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Lecturer(s)
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Šimek Jiří, doc. RNDr. CSc.
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Berka Karel, doc. RNDr. Ph.D.
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Nevěčná Taťjana, doc. RNDr. CSc.
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Course content
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They are also focused on ISO standards. Last but not least, they deal with the tools ensuring the quality by means of audits linked with quality. The final lectures are concerned with particular examples of quality systems in pharmacy, food industry, and cosmetics, where the knowledge of chemistry can be used most. Syllabus od the Course 1. Introduction. Century of Quality. The development of the current view on quality. Current trends for QA/QC. Quality standards. 2. Standardly used quality assurance instruments. Seven basic quality tools, their use and interpretation - tables, graphs, flow diagrams, histograms, Ishikava charts, Pareto analysis and control charts. Eligibility process - methods of process analysis and seven new quality tools. 3. Common quality management systems - Documentation of quality systems.SOP for creating and managing documentation. Corporate Organizational Policy. 4. Validations and qualifications. 5. Quality Risc Management - statement of requirements, risc evaluation, risc control and risc-sharing, risc reevaluation. Risc analyse instruments. 6. Quality Management in the medicinal production. 7. Quality Management in the cosmetic production. 8. Quality Management in the food production. 9. Quality Management concept based on the ISO . ISO 9001, 14001 and OHSAS 18001 Standards. 10. Quality Management in testing as well as medical laboratories. 11. Procedure for certification of company quality system according to the selected.
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Learning activities and teaching methods
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Lecture, Dialogic Lecture (Discussion, Dialog, Brainstorming)
- Preparation for the Exam
- 90 hours per semester
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Learning outcomes
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These lectures deal with quality control systems, quality economics and quality human resources.
Students will acquire basic knowledge in quality management, particularly in the area of quality management in the food, cosmetic and medical production.
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Prerequisites
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unspecified
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Assessment methods and criteria
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Oral exam
Orientation in quality systems, quality and economy in the basics of human resource issues of quality, written test and an oral colloquium.
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Recommended literature
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ČSN EN ISO 15189.
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ČSN EN ISO 17025.
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ČSN EN ISO 22716.
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Zákon č. 378/2007 Sb., o léčivech, a na něj navazující vyhlášky O správné výrobní praxi.
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Nenadál, J. a kol. (2002). Moderní systémy řízení jakosti. Quality management. . Praha.
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Šimek, J. (2013). Moderní systémy řízení jakosti. VUP Olomouc.
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