- 3 days
Method validation is an essential part of establishing and ensuring the quality of analytical data. It cannot be guaranteed that data will be fit for purpose unless the performance of the test method has been studied and demonstrated to be adequate. Method validation is the process that provides evidence that a test method is capable of providing data that are suitable for a particular application. It is a requirement of the ISO/IEC 17025 laboratory accreditation standard and many other sectoral regulations and directives. Method validation should always be a planned activity. This course introduces the statistics required for interpreting validation data and provides the tools to plan and carry out effective validation studies.
Download the course programme.
What are the benefits?
This course will help you:
- Understand method validation and its requirements
- Select and apply the statistics required during method validation
- Select and use the appropriate types of method validation studies
- Appreciate and understand the link between method validation and measurement uncertainty
The course will cover:
Day 1 - Essential statistics
- Introduction to statistics for method validation
- Significance testing – t-tests and the F-test
- Analysis of variance (ANOVA)
- Linear regression
Day 2 - Providing the tools
- Introduction to the concepts of method validation
- Performance parameters: precision, bias and ruggedness.
Day 3 - Further tools
- Performance parameters: selectivity, capability of detection, linearity and working range
- Using validation data to estimate measurement uncertainty.
Who should attend?
This course is primarily designed for analysts and laboratory managers in the analytical chemistry and related sectors.