AMMI Webinar: Sterile Medical Packaging Standards

About Course

The sterile packaging standards published by the ISO/TC 198/WG7 were revised in the last couple of years and it is important to learn the key focus areas of these revisions. During this session, Mr. Thierry Wagner will cover some of the highlights of revisions in the packaging standards. Thierry will deep dive into the ISO 11607:2019 Part 2 ‘Validation requirements for forming, sealing and assembly processes’ and shall share thoughts on future standardization work in the area of sterile packaging.

General overview of ISO 11607-1/2:2019 'Packaging for terminally sterilized medical devices
The latest edition (edition 2) of ISO/TS 16775:2021, Guidance on the application of ISO 11607-1/2: Key Focus Areas
Deep dive into ISO 11607-2: Validation requirements for forming, sealing, and assembly processes
A high-level overview of the current amendment project of ISO 11607-1/2 to extend requirements for risk management.
Thoughts on future standardization work for ISO/TC 198/WG7