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Qbd Across Drug Product Operations

Monday, November 9, 2009: 3:15 PM
Hermitage D (Gaylord Opryland Hotel)

Description:
This session focuses on work where multiple steps in the drug product operation are considered simultaneously in a Design Space. Authors are invited to discuss the physical circumstance (how and why the multiple steps are linked) and the tools they used to quantify, visualize and define the design space


Sponsor:
Topical I: Comprehensive Quality by Design to Develop and Manufacture Pharmaceutical Products
Co-Sponsor(s):
Systems and Process Design (10a), Process Development Division (12), Pharmaceuticals (15b)


Chair:
Mary T. Am Ende
Email: mary.t.am.ende@pfizer.com

Co-Chair:
John Strong
Email: john.strong@abbott.com


3:15 PM
(166a) Design Space Continuum: From Drug Substance to Drug Product
T. Kourti

3:35 PM
(166b) Implementing Risk- and Knowledge Management Tools Into Product- and Process Development According to Quality by Design
Brigitte Guebitz, Johannes Fritz, Hubert Schnedl, Siegfried Adam, Stefan Radl and Johannes Khinast

3:55 PM
(166c) Application of QbD Principles to Analytical Methods
Kimber Rundlett

4:15 PM
(166d) The Development of Methods to Link Design Space Models to Product Stability
Zhixin Zong, Peter L. Wildfong, Lee E. Kirsch, Aditya M. Kaushal, Eric J. Munson, Raj Suryanarayanan, Dewey H. Barich, Kalyana Pingali, Fernando J. Muzzio, Defne Kayrak-Talay, Salil D. Desai and Ira Shea Buckner

4:35 PM
(166e) Establishing Appropriate Particle Size Specifications for Solid Oral Dosage Forms
Zhigang Sun

4:55 PM
(166f) Using QbD Approaches to Enable Development of Real Time Release for a Continuous Drug Product Process
David C. A. Sharp

5:15 PM
(166g) Multivariate Texture and Image Analysis for Solid Dosage Intermediate and Final Product Characterization and Downstream Performance Prediction
Salvador Garcia-Munoz and Alan Carmody
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture