As FDA continues to facilitate the implementation of Quality-by-Design (QbD) for pharmaceutical process/product development and manufacturing in the 21st Century, a great amount of challenges and opportunities are emerging from various aspects across industry, regulatory, and academia. This calls for collaborative efforts among various stakeholders. In this session, leaders and authority in various fields will be invited to present their views to address some of the critical issues and point out some of the future directions for QbD Implementation. Opportunities pertinent to the chemical engineering discipline will be highlighted.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Pharmaceuticals (15b)