process. A panel of speakers from facilities of different sizes and organizational structures will discuss how they would handle different testing and release scenarios. Audience response devices will also be utilized in what promises to be a highly interactive session.
LEARNER OUTCOMES:
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Compare strategies for exceptional release of CT products that fail to meet release criteria.
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Compare strategies for release of novel cell therapy products.
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Discuss and compare lot release testing for different products such as HPCs, somatic cells, MSCs, etc.
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Discuss various approaches to handling release of products in low staffing situations such as small laboratories or nights and weekend shifts.
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Review how different types of CT facilities handle problems encountered during product testing.
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.