Valid Statistical Techniques Made Easy Part 2


This training is targeted to professionals concerned with a specific application of valid statistical techniques to satisfy Process Validation requirements of the FDA:s Quality System Regulation. Sampling a product or process and measuring a quality characteristic is an efficient way to make an inference about the quality of all products or the entire process. Simply put, if it is too expensive to measure everything, then you would be wise to sample and measure a subset. If you decide to sample, then comes the age-old question: How much is enough?

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Description – On-demand Training

In the previous session we asked: How do you know you have quality if you cannot reliably measure what you are doing? This second session will focus on Attribute Measurement Systems – that is, the subjective inspection of items to see if they satisfy requirements. Since humans are the gauges, attribute measurement systems can have high variation. How do you evaluate this human judgement and how can you improve their results? And how is it made easy? This session will provide simple metrics to evaluate the human performance and industry best practices to reduce variation. It’s as simple as that!

Test Method Validation (TMV), also known as: Measurement System Analysis (MSA) and Gauge R&R (GR&R). The name is not important, the application of this very valuable statistical methodology is essential for a quality system. The material covered in this webinar is completely independent of the first part on Variable TMV. Thus, attending the first part on Variable TMV is NOT a requirement to attend this one.

Attribute measurements typically end up with a Pass/Fail or Accept/Reject decision. This session provides a very practical approach to conducting Attribute TMVs. Participants will gain a working knowledge of how to organize an Attribute TMV, collect data, analyze the results and improve the measurement system.

The presenter’s keep it simple approach will avoid statistical complexity – participants do NOT need to have a background in statistics.

This session is targeted to professionals concerned with the application of valid statistical methods and tools to satisfy the requirements of the FDA:s Quality System Regulation and ISO 13485:2016. In particular, the Attribute TMV methodology is important for Design Control and Process Validation.


  • Fundamentals of TMV/MSA/GR&R
  • Definitions and Terminology
  • Quality System Regulation and Guidance Documents
  • Significant Trends and FDA Warning Letters
  • Variable TMV Introduction
  • Quality Metrics
  • Cost of a Poor Measurement System
  • Sample Size Considerations
  • Set Up and Data Collection
  • Reviewing Metrics and Graphics
  • Examples from Industry
  • Validation of Analytical Procedures (VAP)
  • FDA Regulations and Guidance and ICH Guideline (ICH Q2(R1))
  • Definitions, Terminology and Mapping to TMV Concepts
  • Example from Industry
  • User´s Manual for Variable TMV

Duration: 2 hours


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