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ASQ: Understanding Medical Device QMS: What they don’t teach you at work

February 10, 2022 @ 8:00 am - 12:00 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 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/BMCUnderstandingQMS3364791

Topics to be covered in this two half-day workshop:

  • 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 & Records
    • What’s the difference and how do you produce good ones?
  • Control of Nonconforming Product
    • “Product” may not mean what you think it does.
  • Customer Feedback
    • Not all feedback is a complaint?
  • Audits
    • What are internal audits supposed to be for, and what happens in an external audit?
  • CAPA
    • Why is this so important and why do manufacturers keep getting it wrong?
  • Design Control
    • What is it and when does it really begin?
  • Design Transfer
    • What is it and when does it really begin?
Date & Time:
Wednesday February 9th, 2022 8:00am CST
End Date & Time:
Thursday February 10th, 2022 12:00pm CST
Virtual and On-Site
St. Cloud State University – Plymouth
9750 Rockford Road
Plymouth, MN 55442
United States


February 10, 2022
8:00 am - 12:00 pm
Event Category:


St.Cloud State University – Plymouth
9750 Rockford Road
Plymouth, MN 55442, MN 55386 United States
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