2007 Annual Meeting

Session: Quality by Design

Chair

Christine Seymour, Pfizer

Co-Chair

Huiquan Wu, FDA

Presentations

03:30 PM

Welcoming Remarks

03:35 PM

(318a) An 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

04:00 PM

(318b) Quality 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

04:25 PM

(318c) The 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

Shanthi Sethuraman, Chad Wolfe

04:50 PM

(318d) Mathematical Modeling Of The Impact Of Raw Material Variabilities On Granule Particle Size Distribution During Fluidized Bed Granulation

Pavol Rajniak, Rey Chern

05:15 PM

(318e) Synchronized Approach to Developing Optimal Control and Design Spaces

Jerry D. Mitchell, Bernard McGarvey, Kumar Abhinava, Kevin Seibert, Shanthi Sethuraman, Kristi Griffiths

05:40 PM

(318f) Correlation between Excipient Characteristics and Product Properties through Numerical Simulations of Tablet Compaction

Athanas A. Koynov, Alberto Cuitino

06:05 PM

(318g) Characterizing the Influence of Raw Material and Process Variation on Product Quality and Yields

Chris McCready

06:30 PM

Panel Discussion