Launching in the U.S.: FDA Transport Validation Compliance Essentials for European Manufacturers
Entering the U.S. market comes with a unique set of regulatory challenges, particularly when...
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How to Respond to Cold Chain Information Requests
How to Respond to Cold Chain Information Requests
Join Modality Solutions Andrew Larrigan, Technical Operations Manager, and Carson Dickey, Senior Consulting Engineer, in an informative webinar on how to respond to Cold Chain Information Requests from the FDA. Discover how we use Transport Simulation to mitigate agency concerns with thorough, acceptable responses.
During this 30-minute pre-recorded webinar, you will take away valuable information on:
- Real cold chain IR examples & discuss accepted responses
- How Transport Simulation mitigates FDA questions
- The benefits of using Transport Simulation instead of ASTM-ISTA approaches
- How using Transport Sim from the start can reduce potential IRs
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