Duration
Principes de management pharmaceutique : 10h Th
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité : 20h Th
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques : 7,5h Th
Number of credits
| University certificate in radiopharmacy - long training | 5 crédits | |||
| University certificate in radiopharmacy - short training | 5 crédits |
Lecturer
Principes de management pharmaceutique : Walid El azab
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité : Roland Marini Djang'Eing'A, Joëlle Widart
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques : Joëlle Widart, Eric Ziemons
Language(s) of instruction
French language
Organisation and examination
All year long, with partial in January
Schedule
Units courses prerequisite and corequisite
Prerequisite or corequisite units are presented within each program
Learning unit contents
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité
During this course dedicated to quality assurance in pharma, students will learn about quality norms, and some useful tools (5M, 3 Why, ...).
In addition, a referenttiel will be presented in details. Finally, validation of analytical methods will be studied in particular.
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques
- PAT: Process Analytical Technology
- Risk Analysis : Explanation of the risk management
Learning outcomes of the learning unit
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité
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 radiopharma products
- Good Manufacturing Practices knowledge (theoritical and practical)
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques
Studdents will be sensitized to PAT and risk analysis concepts.
Prerequisite knowledge and skills
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité
None
Planned learning activities and teaching methods
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité
- Ex cathedra
- Pratical exercices during course
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques
- Presentation
- Exercices during courses
Mode of delivery (face to face, distance learning, hybrid learning)
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité
- face-to-face or remotely depending on sanitary conditions
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques
Face-to-face (Remote according to the health recommendations)
Course materials and recommended or required readings
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques
https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-3.pdf
https://www.fda.gov/media/71012/download
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité
Evaluation based on an exercice and a test at the end of the period (face-to-face or remote depending ond sanitary conditions)
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques
PAT : Oral evaluation at the end of the period.
Risk Analysis : evaluation based on the exercice
Work placement(s)
Organisational remarks and main changes to the course
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité
Course can be given both Q1 and Q2 from B1 depending from year to year.
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques
Courses will be organised both at Q1 or Q2, depending from year to year.
Contacts
Assurance qualité, partim a : Concepts de base et organisation de l'assurance qualité
- Roland Marini
Tel. : +32 4 366.36.42
e-mail: rmarini@uliege.be
- WIDART Joëlle
Tel : +32 4 366.44.70
e-mail : jwidart@uliege.be
Assurance qualité, partim b : Technologie analytique des procédés et analyse des risques
WIDART Joëlle
jwidart@uliege.be
04/3664470
ZIEMONS Eric
eziemons@uliege.be
04/3669801