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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.

Are You Cutting Corners on Your Lean Lab Journey?

Are You Cutting Corners on Your Lean Lab Journey?

09 November 2010

Lean implementation in QC and other labs requires real cultural and paradigm change, say BSM's Lorcan Mannion and Pfizer's Ciaran Crosbie. There can be no shortcuts.

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Defining the Role of Excipients in a QbD World

Defining the Role of Excipients in a QbD World

08 November 2010

How do we reconcile the demands of the excipient user and manufacturer, who approach QbD in very different ways? Dr. Chris Moreton's new publication explores the role of excipients in the QbD paradigm.

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School Support: How Universities Can Aid Your QbD Efforts

School Support: How Universities Can Aid Your QbD Efforts

05 November 2010

Where will your early-phase QbD money be better spent—with your employees, or sleuthing and solving with graduate students and post-docs?

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QbD Roundup: What You May Have Missed

QbD Roundup: What You May Have Missed

04 November 2010

An untamed collection of news and tidbits from the past week in the QbD digital world.

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Draft Guidance: Qualifying Drug Development Tools

Draft Guidance: Qualifying Drug Development Tools

03 November 2010

The FDA issues draft guidance for biomarkers and patient reported outcome tools, and hopefully much more.

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Tracking the Rapidly Evolving World of Rapid Micro Methods

Tracking the Rapidly Evolving World of Rapid Micro Methods

27 October 2010

Consultant Michael Miller has been chronicling the talk on rapid microbiological methods at this week's PDA Global Conference on Pharmaceutical Microbiology.

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