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.
Summary
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? (on24.com)