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Statistical Process Control (SPC) Charts - A World Class Tool

Upcoming Virtual Courses

Quality Systems

Statistical Process Control (SPC) Charts - A World Class Tool (Jan 2025)

Jan 14 to Jan 14, 2025

Register

Overview

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.

Objectives

  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

    Background
    • 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

Who Should Attend?

The content should have great value to individuals in industry and the FDA who are involved with: process development; manufacturing, process, and quality engineering; operations; quality assurance; quality control; management review; and regulatory compliance. Through this overview, managers and members of the leadership team would see how value is added to a product or process.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.

Faculty

Peter Knepell

Dr. Peter Knepell is the President of Peak Quality Services. He is a Certified Master Black Belt (MBB), Certified Quality Engineer (CQE), and Certified Software Quality Engineer (CSQE). He has broad industry experience helping firms adopt Lean Six Sigma quality systems and meet FDA-regulatory requirements. In the mid-1990s, Pete assisted the FDA with the introduction of their Quality System Regulation. Pete has presented over 30 webinars and is on AAMI’s faculty for: Valid Statistical Techniques, Design of Experiments, and Process Validation.