Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar
Stan Mastrangelo, Consultant
Salt Lake City, UT
| Thursday, December 15, 2016 | Friday, December 16, 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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Salt Lake City, UT (Venue to be announced shortly)
December 15-16, 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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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.
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Liberty Park and Tracy Aviary
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