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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 (within many companies) that based on their actions and behaviors, CEOs and other top managers just don't get it when it comes to ISO 9001 and all the derivative standards. The following 10 signs that your CEO still has no idea about ISO 9001 and Lean 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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Reducing Human Error on the Manufacturing Floor

Ginette Collazo

As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments. Sadly, little is known about the nature of these events mainly because quality event investigations end where human error investigations should begin. Human error is about explaining human behavior. Chemical engineers explain product behavior, mechanical engineers explain equipment behavior, industrial engineers explain process behavior, but who explains human behavior?

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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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April 14-15, 2010, Boston, MA

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Do you know what it is that pharmaceutical manufacturers should do every 12-18 months? According to a recent FDANews update, pharmaceutical manufacturers should "conduct audits every 12 to 18 months for suppliers of critical materials," "perform a risk analysis to identify areas of concern for monitoring," and "negotiate quality agreements before signing a contract with a new supplier."
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