{"id":3917,"date":"2023-05-11T16:12:08","date_gmt":"2023-05-11T14:12:08","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/training-statistics-pharmaceutical-quality-control\/"},"modified":"2025-12-04T12:12:18","modified_gmt":"2025-12-04T11:12:18","slug":"training-statistics-pharmaceutical-quality-control","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/quality-and-process\/training-statistics-pharmaceutical-quality-control\/","title":{"rendered":"Statistical Tools for Pharmaceutical Quality Control"},"content":{"rendered":"<p>The training course &#8220;<strong>Statistical tools for pharmaceutical quality control<\/strong>&#8221; wish to provide useful tools for understanding and making the best use of statistical tools in the field of pharmaceutical quality control and R&amp;D. The language of the course makes it suitable even for those who do not have strong university statistical backgrounds (such as chemists, pharmaceutical chemists, and biologists) and is structured in three parts.<\/p>\n<p>The first introduces the main basic concepts of statistical methods accompanied by practical computational and application examples.<\/p>\n<p>The second part is devoted to comparing multiple sets of measurements &#8211; the need that most often arises in quality control, method validation, quality assurance, research and development, etc.\u00a0 Again, the topic is addressed in both its theoretical and practical-application aspects.<\/p>\n<p>The last part, finally, focuses on linear regression and correlation. Regression analysis is certainly the most widely used approach to make predictions or explain (or just summarize) the relationship between the response and its predictors. Its use is indispensable both in the laboratory and in all other areas of chemical-pharmaceutical and pharmaceutical quality.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The training course &#8220;Statistical tools for pharmaceutical quality control&#8221; wish to provide useful tools for understanding and making the best use of statistical tools in the field of pharmaceutical quality control and 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COURSE DAY 1\r\n09:00 \u2013 13:00 SESSION COURSE DAY 2\r\n\r\nINTRODUCTION\r\n<ul>\r\n \t<li>Descriptive Statistics vs. Inferential Statistics<\/li>\r\n<\/ul>\r\nSTATISTICAL METHODOLOGIES\r\n<ul>\r\n \t<li>Notions of Probability and probability function<\/li>\r\n \t<li>Main discrete (Binomial and Poisson) and continuous (Normal or Gaussian and Student's t-distribution) probability functions with practical application examples<\/li>\r\n \t<li>The Normal distribution<\/li>\r\n \t<li>Concept of confidence interval and how it is calculated<\/li>\r\n \t<li>Hints at Prediction and Tolerance intervals<\/li>\r\n \t<li>Outliers: statistical tests to detect their presence (e.g., Grubbs, Dixon) and possible operational approaches (e.g., Winsorization, Trimming)<\/li>\r\n \t<li>Normality tests (Anderson-Darling, Kolmogorov-Smirnov, Shapiro-Wilk) and data transformation techniques<\/li>\r\n<\/ul>\r\nCOMPARISON OF MULTIPLE SETS OF MEASUREMENTS\r\n<ul>\r\n \t<li>Null and alternative assumptions: errors of species I and II<\/li>\r\n \t<li>Significance of difference between means: Student's t-test (one-sided and two-sided test; dependent or independent samples); ANOVA test (fully randomized model: one-way, two-way)<\/li>\r\n \t<li>Significance of difference between variances: F-test, Bartlett's test, Cochran's test<\/li>\r\n \t<li>The alternative to significance tests: equivalence tests<\/li>\r\n \t<li>Components of variance for precision estimates<\/li>\r\n<\/ul>\r\nLINEAR REGRESSION\r\n<ul>\r\n \t<li>Method of least squares<\/li>\r\n \t<li>Linearity tests (lack-of-fit, Mandel's test)<\/li>\r\n \t<li>Analysis of residuals and influence of data (Bias and Leverage)<\/li>\r\n \t<li>Interpretation of ANOVA test on linear model<\/li>\r\n \t<li>t-test for intercept and slope<\/li>\r\n \t<li>Linear regression and comparison of calibration models (traditional tests vs. Akaike Information Criterion (AICc), TOST for bias)<\/li>\r\n<\/ul>","corso_target":"Personnel involved in the pharmaceutical sector:\r\n<ul>\r\n \t<li>Analytical Development<\/li>\r\n \t<li>Quality check<\/li>\r\n \t<li>Conformity and Quality Assurance<\/li>\r\n \t<li>Research and development<\/li>\r\n \t<li>Production<\/li>\r\n \t<li>Regulatory Affairs<\/li>\r\n<\/ul>","corso_competenze":[{"corso_competenze_item":"The regulatory requirements related to Environmental Monitoring"},{"corso_competenze_item":"The sampling methods and techniques, and how to validate them"},{"corso_competenze_item":"Perform microbiological and particulate validation of 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