Talk by Tom J. Monica “Quality by Design and the Process Validation Lifecycle”
Rathman Professor Matt Croughan and The Amgen Bioprocessing Center Present
"Quality by Design and the Process Validation Lifecycle"
Tom J. Monica, Ph.D.
Director of Process Development
FRIDAY, APRIL 26, 2013
Tom is currently the Characterization, Validation, In-process controls and Process Monitoring Global Lead at Amgen. In that role Tom leads a company wide network responsible for Amgen's strategy and in implementation of a Process Validation Lifecycle approach. He was a core team member of the group that developed Amgen's QbD based control strategy approach. Tom has 20 years of experience in the Biopharmaceutical industry, working at Bayer (and Berlex/Schering before its merger with Bayer), Genentech and Xoma, leading groups engaged in process transfer, process characterization and development, manufacturing support, and serving as an overall operations lead for late stage programs. Tom has a BS and MS in Chemical Engineering from Lehigh University, and a Ph.D. in Chemical Engineering from Stanford University.
|Where:||535 Bldg., 152 Classroom|
|When:||April 26, 2013, 10:30 a.m. - 12:00 p.m.|