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2022 ISPE Annual Meeting & Expo

SES108c - Inspections from Global Regulators for CAR-T Products

Oct 31, 2022 1:45pm ‐ Oct 31, 2022 3:15pm


his presentation will outline a strategic playbook on how to prepare for and manage regulatory inspections from multiple, global health authorities. Key inspection readiness elements were identified and organized in a continuous improvement model, which has led to successful inspection outcomes, permitting patient access to life-saving therapies.


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