Session 255 - Quality by Design- Invited Talks and Round Table Discussion


Pharmaceuticals
Session 255 - Quality by Design- Invited Talks and Round Table Discussion
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.
Chair:	Huiquan Wu
CoChair:	Christine Seymour
CoSponsor(s):	Process Development Division
	255a	FDA Update on Implementation of Quality by Design Christine M.V. Moore
	255b	Novartis/fda Crada Qbd Project – Real Life Case Studies of Qbd Applied to Active Pharmaceutical Ingredient and Drug Product Manufacturing Processes Marc Goeller
	255c	Particle Technology Gaps of Qbd Fernando J. Muzzio
	255d	Quality-by-Design (QbD) Case Study: Powder Blending Process Kinetics Evaluation Huiquan Wu, Mansoor A. Khan
	255e	Move the Boundary and Raise the Bar San Kiang, Shih-Ying Chang
	255f	The Role of ChEmical Engineering in Quality by Design Daniel R. Pilipauskas, David J. am Ende

Pharmaceuticals