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Public webinars


Keeping Score – Measuring Process Capability

On-line webinar

Course description:

A famous sports coach once said: “If you are not keeping score, you are just practicing.” The FDA’s Quality System regulation says that manufacturers “shall establish and maintain procedures for… verifying the acceptability of process capability and product characteristics.” That’s asking folks to keep score. But regulatory compliance is not the only issue. Any organization that wants to pursue world-class quality should rely on meaningful measures of quality.

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 make statistical concepts easy to apply – participants do not need to have a background in statistics.

The primary goal of this webinar is to develop a simple flow chart on methods to establish and maintain process capability through meaningful measures of quality. Statistically valid techniques and industry best-practices are presented. 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.

Program objectives

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

  • Describe the fundamental purpose of process capability measures
  • Select and calculate product or process capability indices for the following types of data:
    • Attribute Data
    • Variable Data That Are:
      • Normally Distributed
      • Not Normally Distributed
  • Decide if variable data come from a Normal distribution
  • Discuss FDA regulatory requirements and expectations


  • Background
    • FDA Regulatory Requirements
    • Introduction to Jargon and Commonality Among Measures
    • Capability Study Decision Tree
  • Attribute Data Process Capability Measures
    • Measures of Yield
    • Measures of Defects and Defectives
  • Variable Data Process Capability Measures
    • Process capability measures for Normally distributed data
      • Properties of the Normal distribution
      • Practical ways to determine if data come from a Normal distribution
      • Special Topics:
        • Ppk vs. Cpk
        • Tolerance Intervals
    • Process capability measures for non-Normally distributed data
      • Transformed data
      • Data that cannot be transformed
  • Wrap Up and Q&A
    • Expressing Risk in a Decision
    • Important Considerations for Application
    • Questions & Answers

Who should attend:

The content should have great value to individuals in industry 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 process capability measures, managers and members of the leadership team would see how value is added to a quality process.


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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Course facts

Course no:
Medical Devices

CS region:

Peter Knepell
Peter Knepell, PhD
President, Peak Quality Services

4 May 2020

14.30 - 16.30 (120 min) CET (Central European Time)

Price (excl. local VAT):
250 Euro for the first participant.
115 Euro for the following participants on the same registration and invoice.
Course handouts (PDF) and certificate of attendance is included.
For larger groups, please contact us for an offer.

Equipment needed:
You need access to a computer, tablet or mobile phone with internet connection (preferably min 700kB/s) and audio capabilities (speakers or headphones).
We are using the easy to use application "GoToWebinar".
See more about how to join a session and the system requirements here »

Instructions will be attached to your order confirmation.

Cancellation policy for webinars:
Cancellations received less than 24 hours before the webinar will be charged 50% of the course fee.

If you for any reason is unable to attend, substitution is always possible and preferred. All cancellations and/or substitutions must have been communicated with and confirmed by us.

In case of failure to cancel before the course, the course fee will be charged in full.

Cancellation of webinars:
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value.