COURSE OVERVIEW
Who is this course for?
This course is for analysts who require a better understanding of the practical aspects of designing and running a validation in support of a typical instrument analytical method.
It is also of benefit to those in a quality assurance or project management role who have to review validation protocols and reports.
Previous Knowledge
Good knowledge of typical instrumental analysis and associated data.
What you will learn
- Overview of the validation process
- The validation protocol
- Specificity
- Accuracy and recovery
- Linearity and range
- Sensitivity
- Precision
- Robustness
COURSE OUTLINE
The Method Validation Process
Regulations
- ICH Guidelines
- Validation Protocol
- Nested Design
Specificity
- Accuracy (Trueness) and Recovery
- Linearity and Range
Precision
- Repeatability
- Intermediate Precision
- Reproducibility
Sensitivity
- Limit of Detection (LOD)
- Limit of Quantitation (LOQ)
Robustness
- The following topics will be considered for each of the major validation parameters
- ICH Guidelines
- Definitions
- Applicability
- Typical Experimental Approaches
- Relationship with Method Development
- Workshop exercises