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March 2010

Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean

Mike Micklewright

It's pretty obvious that in so many companies, based on their actions and behaviors, CEOs and other top managers just don't get ISO 9001 and all the derivative standards. The following 10 signs are written in no particular order. You'll need to be the judge as to which ones are most prevalent within your own organization. How many can you relate to?

After reading this article, you may also wish to forward it to someone who should probably read this, like maybe...oh, I don't know...your CEO...or ummmm...some other top executive? Directions for how to do so without getting into trouble are at the end of this article.

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The Future is Now for Computer-Based Quality Systems

Jack Garvey

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 using computers to facilitate their regulatory obligations for maintaining quality systems. Throughout this 25-year period, there has been extraordinary progress in technology, features, functionality, and scope of the solutions; along with an equal amount of disappointing results and unrealistic expectations. Many companies over the years have spent small (and some not so small) fortunes on systems that sometimes just didn't work, or if they did, didn't work the way the organization expected them to. The great news for FDA-regulated companies of all sizes is that the future is finally here, and there are now highly-effective, highly configurable, computer-based system options for small, medium and large FDA-regulated manufacturers, with solutions to fit every budget.

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Better Innovation for Product Development and Process Improvement

Ellen Domb Joe Miller

What is a problem-solving method based on logic and data, not intuition? What is a problem-solving method that accelerates, broadens, and deepens a project team's ability to creatively solve difficult, pertinent problems? The answer is TRIZ. TRIZ provides repeatability, predictability, and reliability due to its structure and algorithmic approach. "TRIZ" is the (Russian) acronym for the "Theory of Inventive Problem Solving." G.S. Altshuller and his colleagues in the former U.S.S.R. developed the basic method between 1946 and 1985, and it has been greatly enhanced by international researchers from 1985 to now.

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World Conference on Quality and Improvement
May 24-26, 2010, St. Louis, MO

MD&M East 2010
June 7-10, 2010, New York, NY

AdvaMed 2010
October 18-20, 2010, Washington D.C

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Did you know that FDA inspections are bound to increase by as much as 50 percent in locations outside of the U.S? During these inspections, the FDA will be likely to focus on basic issues such as sterility levels but other concerns can be raised at any time and the entire supply chain will have a higher chance of being audited as as opposed to auditing only the "tail-end" supplier.
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