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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.

Special Report: Hitting the Bull’s Eye with QbD

Special Report: Hitting the Bull’s Eye with QbD

02 April 2013

This e-resource examines how QbD concepts were applied to optimize a new blow-fill-seal process, and to ensure the right formulation early in the preformulation process.

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ISPE Conference to Benchmark and Advance Quality by Design in the Biopharmaceutical Industry

ISPE Conference to Benchmark and Advance Quality by Design in the Biopharmaceutical Industry

29 March 2013

ISPE it will hold its first-ever conference focused on benchmarking and advancing the development of Quality by Design in the biopharmaceutical industry.

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Quality by Design, Part 2

Quality by Design, Part 2

20 March 2013

In part one of this two-part series, quality by design was discussed as a business problem involving successive gaps in new product introduction. A five-phase architecture was introduced. Part two looks at the last two elements of this architecture, customer-focused optimization and dominance over variability. Customer-focused optimization  Read more...

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QbD Implementation in the Generics Industry:  Overview and Teva Case Study

QbD Implementation in the Generics Industry: Overview and Teva Case Study

18 March 2013

As generic pharmaceutical manufacturers work to find the balance between speed, efficiency and product quality excellence, QbD approaches are playing an important role.

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PAT, QbD and Process Validation – The Enablers of Pharmaceutical Quality

PAT, QbD and Process Validation – The Enablers of Pharmaceutical Quality

12 March 2013

PAT, QbD and Process Validation - The Enablers of Pharmaceutical Quality

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Analytical Methods & QbD: A Perfect Match

Analytical Methods & QbD: A Perfect Match

05 March 2013

Analytical Methods & QbD: A Perfect Match. There is general consensus that the execution of an analytical method is, in fact, a process.

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