Cell Product Handling & Regulatory 101 v2.0 2024-10
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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:
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Acknowledgement
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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
Summative Assessment
20 Questions | 2 attempts | 15/20 points to pass | Graded as Pass/Fail
20 Questions | 2 attempts | 15/20 points to pass | Graded as Pass/Fail
There are a total of 20 questions associated with this exam. You must achieve a total score of 93 out of 120 in order to pass.
You have two attempts to complete the exam. Any of the course resources made available to you in the course modules may be used during this examination.
