Tuesday, October 18, 2011: 8:30 AM
Symphony III (Hilton Minneapolis)
Description:
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.
Sponsor:
Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsor(s):
Pharmaceuticals (15b)
Chair:
Co-Chair:
- indicates paper has an Extended Abstract file available on CD.
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture