2007 Annual Meeting

Session: Quality by Design

Chair

Seymour, C., Pfizer

Co-Chair

Wu, H., 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

04:00 PM

(318b) Quality By Design Using An Integrated Active Pharmaceutical Ingredient-Drug Product Approach To Development

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

04:50 PM

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

05:15 PM

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

05:40 PM

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

06:05 PM

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

06:30 PM

Panel Discussion