2016 AIChE Annual Meeting

Session: Quality By Design in Drug Substance 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

Joe Hannon, DynoChem Inc

Co-Chair

Kevin Seibert, Eli Lilly and Company

Presentations

08:30 AM

Michael Ryan, David Willcox, Patricia Hurter, Thomas Gandek, Adam Looker, Drew Kuzmission, Geny Doss, Stephanie Krogmeier, Derek Vrieze, William Rowe

08:51 AM

09:12 AM

09:33 AM

09:54 AM

Carla Luciani, Salvador Garcia-Munoz, Kevin Seibert, Eric Crick, Thomas Wilson, Michael Kobierski, Colm O'Mahony

10:15 AM

10:36 AM