Duration
10h Th, 20h Pr, 10h SEM
Number of credits
| Master in biomedicine, professional focus in quality assurance | 3 crédits | |||
| Master in biomedicine, professional focus in quality assurance | 4 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
The internal and external audit course aims to provide future quality assurance professionals with essential theoretical knowledge. It aims to provide the basic tools and knowledge required by anyone who will be an auditor or auditee. To this end, the course will consist of the following chapters (non-exhaustive list):
- Introduction
- The audit process: general information
- Standards and guidelines
- How to shedule an audit planning
- Preparing for an audit
- Conducting an audit
- The audit report
- The action plan
- Monitoring the action plan
Learning outcomes of the learning unit
At the end of the course, students will have acquired the basic knowledge required to perform audits (internal or external).
The Internal/External Audits course is an integral part of the specialized focus on quality assurance and is complemented by all the other courses in the Master's program. It therefore only makes sense within an integrated vision of Quality Assurance.
Prerequisite knowledge and skills
None
Planned learning activities and teaching methods
The course consists of theoretical classes that incorporate practical case studies. Active participation in the various classes and participation in the exercises carried out during the theoretical classes is required.
Mode of delivery (face to face, distance learning, hybrid learning)
Face-to-face course
Further information:
Face-to-face course
Additional information:
faculty schedule.
Course materials and recommended or required readings
Platform(s) used for course materials:
- MyULiège
Further information:
Course materials will be made available during the course. No reading is recommended.
Students are advised to familiarize themselves with the following websites: Eudralex: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en ICH: https://www.ich.org/ CFR: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm ISO: https://www.iso.org/fr/home.html
ISO 19011
Exam(s) in session
Any session
- In-person
written exam ( open-ended questions ) AND oral exam
Further information:
Exam(s) in session
All sessions combined
- In person
Depending on the number of students, assessment will be oral or written (open-ended reflection question) and will account for 70% of the final note.
Additional explanations:
Oral or written exam (1st and 2nd sessions) covering the theoretical concepts addressed in the various classes as well as the documentary audit report produced.
Students are also required to produce a documentary audit (writing an audit report), which will account for 30% of the final note. It is due in December.
Work placement(s)
Organisational remarks and main changes to the course
none
Contacts
Teacher : Yannick Labeye
Email address : ylabeye@uliege.be