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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.

Reviewing the Basics of Stats

Reviewing the Basics of Stats

17 December 2012

A quick check of the fundamentals will help you approach manufacturing analytics with the right statistical mindset for QbD or other efforts

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Pharmaceutical Manufacturing eBook: Holistic QbD

Pharmaceutical Manufacturing eBook: Holistic QbD

20 November 2012

This e-book offers general resources in the area of QbD, and discusses how West Pharmaceuticals has been bringing a QbD approach to its packaging components.

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AAPS Awards FDA’s Mansoor Khan, University of Maryland’s Augsburger for PAT/QbD Work Research Achievement Award in Formulation Design and Development

AAPS Awards FDA’s Mansoor Khan, University of Maryland’s Augsburger for PAT/QbD Work Research Achievement Award in Formulation Design and Development

30 October 2012

AAPS awards Khan and Augsburger for PAT/QbD Work Research Achievement Award

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Colorcon QbD Expertise Beneficial in FDA Compliance

21 September 2012

Colorcon offers customer access to its expertise in film coating formulation and process applications to assist pharmaceutical manufacturers with their Quality by Design (QbD) initiatives. Click here for full story Source: Yahoo! Finance

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Winners of 2012 AIChE Awards for QbD

Winners of 2012 AIChE Awards for QbD

05 September 2012

AIChE has announced the Winners of the 2012 AIChE Award for Outstanding Contribution to QbD for Drug Substance and 2012 AIChE Award for Outstanding Contribution to QbD for Drug Substance, both of which will be presented at the 2012 Annual Meeting in Pittsburgh.

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Martin Gadsby Redefines PAT for Manufacturing Environments

Martin Gadsby Redefines PAT for Manufacturing Environments

09 August 2012

For years, gurus have suggested that the P in PAT should be emphasized, to focus on process understanding rather than the analytics and technology involved.  Success has been mixed.  Maybe it was asking too much of people to think first of their processes?  Should it be framed in less idealistic and more pragmatic and business-oriented [...]

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