Nitrosamine Impurities Deadline: Are Your Products Compliant?

I will be giving a webinar on nitrosamine limits, deadlines, and mitigation techniques December 5. For any that all that are interested, a summary and link to register are below.


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 create a quantified mitigation strategy created specifically to minimize nitrosamine formation. Bring your product into compliance while maintaining control of the process at every step of the way!

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 steep barrier of entry and demands an experienced partner to ensure compliance before the deadline

Nitrosamine Impurities Deadline: Are Your Products Compliant? (


This webinar is coming up early next week. We will be covering a thorough mitigation study we recently conducted including a number of the decisions that went into that study. I think this will be very informative to anyone that may be conducting a similar study and those developing control strategies.

The webinar is free and will be available on demand after its conclusion.


Thanks @jason.brown for this opportunity, timing for the webinar is not matching ith Adelaide timing (02:30 am our timing) I would wait till Webinar completion and then request the recording.

Best Regards

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Hi, the webinar was great. Please share the video so that it can be a reference when needed. Hope to have frequent sessions educating us.

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Thank you for the feedback. It was a lot of work. So, it is great to hear it well received.

The same link should continue to work to see the video on demand.

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Jason great presentation… we need to invite you to come to our nitrosamines conversation to deepen in some of the topics you touched during the presentation

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I definitely appreciate the kind words. I’ll reach out directly.