Session: Integrated QbD Approach for Design Space Development Including Real Time Release (2011 Annual Meeting)

Thursday, October 20, 2011: 8:30 AM

Symphony III (Hilton Minneapolis)

Description:

Quality by design approach is best implemented if it is integrated as part of the development process. Case studies demonstrating the integration of QbD into development and the benefits gained from a manufacturing, regulatory, quality and financial perspective will be presented. Improvements or lessons learned from the intergration of QbD should be highlighted. The session will also focus on the use of QbD principles as they relate to real time release regulatory applications and approvals.

Sponsor:

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Co-Sponsor(s):

Pharmaceuticals (15b)

Chair:

Nancy E. Sever
Email: nancy.sever@abbott.com

Co-Chair:

Adam Siegfried
Email: siegfried.adam@rcpe.at

- indicates paper has an Extended Abstract file available on CD.

8:30 AM

(655a) Managing Uncertainty In Design Space
Patrick J. Whitcomb and Mark Anderson

8:50 AM

(655b) An Integrated Design Space Involving All Unit Operations in Tablet Manufacturing
Theodora Kourti

9:10 AM

(655c) Design Space Definition Using a Variational Bayes' Approximation
Linas Mockus, José Miguel Laínez, Lee E. Kirsch and Gintaras V. Reklaitis

9:30 AM

(655d) A Data-Driven Modeling Approach Using the Design of Dynamic Experiments Methodology In Calculating the Design Space of Batch Pharmaceutical Processes
Christos Georgakis

9:50 AM

(655e) Dynamic Design Space As An Integrated Component of Quality by Design
Benoit Igne, Carl A. Anderson and James K. Drennen III

10:10 AM

(655g) Dissolution Testing of Prednisone and Salicylic Acid Calibrator Tablets At Different Tablet Locations
Anandhavalavan Arulmozhi and Piero M. Armenante

See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

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