(255b) Novartis/fda Crada Qbd Project – Real Life Case Studies of Qbd Applied to Active Pharmaceutical Ingredient and Drug Product Manufacturing Processes
AIChE Annual Meeting
2008
2008 Annual Meeting
Food, Pharmaceutical & Bioengineering Division
Quality by Design- Invited Talks and Round Table Discussion
Tuesday, November 18, 2008 - 8:55am to 9:20am
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.