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Lecturer(s)
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Course content
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Lectures: 1) Basic information about accredited analytical laboratories 2) Standard operating procedure 3) Reference materials 4) Laboratory instrument qualification 5) Validation of analytical methods 6) Sampling and sample storage 7) Educational excursion to an accredited analytical laboratory (not guaranteed)
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Learning activities and teaching methods
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Monologic (reading, lecture, briefing), Dialogic (discussion, interview, brainstorming), Demonstration
- Preparation for classes
- 20 hours per semester
- Preparation for credit
- 25 hours per semester
- Preparation for exam
- 30 hours per semester
- Class attendance
- 20 hours per semester
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Learning outcomes
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Introduce students to real laboratory practice in accredited analytical laboratories and teach them basic skills which are not only highly valued in the private sector, but are also essential for quality research.
Student will acquire basic knowledge in proving competence of laboratory instruments (instrument qualification), proving suitability of analytical procedures (validation of analytical procedures) and familiarization with specifics of work in regulated industry according to controlled documentation.
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Prerequisites
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No special prerequisites.
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Assessment methods and criteria
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Oral examination, Written examination
To pass the course student must pass both written (min. 70%) and oral exam.
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Recommended literature
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B. Magnusson and U. Örnemark (eds.) Eurachem Guide: The Fitness for Purpose of Analytical Methods ? A Laboratory Guide to Method Validation and Related Topics, (2nd ed. 2014). ISBN 978-91-87461-59-0. Available from http://www.eurachem.org.
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EN ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories.
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http://www.eurachem.cz/metodicke-listy.php.
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ICH - Q2(R1) Validation of Analytical Procedures.
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Materiály ze školení konzultační společnosti GM Project s.r.o..
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S. L. R. Ellison and A. Williams (Eds). Eurachem/CITAC guide: Quantifying Uncertainty in Analytical Measurement, Third edition, (2012) ISBN 978-0-948926-30-3. Available from www.eurachem.org.
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USP / General Information: <1058> Analytical Instrument Qualification.
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USP / General Information: <1225> Validation of Compendial Procedures.
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