401 Application of PAT in the Manufacturing Setting

Wednesday, October 31, 2012: 8:30 AM
Allegheny II (Westin )
This section focuses on the use of Process Analytical Technologies to monitor, control, and gain a better understanding of Pharmaceutical manufacturing processes at commercial scales (drug products and drug substances (APIs)). Authors are encouraged to submit papers discussing case studies, research, and value-added applications of PAT in manufacturing settings as well as challenges overcome and lessons learned while implementing PAT in pharmaceutical manufacturing operations.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Systems and Process Control (10B)

Stelios Tsinontides
Email: stsinont@cephalon.com

Sharmista Chatterjee
Email: sharmista.chatterjee@fda.hhs.gov

- indicates paper has an Extended Abstract file available on CD.

File available
8:30 AM
(401a) Process Understanding Tools in PAT Implementations
Joao Machado, Tiago Robalo, Pedro Felizardo and Jose Menezes

8:55 AM

10:35 AM
(401f) Near Infrared Spectroscopy (NIRS): An Enabling Tool for Pharmaceutical Quality by Design (QbD)
K. Geoffrey Wu, Suhas Patankar, Lane V. Christensen, Robert A. Lionberger and Lawrence X. Yu