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Qualification and Validation Engineer course

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Post-bachelor: Qualification and Validation Engineer

In cooperation with HAN University of Applied Sciences (the Netherlands), we have developed a post-bachelor course: Qualification and Validation Engineer. This unique training allows you to become a certified qualification and validation engineer within 18 training days spread over 6 months. This course offers you intensive guidance from seasoned professionals. This is the only Qualification and Validation post-bachelor within Europe. 

You can find more information about this course here.

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Products in the pharmaceutical/life sciences industry need to meet very high standards when it comes to quality. Strict regulations (such as GMP) are in place to ensure this. One of the important principles is documented testing and proof that processes, methods and equipment work reliably and meet predefined requirements. A Qualification and Validation Engineer is responsible for this.

What do you learn?

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.

Who is this course for?

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.


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.

Join our free trial course day

Explore the course by the free trial days organized in June and September. The exact dates, times and place will be communicated on this page later on. Please click on de button below if you want to receive more information on the trial course day.

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