May 2025 Program Meeting – “Risk Based Approach vs. Risk Management” by Steve Gompertz
When: Tuesday, May 13, 2025
Where: Hybrid
Recertification units available:
0.1 RU Meeting (Business/Networking)
0.1 RU Workshop (1 hour)
Agenda:
6:00 P.M Registration & Dinner (in-person)
6:30 P.M. Welcome, Announcements
7:00 P.M. Presentation: Steve Gompertz, “Risk Based Approach vs. Risk Management”
7:55 P.M. Closing Notes
About the Presentation:
Title: Navigating Transformation: Insights into Modern Organization
For years, regulations and standards have been increasing their focus on the application of a Risk- Based Approach (RBA) to quality management. Unfortunately, many people have confused that concept with the more formal Risk Management (RM) process when they are two related but different concepts. At its simplest, RM is a subset of RBA, for use when formal risk analyses, evaluation, and control are necessary. But in most situations, an awareness of the risks and how to mitigate them is all that's required, i.e. - applying risk-based thinking; a risk-based approach. This presentation will explain the differences by establishing a clear understanding of the basic concepts of Risk, Risk-Based Approach, and Risk Management, along with when to apply each within the Quality Management System.
Attend this presentation to learn more about:
- Understand the differences and relationship between Risk-Based Approach and Risk Management
- Understand when to apply each
- Learn how to demonstrate how your QMS is applying a Risk-Based Approach
About Our Speaker:
Steve Gompertz (CMQ/OE, CMDA, RAC-US, CMII) is a leader in Quality Systems management with over 30 years of experience in the medical technology industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the medical technology industry providing guidance on quality systems and regulatory compliance.
Steve holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, medical device auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality-related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in the “M.S. in Medical Technology Quality” program. He is a Distinguished Speaker with the Society for Quality Assurance (SQA) and was awarded the 2023 Charles W. Britzius Distinguished Engineer Award by the MN Federation of Engineering, Science, and Technology Societies (MFESTS).
Register now using the link below!