Displaying 1–25 of 228 results for Agnes Shanley, Editor in Chief

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Facilities of the Future

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Success depends on speed, and addressing all potential risks and regulatory questions from the earliest design stages.

From the Editor: Long Live the Revolution!

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Evolutionary change is good, but as Takeda’s EVP Tadataka Yamada recently said, revolutionary change is best. Just remember that it is built on the back of failure.

Troubleshooting Tableting

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Anything from excess moisture to variable API loading can affect tablet quality. PAT methods and equipment innovations can reduce variability.

BIO’s Greenwood: The Traditional Venture Capital Model is Broken

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Expect to see more “co-opetition,” and increased government and private foundation in early stages, he said.

Holiday Inspiration from Takeda's EVP, Tadataka Yamada

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Become partners with emerging markets, in the broadest sense, he said, and always support, and embrace, revolutionary, rather than evolutionary change.

cGMP Judgment Day

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A look at recent FDA enforcement activities and lessons to be learned.

From the Editor: Quality Systems Lessons from NECC

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Is the risk of operating unsafely ever worth the short-term reward?

BMS Wins Emerson’s Innovation Award for its Devens Facility

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At the Emerson Global Users Exchange in Anaheim California last week, BMS was awarded the Innovation award for most innovative application of Emerson technologies at its new facility in Devens, Massachusetts, which received FDA approval for manufacturing earlier this year.

Managing Contract Partners: Do We Have a Failure to Communicate?

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Are you managing your contract partners, or are they managing you?

From the Editor: Protecting the Wind

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What would happen if everyone tried to patent good science, and the way to a good Design Space?

From the Editor: Inspiration and Innovation

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The yin is just as important as the yang; sometimes, even more so.

cGMPs and Statistics

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FDA’s Rick Friedman and Karthik Iyer explain why some manufacturers need to get a better grip on GMP-related statistics.

Emerson Process Management's Chris Amstutz on PAT & QbD

(Multimedia)

Pharmaceutical Manufacturing Editor in Chief Agnes Shanley discusses trends in the industry's use of PAT and QbD with Emerson Process Management's Director of Life Sciences Chris Amstutz. The industry has moved beyond "kicking the tires" of QbD, Amstutz says.

From the Editor: Brush Up on Statistics (Or Face the Consequences)

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Are you using statistics to support the status quo, or to get to true root cause?

Potato Chips, Soap Flakes, Biopharm (and Pharma)

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Consultant Robert Dream shares thoughts on evolving industries

PDA Examines Benefits and Flaws of Single-Use Systems

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This year’s PDA Annual Conference paid special attention to the issues posed by use of single-use biopharmaceutical processing equipment.

From the Editor: Pangloss or Popper: Has Drug Manufacturing Advanced in the ...

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Can drug manufacturing reach its potential without standards, science and an admission that there’s a need for improvement?

The Pulse of Pharmaceutical Manufacturing

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The big picture has changed very little in ten years. While pointing out root causes, observers also see reasons for optimism.

Raman's New Reach

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Allied with other imaging techniques, Raman spectroscopy is being used for more QC, process control, and QbD efforts.

From the Editor: The Cost of Poor Quality, Too High a Price?

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Assessing the cost of poor quality doesn’t just prevent disasters; it’s good for business.

From the Editor: A Culture of Arrogance

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Analysts say that 2012 may prove to be pharma’s most challenging year ever.

From The Editor: First, Do No Harm

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Modern control is the best way to ensure patient safety (and corporate survival).

Groundbreakers: Tomorrow's Drug Manufacturing Facilities

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Modular construction and disposable process equipment are maximizing agility and minimizing risk.

From the Editor: Adulteration, 21st Century Style

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As legislators and the courts re-examine an old fashioned word, sins of omission will count as much, if not more, than sins of commission.

From the Editor: Entropy: Can the Center Hold at Your Facility?

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Operations, like natural systems, are drawn to chaos. Only energetic management can stop the slide.

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