August… Summer… Sun, sand and surf… As the song goes: “summertime and the living is easy…” My hope is that all of you involved in quality and compliance are enjoying some time off with friends and/or family and getting a chance to read a good book on a quiet beach somewhere.
Unfortunately, for FDA-regulated companies,...
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Latest Story
A Low Cost, Seven-Step Approach to Reducing FDA Enforcement Risk
Urgency: Promise or Problem for FDA-Regulated Companies
A couple of months ago I was engaged in a brief, friendly dialogue with one of my close friends – a college buddy – about a current business imperative: urgency. My friend is a Senior Partner with a large, very well-known business consulting firm,...
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CAPA – The Untold Story
Try as I might in my consulting work, I can never seem to get away from CAPA. As much as I would like to help companies prospectively improve their process control; embrace better quality system integration and document design; assess and implement computer-based quality...
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UPDATE: Free FDA GMP / QSR Ebooks for IPhone, IPad
This is an UPDATE to a post from May 2010.
Please click this link for the original post.
On Monday, June 21, Apple released the IPhone OS4. This update to the...
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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’...
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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...
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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...
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Four Important Lessons From J&J/McNeil’s FDA Enforcement Troubles
It is almost impossible to fathom that a company with Johnson & Johnson’s reputation for excellence could be in the depth of difficulties it is currently experiencing with the...
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Free FDA GMP / QSR Ebooks for IPhone, IPad, Blackberry & Other E-Reader Devices
Aren’t the IPhone and the IPad great?? All of the information you could possibly want, right there at your fingertips! As Quality & Compliance professionals, we often need to...
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