Study Programmes 2016-2017
QUAL0435-1  
Microbiological quality assurance of the environment
Duration :
10h Th, 15h Pr
Number of credits :
Master in biomedicine (120 ECTS)3
Lecturer :
Pierrette Melin
Language(s) of instruction :
French language
Organisation and examination :
Teaching in the first semester, review in January
Units courses prerequisite and corequisite :
Prerequisite or corequisite units are presented within each program
Learning unit contents :
Contents


  • Introduction
  • Identifications of hazards associated with microbiological contaminations
  • Description of contaminating microorganisms, reservoirs and transmission
  • Contaminations: risks, causes and outcomes
  • Control of microbiological contamination during manufacture  
  • GMP and QA
  • Systems of reference, official and unofficial limits
  • Development of preservative systems
  • Microbiological methods
  • Rules of Biosecurity
  • Microbiological controls
  • Internal quality control in microbiology
  • Aims and criteria for screening, diagnostic and confirmation tests
  • Verification and validation
Learning outcomes of the learning unit :
At the end of this course, students will be able to:


  • describe risks of microbiological contamination along a manufacturing process
  • describe the main contaminating microorganisms, reservoirs and transmission.
  • describe the varied hazards associated with microbiological contamination of pharmaceutical products, of cosmetics and toiletries, of food products or on results in a microbiology lab.
  • apply and integrate the concepts in GMP, GLP and QA.
  • refer to systems of reference, official and unofficial limits.
  • implement and manage a internal quality control system in a microbiology lab
  • propose and perform the validation and verification of new methods, new reagents or new equipment in a microbiology lab.
  • propose recommendations for biosecurity related to operators and environment
 
 
Prerequisite knowledge and skills :
Prerequisite or corequisite units are presented within each program.
Planned learning activities and teaching methods :
The course is taught as lectures, supported by PowerPoint-type slides. Students are invited to ask their questions during lectures, after or by email. The practical work aims to put the student in a real life-like situation. He is asked to audit microbiological related aspects of a sector of the clinical microbiology lab of the university hospital. He visits the sector, interviews the lab technicians or any operator on the activities.  He has to estimate the microbiological risks either for the operator or the results of the performed analysis.  He proposes a control plan and performs the microbiological controls of the environment. He reads the cultures and prepare an extensive report from the analysis of the situation up to the interpretation of results; possibly suggests corrective actions.
 
Mode of delivery (face-to-face ; distance-learning) :
Face to face and practical training
Recommended or required readings :
Print of set of slides are distributed before starting lectures or are posted on the ULg website and can be downloaded by the students.
Reference books that could help for better understanding or for extensive learning:
- Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries, R. Baird,  Sally F. Bloomfield, Taylor and Francis, 1996
- Cumitech 31A, 2009, Verification and Validation of Procedures in the Clinical Microbiology Laboratory, ASM press
- Cumitech 39, 2003, Competency Assessment in the Clinical Microbiology Laboratory, ASM press
- Bactériologie médicale, F.Denis, MC. Ploy, C. Martin, E. Bingen, R. Quentin et al. 2ème Ed., 2011, Masson Paris
Assessment methods and criteria :
The global assessment includes - an oral exam with written preparation - and the mark of the pactical work report
Work placement(s) :
Internship opportunity during last year of master (final thesis)
Organizational remarks :
The practical work aims to put the student in a real life-like situation.
They are organized within the clinical microbiology lab of the university hospital of Liege
Contacts :
Clinical Microbiology Department University Hospital of Liège, B-23 Sart Tilman, 4000 LIEGE Belgium Secretary For any contact or appointment request, please address your demand to the secretary Mrs MC Lhôte
Professor Pierrette Melin    - Pierrette.Melin@ulg.ac.be
 
Items online :
Quality assurance microbiology
slideset