This webinar series provides a comprehensive overview of the proposed changes to Annex 1 with a focus on Environmental Monitoring and Quality Control.

Keeping up with Annex 1 Revisions - Impact of Major Changes covers what is in the current Annex 1; what’s changed between revisions; and how any changes might affect the pharmaceutical industry, with a focus on the comments regarding the fundamental principles and guidance of Contamination Control Strategy (CCS) for sterile and non-sterile medicinal products. 

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Keeping Quality Control, Bioburden Testing, and New Technologies Current with Annex 1 includes 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. 

Environmental Monitoring and Cleanroom Qualification: What to Expect in the New Annex 1 will examine the current regulatory requirements and what’s expected to change in the next revision regarding viable environmental and process monitoring, cleanroom qualification, and overall contamination control strategies.

All the webinars are available on-demand