Medical Device Risk Management Beyond FMEA — New Tools To Assure Your Risk Management Program Meets New Standards

$1,797.00
 
 

Imagine, in two days you can learn about 5 risk management tools and 4 emerging 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  • FDA Draft Guidance — Applying Human Factors and Usability Engineering to Optimize Medical Device Design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.

July 11-12, 2013
Hyatt Regency Boston
1 Ave De Lafayette
Boston, MA 02111
Toll Free: (800) 233-1234
+1 (617) 912-1234
www.regencyboston.hyatt.com
Room rate: $209.00 plus 14.45 percent tax
Reservation cut-off date: June 19, 2013

Nov. 5-6, 2013
Omni Hotel Chicago
676 North Michigan Ave.
Chicago, IL 60611
Toll Free: (800) THE-OMNI (843-6664)
Fax: +1 (312) 644-6664
www.omnihotels.com/chicago
Room rate: $219.00 plus 16.4 percent tax
Reservation cut-off date: Oct. 14, 2013

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 two 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.

2-4 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.


Can’t make it to Chicago? The Medical Device Risk Management workshop is also available in Boston, MA, July 11-12, 2013.

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

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 of 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.