Count Every Second Until the Event

2023-10-12 8:00

Course Overview

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.

Why join the event

Key takeaways of the program

A deep understanding about the requirements for Process Validations of Medical Devices

A regulatory overview of the most important international requirements

An understanding of the special characteristics of such Process Validations

An overview of connected systems like risk management, documentation and change control management systems

Numerous examples directly from practice

New ideas from an expert and from participants directly from practice

Who Should Attend

An event precisely for you

QA & QC Managers
QA & QC Managers
Regulatory Affairs Manager
Regulatory Affairs Manager
Manufacturing Management
Manufacturing Management
Research & Development
Research & Development
Process Validation Specialists
Process Validation Specialists

The speaker

Meet your trainer

Dr. Felix Tobias Kern is Head of Manufacturing at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich. He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology. In the past 8 years he worked as a QA Manager in a worldwide operating medical device and medicinal product company, as well as head of manufacturing for the production of bulk tablets. Same time he gave lectures and practiced as consultant in the fields of GMP, quality, risk management, as well as regulatory requirements in the fields of medicinal products and medical devices.

Dr. Felix Tobias Kern

Dr. Felix Tobias Kern

Head of Manufacturing
Merck KGaA - Germany

The Curriculum

What you’ll get from this exclusive event

Fresh Content

Knowledge is only useful when it is relevant. This event is based on the latest research, best practices and industry information. As a result, we close events with a strong knowledge base that helps achieve same-day results.


Meet and collaborate with like-minded professionals across the globe. Grow your professional network, exchange ideas, and learn more about the industry with your own peers, together.


Experience comes with practice, and this event will guide you on the right path in becoming a well renowned expert in your field. You will learn through a combination of lecture-based content, real-life case studies, and a more hands-on experience.

Q&A Session

By joining this class, you will be given the opportunity to constantly engage with your peers and raise your concerns, questions, or doubts you may have pertaining to the subject. And, receive well-founded, well-thought-out answers to your every need by leading experts in the industry. 

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