Tag Archive | "Toyota"

Cutting Through the QbD Foliage, Aiming for the Roots

By Hedley Rees, Managing Director, Biotech PharmaFlow Ltd

These days in Pharma development circles, hardly a day goes by without mention of Quality by Design (QbD). Who is doing it properly? Is it too expensive? What is the business case? Can small companies afford it? How do we get executive management interested?

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Tunnell’s Robert Spector With Lessons for Pharma from Toyota

By Agnes Shanley

In this interview, part of a series, Tunnell Consulting principal Robert Spector examines pharma’s progress in implementing Toyota’s principles and lessons that can be learned from the automaker’s recent quality woes.

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Bikash Chatterjee With Lessons From Toyota

by Agnes Shanley, Editor in Chief

Bikash Chatterjee, President of Pharmatech Associates, recently shared his view of pharma’s progress in implementing Toyota Production System principles and the Toyota Product Development System. He also touched on lessons that the automaker’s recent recalls and quality problems offer the industry. Voice of the Customer, he says, contributed to some of Toyota’s recent problems.

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

By Agnes Shanley, Editor in Chief

Ulf Schrader, a partner in McKinsey’s German office and leader of the company’s Pharma/Ops joint venture, recently discussed Toyota’s recent crisis, lessons it may offer the pharmaceutical industry and pharma’s implementation of the Toyota Production System.

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

By Agnes Shanley, Editor in Chief

Thomas Friedli, professor at the University of St. Gallen in Switzerland, and his colleagues have been studying pharma’s implementation of operational excellence principles for several years. He commented on lessons the industry might draw from Toyota’s recent quality problems, and how well the pharmaceutical industry is implementing the principles of the Toyota Production System (TPS).

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

By Agnes Shanley

After FDA’s Process Analytical Technologies (PAT) and Quality by Design (QbD) meeting in Bethesda last month, Gawayne Mahboubian-Jones shared some of his views on pharma product quality initiatives and why so little change seems to have taken place in the industry since the PAT guidance was issued.  He also graded the pharmaceutical industry on its implementation of Toyota Production System (TPS) principles, and touched on quality lessons that pharma might learn from the automaker’s recent setbacks.

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