April 19, 2010
Holmes on Homes Over the last few months, I’ve become a big fan of a TV show called Holmes on Homes. The show features super-hero contractor Mike Holmes coming to the rescue of homeowners across Canada and the United States that have been the victims of shoddy home contracting work. Wildly successful on HGTV, Holmes […]
April 1, 2010
Click here to read Jack’s article in GxP Lifeline by Master Control on “The Future is Now for Computer-Based Quality Systems” Text of Article Follows: The Future is Now for Computer-Based Quality Systems Especially for users of paper-based quality systems, it’s hard to believe that it’s been close to 25 years since companies first began […]
March 26, 2010
Imagine seeing the following (imaginary) Wall Street Journal headlines: ACME Pharmaceutical Admits Product is No Better Than Competitor CRO Co. Report Shows Poor Clinical Program Effectiveness Device Co. Reveals Close to 25% of Research Money Wasted Without a doubt, these headlines would surprise us. As well-educated, experienced industry participants, we have come to expect virtually […]
March 20, 2010
The following transcript is taken from Business Intelligence Solutions Interview that talks about FDA Inspection Readiness. with Jack Garvey What are the biggest issues currently facing FDA-regulated companies when it comes to FDA inspections? FDA regulated companies are currently dealing with a multitude of challenges. Initially, companies have been aware of the reduction in FDA […]
March 10, 2010
A review of FDA enforcement news over the last year should clearly demonstrate an important shift in approach by the FDA that the “cop” side of FDA is back on the beat. During the last 8 – 10 years, in a period marked by principles of de-regulation and reduced oversight for all businesses, the federal government […]
March 4, 2010
Like a lot of people, when I was a younger, I always wanted the newest toy or the shiniest item in the store. An unfortunate reality of growing up is that as we become adults, we come to the realization that things cost money and that there are limits to what we can spend. We […]
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