Essentials of Cell Therapy Product Manufacturing, Qualification and Validation v.2024-06
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Essentials of Cell Therapy Product Manufacturing, Qualification and Validation
Designed for experienced CGT staff and lab managers to learn topics related to process validation and manufacturing.
- Developing a CAR-T Program
- Does terminology matter?
- Practical FDA recommendations
- Test method qualification requirements
- Has the goalpost been moved?
- Starting materials for IND-type products (tissues, cell lines) and manufacturing
- Developing a Validated Assay That Will Please the FDA
- Assay qualification or validation
- Potency assay
- Stability testing
- Role of Manufacturing in Regulatory Submissions
- CMC preparation and expectations
- Considerations in filing an IND, FDA pathways, and designations
- FDA interactions
- Cryopreservation and Stability
- Cryopreservation
- Thawing methods
- Stability studies
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.
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Acknowledgement
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Non-Distribution Statement for Content and Exam Materials
Session 1 Recording: Developing a CAR-T Program
Open to view video.
Open to view video.
F. Enrique Alvarez, BS, MLS (ASCP)CM, CQA (ASQ) & Indresh Kaur, PhD
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
17 Questions | 3 attempts | 13/17 points to pass | Graded as Pass/Fail
17 Questions | 3 attempts | 13/17 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%.