Tuesday, November 6, 2007: 3:30 PM-6:00 PM
M - Salon B (Marriott Salt Lake City-Downtown)

Topical I: Pharmaceutical Engineering for the 21^st Century (TI)

#318 - Quality by Design (TI003)
Successes and Challenges in developing a Design Space, a PAT CMC, or risk based quality systems should be submitted here.
Chair:Christine Seymour
CoChair:Huiquan Wu
CoSponsor(s):Process Research and Innovation (12a)
3:30 PM Welcoming Remarks
3:35 PM318aAn Integrated Quality by Design Qbd Approach for Pharmaceutical Powder Blending Unit Operation: Process Monitoring, Endpoint Determination, and Concentration Quantification
Huiquan Wu, Mobin Tawakkul, Mansoor A. Khan
4:00 PM318bQuality By Design Using An Integrated Active Pharmaceutical Ingredient-Drug Product Approach To Development
Mary T. am Ende, Vincent E. McCurdy, Thomas P. Garcia, Frank Busch, Mark R. Berry
4:25 PM318cThe Use Of Routine Process Capability In The Determination Of Proven Acceptable Ranges (Pars) Critical Process Parameters (Cpps) And Mapping Of The Design Space For An Api Process
Kevin D. Seibert, Shanthi Sethuraman, Chad Wolfe
4:50 PM318dMathematical Modeling Of The Impact Of Raw Material Variabilities On Granule Particle Size Distribution During Fluidized Bed Granulation
Pavol Rajniak, Ecevit Bilgili, Rey Chern
5:15 PM318eSynchronized Approach to Developing Optimal Control and Design Spaces
Jerry D. Mitchell, Bernard McGarvey, Kumar Abhinava, Kevin Seibert, Shanthi Sethuraman, Kristi Griffiths
5:40 PM318fCorrelation between Excipient Characteristics and Product Properties through Numerical Simulations of Tablet Compaction
Athanas A. Koynov, Alberto Cuitino
6:05 PM318gCharacterizing the Influence of Raw Material and Process Variation on Product Quality and Yields
Chris McCready
6:30 PM Panel Discussion

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