Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar
Stan Mastrangelo, Consultant
Thursday, May 5, 2016 | Friday, May 6, 2016
Thursday, September 8, 2016 | Friday, September 9, 2016
The course is designed for Medical Products Manufacturers. The course will be taught for Medical Devices and Combination Products, but will also be of benefit to Pharmaceutical Manufacturers.
Upon completion of the course, the participants will have learned how to implement good risk management principles into medical products manufacturing operations such as medical devices, combination products, and pharmaceuticals:
- Understand what are the current issues and recommended solutions
- How to implement the ISO 14971 framework
- Use a Traceability Report for improved risk management operations
- How to Use Standards to Facilitate Product-to-Market Achievements
- How to Use Risk Management to Identify the Critical Success Factors
- Key implementation issues related to Risk Management
- Using Risk Management to identify key opportunities for the organization
- Risk Integration Issues, especially related to the Quality System and Design Controls
- Use of appropriate risk management tools beyond FMEA
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
Who will benefit:
The course is designed for manufacturing professional employees that must interface with or implement product risk management activities in a medical product manufacturing operation.
- Product Risk Managers
- Quality Assurance
- Regulatory Affairs
- Research & Development
- Project Managers
- Operations Managers
- Manufacturing Managers
|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
- Introduction to Risk Science
Introduction to ISO 14971
What Is New?
- What Is So Special About Medical Products?
- Complexity Theory, Chaos Theory, and Decision-making
Frameworks for Successful Risk Management
- New European Requirements
- Risk Management in IEC 60601
- Human Factors
Planning for Effective Risk Management
- Review of ISO 31000
- Combination Products and ICH Q9
The Master Document – The Traceability Report
- Integrating Risk Management into Design Controls
- Risk Concepts in Project Planning
ISO 14971 - By The Numbers
- Key role of this document
- Leverage this report to meet new EN requirements
- Management Responsibility
- Risk Policy
- Establishing Risk Acceptability Criteria
- The Importance of Preliminary Hazard Analysis
- Risk Estimation – Effective Use of Qualitative Analysis
- Using More Tools Than Just FMEA
- Risk Assessments
Risk Control Techniques
- Using a Modular Strategy for Complex Products
- How to Assess Overall Risk and Risk-Benefit
Production & Post – Production
- Verification of Implementation
- Using Validation for Effectiveness
Risk Management in R&D
- Is Production Being Monitored and Documented in the Risk File?
- Documenting Field Performance in the Risk File
- Making Recall Decisions
- Communicating Risk to Stakeholders
Risk Management in IEC 60601, Third Edition
- Risk Science in the Research Phase
- Risk Management in Design Phase Reviews
Risk Management in the Supply Chain
- Using Risk Science to Address Unique Product Characteristics
- The Test Lab and the Risk Management File
Organization of the Risk Management File
- Assessing Supply Chain Risk
- Controlling Supply Chain Risk
- Product Families
- Products and Accessories in Medical Systems
- Confirmation of Learning Objectives
- Key Topics to Watch
Meet Your Instructor
Stan Mastrangelo has over 30 years of professional work experience in Quality Assurance of medical devices, pharmaceuticals, and foods. Stan has held positions such as Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, QA Director, and Consultant. Stan was a member of the ANSI Executive Standards Board. Stan has had extensive involvement in the development of International Risk Management Standards. Stan was a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971). Stan was a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management that developed ISO 31000 which is the Risk Management Standard for all sectors. Stan was on the US PhRMA (Pharmaceutical Research and Manufacturers Association) Team that supported the development of ICH (International Conference for Harmonization) Standard Q9 titled Quality Risk Management for Pharmaceuticals. Stan also served on various IEC Standards Teams related to IEC 60601, IEC 80001 and Risk Management in the Software Lifecycle. Stan is an Adjunct Professor at Virginia Tech and was a co-developer of a Masters Degree Program in Medical Product Risk Management. Stan is on the Risk Management Committee for the IECEE.
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Boston, MA(Venue to be announced shortly)
May 5-6, 2016
Chicago, IL (Venue to be announced shortly)
September 8-9, 2016
Well-chosen topics, experienced presenter and excellent support material. In all, a good training experience.
- Manager, Instrument Risk, Abbott Molecular, Inc.
Very useful support material and a good presenter. The course was well structured.
- Senior Project Manager, Risk Management, Abbott Molecular, Inc.
The presenter offered a fresh perspective of the subject.
- Regulatory Affairs Supervisor, Hu-Friedy
The seminar content and presentation were both good.
- Quality Engineer, Hu-Friedy
The topics covered were really helpful and the presenter had a wealth of information to share. The support material provided during the course was useful too.
- Senior Quality Engineer, Harvard Apparatus Regenerative Technology
The presentation was designed well and the presenter was conversant. I found the sessions interactive and well-planned.
- QA Program Engineer II, Abbott Medical Optics Inc.
The topics covered were sound. The group interaction and discussions were helpful.
- Program Engineer III, Abbott Medical Optics Inc.
The course covered everything I thought it would. Overall well presented.
- Lead Compliance Agent, ForeverGreen International
I found the presenter to be very knowledgeable and he spent time covering all the topics effectively. The support material he shared with us was quite useful too. The topics covered and the overall presentation were both sound.
- Regulatory Affairs / Compliance Manager, LSI SOLUTIONS®
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Boston, MA, Local Attractions
Chicago, IL, Local Attractions
Boston Public Garden
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.
Boston Public Library
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.
Museum of Fine Arts
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.
Museum of Science
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.
Old North Church
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.
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.