Quality by Design | AIChE

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Quality by Design

Chair(s)

Seymour, C., Pfizer

Co-chair(s)

Wu, H., FDA

Successes and Challenges in developing a Design Space, a PAT CMC, or risk based quality systems should be submitted here.

Presentations

3:30 PM
Welcoming Remarks
3:35 PM
(318a) An Integrated Quality by Design Qbd Approach for Pharmaceutical Powder Blending Unit Operation: Process Monitoring, Endpoint Determination, and Concentration Quantification
4:00 PM
(318b) Quality By Design Using An Integrated Active Pharmaceutical Ingredient-Drug Product Approach To Development
4:25 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
4:50 PM
(318d) Mathematical Modeling Of The Impact Of Raw Material Variabilities On Granule Particle Size Distribution During Fluidized Bed Granulation
5:15 PM
(318e) Synchronized Approach to Developing Optimal Control and Design Spaces
5:40 PM
(318f) Correlation between Excipient Characteristics and Product Properties through Numerical Simulations of Tablet Compaction
6:05 PM
(318g) Characterizing the Influence of Raw Material and Process Variation on Product Quality and Yields
6:30 PM
Panel Discussion

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Pricing

Individuals

AIChE Pro Members $150.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
AIChE Explorer Members $225.00
Non-Members $225.00

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