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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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Designing a Learning and Performance Program in Tissue and Organ Banking

Keeping up with training management and additional changes in tissue and organ bank environments is an ongoing process. After all, we who work in these environments know what works well and what doesn't. We know for example that with a field-based staff, classroom training is difficult to pull off. Coordinating with everyone's schedules and working around a case load makes training complex! What we have found is that online learning or on-demand learning does work. It allows all of the staff to access training when and where they need it.

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Automating Training Control Processes to Comply with FDA and ISO Requirements

FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25) These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This paper identifies the basis for the requirements and examines the associated challenges for meeting those requirements, and in addition, the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking of requirements is presented.

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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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