Session: Quality by Design In the Pharmaceutical Industry

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 product and drug substance processes. This session will be followed by a QbD roundtable panel discussion with invited speakers