Valid Statistical Techniques Made Easy Part 1


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?

SKU: 8010 Category: Tag:

Description – On-demand Training

ow do you know you have quality if you cannot reliably measure what you are doing? Are you afraid of complex statistical concepts and procedures? These two webinars will help you to evaluate your measurement systems, diagnose problems, and fix them. How is it made easy?? This first webinar will provide a User?s Manual to apply valid statistical software to a TMV methodology. The software will yield simple metrics to evaluate the measurement system and graphical tools to identify problem areas and fix them. It´s as simple as that!

Participants receive a working knowledge of Test Method Validation (TMV), also known as: Measurement System Analysis (MSA) and Gauge R&R (GR&R). Concepts covered are also applicable to Analytical Procedures. The names are not important, the application of this very valuable statistical methodology is essential for a quality system. Thus, the valid statistical techniques satisfy requirements of: the US FDA´s QS and cGMP Regulations, ISO 13485:2016, and ICH Q2(R1). In particular, the TMV/MSA/GR&R methodology is vitally important for Design Control, Process Validation and Analytical Procedures.

This is the first of two vital sessions on the subject. Part 1 will cover TMV/MSA/GR&R for Variable measurements. Part 2 will cover Attribute (e.g., pass/fail) measurements. We will cover the details of application together with some examples of best practices in industry. Analysis results and graphics from popular statistical software programs will be illustrated. Participants will gain a working knowledge of how to organize a Variable 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.


  • 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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