Duration
part I : Implementing an integrated system (exercise) : 1,5h Pr, 26h Internship
part II : oral presentation : 2,5h Pr, 50h Internship
Number of credits
| University certificate in quality assurance as applied to laboratories and chemical, pharmaceutical and biotechnology industries | 3 crédits |
Lecturer
part I : Implementing an integrated system (exercise) : Collégialité
part II : oral presentation : 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
part I : Implementing an integrated system (exercise)
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.
part II : oral presentation
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
part I : Implementing an integrated system (exercise)
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)
part II : oral presentation
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
part I : Implementing an integrated system (exercise)
None
part II : oral presentation
None
Planned learning activities and teaching methods
part I : Implementing an integrated system (exercise)
- Ex cathedra
- Pratical exercices during course
- Integrated exercices (groups)
part II : oral presentation
- Ex cathedra
- Pratical exercices during course
- Integrated exercices (groups)
Mode of delivery (face-to-face ; distance-learning)
part I : Implementing an integrated system (exercise)
Face-to-face
part II : oral presentation
Face-to-face
Recommended or required readings
Assessment methods and criteria
part I : Implementing an integrated system (exercise)
Written evaluation by the end of the course or the period (depending on each course).
Presentation of the integrated exercice
Oral evaluation
part II : oral presentation
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
part I : Implementing an integrated system (exercise)
Course are given at Q2
part II : oral presentation
Course are given at Q2
Contacts
part I : Implementing an integrated system (exercise)
- HUBERT Philippe
- WIDART Joëlle
part II : oral presentation
- HUBERT Philippe
- WIDART Joëlle