Introduction in Life Sciences principles
Every first week of the month, we organise several days in which the basic principles for Life Sciences professionals are handled. Afterwards, you’ll receive a training certificate.
Slides are in English. The training will be performed in Dutch or English depending on the participants.
Good Testing Practices
In this training, we’ll focus on how and when different types of testings should be applied. The difference between qualification, verification and validation testings. For example: which tests are relevant for FAT, SAT, commissioning, etc., and when should these be applied? Also the different testing phases and classes as well as the requirements, do’s and don’ts are highlighted.
This basic course on validation is based on the V model to understand the most common validation related concepts:
- Interpretation and application of GMP regulation
- Validation methodology (V model) and concepts (VMP, URS, IQ,…)
- Interpretation of correlation between validation, life cycle and validation methodology
- Introduction to typical project phases: specification, design, installation, qualification and performance
- Introduction to processes and plans during operations
- Introduction to change management
- Good practices with regards to documents and data
- GHP into practice
Medicines in Pharma
This course focuses on:
- The life cycle of medicines
- Classification of types of medicines according to market, process and application
- Walk-through the development of a medicine
- Quality related aspects to medicines
Validation of a multifunctional (workshop)
This workshop puts theory into practice: the theory of the courses ‘Good Testing Practices’, ‘Validation Basics’ and ‘Medicines in Pharma’ are applied into practice via a case study.