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.

gloved hands holding and writing on clipboard
binder notebooks full of paper

Understanding the EU GMP Annex 1 Revisions


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In the first of this two-part webinar series, we’ll provide an overview of Annex 1 that will include a comparison between the upcoming revision and 2008’s, as well as its place in the regulatory frameworks of other guidelines such as ICH Q9 and Q10.
hand holding compass

Addressing the Proposed EU GMP Annex 1 Changes, Your EM Program, and Micro QC Operations

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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.