February 2014

For Blood & Biologics Companies

“3 Loops in 1” as Reflected in FDA Warning Letters

by Cindy Fazzi, MasterControl Inc.

Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).

Many of the citations could have been avoided, or at least mitigated, with the help of a closed-loop or “three loops in one” CAPA process. What is it and why is it critical?

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What’s in Your Training Toolkit?

by David Hofstetter, New England Organ Bank

I have to ask the question: as trainers, are we doing a good enough job at scoping a training request when they come in?

The answer is… sometimes!

So what tools should we add to build that toolbox to be able to move the answer to “yes”?

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A Risk-Based Approach to Validation

by Peter Knauer, MasterControl Inc.

FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process. This article describes a new definition of validation that has emerged. What is this new definition and how does it affect you?

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