Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar
Dr. Harvey Rudolph, HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)
Thursday, September 11, 2014 | Friday, September 12, 2014
Thursday, December 11, 2014 | Friday, December 12, 2014
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.
- 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
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.
|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
Risk management essentials and requirements
- What is risk management?
- Global requirements
- ISO 14971
- New European requirements and EN/ISO 14971:2012
Establishing a risk management policy
- Risk management philosophy
- Role of Management
Risk management planning
- Required inputs
- Developing a workable policy (Exercise)
Risk acceptability criteria/constructing a risk chart
- Necessary elements
- Relationship with quality planning
- Defining the product
- Measuring risk (Exercise)
- How to establish risk acceptability criteria
- EN/ISO 14971:2012 requirements
- Construct a practical example
Risk Analysis tools
- Safety analysis (Exercise)
- Hazards and hazardous situations
- Identifying hazards and hazardous situations (Exercise)
- What's available
- Use and utility of tools (Exercise)
Using standards and risk management
Risk Evaluation and Risk Control
- Quantitative and qualitative risk estimation (Exercise)
- Pitfalls such as software
- Practical example (Exercise)
- Using a risk chart (Exercise)
- Use of ALARP
- Option analysis for risk control
- Risk Control (continued)
- The iterative process
- Practical example (Exercise)
- Verification, residual risk and completeness
- Satisfying EN/ISO 14971:2012
Overall residual risk & the risk management report
- EN/ISO 14971:2012 requirement
- How to do it?
Assessing production & post-production information
- New ISO guidance on evaluating overall residual risk
- Content and use of the Risk Management Report
- What are the requirements?
- What you need to do
- New guidance from ISO
- Risk management philosophy
- Risk management and the quality management system
- Helpful hints
Meet Your Instructor
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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Chicago, IL (Venue to be announced shortly)
September 11-12, 2014
Tampa, FL(Venue to be announced shortly)
December 11-12, 2014
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Chicago, IL, Local Attractions
Tampa, FL, Local Attractions
One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.
Adler Planetarium and Astronomy Museum
The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!
Arlington International Racecourse
With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.
Art Institute of Chicago
You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.
Auditorium Building and Theatre
A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.
Museum of Science & Industry (MOSI)
More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.
Salvador Dali Museum
Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.
Tampa Museum of Art
Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.
Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.
Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.
At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.