As FDA continues to facilitate the modernization of regulatory processes related to pharmaceutical products in the 21st Century, there has been an over-whelming desire for real world case studies (1) to illustrate the utilization of the risk-based and integrated approach for QbD implementation; and (2) to characterize the scientific merits highlighted in the regulatory documents. The invited speakers for this session will present real world case examples, in conjunction with discussion on challenges and opportunities associated with the implementation of QbD. An in-depth Q&A following the presentations should stimulate innovative researches in the pharmaceutical CMC area.

Pharmaceuticals

Process Development Division (12)