Displaying 1–25 of 230 results for Agnes Shanley, Editor in Chief
Success depends on speed, and addressing all potential risks and regulatory questions from the earliest design stages.
Evolutionary change is good, but as Takedas EVP Tadataka Yamada recently said, revolutionary change is best. Just remember that it is built on the back of failure.
Anything from excess moisture to variable API loading can affect tablet quality. PAT methods and equipment innovations can reduce variability.
Expect to see more co-opetition, and increased government and private foundation in early stages, he said.
Become partners with emerging markets, in the broadest sense, he said, and always support, and embrace, revolutionary, rather than evolutionary change.
A look at recent FDA enforcement activities and lessons to be learned.
Is the risk of operating unsafely ever worth the short-term reward?
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.
Are you managing your contract partners, or are they managing you?
What would happen if everyone tried to patent good science, and the way to a good Design Space?
The yin is just as important as the yang; sometimes, even more so.
FDAs Rick Friedman and Karthik Iyer explain why some manufacturers need to get a better grip on GMP-related statistics.
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.
Are you using statistics to support the status quo, or to get to true root cause?
Consultant Robert Dream shares thoughts on evolving industries
This years PDA Annual Conference paid special attention to the issues posed by use of single-use biopharmaceutical processing equipment.
Can drug manufacturing reach its potential without standards, science and an admission that theres a need for improvement?
The big picture has changed very little in ten years. While pointing out root causes, observers also see reasons for optimism.
Allied with other imaging techniques, Raman spectroscopy is being used for more QC, process control, and QbD efforts.
Assessing the cost of poor quality doesnt just prevent disasters; its good for business.
Analysts say that 2012 may prove to be pharmas most challenging year ever.
Modern control is the best way to ensure patient safety (and corporate survival).
Modular construction and disposable process equipment are maximizing agility and minimizing risk.
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.
Operations, like natural systems, are drawn to chaos. Only energetic management can stop the slide.