Tag Archive | "PAT"

Emerson’s Herkt: Where Is the “Burning Ambition” for PAT/QbD?

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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Webber: Envisioning Control with “Almost No Chance of Failure”

At FDA’s “Partnering with Industry” conference in early May, CDER Deputy Director Keith Webber discussed Process Validation and the Agency’s new draft guidance, among other topics. (A previous post of Webber discussing whether PAT should be mandated or highly incentivized garnered quite a bit of interest, and so we are presenting more transcribed snippets from Webber’s talk, followed by “backpack” video of his presentation:

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Exploring Three-Letter Acronyms in Bethesda

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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Dangling a Carrot: Should PAT Be Mandated, or Incentivized?

At a May 11-12, 2010 conference on PAT and QbD in Bethesda, Maryland, Keith Webber, Deputy Director of FDA’s CDER, explained why the Agency will not mandate PAT for manufacturers. The “backpack video” is below.

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Are “Green” PAT and QbD Taking Root?

The cover story of Pharmaceutical Manufacturing’s May issue—“Green Processes: PAT and QbD Take Root”—looks at how drug manufacturers are beginning to leverage PAT, as well as QbD, to green their processes—that is, to reduce waste, save energy, cut back on solvent use, and so on. (The article was a follow-up to last fall’s “Pharma’s Green Evolution“, which focused on how manufacturers are going green at the facility level.) The piece explores how GSK, Allergan, DSM, and the industry in general are looking at PAT and QbD with an eye towards sustainability, and cites survey data from our readers.

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Baking Cookies: A Recipe for QbD Success?

Dr. Andrew Walsh’s “Contemporary Concepts in Pharmaceutical Validation” class at New Jersey’s Stevens Institute of Technology strives to teach the precepts of Quality by Design (from statistics to risk management) to graduate students prepping themselves for careers in the drug industry, even though many of those practices might not be commonly used within the industry . . . yet.

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