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.

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

PROGRAM-AT-A-GLANCE:/p>

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