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Cell Product Handling & Regulatory 101 v.2023-09

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Cell Product Handling & Regulatory 101

Designed for any beginners to the CGT field to learn the basics of manufacturing a cell therapy treatment.

  • Collections
    • Cell sources and how they are collected (apheresis, bone marrow, cord blood)
    • Comparison of the different cell sources (apheresis vs bone marrow vs cord blood)
    • Types of donors (haploidentical, matched related, matched unrelated)
    • Donor suitability and eligibility
  • Processing and QC
    • Basic processing techniques
    • Manual vs automated systems
    • Fundamentals & advances in processing and manufacturing – the example of RBC reduction
  • Quality Assurance/Regulatory
    • Operational GTPs
    • Nonconformities & deviations: communication & roles
    • Product release
  • Product Storage, Distribution & Logistics
    • Scheduling, orders & communication
    • Shipping vs transportation
    • Equipment associated with storage and distribution
    • Thawing, tracking

Key:

Complete
Failed
Available
Locked
Collections
Session 1 Recording: Collections
Open to view video.
Open to view video. Federico Rodriguez Quezada, SBB, MLS(ASCP)
You must register to access.
Session 1 Slides: Collections
Open to download resource.
Open to download resource. Federico Rodriguez Quezada, SBB, MLS(ASCP)
You must register to access.
Processing and Quality Control
Session 2 Recording: Processing and Quality Control
Open to view video.
Open to view video. Darin Sumstad, MLS(ASCP)
You must register to access.
Session 2 Slides: Processing and Quality Control
Open to download resource.
Open to download resource. Darin Sumstad, MLS(ASCP)
You must register to access.
Quality Assurance/ Regulatory
Session 3 Recording: Quality Assurance/ Regulatory
Open to view video.
Open to view video. Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ)
You must register to access.
Session 3 Slides: Quality Assurance/ Regulatory
Open to download resource.
Open to download resource. Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ)
You must register to access.
Product Storage, Distribution & Logistics
Session 4 Recording: Product Storage, Distribution & Logistics
Open to view video.
Open to view video. Ljiljana Vasovic, MD
You must register to access.
Session 4 Slides: Product Storage, Distribution & Logistics
Open to download resource.
Open to download resource. Ljiljana Vasovic, MD
You must register to access.
Course Assessment
Course Evaluation Form
11 Questions
11 Questions Participants must complete this feedback survey to receive a Certificate of Participation
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Certificate of Participation
No credits available  |  Certificate available
No credits available  |  Certificate available
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Course Quiz
13 Questions  |  3 attempts  |  10/18 points to pass  |  Graded as Pass/Fail
13 Questions  |  3 attempts  |  10/18 points to pass  |  Graded as Pass/Fail Participants must complete this quiz to receive a Certificate of Completion for CE hours. The passing score for this quiz is 80%.
You must register to access.
Certificate of Completion
No credits available  |  Certificate available
No credits available  |  Certificate available
You must register to access.