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2026-2027 / MCER2023-1

Module VI: integration of knowledge on quality control

Part 1: exercise in establishing an integrating system

Part II: oral presentation

Duration

Part 1: exercise in establishing an integrating system : 1,5h Pr, 72h Internship
Part II: oral presentation : 2,5h Pr, 4h Internship

Number of credits

 University certificate in quality assurance as applied to laboratories and chemical, pharmaceutical and biotechnology industries3 crédits  

Lecturer

Part 1: exercise in establishing an integrating system : Collégialité
Part II: oral presentation : Collégialité

Coordinator

Joëlle Widart

Language(s) of instruction

French language

Organisation and examination

All year long, with partial in January

If a student fails an examination during the first term:

  • They are permitted to resit the assessed subject during the second term (May-June);

Schedule

Schedule online

Units courses prerequisite and corequisite

Prerequisite or corequisite units are presented within each program

Learning unit contents

This module does not include any lectures.

It is an integrative module that combines the integrated exercise (in groups) and the oral assessment. 

Part 1: exercise in establishing an integrating system

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 1: exercise in establishing an integrating system

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 1: exercise in establishing an integrating system

None

Part II: oral presentation

None

Planned learning activities and teaching methods

Part 1: exercise in establishing an integrating system

  • 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, hybrid learning)

Part 1: exercise in establishing an integrating system

Face-to-face

Part II: oral presentation

Face-to-face

Course materials and recommended or required readings

Assessment methods and criteria

Exam(s) in session

Any session

- In-person

written exam ( multiple-choice questionnaire, open-ended questions ) AND oral exam

Continuous assessment

Out-of-session test(s)


Further information:

Modules I through V of this certificate are assessed in different ways depending on the course: on an ongoing basis, through out-of-session assessments, or during the exam period. 

 

This module VI is assessed in two parts:

- Presentation of the integrated exercise

- Integrated oral exam

 

Additional Information:

 

The grade for this module will be based on the scores earned on the integrated exercise portion (one score per group) and the scores earned on the integrated oral portion, with each portion accounting for 50% of the total points. The "fail-one-fail-all" policy applies. Therefore, if a student fails either portion, the course will not be credited. 

 

Part 1: exercise in establishing an integrating system

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)

Organisational remarks and main changes to the course

Part 1: exercise in establishing an integrating system

Course are  given at Q2

Part II: oral presentation

Course are  given at Q2

Contacts

  • Eric Ziemons
Analytical Chemistry Department, Pharmacy Department, Bât. B36 Pharmacy Department, CHU, Tower 4, Quartier Hôpital, Avenue Hippocrate 15, 4000 Liège 1

Tel: 04/366.43.15

e-mail: eziemons@uliege.be

 
 

  • Joëlle Widart 
Pharmacy Department, Bât. B36 Pharmacy Department, CHU, Tower 4, Quartier Hôpital, Avenue Hippocrate 15, 4000 Liège 1

Tel: +32 4 3664470

e-mail: jwidart@uliege.be

 
 

  • Secretariat: 
Murielle Bihain

Tel.: 04/366.43.16

Fax: 04/366.43.17

e-mail: mbihain@uliege.be

Part 1: exercise in establishing an integrating system

  • Pr Eric Ziemons
Analytical Chemistry Department, Pharmacy Department, Bât. B36 Pharmacy Department, CHU, Tower 4, Quartier Hôpital, Avenue Hippocrate 15, 4000 Liège 1

Tel: 04/366.43.15

e-mail: eziemons@uliege.be

 

 

  • Joëlle Widart 
Pharmacy Department, Bât. B36 Pharmacy Department, CHU, Tower 4, Quartier Hôpital, Avenue Hippocrate 15, 4000 Liège 1

Tel: +32 4 3664470

e-mail: jwidart@uliege.be

 

 

  • Secretariat: 
Murielle Bihain

Tel.: 04/366.43.16

Fax: 04/366.43.17

e-mail: mbihain@uliege.be

 

Part II: oral presentation

  • HUBERT Philippe
Département de pharmacie, Bât. B36 Département de pharmacie, CHU, Tour 4, Quartier Hôpital, avenue Hippocrate 15, 4000 Liège 1 Tel. : +32 4 366.43.16 e-mail: ph.hubert@uliege.be
 
  • WIDART Joëlle
Département de pharmacie, Bât. B36 Département de pharmacie, CHU, Tour 4, Quartier Hôpital, avenue Hippocrate 15, 4000 Liège 1 Tel : +32 4 366.44.70 e-mail : jwidart@uliege.be

Association of one or more MOOCs