Duration
60h Th, 12h Pr
Number of credits
| University certificate in quality assurance as applied to laboratories and chemical, pharmaceutical and biotechnology industries | 7 crédits |
Lecturer
Language(s) of instruction
English language
Schedule
Units courses prerequisite and corequisite
Prerequisite or corequisite units are presented within each program
Learning unit contents
During this course dedicated to quality assurance in pharma, students will learn about quality norms, and some useful tools (5M, 3 Why, ...).
Guidelines and norms (Good Manufacturing Practices (GMP), ISO 17025, ...) will be presented. Finally, validation of analytical methods will be studied in particular, but also risk management, among other.
Learning outcomes of the learning unit
At the end of the course, student will have a knowledge about :
- Quality assurance knowledge (theoritical and practical aspects)
- Validation principles for the manufacturing of drugs
- Good Manufacturing Practices knowledge (theoritical and practical)
Prerequisite knowledge and skills
None
Planned learning activities and teaching methods
- Ex cathedra
- Pratical exercices during course
- Integrated exercices (groups)
Mode of delivery (face to face, distance learning, hybrid learning)
Face-to-face
Recommended or required readings
Written evaluation by the end of the course or the period (depending on each course).
Presentation of the integrated exercice
Oral evaluation
Work placement(s)
Organisational remarks and main changes to the course
Course are given at Q2
Contacts
- HUBERT Philippe
- WIDART Joëlle