The upcoming revisions to Annex 1 are meant to provide guidance for the manufacture of all sterile and non-sterile medicinal products, and ensure final product is protected from microbial, particulate, and pyrogen contamination. If you’re wondering how these changes could apply to your Quality Control and bioburden testing programs, you’re not alone.
View the second part of our series to learn more about the proposed changes and requirements, what you need to know so you’re ready for them, as well as where the principles of Quality Risk Management (QRM) must be applied. We’ll also discuss how automation technologies and alternative methods fit into new requirements along with suggestions on how to ensure regulatory compliance.
Lucia Ceresa, PhD
Senior Technology and Market Development Manager
View the other webinars in the series:
- Keeping Up With Annex 1 Revisions: Impact of Major Changes (On Demand)
- Environmental Monitoring and Cleanroom Qualification: What to Expect in the New Annex 1 (On Demand)
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