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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.

Part 1:  A Quality-by-Design Methodology for Rapid LC Method Development

Part 1: A Quality-by-Design Methodology for Rapid LC Method Development

14 February 2013

This installment of Validation Viewpoint describes how statistically rigorous quality-by-design (QbD) principles can be put into practice to accelerate each phase of liquid chromatography (LC) instrument method development.

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Quality by Design is Essential in the New U.S. Regulatory Environment

Quality by Design is Essential in the New U.S. Regulatory Environment

11 February 2013

This increased emphasis on “Quality by Design” (QbD) requires pharmaceutical manufacturers to make larger investments earlier in the product life cycle during process development in advance of approved commercial operations.

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Nominations for AIChE QbD Awards: 2013

Nominations for AIChE QbD Awards: 2013

10 February 2013

AIChE is now asking for nominations for their 2013 QbD awards to celebrated engineers or scientists from industry, academia or regulatory who have helped to further QbD.

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White Paper: Effective ICH Q8 Pharmaceutical Development Reports

White Paper: Effective ICH Q8 Pharmaceutical Development Reports

07 February 2013

A complete PDR is essential to provide a comprehensive understanding of the product and process for the FDA application reviewers and inspectors.

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Asian Pharma Professionals Are Serious About Learning PAT and QbD

Asian Pharma Professionals Are Serious About Learning PAT and QbD

17 January 2013

Insights Emil Ciurczak's trip to Singapore and Shanghai to attend a PAT/QbD conference, give two workshops, and present two papers.

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20% Conference Savings for PharmaQbD.com Members to Attend IBC’s Biopharmaceutical Development & Production Week

20% Conference Savings for PharmaQbD.com Members to Attend IBC’s Biopharmaceutical Development & Production Week

09 January 2013

Members of PharmaQbD.com can save 20%* when you mention savings code BDP13PMSM during registration.

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