Switching Thermal Packaging Mid-Approval: What FDA Regulations Actually Require
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Cold Chain Validation Best Practices Including Immunotherapy
Cold Chain Validation Best Practices Including Immunotherapy
Join Modality Solutions principals, Gary Hutchinson and Daniel Littlefield, in an informative webinar on how to successfully integrate and validate your biopharmaceutical cold chain including immunotherapies.
During this 45-minute pre-recorded webinar, you will take away valuable information on:
- Integrating stability data and testing for environmental hazards during transport of your drug product into a Validation Master Plan for cold chain distribution
- Qualifying your transport lanes with an Operational and Performance Qualification approach
- How ASTM D4169 is not enough — Drug Product Testing for Distribution vs. Packaging Qualification Testing
- Understanding how Immunotherapies — ADCs and T-cell therapy have especially complex cold chains. This complexity presents challenges in the tracking, traceability, and storage of the cells a large risk in the treatment process. New validation approaches based on regulatory responses to previously submitted immunotherapy cold chains are presented in the webinar
- Putting it all together for filing and inspection — why go it alone?
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