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

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.