Tag Archive | "Genentech"

Panel: Is QbD Too Great a Burden on Small Manufacturers?

By Paul Thomas, Senior Editor

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QbD for Analytical Methods: FDA and Industry Perspectives

By Paul Thomas, Senior Editor

At AIChE 2011 in Minneapolis today, FDA’s Elaine Morefield, PhD, Deputy Director of the Office of New Drug Quality Assessment, spoke on “FDA Perspectives on QbD for Analytical Methods.” The topic has two sides, she said: using methods in QbD, and using QbD for methods and methods development.

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Shameless Promotion: QbD Webcasts Not to Miss

In the pharma world as in life, there’s always a buzz of activity in the fall—we’re all trying to cram half a year’s worth of work into those few precious months between summer vacation and the holiday season. In addition, we’re swamped with responsibilities on the home front, like making sure the kids have just the right Halloween costumes.

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Genentech’s Najmi: Building Soft Bridges Between Islands of Automation

Islands of automation exist, and we’re not going to be able to get rid of them, says Zubin Najmi, Genentech’s Manager of Automation. “The focus should be the soft bridges between the islands, and these should be data entry and extraction.” In this video from the Emerson Global Users Exchange in San Antonio (filmed September 27), Najmi explains how Genentech is bridging islands, treating automation differently than it did even five years ago.

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Bio QbD at Pfizer, Genentech: From Concept to Implementation

By Paul Thomas, Senior Editor

Think QbD is daunting? Double that for the biotech arena, where the size and complexity of molecules and the difficulty in defining the attributes that determine quality and safety mean that QbD boils down to a science of educated guesswork.

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