Validation Statistics for Non-Statisticians

Validation work depends on statistics, but you don't need to be a statistician to use the core tools well. This 60-minute validation statistics webinar explains the common techniques through real-world examples and an interactive exercise.

You'll start with what statistics is, why validation needs it and what regulators expect. The session then focuses on variance: where it comes from, how to measure it, normal and non-normal distributions, and how to express it with variance, standard deviation and the coefficient of variation.

It finishes with process capability: whether your system can do what you need, how to measure capability and how to use it to set acceptance criteria for validation.

• Explain why statistics is needed in validation and what regulators expect
• Identify sources of variance and measure it
• Tell normal from non-normal distributions
• Express variance using variance, standard deviation and coefficient of variation
• Assess whether a process is capable of meeting requirements
• Use process capability to set validation acceptance criteria

Introduction

• What statistics is
• Why validation needs statistics
• Regulatory expectations

The concept of variance

• Why variance matters
• Sources of variance
• Measuring variance
• Normal and non-normal distributions

Expressing variance

• Variance
• Standard deviation
• Interactive exercise: measuring variance
• Coefficient of variation

Process capability

• Can your system do what you need it to do?
• Measuring capability
• Using capability to set acceptance criteria for validation

Conclusion and discussion

Anyone involved in validation needs a basic understanding of statistics and how it applies to their work. Without it, acceptance criteria and conclusions are harder to justify.

This session suits validation engineers, R&D and technical support scientists, quality assurance and regulatory affairs professionals, and production staff involved in validation in the medical device and pharmaceutical industries.

• Quality Assurance Professionals
• R&D Scientists
• Technical Support Scientists
• Regulatory Affairs Professionals
• Manufacturing and Production Personnel involved in validation activities

Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents, and published numerous papers and abstracts. Alan then transitioned to a quality assurance role wherein both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support, and operations.

Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation, and statistics. He has been lecturing on these topics worldwide for over 10 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops, and seminars in many areas of quality assurance.

Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.