| |
| Previous course: C3042 |
| Offered by:
Department of Biotechnology
(IBT) |
| No credit points with: C3042 |
| Prerequisite: 30203/30212 |
| Recommended semester:
7th-9th semester |
| Limitation: Max. 24 |
| Scope and form: 3 week's course. Attendance mandatory throughout the course. |
| Examination:
Written exam
(
pass/fail
) |
| Contact person: |
Claus Emborg, IBT, Building 223, Tel. +45 4525 2702 |
|
| 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. |
| 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. |
