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:
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
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.