TECNICHE DI VALIDAZIONE DELLE METODICHE DI ANALISI E CONTROLLO QUALITA'
Academic Year 2026/2027 - Teacher: SALVATORE BARRECAExpected Learning Outcomes
Knowledge and understanding:
Classroom-based lectures will enable students to acquire a basic understanding of validation techniques, performance verification and quality control in chemical analysis across various fields of application.
Applying knowledge and understanding:
To be able to identify the parameters to be considered for validation, performance verification and quality control in relation to chemical analysis across various fields of application.
Making judgements:
To enable the objective evaluation of results, also in relation to the skills learnt.
Students will be able, on the basis of theory, to assess the potential application of a proposed analytical method and the associated quality control measures.
Communication skills:
To develop and/or improve the ability to explain scientific concepts, including complex ones, using appropriate technical terminology.
Learning skills:
To learn the main quality control procedures and the steps to be taken for performance validation and verification processes.
Course Structure
Required Prerequisites
Attendance of Lessons
Detailed Course Content
Course overview (2h)
Introduction to the course and problems. Validation and performance assessment of methods. Differences between standardised, non-standardised and in-house methods. (2h)
Revision of basic statistics and their application (8 hours)
Systematic and random errors. Absolute and relative error. Possible sources of error. Applications. (2 hours)
Probability distribution. Confidence intervals. Normal distribution and significance tests. Comparison of repeatability and reproducibility of analytical data. Applications. (2 hours)
Estimates of precision and accuracy. Comparison of means. Dixon’s test (or Q-test) and applications. (4 hours)
Introduction to validation systems and quality control (18 hours)
Robustness, selectivity and sensitivity of a method. Limits of detection and quantification, and methods for their determination. Calibration curves. Recovery tests and dilution tests. (6 hours)
Accuracy, trueness and precision. Dynamic and linear ranges, definitions and applications. (4 hours)
Measurement of uncertainty (top-down, bottom-up, Horwitz and mixed approaches) and applications. (8 hours)
Quality control systems (10 hours)
Good laboratory practice and monitoring of data. (2 hours)
Validation of the analytical system using second-source standards and matrix spikes. (4 hours)
Shewhart control charts and applications
Textbook Information
Course Planning
| Subjects | Text References | |
|---|---|---|
| 1 | Course overview (2h)Introduction to the course and problems. Validation and performance assessment of methods. Differences between standardised, non-standardised and in-house methods. (2h)Revision of basic statistics and their application (8 hours)Systematic and random errors. Absolute and relative error. Possible sources of error. Applications. (2 hours)Probability distribution. Confidence intervals. Normal distribution and significance tests. Comparison of repeatability and reproducibility of analytical data. Applications. (2 hours)Estimates of precision and accuracy. Comparison of means. Dixon’s test (or Q-test) and applications. (4 hours)Introduction to validation systems and quality control (18 hours)Robustness, selectivity and sensitivity of a method. Limits of detection and quantification, and methods for their determination. Calibration curves. Recovery tests and dilution tests. (6 hours)Accuracy, trueness and precision. Dynamic and linear ranges, definitions and applications. (4 hours)Measurement of uncertainty (top-down, bottom-up, Horwitz and mixed approaches) and applications. (8 hours)Quality control systems (10 hours)Good laboratory practice and monitoring of data. (2 hours)Validation of the analytical system using second-source standards and matrix spikes. (4 hours)Shewhart control charts and applications |
Learning Assessment
Learning Assessment Procedures
Examples of frequently asked questions and / or exercises
Examples of frequently asked questions and/or exercises
Key differences between the standardized method, non-standardized method, and in-house method.
Principles of a control chart and data monitoring.