238 Application of Quality By Design in API Process Development

Tuesday, November 18, 2014: 8:30 AM
203 (Hilton Atlanta)
Modernization of regulatory processes in the pharmaceutical industry has led to several innovative approaches to risk-based implementation of Quality by Design. Speakers for this session should include topics describing their application of QbD principles with examples of determination of critical process parameters (CPPs), mapping of design spaces (DS), real time process monitoring, and the determination of appropriate control strategies for small and large molecule drug substance processes.

Pharmaceutical Discovery, Development and Manufacturing Forum

Kevin Seibert
Email: seibert_kevin_d@lilly.com

Samrat Mukherjee
Email: samrat.mukherjee@abbvie.com

Partha Mudipalli
Email: Partha.Mudipalli@tevapharm.com

8:30 AM
(238a) Managing Residual Risk Via the Control Strategy: A Case Study
Luke Schenck, Shane T. Grosser, Marguerite Mohan, Brett Duersch and John Lepore

8:55 AM
(238b) Estimation of Product Robustness: Prediction of Manufacturing Variability
Jose E. Tabora, Nathan Domagalski, Jacob Albrecht, Ronald Behling, Jun Li, Gerard Sentveld, John R. Crison and Jennifer Walsh

9:20 AM
(238c) Digital Determination of Pars for the Synthesis of a Pharmaceutical Intermediate
Carla Luciani, Michael Kobierski, Allison Fields, Kevin Seibert, David Varie and Salvador García-Muñoz