At the recent Interphex 2012 show in New York City, Agnes Shanley caught up with Chris Amstutz, Director of Life Science Industry Consulting at Emerson Process Management. In the video below, Amstutz provides a brief look at the recent progression of PAT and QbD in the drug industry.

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A fast-changing environment and slow-changing species can only lead to one thing—extinction, says Claus Weisemann, VP Quality & Regulatory Compliance for Grifols Biologicals. Weisemann should know, having seen the drug industry from myriad positions and companies over a long career. As such, he has developed a set of rules for moving manufacturing forward, from production to quality testing, and presents them in the video below with humor and passion. The video was filmed September 27, 2010, at the Emerson Global Users Exchange in San Antonio.

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Another video from this week’s Emerson Global Users Exchange (apologies for the inundation):

Why do key members of drug development teams struggle to work together? Claus Weisemann, VP Quality & Regulatory Compliance for Grifols Biologicals, speaking this week in San Antonio, says that automation engineers and chemists/biologists are not speaking the same language, and this needs to change.

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It’s one thing to change–and the drug industry is certainly doing just that–but quite another to change successfully. Those manufacturers who not only handle change but embrace it have a clear competitive advantage. Speaking yesterday in San Antonio, Emerson’s Melissa Herkt reminded an audience of automation engineers that change (such as that required by PAT and QbD) needs to be addressed enthusiastically and systematically.

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At FDA’s May 11-12 “Partnering with Industry” conference in Bethesda, Maryland, Emerson Process Management COO Melissa Herkt discussed the need—and opportunities—for change and inspirational leadership within pharma in order to drive PAT, QbD, and modern manufacturing excellence. (Video below.)

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By Agnes Shanley

Anyone looking for hopeful signs of change in the ongoing industry/FDA impasse on smart manufacturing–specifically, PAT and QbD–was bound to be disappointed by this week’s FDA “Partnering with Industry” meeting in Bethesda.

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