Tag Archive | "Pfizer"

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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QbD and FDA’s Process Validation Guidance: Square Peg, Round Hole?

By Paul Thomas, Senior Editor

At the beginning of his talk at last week’s Bioprocess Development & Production Week event in San Diego, Amit Banerjee, a research fellow in global biologics with Pfizer, posed the following question: Is the QbD approach aligned with FDA’s new Process Validation guidance?

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Panel: Is QbD Too Great a Burden on Small Manufacturers?

By Paul Thomas, Senior Editor

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Memoirs from IFPAC 2012

By Emil Ciurczak, Contributing Editor

Sunday, January 22, 2012

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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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