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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.

An Update on PDA’s PCMO: Getting Technical

An Update on PDA’s PCMO: Getting Technical

12 April 2011

The group’s initiative to further the technical implementation of Quality by Design principles has come a long way in a short time.

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Posted in Expert Insights0 Comments

Process Validation: Can We Now Get Back to Basics?

Process Validation: Can We Now Get Back to Basics?

08 April 2011

FDA’s new guidance on process validation gets back to the original language of the GMPs on the subjects of control and sampling, Ali Afnan writes. After all, FDA never intended for three consecutive batches to satisfy either the spirit or the letter of the law.

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Posted in Expert Insights3 Comments

Published Pharma R&D Costs are Highly Exaggerated, According to a London School of Economics Journal Article

Published Pharma R&D Costs are Highly Exaggerated, According to a London School of Economics Journal Article

06 April 2011

Have pharmaceutical R&D costs, the Tufts University numbers always bandied about, been vastly exaggerated? Professors from Stanford, Princeton and University of Victoria (B.C.) deconstruct the data.

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Posted in Expert Insights, QbD News1 Comment

Ciurczak’s Pittcon Picks: 5 Cool New Technologies You May Have Missed

Ciurczak’s Pittcon Picks: 5 Cool New Technologies You May Have Missed

28 March 2011

At Pittcon 2011 in Atlanta, our roaming expert Emil Ciurczak tracked down five hot technologies you may have missed, from companies you may want to pay more attention to. We've got them on video.

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Posted in Audio & Video, Expert Insights0 Comments

A Practical Roadmap to Pharmaceutical Process Validation

A Practical Roadmap to Pharmaceutical Process Validation

22 March 2011

A staged and structured approach can allow organizations to make the most of FDA’s new process validation guidance

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Posted in Expert Insights4 Comments

It’s Official: FDA, EMA Will Pilot Parallel QbD Review

It’s Official: FDA, EMA Will Pilot Parallel QbD Review

16 March 2011

FDA and EMA announced a new pilot program that will allow parallel evaluation of QbD-based drug submissions.

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Posted in QbD News0 Comments

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