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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.

Winning the Space Race

Winning the Space Race

11 April 2010

ICH Q8 and the QbD guidance issued by the FDA offer pharmaceutical manufacturers a significant opportunity to design quality into their manufacturing processes instead of inspecting it in after the fact.

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BioProcess Control: What the Next 15 Years Will Bring

09 April 2010

Mammalian cell culture bioreactor processes are difficult to characterize and they demonstrate variability between batches. Without sufficient online detection and control, variations can lead to a high number of failed batches.

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A QbD-based Methodology for the Rapid Development of LC Methods

09 April 2010

Using ICH Q8 principles for Design of Experiments, S-Matrix Corp. has developed a means of defining a design space for optimizing the performance and robustness of liquid chromatography operations.

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Thoughts on Applying QbD to Analytical Methods

09 April 2010

QbD has been applied to manufacturing processes but can it be applied to analytical methods?

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Does Six Sigma = QbD in Production?

09 April 2010

The debate over whether the Six Sigma process improvement methodology is applicable to the pharmaceutical sector, and in what way, has been on the table for some time. It seems clear that "copying" the automotive model, for example, is not appropriate, because pharmaceutical processes have little to do with assembly lines.

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Webcast: Redefining Pharmaceutical Process Validation

09 April 2010

FDA's new process validation guidance spells out the new rules for process validation.

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