Tag Archive | "AIChE"

No Campaigning, But Plenty of Worthy Candidates

AIChE is again accepting nominations for its Excellence in QbD awards, to be presented at its annual meeting in Pittsburgh this fall. Now is the time to “nominate an engineer or scientist from industry, academia or regulatory.

There are three awards handed out:

  • Excellence in QbD for Drug Substance, sponsored by DynoChem (Scale-up Systems)

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Snippets from AIChE: Navigating QbD’s Shades of Gray

Last Wednesday at AIChE 2011 in Minneapolis, speakers from FDA and industry joined in a Round Table discussion on Quality by Design regulatory filings. What follows are some snippets from the open forum. Among the questions raised: Do we really need to distinguish between a QbD and non-QbD filing? How do we get upper management on board for QbD? How do chemical engineers get regulatory professionals believing in a QbD approach?

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Envelope Please: AIChE Hands Out QbD Awards

In Minneapolis on Tuesday night, Joe Hannon, CEO of Scale-up Systems (DynoChem), noted how the Quality by Design track at this year’s AIChE annual meeting in Minneapolis was “more like going to M.I.T. than Las Vegas”–substance over glamor, in other words.

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QbD for Analytical Methods: FDA and Industry Perspectives

By Paul Thomas, Senior Editor

At AIChE 2011 in Minneapolis today, FDA’s Elaine Morefield, PhD, Deputy Director of the Office of New Drug Quality Assessment, spoke on “FDA Perspectives on QbD for Analytical Methods.” The topic has two sides, she said: using methods in QbD, and using QbD for methods and methods development.

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BMS’ Tabora: For PAT and QbD, the Exotic is Becoming Routine

By Paul Thomas, Senior Editor

On October 18 in Minneapolis, Dr. Jose Tabora of Bristol-Myers Squibb will be honored with the 2011 AIChE Award for Outstanding Contribution to Quality by Design for Drug Substance. The award is sponsored by DynoChem Inc., the North American subsidiary of Scale-up Systems Limited. (Two other awards—one for QbD for Drug Product, sponsored by Pfizer, and one for Excellence in Integrated QbD Practice, sponsored by Merck—will also be handed out that evening. More on those recipients to come soon.)

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Who Shows Excellence in QbD? Nominate Now

This year AIChE will once again hand out prizes for Excellence in QbD, following the first-ever awards last year. (Here’s a look at those 2010 winners.) A new award sponsored by Merck will be added to existing awards sponsored by Pfizer and DynoChem. The full list:

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