Tag Archive | "Lean Six Sigma"

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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Does Lean Six Sigma Enhance or Stifle Innovation in Drug R&D?

In the January issue of Drug Discovery Today, three authors from AstraZeneca R&D–Craig Johnstone, Garry Pairaudeau, and Jonas A. Pettersson–tackle the question of whether or not Lean and Six Sigma methodologies, when applied within drug R&D, enhance or stifle innovation. In “Creativity, innovation, and lean sigma: a controversial combination?”, the authors state that they, like other R&D scientists in the industry, “have attempted to adopt the principles of continuous process improvement, such as lean and six sigma, which have successfully revolutionized the cost and quality of manufacturing and service provision in recent decades. This trend for increasing process improvement is not without controversy, however, particularly when one considers the demand for increased innovation as well as cost effectiveness of delivery. There is a genuine and understandable concern that methodologies such as lean (six) sigma, which include standardization and the reduction of variation in their guiding principles, will restrict the freedoms required for innovative ideas to survive and flourish.”

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Are You Cutting Corners on Your Lean Lab Journey?

Recently I listened in on a terrific webinar on implementing “Real Lean Outside Production,” hosted by Lorcan Mannion, operations practice manager at the consulting firm BSM, and featuring Ciaran Crosbie, an operational excellence specialist at Pfizer’s Grange Castle, Ireland facility. (The on-demand webinar, and others in BSM’s recent Lean series of webinars, can be found on this registration page.)

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Lean Upstream: Catalyzing Pharma Product Development

By Bikash Chatterjee, President and CTO, Pharmatech Associates

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A QbD Summer Reading List

Whether you’re bound for the beach, the mountains, or the office, why not take along some summer reading? We’ve compiled a list of some of the more noteworthy QbD-related articles and items to be published this summer from various sources. Upload them to your laptop, or print them and put them in your suitcase. And let us know if you have QbD reading suggestions as well.

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Six Sigma in Drug Development at Covance: The Good, Bad, and Ugly

By Paul Thomas, Senior Editor

Lean Six Sigma is often credited with helping to transform operations at many drug facilities, and rightly so, but that doesn’t mean that its implementation is not without challenges and missteps. Michael Walega, Master Black Belt, Process Excellence and Change Management at Covance, has seen many such speed bumps in the eight some years since his company began down the road to LSS.

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