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Meaningful Quality System Process Monitoring - Webinar

  • ID: 5029717
  • Webinar
  • June 2020
  • Region: Global
  • 90 Minutes
  • NetZealous LLC
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Overview:
When considering the requirements for process monitoring and measurement, the first thought is usually in regard to production processes. However, ISO 13485 and ISO 9001 require companies to monitor and measure all quality system processes.

Too often, this is either ignored, considered to be addressed by internal audit, or focused primarily on cycle-time reduction; none of which actually address the intent of the requirements.

This webinar will help attendees to better understand those intents, how to meet them to realize business value rather than just compliance, and to avoid common mistakes that can result in reduced business value.

Why you should Attend:
  • You probably monitor and measure your production processes, but what about the rest of your quality system processes?
  • Are you relying solely on internal audits to satisfy the requirement for process monitoring?
  • While internal audits can tell you whether your processes conform, how do you determine if the processes are effective?
  • What does effective mean; e.g. – what constitutes effective document control?
  • Have you considered whether your measurements drive the wrong behaviors in process participants?
Areas Covered in the Session:
  • What are the requirements and what are their true intents?
  • Let's revisit what Deming said about management by objective
  • Is there more to ensuring process conformity than just auditing?
  • What does process effectiveness look like?
  • How does process performance relate to product conformity?
  • How to get Management to care?
  • Common mistakes
  • Scaling process monitoring to measure the entire quality system
Who Will Benefit:
  • Quality Manager
  • Quality Director
  • Quality Systems Specialist
  • Quality Engineer
  • Regulatory Affairs Manager
  • Regulatory Affairs Director
  • Regulatory Affairs Specialist
Speaker Profile
Steve Gompertz is a leader in Quality Systems management with over 25 years' experience in the life-science industry.
Note: Product cover images may vary from those shown
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Steve Gompertz is a leader in Quality Systems management with over 25 years' 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, Boston Scientific, Medtronic, Vital Images, and Control Data. He is currently President of Quality Management Systems Potential LLC, a consulting firm focusing on medical device quality.
Note: Product cover images may vary from those shown
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  • Quality Manager
  • Quality Director
  • Quality Systems Specialist
  • Quality Engineer
  • Regulatory Affairs Manager
  • Regulatory Affairs Director
  • Regulatory Affairs Specialist
Note: Product cover images may vary from those shown
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