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Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar

By:
Dr. Harvey Rudolph, HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)
Location 1:-
San Diego, CA

Thursday, January 29, 2015 | Friday, January 30, 2015
Location 2:-
Boston, MA

Thursday, May 7, 2015 | Friday, May 8, 2015
Location 3:-
Chicago, IL

Thursday, Sept 10, 2015 | Friday, Sept 11, 2015

Course "Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

FDA views risk management as an essential process both during inspections and in the review of pre-market submissions. Effective risk management has become critical to medical device manufacturers and this interactive two day seminar is aimed at providing medical device professionals with the tools necessary for effective risk management implementation in device manufacturing and marketing.

It will address both the fundamentals of risk management as well as current best practices for ISO 14971 compliance. The course will look in detail at risk management requirements in the US, the EU, and other parts of the world. Taught using an interactive workshop format, attendees will practice all the risk management activities required by ISO 14971. Exercises are aimed at demonstrating efficient and effective use of risk management, including best practices in applying the ISO standard. Emphasis is placed on practical solutions to practical problems. Seminar instructor Harvey Rudolph, Ph.D., one of the authors of ISO 14971 and a 25 year veteran of FDA, will also provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.

Seminar Instructor Dr. Harvey Rudolph is an ex-FDA official having spent 25 years with FDA and one of the authors of ISO 14971. He will provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.




Learning Objectives:

  • To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle
  • To demonstrate the requirements of ISO 14971, how they reflect FDA concerns
  • To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements
  • To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers
  • To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012
  • To provide attendees with the Dos and Don'ts for an effective and efficient risk management system


Who will benefit:

  • Project managers
  • Quality managers and staff
  • R & D managers and staff
  • Regulatory and compliance managers and staff
  • Anyone with risk management responsibilities


Topic Background:

The 3rd edition of IEC 60601 adds further fuel to the fire with the requirement that electro-medical device manufacturers have a risk management process in place conforming to ISO 14971.  Manufacturers that market devices in the European Union have found additional requirements for their risk management activities as detailed in EN/ISO 14971:2012.





Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Introduction
    • What is risk management?
    • Global requirements
    • ISO 14971
    • New European requirements and EN/ISO 14971:2012
  2. Risk management essentials and requirements
    • Risk management philosophy
    • Role of Management
  3. Establishing a risk management policy
    • Required inputs
    • Developing a workable policy (Exercise)
  4. Risk management planning
    • Necessary elements
    • Relationship with quality planning
  5. Risk acceptability criteria/constructing a risk chart
    • Defining the product
    • Measuring risk (Exercise)
    • How to establish risk acceptability criteria
    • EN/ISO 14971:2012 requirements
    • Construct a practical example
  6. Preliminary analysis
    • Safety analysis (Exercise)
    • Hazards and hazardous situations
    • Identifying hazards and hazardous situations (Exercise)
  7. Risk Analysis tools
    • What's available
    • Use and utility of tools (Exercise)
  8. Estimating risk
    • Quantitative and qualitative risk estimation (Exercise)
    • Pitfalls such as software
    • Practical example (Exercise)
  9. Using standards and risk management
    • New guidance from ISO
  10. Risk Evaluation and Risk Control
    • Using a risk chart (Exercise)
    • Use of ALARP
    • Option analysis for risk control

  1. Risk Control (continued)
    • The iterative process
    • Practical example (Exercise)
    • Verification, residual risk and completeness
    • Satisfying EN/ISO 14971:2012
  2. Risk/benefit analysis
    • EN/ISO 14971:2012 requirement
    • How to do it?
  3. Overall residual risk & the risk management report
    • New ISO guidance on evaluating overall residual risk
    • Content and use of the Risk Management Report
  4. Assessing production & post-production information
    • What are the requirements?
    • What you need to do
    • New guidance from ISO
  5. Wrap up
    • Risk management philosophy
    • Risk management and the quality management system
    • Helpful hints




Meet Your Instructor

Harvey Rudolph
HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)

Dr. Harvey Rudolph is an independent risk management consultant specializing in process development and training in risk management. He has been a member of the Joint Working Group on Risk Management since it began in 1995 and is a primary author of ISO 14971. Currently he co-chairs the US Technical Advisory Group for that standard and is working on the new ISO risk management guidance document.

His 37 years experience with medical devices include 25 years at FDA, where he held a variety of positions and retired as deputy director of the medical device laboratory. He also worked for seven years at Underwriters Laboratory, where he was the global program manager for medical devices developing programs to help clients deal with the global medical device environment.

He brings a wealth of knowledge and practical experience to this risk management workshop, having trained and consulted for numerous large and small companies throughout the world.





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$1,199.00

Seminar One Registration

January 29-30, 2015, San Diego, CA
(Early bird price valid till December 31, 2014)
Actual Price: $1,699

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May 7-8, 2015, Boston, MA
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September 10-11, 2015, Chicago, IL
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San Diego, CA, Local Attractions

Boston, MA, Local Attractions

The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.




Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.




Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.




The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.




Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.




Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.


This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.




The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).




Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.




Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.




The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.




This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.




The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.






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