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Nitrosamine impurities have become a critical concern across the pharmaceutical industry, driven by increasing regulatory scrutiny and the need for robust scientific and risk-based control strategies. As guidance from global regulators continues to evolve, companies are expected to proactively identify, assess, and mitigate nitrosamine risks throughout the product lifecycle.
This expert-led webinar, hosted by US Pharmacopeia (USP), explores the strategic and scientific approaches required to advance nitrosamine control-from detection and risk assessment to regulatory compliance and patient safety. Attendees will gain insights into USP’s scientific leadership in impurity standards, regulatory-aligned tools, and best practices to meet current expectations while future-proofing their quality systems.
Why Attend / Key Takeaways
Understand evolving global regulatory requirements (FDA, EMA, CDSCO) for nitrosamines
Learn strategic approaches for risk assessment, control, and communication
Explore USP’s tools, reference standards, and general chapters (like <1469>) that support compliance
Hear real-world challenges and best practices in nitrosamine detection and mitigation
Gain confidence in implementing science-driven, lifecycle-based nitrosamine strategies
Participate in a live Q&A with leading USP expert