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News
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During a recent interview, the folks at Camstar asked that I share my thoughts on the impact that Closed-Loop Quality Execution on Life Sciences Manufacturing in the “Age of Continuous Innovation”.
Visit Axendia's Life-Science Panorama to see the Read More
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Individual and organizational responses to regulatory compliance fall into one of four categories.
The great philosopher “GI Joe” said “knowing is half the battle.” Understanding an individual’s tendency toward regulatory compliance Read More
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YARDLEY, Pa. and WOBURN, Mass., July 9, 2008 -- Axendia Inc., a trusted advisor to Life-Science Executives on Business, Technology and Regulatory strategies, and CBI Research Inc., a provider of live and electronic conferences for senior-level executives Read More
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Sterile Manufacturing facilities are often, well sterile. They are typically comprised of drab clean-rooms where the color palette is limited to stainless steel and shades of grey.
For this installment of our “2008 Learning from Success” series, Read More
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For years I have been joking about some company marketing a sugar pill based on clinical trial data supporting the “placebo effect”.
I never thought I would see the day when this prediction would come true.
Well, today is the day. Efficacy Brands LLC Read More
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For this installment of our “2008 Learning from Success” series, I had the privilege of speaking with Mark Wagner, Vice President Worldwide Clinical Supply Operations and Sarah K. Doshna Associate Director, Parenteral Manufacturing Pharmaceutical Research Read More
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No, it is not a typo; I mean to spell it C-A-C-A.
Last week, I had the opportunity to present at Camstar’s 2008 “Vision to Value” Manufacturing 360 Customer Conference. One of my sessions was entitled “Shifting from CAPA to PACA”. The takeaway message Read More
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Last week, I was asked me to provide my thoughts before the release of their new eBook entitled “Winning Profit in the Age of Continuous Innovation”
As I read the eBook I kept thinking about Heraclitus’ famous refrain: “The only constant is change.” Read More
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During Interphex 2008, I had the opportunity to interview the winners of the Forth annual Facility of the Year Awards (FOYA) competition, sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine.
The wining companies were:
Boehringer Ingelheim Read More
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Yesterday, a group of seven leading academic research institutions issued a report entitled “A Broken Pipeline? Flat Funding of the NIH Puts a Generation of Science at Risk.”
The report was co-authored by Brown University, Duke University, Harvard University, Read More
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No it is not the title of the latest sci-fi blockbuster film, but one of the lessons I learned from FIRST.
Last week I had the opportunity; no the privilege, of being a judge at the “2008 New Jersey Regional FIRST Robotics Competition (FRC).” FIRST Read More
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That was the theme of the 21st annual DIA Conference for Electronic Document Management (EDM) hosted in Philadelphia on February 5 through 8. The goal of this year’s conference was to focus on grass roots; getting back to basics and best practices. Read More
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In its February 20, 2008, decision in Riegel v Medtronic, Inc., the U.S. Supreme Court ruled that The Medical Devices Act of 1976 (“MDA”) was sufficient to preempt any State law that purported to “establish or continue … any requirement … which is different Read More
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Lately, I have been getting a lot of questions regarding the state of Outsourcing in Life-Sciences.
When I started working in Life-Sciences, nearly two decades ago, going offshore meant moving operations to a company owned facility in Puerto Rico. Read More
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Yesterday, Representative Henry A. Waxman and Senator Edward Kennedy issued a letter asking the General Accounting Office (GAO) to conduct an examination FDA’s staffing, information technology, and other resources necessary for the agency to successfully Read More
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