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Root Cause Analysis for Drugmakers

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February 2011
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You’ve identified a quality problem, either through an audit or inspection, quality assurance activity or complaint. Now you must come up with a solution. Where do you begin?

With a root cause analysis, of course.

Root cause analysis isn’t new, but it is one of the most often misunderstood quality processes drugmakers must master.

In fact, inadequate root cause analysis is one of the FDA’s most common findings during an inspection.

Now you can get it right, the first time — with the management report Root Cause Analysis for Drugmakers from FDAnews.

This nuts-and-bolts primer walks you through the root cause analysis process step by step. You’ll learn:

  • What a root cause analysis is and how to conduct one
  • How to properly correlate risk assessments with a root cause analysis program
  • How to master the basic tools of root cause analysis
    • Brainstorming
    • The Five Why's
    • Cause-and-Effect Fishbone Diagramming
    • Kepner Tregoe Decisionmaking
  • The most common errors in root cause analysis and how to avoid them
  • How to select the right tool for different investigations
  • And much more!

Root Cause Analysis for Drugmakers is based on the very latest FDA regulations as interpreted by the agency and the courts.

And because it’s written in plain English, it’s suitable for new hires and novices as well as seasoned quality experts looking for a brush-up refresher course.

Whether your specialty is Rx drugs, biologics or diagnostics ... whether your job title is quality, regulatory affairs or compliance ... whether you’re a manufacturer, consultant or outside counsel ... you’ll find Root Cause Analysis for Drugmakers the trustworthy, reliable primer that will get you safely through your next FDA inspection — and many more to come.

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