Validating your cold chain to meet and exceed increasingly stringent regulatory expectations in today’s global market is a challenge.
With more than 35 international cold chain regulatory compliance guidance documents, global standards are becoming more comprehensive and increasingly complex. The testing strategies historically used to test packing only (i.e., ASTM, ISTA) is no longer considered a comprehensive test to confirm drug product integrity for regulators around the globe.
Key learning objectives
- Integrate transport simulation testing for environmental hazards into your filing strategy
- Understand why ASTM and ISTA package testing is not acceptable for drug product testing
- Learn the challenges of “real world” testing and why it is less reliable than transport simulation
- Discuss the challenges to “real world” shipment testing in a post-COVID-19 transportation network
- Join industry experts Gary Hutchinson and Dan Littlefield from Modality Solutions in this engaging and informative webinar on how to successfully integrate transport simulation into your biopharmaceutical filing.
Modality Solutions has access to the latest regulatory agency requirements for emerging new therapies and will share how to successfully validate your biopharmaceutical cold chain with transport simulation. Register today for the webinar on a better approach to “real world” shipping tests using transport simulation technology.
There will also be a live Q&A at the conclusion of the presentation.
The webinar will take place on 2 December 2020 at 6PM London / 1PM New York / 10AM San Francisco.
Can’t make the scheduled time? Register and we will send you the recording of the complete webinar.