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FDA Compliance

Two Days of ISO 14971 Training

March 28–29, 2012, in Boston

Published: Friday, January 6, 2012 - 12:33

(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.

And as a bonus, this tightly focused workshop will explain four new standards that call out ISO 14971 and how they can be integrated into your program. The new standards include:
• IEC 60601-1—“Medical electrical equipment—Part 1: general requirements”
for basic safety and essential performance
• IEC 62304—“Medical device software—Software life-cycle processes”
• FDA Draft Guidance—“Applying human factors and usability engineering
to optimize medical device design,” which covers the basic concepts of the assurance case

View the complete agenda here. You’ll leave this workshop a much better risk management professional.

Register today, and mention priority code 12104 when ordering.


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FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration (FDA). Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books, special reports, and conferences to stay in compliance with international standards and FDA’s complex and ever-changing regulations to get their products to market faster and boost profits.