Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar
Stan Mastrangelo, Consultant
Embassy Suites Chicago - Downtown, IL
Thursday, Sept 10, 2015 | Friday, Sept 11, 2015
Salt Lake City, UT
Monday, December 14, 2015 | Tuesday, December 15, 2015
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
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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Embassy Suites Chicago - Downtown/Lakefront
511 North Columbus Drive,
Chicago, Illinois, 60611, USA
September 10-11, 2015
How to Reach
General Driving Directions:
Driving directions from Chicago-OHare International Airport - 17 miles:
Driving directions from Chicago Midway Airport: 12 miles:
- I-90/94 East.
- Exit at Ohio Street.
- Turn right onto Orleans Street and proceed 2 blocks.
- Turn left onto Illinois Street and proceed 10 blocks to Columbus Drive.
- Hotel is at intersection of Illinois and Columbus.
- Cicero Ave to I-55 North to Lake Shore Drive (Hwy 41 North).
- Exit Grand Ave (Navy Pier exit).
- Proceed two blocks and look for hotel on left.
- Hotel parking is before intersection of Grand Ave and Fairbanks.
Disclaimer: Directions to the venue above have been taken from the hotel website. ComplianceOnline is not responsible for any inaccuracies in the same. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue.
Salt Lake City, UT (Venue to be announced shortly)
December 14-15, 2015
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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Chicago, IL, Local Attractions
Salt Lake City, UT, 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.
Temple Square and Related Sites
Temple Square is Salt Lake City's most popular attraction. With its grand six-spired temple, two visitor's centers, lovely flower gardens and fountains - and nearby sites related to the Church of Jesus Christ of Latter-Day Saints. Area attractions include the Assembly Hall, Tabernacle, Museum of Church History and Art, Family Search Center, Beehive House, Lion House, Brigham Young Historic Park, LDS Conference Center and Joseph Smith Memorial Building. Temple Square offers hundreds of free movies, dramatic programs and music events every year.
The Gateway on the west side of downtown Salt Lake is the city's best outdoor shopping center.
City Creek Center
It's designed to be a walkable shopper's paradise, with six acres of green space, the namesake creek, two 18-foot waterfalls, and a massive retractable roof.
The Utah State Capitol, at 300 N. State St., sits atop a hill overlooking the Salt Lake Valley. The building was constructed in 1912-1916 and renovated in 2004-2008.
Utah's Hogle Zoo dates from 1931 and is located at the mouth of Emigration Canyon at 2600 E. Sunnyside Avenue. The Zoo is one of the most visited attractions in Utah and the top paid-for tourist attraction in Salt Lake City. It covers 42 acres and includes more than 800 animals.
This is the Place Heritage Park
This is the Place Heritage Park includes a restored pioneer village with live demonstrations of pioneer life and a restored Brigham Young farmhouse.
University of Utah
The University of Utah is not only one of the state's leading educational institutions but also an important cultural and sports center for the city and the state of Utah.
Liberty Park and Tracy Aviary
Liberty Park is Salt Lake City's second largest public park and includes trails, playgrounds, a pond, paddle boat rentals, tennis courts, picnic facilities, amusement rides and a water play area. Liberty Park includes the Chase Home Museum of Folk Arts and the excellent eight-acre Tracy Aviary, one of two free-standing aviaries in the United States.