Tuesday, November 18, 2008: 8:30 AM-12:00 PM
Room 109-B (Pennsylvania Convention Center)

Pharmaceuticals (15b)

#255 - Quality by Design- Invited Talks and Round Table Discussion (15B03)
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 (12)
8:30 AMFDA Update on Implementation of Quality by Design
Christine M.V. Moore
8:55 AMNovartis/fda Crada Qbd Project Real Life Case Studies of Qbd Applied to Active Pharmaceutical Ingredient and Drug Product Manufacturing Processes
Marc Goeller
9:20 AMParticle Technology Gaps of Qbd
Fernando J. Muzzio
9:45 AMQuality-by-Design (QbD) Case Study: Powder Blending Process Kinetics Evaluation
Huiquan Wu, Mansoor A. Khan
10:10 AMMove the Boundary and Raise the Bar
San Kiang, Shih-Ying Chang
10:35 AMThe Role of Chemical Engineering in Quality by Design
Daniel R. Pilipauskas, David J. am Ende

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