Duration
36h Th, 36h Pr
Number of credits
| University certificate in quality assurance as applied to laboratories and chemical, pharmaceutical and biotechnology industries | 5 crédits |
Lecturer
Collégialité
Coordinator
Language(s) of instruction
French 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.
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
Organisational adjustments related to the current health context
Recommended or required readings
Assessment methods and criteria
Below you will find information on the evaluation methods planned for in-person and remote exams as well as those planned for hybrid sessions. Depending on how the health crisis evolves, the chosen method will be communicated to you no later than one month before the start of the exam session.
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)
Organizational remarks
Course are given at Q2
Contacts
- HUBERT Philippe
- WIDART Joëlle