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Webinar, June 23: Inspection Readiness for a More Aggressive FDA

Join the Center for Business Intelligence for a one-hour, information-packed webinar on managing FDA inspections from a more aggressive FDA.   Now that pharmaceutical, medical device, dietary supplement, and biologics’ companies know that the FDA is back on the hunt for non-compliant companies, what can your company do about it? The short answer is be prepared! Inspection […]

HACCP: Underused, Underappreciated and Exceptionally Powerful

“When everything is critical, nothing is.” Author Unknown When you think back on your career as a Quality & Compliance Executive, how many times have you felt you had a manufacturing operation that was prepared – truly prepared – and ready for an FDA inspection?    Your walkthrough showed that the plant floor was immaculate.   Design […]

Will Robinson – Soldier, Family Man, Professional, Friend – RIP

Memorial Day Week is a fitting time to learn of the passing of a professional colleague and someone that I am proud to have considered a friend.  Willie Horace (Will) Robinson died suddenly on May 24, 2010.   As with all of those we love and care about, the loss of a colleague, friend or family […]

Free FDA GMP / QSR Ebooks for IPhone, IPad, Blackberry & Other E-Reader Devices

FDA GMP / QSR Ebooks Aren’t the IPhone and the IPad great?? All of the information you could possibly want, right there at your fingertips!   As a service to FDA-regulated industry, we are providing FDA GMP/ QSR EBooks for three of the main published FDA regulations for pharmaceuticals, dietary supplements and medical devices.   (More to […]

Mitigating FDA Enforcement Risks: Investing in Compliance to Safeguard Shareholder Value from Non-Compliance Impact

I’m struggling to find an answer to the following question:   If you were the owner of a company, how much would you spend, year over year, to prevent a potential loss in market value to your company of two billion, one hundred twenty million dollars?     Would you spend a half-a-million dollars?   Five million?    Ten million?   […]

Designing Your Quality System: The Risk of Using the GMPs

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 […]