Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar
Stan Mastrangelo, Consultant
Courtyard Boston Cambridge, MA
Thursday, May 7, 2015 | Friday, May 8, 2015
Thursday, Sept 10, 2015 | Friday, Sept 11, 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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Courtyard Boston Cambridge
777 Memorial Drive,
Cambridge, MA 02139, USA
May 7-8, 2015
Special Offer for the attendees of this seminar:
Rooms available at only $219 per night.
Call 866-323-4159 and identify yourself as part of the ComplianceOnline group
Please note: Hotel rooms are limited and based on availability
How to Reach
General Driving Directions:
From Boston Logan International Airport – BOS: 7.3 mile(s) W
From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
- Exit Airport and take MassPike (I-90) West to Exit 20 (Cambridge)
- Continue straight and cross bridge
- Take first right after bridge onto Memorial Drive
- Hotel is 200 yards ahead on the left.
From T F Green Airport – PVD: 62.1 mile(s) NE
- Follow I-293 to I-93S towards Boston
- Take exit 26B (Storrow Drive West) and continue for 3 miles
- Bear right at the Central Square/MassPike exit and turn right at the light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- Take I95N to I93N
- Then, take exit 26 (Storrow Drive West) and follow Storrow Drive
- Take the Central Square/MassPike exit and turn right at light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- South Station: 5 mile(s) SE
- B.U. Central (on the Green Line): 0.8 mile(s) SE
- Central Station (on the Red Line): 0.8 mile(s) NE
- Back Bay Station (BBY): 3 mile(s) SE
- South Station (BOS): 5 mile(s) SE
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.
Chicago, IL (Venue to be announced shortly)
September 10-11, 2015
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San Diego, CA, Local Attractions
Boston, MA, Local Attractions
San Diego Cabrillo National Monument
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.
Sea Creatures at Birch Aquarium
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.
San Diego Zoo Safari Park
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.
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.