Applying Control Charts for Visualizing and Detecting Trends

ONLINE

Course description

Have you ever accused your associates of over-reacting to the slightest changes in production, corrective actions, complaint monitoring, or servicing? Or worse yet, have folks in your organization over-looked obvious trends in those key areas? This webinar will provide a valid statistical procedure that is so simple, you won’t even know that you are applying statistics — all the time. Statistical process control (SPC) charts are highly graphical tools applied in world-class organizations.

Applying SPC charts are invaluable for detecting trends in Process Validation, CAPA, complaint monitoring, technical support issues, and product servicing. This graphical tool is a very efficient way to present data on the front lines and at management reviews. FDA regulatory requirements and the recommendations of the guidance documents developed by the FDA and the Global Harmonization Task Force (GHTF) will be discussed. Best practices applied in a wide variety of industry settings will be illustrated.

This webinar will cover the details of application without the burden of statistical complexity. Analysis results from popular statistical software programs will be illustrated. The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do not need to have a background in statistics.

Learning objectives

At the end of this webinar, participants will be able to:

• Describe the statistical background for control charts
• Apply Statistical Process Control (SPC) charts in a variety of settings
• Know how to select the appropriate SPC chart given the intended use
• Discuss how FDA regulatory and ISO requirements are satisfied using SPC charts

Course content

• Background
  • Decision Making and Assessing Risk
  • Statistical Concepts
  • Applying SPC charts to Detect Trends
• Selection & Demonstration of Five Popular SPC Charts
  • Scenario & Appropriate Chart
  • Interpreting Charts
  • Statistical Software Output
  • Other Considerations
• Regulatory and Other Considerations
  • US FDA Quality System Regulation
  • ISO 13485
  • GHTF Guidance on Process Validation
  • Warning Letters
• Wrap Up and Q&A
  • Key Takeaways
  • Important Considerations for Application
  • Q&A

Who should attend

This webinar is targeted to professionals concerned with the application of Sampling Plans to meet the requirements of the FDA’s Quality System Regulation. The content should have great value to individuals in industry and the FDA who are involved with: new product development; process development; manufacturing, process, and quality engineering; operations; quality assurance; quality control; and regulatory compliance. Through this overview of sampling, managers and members of the leadership team would see how value is added to a product or process.

Prerequisites

There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our “keep-it-simple” approach.

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