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QMS Effectiveness: Tracking and Trending Quality Data

Wednesday, June 14
10:00 am – 11:00 am
Room 49



John Gagliardi

MidWest Process Innovations 




What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This session will take an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.


Attendee Takeaways

  1. Important metrics to measure and manage quality
  2. How metrics correlate to your ISO and FDA processes
  3. The role that metrics play in risk-based decision making


John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner.

Helpful links: Planning for the Unpredictability of Change | Risk Management: The Science of Minimizing Uncertainties