2014 AIChE Annual Meeting

Session: Application of Quality By Design in API Process Development

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.

Chair

Co-Chairs

Samrat Mukherjee, AbbVie Inc.

Presentations

08:30 AM

Luke Schenck, Shane T. Grosser, Marguerite Mohan, Brett Duersch, John Lepore

08:55 AM

Jose E. Tabora, Nathan Domagalski, Jacob Albrecht, Ronald Behling, Jun Li, Gerard Sentveld, John R. Crison, Jennifer Walsh

09:20 AM

Carla Luciani, Michael Kobierski, Allison Fields, Kevin Seibert, David Varie, Salvador Garcia-Munoz

09:45 AM

10:10 AM