By Paul Davies, President, Expo Technologies, LLC

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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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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Industry” conference in early May, CDER Deputy Director Keith Webber discussed Process Validation and the Agency’s new draft guidance, among other topics.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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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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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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FDA has made available a final version of its “Q8, Q9, and Q10: Questions and Answers” document, an updated version of previous Q&A documents that had been released by the ICH Quality Implementation Working Group.

The guidance is helpful for QbD professionals and trivia buffs alike. Some of the questions that are addressed:

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