The performance of a Process Validation is an important part of a quality system to show the reliability and the robustness of a manufacturing process for Medical Devices. Compared to medicinal products there are some special characteristics and requirements for these Process Validations of Medical Devices. In this masterclass we will face the basics, but also the important parts of a Process Validation for Medical Devices. The Advanced Process Validation for Medical Devices Masterclass aims to take you through topics such as change controls before and during Process Validation, the integration of Risk Management systems, and important documents that need to be created for such Process Validations. The course is rounded by two workshops with tasks and discussions about the changes during and documentation of Process Validations. Besides the theoretical explanations, you will get numerous examples for Medical Device Process Validations out of the practical experience of the expert but also of the participants. The course is rounded by two workshops with tasks and discussions about the changes during and documentation of Process Validations.

This masterclass is right for you, if:

• You want to understand the fundamentals of Process Validations for Medical Devices.
• You want to understand new smart ways to carry out Process Validations for Medical Devices.
• You want to understand how to integrate a smart risk and change control management into the Process Validation of Medical Devices.
• You want to get not only an overview from the theoretical, but also from the practical point of view from experts directly from the industry.
• You want to discuss with and get new impulses from colleagues from international companies during the whole course and especially during the 2 interactive workshops.