Learning objectives
To provide the concepts for data processing during the validation of analytical methods as well as during the assessment of quality control
Prerequisites
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Course unit content
Oral lessons followed by computer practice based on the evaluation of: precision, accuracy, linearity, limits of detection and quantification, robustness, quality assurance (development of control charts). Evaluation of Eurachem and ICH guidelines.
Full programme
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Bibliography
handbook UNICHIM 179/1, UNICHIM, Milano <br />
handbook UNICHIM 179/2, UNICHIM, Milano <br />
The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics, EURACHEM Guide, 1st English Edition 1.0-1998, LGC (Teddington) Ltd., http://www.eurachem.ul.pt/ <br />
ICH Q2A: Text on Validation of Analytical Procedures, 1994 <br />
ICH Q2B: Validation of Analytical Procedures: Methodology, 1996 <br />
Teaching methods
oral lessons followed by computer practice
Assessment methods and criteria
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Other information
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