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Biotech R&D Demanding New Analytical Techniques, Technologies An Invitation from PMcG Consulting to Attend the 5th Evening QbD Discussion Group Teva Changing Their Approaches With Quality by Design Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications Tech Transfer in the Age of QbD
 
Biotech R&D Demanding New Analytical Techniques, Technologies

Biotech R&D Demanding New Analytical Techniques, Technologies

Q&A with Dr E. Neil Lewis, Chief Technology Officer, Malvern Instruments

An Invitation from PMcG Consulting to Attend the 5th Evening QbD Discussion Group

An Invitation from PMcG Consulting to Attend the 5th Evening QbD Discussion Group

This discussion group activity provides the opportunity to get up to speed with the current status and future trends of analytical method qualification. Guest speaker will be: Dr. Phil Nethercote, Glaxo SmithKline Inc.  Read more...

Teva Changing Their Approaches With Quality by Design

Teva Changing Their Approaches With Quality by Design

Teva committed to QbD methodology implementation in late 2010. Inna Ben-Anat, QbD Strategy Leader, leads the ‎implementation at Teva's global generic R&D from Sellersville, Pennsylvania.

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

AskAboutValidation.com posted a really great Quality by Design overview piece in late 2012.

Tech Transfer in the Age of QbD

Tech Transfer in the Age of QbD

Arvindh Balakrishnan, Former VP of Life Sciences, Oracle and Russ Somma, President, SommaTech LLC discuss the components of characteristics of modern and effective technology transfer.

Channeling Don McLean

Channeling Don McLean

02 April 2012

To paraphrase a great American folk song, pharma's levee is dry. Nostalgia, or the insistence that “pharma is different,” won't change that, writes Ali Afnan.

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Posted in Expert Insights, Opinion Editorial2 Comments

Toy Story: Ciurczak’s Pittcon Picks of 2012

Toy Story: Ciurczak’s Pittcon Picks of 2012

28 March 2012

Our resident analytics and spectroscopy expert Emil Ciurczak scoured the Pittcon show floor in search of cool, new technologies. Anyone who knows Emil knows that, at Pittcon, he’s like a kid in a toy store.

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Posted in Expert Insights, Resources0 Comments

The Continually Improving Pharma Quality System

The Continually Improving Pharma Quality System

22 March 2012

Erica Brooks and Yasmeen Muhammad provide a broad, current overview of the issues, and explain why the "manager is no longer the manager."

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Posted in Expert Insights, Readers' Choice0 Comments

Keystrokes of Genius? What They’re Saying About QbD on LinkedIn

Keystrokes of Genius? What They’re Saying About QbD on LinkedIn

16 March 2012

A viral debate ensues over whether or not Quality by Design places unfair restrictions, or presents unrealistic challenges, to small drug manufacturers.

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Posted in Expert Insights, Readers' Choice0 Comments

No Campaigning, But Plenty of Worthy Candidates

No Campaigning, But Plenty of Worthy Candidates

09 March 2012

AIChE is now accepting nominations for its annual Excellence in QbD awards.

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Posted in QbD News0 Comments

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

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

05 March 2012

Are FDA's Process Validation and Quality by Design aligned? The proof will be in the pudding, say several industry QbD advocates.

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Posted in Expert Insights, QbD News1 Comment

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