Two Days of ISO 14971 Training by Industry Expert

Many in the medical device industry think of risk management as part of their quality system.

Do not be fooled. Risk management is the foundation for all device regulation.

Just look at recent industry headlines. They are filled with device-related patient injuries, product recalls, GMP violations, consent decrees, manufacturing stoppages, and even disgorgement of past profits.

What's the common theme behind the headlines? Poor risk management.

Today, you cannot take a chance that your risk management plan may not be up to snuff. There is a legion of recently trained FDA investigators focusing on risk management and high-profile enforcement ... your competitors are increasing the speed at which they develop and send innovative new products to market ... and new country-specific guidances come into the international mainstream every few months.

The pressure is on. It is a bigger challenge today to build, maintain and audit your risk management plan than ever before. You have got to act fast — and you must know what you're doing, from A – Z.

That is why you should register today for the two-day interactive workshop, Medical Device Risk Management, presented by Ombu Enterprises and FDAnews. In it, you'll learn:

• How to perform risk and hazard assessments as written in ISO 14971:2007
• The differences between hazards, harms and risks and the unique tools to evaluate each one
• How to develop a risk evaluation matrix — assessing the probability of occurrence and the severity of harm
• How to apply common tools for risk evaluation such as:
  Event tree analysis (ETA)
  Failure modes and effects analysis (FMEA)
  Fault tree analysis (FTA)
  Hazard analysis and critical control points (HACCP)
  Preliminary hazard analysis (PHA)
  Hazard and operability studies (HAZOP)
• And much more

Workshop leader Dan O'Leary, president of Ombu Enterprises LLC, will enhance your training with case studies to illustrate the concept of risk and to examine real-life serious events in medical device manufacturing. Plus, he will incorporate interactive exercises, leading you through the steps from recognizing risks all the way to assuming the role of quality auditor.

Who Will Benefit

• 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

Click here to see the full conference brochure

Meet Your Instructor
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.

Dates and Locations
June 21-22, 2011
Hyatt Regency Minneapolis
1300 Nicollet Mall
Minneapolis, MN 55403
Toll Free: (800) 223-1234
+1 (612) 370-1234
www.minneapolis.hyatt.com

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. Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Team Discounts
Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call +1 (703) 538-7600 for details.

Four Easy Ways to Register
Please mention priority code 11601.
1. Online.
2. Call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.Use your American Express, Visa or MasterCard.
3. Fax your purchase order to +1 (703) 538-7676.
4. Mail your check to: FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431