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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.

McKinsey’s Ulf Schrader on Toyota and Quality Lessons for Pharma

McKinsey’s Ulf Schrader on Toyota and Quality Lessons for Pharma

08 June 2010

Design to Quality...presents industry with a $20-to-$30-billion opportunity to optimize technical development. And that’s just on the cost side, without even considering the customer preference angle. The industry will need to have more cross functional processes, linking “technical development,” which often is still in R&D, and production which is in operations. Removing the wall between them will be a key value driver.

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QbD: Enabling Process Knowledge Beyond Validation

QbD: Enabling Process Knowledge Beyond Validation

07 June 2010

If we, as an industry, do not take to heart that improving quality, science and process knowledge is in our patients’ and shareholder’s best interest, then we deserve the same fate as the Big Three car makers, says consultant Pedro Hernandez. Put another way, is the industry simply making a better Victrola?

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You’re the CEO: Can You Justify the Costs of These QbD Projects?

You’re the CEO: Can You Justify the Costs of These QbD Projects?

04 June 2010

Here are two sample case studies where QbD could be applied to blockbuster drugs. Can you provide financial justification for going through with these projects? Please write in with your "go/no go" decisions and why.

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Pharmaceutical Quality and Lessons from Toyota: Thomas Friedli on Creating a Continuous Improvement Culture in Pharma

Pharmaceutical Quality and Lessons from Toyota: Thomas Friedli on Creating a Continuous Improvement Culture in Pharma

04 June 2010

"You can only achieve long-term savings if you have stable running equipment that enables stable and robust processes. This is a fundamental pre-requisite, before you can reduce lead time and stocks to any significant level. And this is exactly what PAT, QbD and manufacturing science aim to do."

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Pharmaceutical Quality and Lessons from Toyota: Thoughts from Gawayne Mahboubian-Jones

Pharmaceutical Quality and Lessons from Toyota: Thoughts from Gawayne Mahboubian-Jones

03 June 2010

Top management needs to make product quality, and patient needs and perceptions of its products, the top priority. Manufacturing can no longer be seen as merely an add on but as an integral part of the product value chain. Allowing companies to compete based on measurable quality metrics, visible to the consumer, could help get things moving in the right direction.

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Afnan to FDA: Simplify Post-Approval Changes, Spur Innovation

Afnan to FDA: Simplify Post-Approval Changes, Spur Innovation

02 June 2010

21 CFR 314.70, and the process by which FDA reviews changes to already approved applications, needs a risk-based update, now. Consultant Ali Afnan, formerly with FDA, makes his case.

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