Medical Device Risk Management (Sold Out – New Date Added for July 10-11, 2012) Beyond FMEA —
Click here to sign up for the New July 10-11, 2012 MDRM Workshop.
Imagine, in two days you can learn about 5 new risk management tools and 4 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 4 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- FDA Draft Guidance — Applying Human Factors and Usability Engineering to Optimize Medical Device Design
- The basic concepts of the assurance case
Seating is at a premium for this event. Register today. Other areas the event will focus on include:
- How the FDA and international regulatory bodies measure the severity of a risk and what the different levels of seriousness are
- How to create and administer a risk management file — think of it as your risk management file cabinet
- Understand how to score risks and create a risk “scorecard” — how to use severity and probability
- Tips to assure that all your risk management reports contain the 9 checklist items all reports should have
- And much more
You’ll leave this workshop a much better risk management professional.
- Project managers involved in design and development
- Design engineers
- Quality engineers
- Manufacturing engineers
- Quality auditors
- Production managers
- Scientists involved in device research and development
- Medical staff evaluating risk, safety or effectiveness
- Quality or regulatory staff assigned to complaint, CAPA or MDR management
- Training personnel
- General/corporate counsel
|Dan O’Leary has more than 30 years experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs. He is president of Ombu Enterprises LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. O’Leary has a master’s degree in mathematics; is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and six sigma black belt; and is certified by APICS in resource management.|
|March 28-29, 2012
Hyatt Regency Boston
1 Ave De Lafayette
Boston, MA 02111
Toll Free: (800) 233-1234
+1 (617) 912-1234
Room rate: $235.00 plus 14.45 percent tax
Reservation cut-off date: Feb. 27, 2012
Register Early — Space Is Limited
Hurry — register early because space is limited! Your tuition of $1,797 includes the day-and-a-half workshop, all workshop materials, continental breakfast each day and lunch on the first day.
Send Your Team for Maximum Benefit
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600