Is Failure Modes and Effects Analysis (FMEA) the cornerstone of your risk management program? Consider this quote from the FDA's QSR 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 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- FDA Draft Guidance — Applying Human Factors and Usability Engineering to Optimize Medical Device Design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. It's only going to be offered once in 2012. 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.
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
March 28-29, 2012
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: $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.
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 12104 when ordering.
- Order online.
- Call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.
- Use your American Express, Visa or MasterCard.
- Fax your purchase order to +1 (703) 538-7676.
- Mail your check to: FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431.
Substitutions/Cancellations: 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.