follow the Qualification and Validation Engineer program
In the Qualification and Validation Engineer program, you learn to perform the entire validation and qualification process. You also gain additional background knowledge and skills needed to practice the profession effectively in the pharmaceutical and life sciences environment.
The course provides:
- Thorough knowledge of processes and regulations in the pharmaceutical/life sciences industry.
- Extensive knowledge of relevant GMP and ISO quality managment systems (including documentation, deviation management, change control and risk management).
- Knowledge and practical skills with respect to commissioning, qualification and validation.
- In-depth knowledge of various types of equipment/installations & processes and the specific characteristics, risks, requirements and tests typically associated with them.
- Soft skills and project management skills.
After completing the course, you’ll be able to work as a qualification and validation engineer. The program is designed for entry-level to experienced qualification and validation engineers who want to refresh or deepen their knowledge. The program is suitable for quality assurance staff and other professionals in the commercial phase of drug development in the life sciences industry.
The program in a nutshell
Below you can find the topics that will be assessed in this (post)bachelor course:
- Understanding the life sciences & health industry
- The development trajectory of a medicine or medical device
- Pharmaceutical and medical device legislation in the life sciences industry
- History and background of GMP, GDP and MDR
- EU and FDA GMP regulations in more detail
- Medical device regulations
- Validation and qualification: Basic pharmaceutical processes
- Overview of regulations and guidelines (guidance) regarding qualification and validation
- The various steps in each validation and qualification process
- Validation/qualification project management
- Qualification of specific systems: water systems, clean rooms, process equipment and information systems
- Production processes: process validation
- Computerized systems validation
- Analytical equipment (QC labs, IPCs)
- Medical gases and compressed air
Program details
Once you're finished...
... You will be able to work as a qualification and validation engineer. Furthermore, you have learned to perform the entire process of validation and qualification.
You also gained additional background knowledge and skills needed to practice the profession effectively in the pharmaceutical and life sciences environment.
Admission
What are the admission requirements? And how do I apply?
