The course provides:
- Thorough basic knowledge of processes and regulations in the pharmaceutical/life sciences industry.
- Extensive knowledge of relevant GMP quality systems (including documentation, deviation management, change control).
- 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 that will help you be effective in this work.
After completing the course, you’ll be able to work as a (junior) qualification and validation engineer. The course is also well suited for QA personnel who need to review validation and qualification processes and documentation for compliance with regulations and internal quality standards.
The program in a nutshell
Below you can find a selection of 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 legislation in the life sciences industry
- History and background of GMP and GDP
- 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
- Production processes: process validation
- Computerized systems validation
- Analytical equipment (QC labs, IPCs)
- Medical gases and compressed air
The course consists of 18 days spread over 7 months. During the course, you'll attend lectures and complete practical assignments. You study the theory, and experts from the pharmaceutical industry tell you how the theory is applied in practice. You get hands-on experience with various writing assignments, such as the generation of various qualification documents. And you practice your role as validation/qualification engineer in a project team, give presentations and work on a qualification and validation project.
The post-bachelor course Qualification and Validation Engineer takes place at the HAN campus in Nijmegen. It consists of 18 course days (usually Tuesdays from 15:00 – 20:00.
The next edition of the course will take place in fall 2024. The exact start date of the coming edition is not known yet at the moment. As soon as the start date becomes clear, it will be mentioned on this website.
Would you like to express your interest or apply already so we can reserve your spot? You can apply via the ‘apply-now’ button at the top of the page, or send an e-mail to email@example.com.
The lecturers are experienced professionals from the pharmaceutical industry.
The program has been developed in collaboration with PharmSupport B.V.
Once you're finished...
... You will be able to work as a (junior) 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.
What are the admission requirements? And how do I apply?