Lifecycle Goals

Plenary Session 5
Moderator:Zena Kaufman, Abbott Laboratories

While the PQS is applicable from development through product discontinuation, certain elements of the PQS become more or less relevant over the lifecycle. The principles of Quality by Design can be embraced during the development to assure a product, including the processes used to manufacture and test the product can be successfully commercialised. 

This session will look at approaches for applying the elements and the tools of the PQS into development of drug substance and drug product with the goal of smooth technology transfer into commercial launch. Moreover, this session will look at lessons learned through commercialisation and post market surveillance to effect continuous improvement of the product.

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Conference Highlights