Quality assurance in analytical methods used in environmental,farmaceutical and food analyses, forensics and clinical chemistry: Sample (preparation and sampling procedures), Methods of analyte determination and Validation of the method. Interferences. Method Validation Key Performance Parameters (Selectivity, Specificity, Accuracy, Precision, Limit of detection and quantitation). Interlaboratory testing. Validation by Using Certified Reference Materials. Calibration. Measurement Uncertainity in spectroscopic, immunoassays and electroanalytical methods and chromatography. Reporting of results. Normization procedures and system (Application of HRN EN ISO/IEC 17025). Laboratory Accreditation.
LEARNING OUTCOMES:
- understand the terms and definitions used in analytical method validation
- describe of different methods of sampling and sample preparation
- understand the advantages and disadvantages of sampling methods
- for any analyte - select and apply an appropriate calibration method and its statistical evaluation
- define the characteristics of the analytical measurement procedure
- apply of parametric and non-parametric statistics for data evaluation
- define of the of quality assurance requirements
- describe quality control requirements
- define the principles of project management
- formulate how to assess, document and report the results and conclusions and how to prepare a validation protocol and quality assurance report
- know where to find relevant regulatory and professional validation guidelines and how they may be interpreted (e.g. HRN EN ISO/IEC 17025, ILAC, EA, IUPAC, Eurolab, etc.)
- understand and appreciate the requirements for laboratory accreditation
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- 1. M. Kaštelan-Macan, Kemijska analiza u sustavu kvalitete, Školska knjiga, Zagreb 2003.
2. P. De Bievre i H. Guenzler, Validation in Chemical Measurement, Springer-Verlag, Berlin 2005.
3. P. De Bievre i H. Guenzler, Measurement Uncertainity in Chemical Analysis, Springer-Verlag, Berlin 2003.
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