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ASQ: Understanding Medical Device Quality Systems – What they don’t teach you at Work

December 7 @ 8:00 am - 4:30 pm

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 and standards 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. But 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.

These two days are packed with information and the perfect time to have your Quality Management System questions answered. Come with specific scenario’s to discuss and receive clarification on.

Topics to be covered:
Day 1 Wednesday, December 7, 8:00 am – 4:30 pm CST

  • 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?
    • You need more resources than just people
Date & Time
Wednesday December 7th, 2022
End Date & Time
Thursday December 8th, 2022
Venue
St Cloud State at Plymouth
Address
9750 Rockford Rd
Plymouth, MN 55442
United States
Webinar Link / Meeting Instructions
Dates:  Wednesday, December 7th & Thursday December 8th
Time:  8:00 AM CST – 4:30 PM CST
Cost: Minnesota ASQ Member – $125.00
          Non-Members – $175.00
Location:   St. Cloud State in Plymouth.  9750 Rockford Road, Plymouth MN 55442
Additional Information
Instructor Bio
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.  Steve can be reached at , and more information about his experience is available at https://www.linkedin.com/in/stevegompertz/

Event Sponsor Information

he American Society for Quality (ASQ), is a knowledge-based global community of quality professionals, with nearly 80,000 members dedicated to promoting and advancing quality tools, principles, and practices in their workplaces and communities.  As your career partner, ASQ membership benefits are designed to help meet your growing needs as a quality professional.  Membership provides exclusive access to quality knowledge, solutions and resources to solve challenges, and skill development to advance your career. ASQ is committed to providing enhanced expertise, professional networks, tools, and solutions to help our members advance their products, services, and industries.

The MN ASQ Biomedical Consortium (BMC) focuses on the medical device industry specifically.  This is a volunteer membership.  ASQ Membership is not required to join.  There are many ASQ perks provided when joining the BMC.

Consider becoming a member of one or both to enhance your professional experience.

Venue

St. Cloud State – Plymouth Campus
9750 Rockford Road, Suite 100
Plymouth, MN 55442 United States
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