Educational offer - University of Padova

Syllabus

Prerequisites:	Good knowlegde of anaytical chemistry fundamentals and theoretical basis of common analytical techniques. Basic knowledge of classical statistics provided within the courses Analytical Chemistry I and II.
Target skills and knowledge:	The lessons will be dedicated to the underdstanding of basic concepts of statistics and to the use of sofwtare (Matlab and R) in order to solve simple problems. The student will acquire knowlegde of the theoretical basis of the norms for control and validation of an analytical method. The student will be familiar with the application of the norms to real problems in analytical chemistry. The scope of the course is also to teach how to manage quality control in a company in order to prevent the production of non-compliant services or products.
Examination methods:	Oral exam
Assessment criteria:	Knowledge of the concepts explained during classes and ability to solve practical problems.
Course unit contents:	The course offers theoretical bases, regulatory aspects and practical case studies of quality control in analytical chemistry. It will also introduce to the use of software (Matlab and R). The student will acquire a background in statistics and application sofwtare that will be an asset in any field. Moreover, it will be useful to future laboratory managers and certificators. The course will be structured in the following chapters: 1. ELEMENTS OF STATISTICS 2. PHASES OF THE ANALYTICAL METHOD AND SOURCES OF UNCERTAINTY 3. VALIDATION OF THE ANALYTICAL METHOD 4. CONTROL TECHNIQUES OF THE ANALYTICAL DATA Detailed program: 1.ELEMENTS OF STATISTICS Types of error. Elements of classical statistics. Normal distribution. Student's t-distribution. Fisher's F-distribution. Sample distribution of the mean. Central limit theorem. Statistical inference (Parametrical Tests). Non-parametric statistics (Non-parametric tests). ANOVA. Experimental design. Youden's factorial design. Calibration. 2. PHASES OF THE ANALYTICAL METHOD AND SOURCES OF UNCERTAINTY Sampling. Sample preparation. Choice of reference material suitable for the measurement system. Instrumental calibration. Data acquisition. Data analysis. Result presentation. Result interpretation. List of possible sources of uncertainty. 3. VALIDATION OF THE ANALYTICAL METHOD Accreditation and certification. What is method validation? Definitions. Why is method validation necessary? When should methods by validated or verified? Who does method validation? How is method validation done? Performance parameters of an analytical method. 4. CONTROL TECHNIQUES OF THE ANALYTICAL DATA Estimating Trueness. Estimating Precision. Different approaches to the estimation of uncertainty. Detection limit. Quantification limit. Linearity range. Estimation of Robustness of analytical method. Internal Controls. External controls. Internal audit for maintaining laboratory accreditation according to UNI CEI EN ISO/IEC 17025:2005. Control charts and UNI ISO 7870-2:2014.
Planned learning activities and teaching methods:	During the lesson power point presentations will be used. Such slides will be available to students at the end of each class. Case studies will be carried out in interactive lessons. Matlab or R will be used during some lessons. Some exercices will be solve on a blackboard. For individual exercices and calculations the stundent can use the computer room or a personal laptop.
Additional notes about suggested reading:	The lesson material and slides will be available online (http://www.chimica.unipd.it/case). Other reference materalial and guidelines: • EURACHEM. The fitness for purpose of analytical methods. A laboratory guide to method validation and related topics. First edition, 1998 (www.eurachem.ul.pt) • UNICHIM. Linee guida per la validazione di metodi analitici nei laboratori chimici. Criteri generali. Manuale N. 179/0, Milano, 1999. • Thompson M., Ellison S.L.R., Wood R. Harmonised guidelines for the single-laboratory validation of methods of analysis (IUPAC technical report). Pure Appl. Chem. 74(5): 835-855, 2002. www.iupac.org • Guida Eurachem/CITAC per la qualità in chimica analitica quale valore aggiunto ai fini dell’accreditamento “Guide to Quality in Analytical Chemistry. An Aid to Accreditation” • T. Raykov and G.A. Marcoulides. Basic Statistics: An Introduction with R. Rowman & Littlefield Publishers, 2012
Textbooks (and optional supplementary readings)	Giuseppe Cichitelli, Probabilità e Statistica. --: Maggioli Editore, --.