Tuesday, October 30, 2018
In the finale of this two-part webinar series, we’ll break down the revised guideline to help you understand how the coming changes will affect your environmental monitoring and micro QC operations.
Webinar Series: How will changes to EU GMP Annex 1 impact your lab?
Annex 1 of the EU GMP guidelines describes the requirements for the manufacture of sterile medicinal products, including those exported to the European Union. With the revised document set for release in early 2019, the updates significantly impact QC/QA and all laboratory activities, more so now than in previous revisions.
In this two-part webinar series, we’ll break down the revised guideline to help you understand limitations of current industry best practices, the impact of these new requirements and their effect on environmental monitoring activities, and the introduction of new technologies with the goal of an effective sterility assurance program in aseptic processes.