Cell Product Handling & Regulatory 101 v.2024-06
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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
Participants will receive a certificate of completion upon completing and passing the module assessments. Participants will receive a certificate of participation upon completing the course evaluation survey.
Key:
Complete
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Acknowledgement
Agree to terms to continue.
Agree to terms to continue.
Non-Distribution Statement for Content and Exam Materials
Course Evaluation Form
10 Questions
10 Questions
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Certificate of Participation
No credits available | Certificate available
No credits available | Certificate available
Course Quiz
13 Questions | 3 attempts | 10/13 points to pass | Graded as Pass/Fail
13 Questions | 3 attempts | 10/13 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%.
