Medical Device Risk Management An Interactive Workshop Presented by Ombu Enterprises and FDAnews


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

Don’t be fooled. Risk management is the foundation for all device regulation.

Just look at recent industry headlines. They’re 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, it’s a bigger challenge to build, maintain and audit your risk management plan than ever before. You’ve got to act fast – and you must know what you’re doing, from A – Z.

That’s why you should register today for the two-day interactive workshop Medical Device Risk Management, presented by Ombu Enterprises and FDAnews.

You’ll learn what elements your risk management plan must include ... how to apply the plan to your products ... how to create a risk evaluation matrix ... techniques to evaluate, control and mitigate risk ... how to integrate risk management into a Quality Management System following the GHTF approach ... and more.

You’ll also dig deep into the intricacies of ISO 14971, including how it helps control and mitigate medical device risk ... how the FDA interprets it ... and its role as an
EU-harmonized standard for the MDD and IVDD.

Plus, you’ll sort out the alphabet-soup of risk evaluation tools — ETA, FMEA, FTA, HACCP, PHA and HAZOP — and come to understand each one. More important,
you’ll know how to implement the one(s) most appropriate to your own operation.

Your workshop leader will be Dan O’Leary, president of Ombu Enterprises LLC. He has spent more than 30 years in quality, operations and program management in four highly regulated industries — devices, clinical labs, aviation and defense.

He’ll enhance your training with numerous case studies that will illustrate the concept of risk and examine real-life serious events in medical device manufacturing. Plus, he’ll 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

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.

Date and Location

June 21-22, 2011
Hyatt Regency Minneapolis
1300 Nicollet Mall
Minneapolis, MN 55403
Toll Free: (800) 223-1234
+1 (612) 370-1234
Room rate: $174.00 plus 13.4 percent tax
Reservation cut-off date: May 30, 2011

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
Get your team up to speed!

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. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
globally with any questions.

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

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Cancellations and Substitutions

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.