2012 AIChE Annual Meeting

Session: Application of Quality by Design in API Process Development

Presentations

12:30 PM

Welcoming Remarks

12:35 PM

(466a) Application of Quality by Design Principles for An Existing Product for the Control of the Dimer Impurity in the Manufacturing Process
Gautam Samanta, Praveen K Sharma, S Srividhya, Kamlesh Pai Fondekar, K R Janardan Sarma, Saurabh Gupta, Grb Ravish, Y Raghuram

12:55 PM

(466b) Investigation of the Impact of Mode of Operation (Batch vs Flow) On Design Space Map
Sze Wing Wong

01:15 PM

(466c) A QbD Approach to the Process Development of Tofacitinib
Bob Dugger

01:40 PM

(466d) Design of a Pharmaceutical Manufacturing Process Using QbD Principles: The Challenge of Technical Transfer to Manufacturing and Lifecycle Development
Conor Collins, Steve Ball

02:00 PM

(466e) Strategy and Process for Effective Scale-up On the Removal of Pd During the Synthesis of A Drug Substance
Alexander Chu-Kung, Hsien-Hsin Tung

02:20 PM

(466f) Implementation of Reaction Modeling and Process Analytical Technology in Design Space Development
Michael Fenster, Antonio Ramirez, Robert Wethman

02:40 PM

(466g) Application of Quality by Design in API Process Development
Nirav Shah, Conny Vikstrom, Erik Johansson

03:00 PM

Concluding Remarks