Validation of Sterile Packaging Processes and Packaging Design for Medical Devices
Tue, Sep 17
|New Brighton
With this seminar, participants will; acquire sound knowledge of the requirements for sterile packaging in accordance with EN ISO 11607, receive practical know-how for validating your packaging processes, and learn how to ensure the sterility of your medical devices.
Time & Location
Sep 17, 2024, 9:00 AM – Sep 18, 2024, 5:00 PM
New Brighton, New Brighton, MN 55112, USA
About the event
In this seminar, you will learn in a practical way all about the standard EN ISO 11607-1:2020, EN ISO 11607-2:2020 and their requirements for the validation of sterile packaging design and processes for terminally sterilized medical devices. Implementing these standards precisely is essential for medical device manufacturers but is often a challenge. Through the expertise of our specialists, participants will gain a deep insight into the core requirements of these standards and learn how to effectively design validation processes according to specific specifications. In addition, we provide clarity on regulatory requirements for conducting validation studies, including risk analysis and documentation of results. The seminar is designed to be interactive, with lectures, discussions, and exercises to promote successful application in everyday working life. It is aimed at newcomers and experienced professionals in the medical device industry who wish to expand their knowledge of validating sterile packaging.
You will get a basic…