(255b) Novartis/fda Crada Qbd Project – Real Life Case Studies of Qbd Applied to Active Pharmaceutical Ingredient and Drug Product Manufacturing Processes

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Since 2006, teams from Novartis Pharmaceuticals Corp. and the FDA's Division of Product Quality Research have been collaborating through a Cooperative Research and Development Agreement (CRADA) on the implementation of Quality by Design principles to the API and Drug Product manufacturing processes of a commercial product. This presentation will therefore consist of case studies extracted from this pilot project and will also highlight the key lessons learned.