We are aware of an issue with certificate availability and are working diligently with the vendor to resolve. The vendor has indicated that, while users are unable to directly access their certificates, results are still being stored. Certificates will be available once the issue is resolved. Thank you for your patience.

(48c) Challenges and Opportunities for Process Systems Engineering Approaches to QbD and Design Space

Reklaitis, G. V., Purdue University

The key components of the QbD concept, namely, the Design Space and PAT, do draw extensively for their realization on tools from the domain of process systems engineering methodology. Both the challenges and the opportunities in adapting core PSE methodology, such as process modeling and simulation, process dynamics and control, monitoring and fault diagnosis, quantification of process uncertainty and risk, and product and process optimization,   to the development and manufacture of pharmaceutical products are  significant.  In this presentation we will review the progress made in the application of pse methods to this domain and outline some of the important developments that remain to be realized.