Webinar | December 5, 2023

Nitrosamine Impurities Deadline: Are Your Products Compliant?

The FDA has made nitrosamine reduction in medication a top priority for the entire industry, with deadlines for compliance fast approaching. There is no magic bullet for this challenge, no one-size-fits-all solution. To be effective and sustainable, a mitigation strategy needs to be custom-built for a specific molecule, formulation, and microenvironment.

In this webinar, nitrosamine mitigation expert Jason Brown will walk you through a multi-pronged approach to addressing the issue head-on, and discuss potential strategies for vulnerable drug products. You will learn how to select an experienced provider of nitrosamine mitigation services and how to work with them to craft a quantified mitigation strategy created specifically to minimize nitrosamine formation. Bring your product into compliance while maintaining control of the process at every step.

Key Learning Objectives:

  • The FDA's guidance on nitrosamine sets tight compliance deadlines that are quickly approaching
  • Nitrosamine mitigation is a complex challenge without a simple one-size-fits-all solution
  • Nitrosamine mitigation has a steep barrier of entry and demands an experienced partner to ensure compliance before the deadline
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