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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.

Quality by Design, Part 1 – Preventing Quality Failures At Their Source

Quality by Design, Part 1 – Preventing Quality Failures At Their Source

05 March 2013

Quality by design is a systematic approach, supported by a wide variety of statistical, economic, planning, psychological, and other tools, to close these gaps and shut down the hatchery of failures.

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QbD-Based RTR: A Systems Engineering Approach

QbD-Based RTR: A Systems Engineering Approach

27 February 2013

Today, many assume that real-time release (RTR) is about testing a product quality real-time at the end of its manufacturing process and then from the result obtained deciding about lot release.

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The Building Blocks of Quality by Design (QbD) Implementation

The Building Blocks of Quality by Design (QbD) Implementation

27 February 2013

This post is part of a monthly series of short commentaries from the Institute of Validation Technologies (IVT) on the use of Quality by Design (QbD) in the pharma and biotech industries. The use of QbD has steadily grown since its introduction around 2005. The growth has not been fast enough for some and perhaps [...]

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Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues

Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues

25 February 2013

Hospira is taking a quality by design-oriented approach to compliance remediation and quality improvement at its key Rocky Mount, North Carolina injectable manufacturing facility.

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

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

21 February 2013

Quality-by-design (QbD) is a methodology gaining widespread acceptance in the pharmaceutical industry. A core tenet of this methodology is the idea of establishing the design space of a product or process as a primary R&D goal.

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

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

19 February 2013

Part I of this article described the application of Quality-by-Design (QbD) principles to the task of screening analytical columns. In a QbD approach a statistical experiment design plan (Design of Experiments, or DOE) [1] is used to systematically vary multiple study factors in combination through a series of experiment trials that, taken together, can comprehensively [...]

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