Duration
12h Th, 18h Pr
Number of credits
| Master in biomedicine, professional focus in quality assurance | 3 crédits |
Lecturer
Language(s) of instruction
French language
Organisation and examination
Teaching in the first semester, review in January
Schedule
Units courses prerequisite and corequisite
Prerequisite or corequisite units are presented within each program
Learning unit contents
A. Quality and Quality Recognition in the Life Sciences
* Introduction to the various forms of recognition and associated standards in line with the academic curriculum of the Quality Assurance program.
* Description and discussion of the role and implications of quality in the relevant activities.
* Practical exercises involving the evaluation of real-world cases related to the standards presented.
B. Quality Risk Management and Risk Analysis Tools
* Introduction to quality risk analysis and quality risk management tools.
* Presentation and discussion of a practical case study.
* Case study evaluation on the practical application of quality risk management.
C. Essential Elements of a Quality Assurance System
* Presentation of the general philosophy of quality systems and the essential elements that comprise them, such as deviations, root cause analysis, and the development of corrective and preventive action plans (CAPA),...
* Practical exercises involving the analysis of a concrete case of quality system elements.
Learning outcomes of the learning unit
Gain an understanding of the context of the main regulatory standards applicable to the life sciences.
Become familiar with the quality approach and the main components of a quality system, including the concept of quality risk.
Prerequisite knowledge and skills
No specific skills or prerequisites are required.
Planned learning activities and teaching methods
A lecture-based course delivered "in person" for the majority of the instructional content, supplemented by a portion of practical work, which may be conducted in groups.
Mode of delivery (face to face, distance learning, hybrid learning)
Face-to-face course
Course materials and recommended or required readings
Exam(s) in session
Any session
- In-person
oral exam
Written work / report
Continuous assessment
Further information:
During the course, two exercises will be assigned, which may require the submission of reports (individually or in groups). Two grades will be based on these exercises.
Additional Information:
The grade for this module will be based on the marks obtained for the theoretical part (in-person oral examination) and for the practical part (participation and, where applicable, a report); the theoretical part will account for 60% of the final grade, while the practical part will account for 40%. The absorbing-grade principle applies: therefore, in the event of failure in either part, the course cannot be credited.
Work placement(s)
Organisational remarks and main changes to the course
Lab session and/or practical work is compulsory. The concepts covered are likely to form part of the assessment. Any absence must be justified and, where appropriate, students are required to put their work in order. If a report is required, it must be completed even in the event of absence.
Contacts
- Cédric Hubert
Tel: 04/366.43.26
e-mail: chubert@uliege.be
- Joëlle Widart
Tel: +32 4 3664470
e-mail: jwidart@uliege.be
- Secretariat:
Tel.: 04/366.43.16
Fax: 04/366.43.17
e-mail: mbihain@uliege.be