University of Liege | Version française
Academic year 2014-2015Value date : 09/05/2015

Faculty of Medicine

Description of course programmes, learning outcomes and career openingsEnrolments and AdmissionFaculty websiteSchedule

Certificat d'université :
Or
Th
Pr
Au
Credits

Quality assurance applied to laboratories and chemical, pharmaceutical and biotech industries

Informations complémentaires



Information

ULG :
Mr Philippe HUBERT
Analytical chemistry
Bldg B36 - Avenue de l'Hôpital 1 - 4000 Liege
Person of contact : Florence BONIVERT
Phone/Fax number : 04/366.43.16
E-mail address : florence.bonivert@ulg.ac.be
http://www.formation-biotechnologie.be




FOREM :
Mr Laurent CORBESIER
Forem Formation Biotechnology
Tower GIGA, Bldg b34
4000 LIEGE
Phone number : 04/366.39.00
Fax number : 04/366.94.98
E-mail address : forem-biotech@skynet.be
Person of contact : rachel.navet@ulg.ac.be

Presentation / Study programme

The quality assurance manager is involved in the design, implementation and monitoring of the company¿s quality policy in order to guarantee and optimise the quality of all its processes and products. Therefore, they are responsible for defining procedures and instructions that will be used at all levels within the company. Through the various audits they organise, they must take care of the adequacy, improvement and monitoring of the procedures and ensure they are respected. To exercise this job, the quality assurance manager must work in an organised, methodical and rigorous manner but must also be able to communicate efficiently with the teams in the company, in order to ensure the rules and instructions of the quality assurance system in place are applied and respected.


The aim of the training offered is for participants to acquire the technical, methodological and behavioural skills required to exercise this profession, i.e.:
- to understand the principle, the functioning, the setting up and the monitoring of a quality system in laboratories and pharmaceutical, chemical and biotech industries
- to take part in audits, as auditor and auditee
- to develop a sense of communication and project management

Although essentially theoretical, this training includes practical exercises and cases studies.


Special conditions of access / students concerned

This training is intended for people with one of the following diplomas: bachelor¿s/master¿s ¿ (bio)engineer ¿ doctor in one of the following subjects: chemistry, biology, biochemistry, medical biology, biotechnology, agronomics, pharmaceutical and biomedical sciences, agrifood.

The training is also accessible - upon application - to applicants with at least five years proven professional experience in one of the abovementioned areas. A bachelor¿s degree plus experience can be taken into account in the calculation (e.g.: 3-year bachelor¿s + 2 years experience = 5 years).

Must have good knowledge (baccalaureate level) of English (lectures taught in French and English).


Duration of the training

Année unique organisée en 5 modules + l'intégration des connaissances en assurance qualité (476H dont 152H d'exercices pratiques) pour un total de 38 crédits.

Possibilité d'étaler la formation sur maximum 3 années excepté pour les demandeurs d'emploi).

L'inscription modulaire est autorisée.

Courses programme

Place of the formation : Forem Formation Biotechnology, tower GIGA, Bldg 34, Avenue de l'Hôpital 1, B-4000 Liege

Teaching Collegiality:

Coordinator : Philippe HUBERT

Members : Marie DELGAUDINE, Philippe CALMANT, Joëlle WIDART, Willy ZORZI, Gentiane VERSTRAETEN, Laurence MELEN-LAMALLE, Véronique BEAUVOIS, Lucas FOTSING, B. CAMPO, Stephan LEBECQUE, Pierre DOUETTE, Fabien DUMONT, A. FAUCONNIER, Marc DOORENBOS, Eric VANLANDUYT, Eric ROZET, Roland MARINI.

Compulsory courses

MCER2018-1

Module I : Quality assurance : frames of reference - Collégialité

84
12
-
9

MCER2019-1

Module II : Quality assurance : application in daily life - Collégialité

36
36
-
5

MCER2020-1

Module III : Drug's life cycle : Regulation and good practices - Collégialité - [4h Internship]

76
8
[+]
8

MCER2021-1

Module IV : Quality assurance : inter-personal and management skills - Collégialité

60
-
-
6

MCER2022-1

Module V : Quality control : validation, quality by design (english language) - Collégialité

60
12
-
7

MCER2023-1

Module VI : Integration of knowledge in quality assurance




3
-
part I : Implementing an integrated system (exercise) - Collégialité - [26h Internship]
-
1,5
[+]
-
part II : oral presentation - Collégialité - [50h Internship]
-
2,5
[+]

Assessment

Students who have enrolled for the complete certificate are assessed as follows:
- elaboration of an integrated exercise to implement an integrated system whose results will be presented, by a group of four participants, to a panel composed of at least three assessors
- integrated QCM assessing the acquisition of knowledge in each training module by the participants
- individual oral exam

Students who have enrolled in one or more modules are assessed as followed:
- integrated QCM assessing the acquisition of knowledge in each training module. A certificate is awarded for passing the module(s).


Registration

For people "in work":
Where? : ULg¿s Continuous Education Unit.
Bring the following documents:
- Enrolment authorisation from the Dean
Enrolment fees:
- Complete course: € 8 000
- Module I: € 2 500
- Module II: € 1 500
- Module III: € 2 000
- Module IV: € 1 500
- Module V: € 1 500
- Module VI: € 500



For "job-seekers" :
Where ? : At FOREM on the basis of the ¿DG" form
Bring the following documents: copy of your identity card, diploma (or document certifying the equivalency of your diploma) and, if necessary, copy of your work permit
Enrolment fees: free training subsidised by FOREM (providing you are selected through the FOREM selection process).



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Caption

Column "Or" = Course Organization
TA:All year
Q1:First quadrimester
Q2:Second quadrimester

Students and Studies Administration - Academic Affairs - Contact : Monique Marcourt, General Director for Education and Training - Developed by SEGI