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