Understanding Medical Device QMS: What they don't teach you at work
Biomedical manufacturers and their suppliers rely on an effective quality management system to ensure they produce safe and effective products, and comply with numerous regulatory requirements.  Despite the critical importance of the quality management system, many of those working for these types of companies have had little or no formal training.  Or, training only focuses on presenting what the regulations and standard state, without really explaining their intent.  This class fills that gap by explaining what a quality system is and what its real intent is, the history of the regulations that define the requirements, what those requirements are, and what they really mean. 

This class will be particularly beneficial for those who typically only get to work within a small part of their company’s quality management system.  However, those who have been in the industry for a long time in many roles, may also be surprised by what they hear and learn in this class as the instructor provides a clearer view of the entire system.

REGISTRATION: https://events.eply.com/UnderstandingMedicalDeviceQMS3360706

January 21 & 22nd  8am - 12:30pm
Cost: $90 Members. $100 Non-Members
RUs: 0.8

Steve Gompertz (CQM, CBA, RAC-US, CMII) is a leader in Quality Systems management with over 25 years of experience in the life-science 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 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, biomedical 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 M.S. in its Medical Technology Quality program.

Topics to be covered:
  • History of Quality, Standards, Regulations, and the FDA
    • How did we get here?
  • Quality System Basic Concepts & Intents
    • What is Quality and why is it a system?
  • Management Responsibility
    • Why does leadership matter to quality?
  • Resource Management
    • Are training and competency the same thing?
    • BTW, there are other resources to manage besides humans
  • Documents &
Date & Time
Thursday January 21st, 2021 8:00am CST
End Date & Time
Friday January 22nd, 2021 12:30pm CST
Host Type
Webinar Link / Meeting Instructions
Workshop will be via Zoom. Meeting details to be provided after registration.
Additional Information

8:00 – 8:30      Introductory Information    
8:30 – 9:00      History of Quality Standards & Regulations    
9:00 – 9:30      History of the FDA    
9:30 – 9:45      Break    
9:45 – 10:15    Quality System Concepts    
10:15 – 12:00  General Requirements    
                           Management Responsibility
                           Resource Management
                           Documents & Records

8:00 – 8:15     Day 1 Review
8:15 – 9:00     Good Documentation Practices    
9:00 – 9:15     Break    
9:15 – 10:30   Product Realization    
                            Design & Development
                            Production & Service
10:30 – 12:00  Measurement, Analysis, & Improvement    
                            Feedback, Complaints, & Reporting
                            Internal Audit
                            Monitoring & Measuring
12:00 – 12:30  Wrap-up/Questions
Category Public Calendar

Event Map

Date & Time: 01/21/2021 08:00:00 AM CST