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ASQ: Understanding Medical Device QMS: What they don’t teach you at work
January 21 @ 8:00 am - January 22 @ 12:30 pm
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.
January 21 & 22nd 8am – 12:30pm
Cost: $90 Members. $100 Non-Members
ABOUT OUR PRESENTER
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 &
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
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
Monitoring & Measuring
12:00 – 12:30 Wrap-up/Questions