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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.

Embracing Risk

30 March 2010

As we move ahead as an industry, transforming our concept of quality to align with the latest FDA and international regulations, we find ourselves in uncharted waters. The dilemma of implementing Quality by Design (QbD), Risk-Based Validation (RBV) and Process Analytical Technology (PAT) has challenged traditional quality thinking.

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Does Six Sigma = QbD in Production?

30 March 2010

The Six Sigma methodology is fully aligned with Quality by Design.

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New Patterns for Quality

30 March 2010

FDA's "Pharmaceutical Quality for the 21st Century — A Risk- Based Approach" squarely takes aim at the issue of product quality, this time from a lifecycle perspective.

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Is QbD Still Lost in Translation?

30 March 2010

EFPIA’s mock examples are a significant step in the right direction, but many manufacturers (especially in Europe) have fundamental concerns and questions about QbD implementation; a report from PDA's QbD workshop in Frankfurt.

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Optimizing Design of Experiments for Fluid Bed Coating

30 March 2010

Upsher-Smith Laboratories (Minneapolis, Minn.) faced a problem with a fluid bed coating process that produced inconsistent results. Many of the coating parameters interacted with each other, so conventional one-factor-at-a-time (OFAT) experiments were unable to resolve the issue

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Video: Got Goat? First Approved Drug from Engineered Animal

30 March 2010

FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. These patients can develop blood clots during high-risk situations such as surgery and childbirth. The approval gives patients with this disease an important new treatment option.

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