COURSE PROGRAM
1. Introduction to Validation
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- General concept
- Summary of ISO 17025 requirements
- Need for validation
- Types of methods and validation
2. Validation Design and Records Obtained
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- Planning
- Execution
- Control
- Documents and records
3. Validation and Standardized Methods
4. Method Parameters
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- Definition of parameters: accuracy, precision, working interval, linearity range, limits of detection and quantification, selectivity and specificity, uncertainty
- Instrumental calibration
5. Statistical Concepts
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- Introduction
- Distribution models
- Estimators
- Appendix: Student’s t distribution table
6. Validation and Quality Assessment
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- Introduction
- Obtaining validation data from statistical control activities
- Deriving limit values from validation data
7. Validation Systematics
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- With established reference value
- Validation based on interlaboratory tests
8. Practical Validation Examples
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- Validation example based on prior information
- Validation of an instrumental method using the standard addition technique
- Example of accuracy and compatibility index
- Validation based on interlaboratory tests
9. Introduction to Uncertainty
10. Black Box Uncertainty Estimation – Theoretical Introduction
11. Examples of Uncertainty Estimation (Black Box Application)
11. Examples of Uncertainty Estimation (Black Box Application)
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- Validation with reference material and black box uncertainty estimation
- Estimation of uncertainty from interlaboratory test validation
