(FDAnews: Falls Church, VA) -- Is failure mode and effects analysis (FMEA) the cornerstone of your risk management program? Consider this quote from the Food and Drug Administration’s (FDA) quality systems regulation expert Kim Trautman: “Are FMEA or FMECA… good tools? Yes. They are very good tools that can be utilized. Are they in and of themselves a risk management system? Absolutely not. I can’t tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA—that is not a risk management system. Do not make the mistake of presenting FMEAs as your whole risk management system.”

Imagine, in two days you can learn about five new risk management tools and four emerging new standards to transform your risk management program.

FDAnews and Dan O’Leary, president of Ombu Enterprises, have developed a comprehensive workshop that is packed with immediate-use tools and techniques to improve your current program. This course goes well beyond FMEA to show you how its limitations could be your downfall.

Plus, the program provides interactive sessions to put the tools to use in mock scenarios. You’ll learn how ETA, FTA, HACCP, PHA, and HAZOP could be the keys to avoiding your next device disaster.

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