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Lecturer(s)
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Pauk Volodymyr, Mgr. Ph.D.
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Nytka Marianna, Ph.D.
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Course content
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The course is intended for the students of bachelor's degree program as well as master's program. It focuses on reading, translating, understanding and using laboratory documentation in English in accordance with a common workflow. Safety rules, safety data sheets, materials disposal. Quality control. Instruction manuals, instrument software, standard operating procedures, work instructions, validation protocols. Data processing, final report creation and presentation of results. Communication with foreign partners, correspondence, orders, invoices, contracts.
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Learning activities and teaching methods
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Lecture, Dialogic Lecture (Discussion, Dialog, Brainstorming)
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Learning outcomes
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The course will prepare students for work with laboratory documentation in English. Processing and presentation of results, elaboration of laboratory protocols for cooperation or trade of Czech companies with foreign partners will be considered as well. Particular attention will be paid to documentation within good manufacturing practice system (GMP). The course is intended to strengthen employment opportunities of bachelor's degree students in industrial and control laboratories. Students must have sufficient knowledge of general and chemical English as well as basics of analytical chemistry before signing up for this course. Knowledge of GMP basics is encouraged (e.g. course ACH/SVP).
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Prerequisites
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Students must have sufficient knowledge of general and chemical English as well as basics of analytical chemistry before signing up for this course. Knowledge of GMP basics is encouraged (e.g. course ACH/SVP).
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Assessment methods and criteria
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Oral exam, Student performance
The student must be familiar with the laboratory documentation and must be able to extract the information necessary for own work in research and commercial laboratories. The student must fulfill the 75% attendance requirement and pass the final test (min. 50% points) to obtain a credit.
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Recommended literature
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Food and Drug Administration. (2015). Analytical Procedures and methods Validation for Drugs and Biologies,. U.S. Department of Health.
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Good Manufacturing Pracicle (GMP) Guidelines. EudraLex-volume 4.
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ICH Guidelines. ICH Guidelines.
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Occupational Safety and Health Administration. (2014). Laboratory Safety Guidance. Createspace Independent Publishing Platform.
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World Health Organization. (2011). Laboratory Quality Standards and Their Implementation. World Health Organization.
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