Session: Quality-by-Design (QbD) Round Table Discussion Session: An Integrated and Science-Based Approach for Quality by Design (QbD) Implementation in Pharmaceutical Industry

As the FDA and the pharmaceutical industry work together to embrace the shift of pharmaceutical quality regulation towards Quality-by-Design (QbD), significant efforts and progress have been made in various CMC areas of pharmaceutical development, scale-up, manufacturing process control, instrumentations, etc. The invited speakers for this session will present real world case examples to share successful experiences and lessons learned, and to discuss challenges and opportunities associated with the implementation of QbD in the pharmaceutical community. An in-depth Q&A following the presentations should stimulate innovative ideas and strategies in the pharmaceutical CMC area.