In the post-bachelor course Qualification and Validation Engineer, you learn to perform the entire process of validation and qualification. You also gain additional background knowledge and skills needed to practice the profession effectively in the pharmaceutical and life sciences environment.

The post-bachelor course Qualification and Validation Engineer is for recent graduates of Life Sciences or a technical discipline who would like to work in the pharmaceutical/life sciences industry. The course is also for professionals currently working in the field or a related field.

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 in Nijmegen. Course days are from 15.00 to 20.00. The course dates and trial classes are communicated on the website of HAN university of applied sciences.

The lecturers are experienced professionals from the pharmaceutical industry.

The program has been developed in collaboration with HAN university of Applied Sciences.