| Type: | Ph.D.-level
Language: Danish |
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Previous course: C3042
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No credit points with: C3042
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Prerequisite: 30203/30212/30210
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Recommended semester: 7th - 9th semester
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Scope and form: 3 week's course. Attendance mandatory throughout the course.
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Examination: Written exam (Pass/fail)
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Participant limitation: max. 24
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| Contact person: | Claus Emborg, Building 223, Tel. +45 4525 2702, email ce@ibt.dtu.dk |
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Department: Department of Biotechnology
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Aim: To understand GXP-problems in working conditions, which operate in accordance with GXP and/or ISO principles. To understand quality assurance as a complex, interdisciplinary engineering problem, involving logistics, techniques, education, documentation, management authorities (including auditing). To understand that quality assurance also involves creative research. To learn team-work in a matrix organization and in collaborative groups.
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Contents: Scenarios on production of a bulk product. The product is manufactured in the pilot plant by fermentation with Saccharomyces cerevisiae. The production must be made ready for GMP-inspection the second last day of the course.
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