EXPORT-ORIENTED MANAGEMENT - IMC Fachhochschule Krems

Teaching Methods
Laboratory
Evaluation
Exam/laboratory protocols/Laboratory work
GLP/GMP
Semester Hours per week Subject code ECTS
Fall 1 GLP_T 1
Learning Outcomes / Course Objectives
GMP / GLP is a one hour credit course, designed to teach a clear understanding of the
field of pharmaceutical quality management. The course should provide the students with
an overview on GLP regulation, general GMP regulation and GMP in biotechnological
development processes.
Prerequisites / Level
None
Course Description
The lecturers will give an overview on GMP and GLP regulations, which is the main
regulation governing the working environment in pharmaceutical industry. Starting with
the GLP regulations, which cover the setup of test facilities responsible for safety
techniques the lecture moves on to GMP regulations, which cover the pharmaceutical
production process. A final, more detailed look on these regulations in the production of
biopharmaceutical and during the drug development process will close the lecture.
Teaching Methods
The study subject will be taught according to general OECD / WHO /EU and local
directives and local guide lines. Students will be provided with power point presentations
and supplemental material as appropriate.
To deepen the students understanding, study questions will be given to the students at
the end of each lecture. The students are expected to solve these questions as home
work in preparation for the following lecture. These will allow them to follow the progress
of the course and prepare themselves for the final exam.
Evaluation
Final exam
Instrumental Analytics Laboratory
Semester Hours per week Subject code ECTS
Fall 2 IA_L 3
Learning Outcomes / Course Objectives
The course aims to give the student a basic understanding of instrumental analytic
methods used in biotechnology.
Prerequisites / Level
Basic Laboratory working techniques
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