| Recommended semester: 7th - 9th semester |
| Scope and form: 3 week's course. Attendance mandatory throughout the course. |
Evaluation: Written exam
Inspection by extern GMP-visitation and of GLP-book plus an individual written exam. |
| Examination: Pass/fail |
| Previous course: C3042, 30242 |
| Prerequisites: Kemi-, miljų- og biofagpakke eller tilsvarende, 27031, 27403 |
| No credit points with: C3042, 30242 |
| Participant limitation: Max. 24 |
| 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. |
| Contact: Claus Emborg, building 223, (+45) 4525 2702, claus.emborg@biocentrum.dtu.dk |
| Department: 027 BioCentrum-DTU |
| Updated: 14-05-2001 |
