Zamann Pharma Support offers a highly interactive Nitrosamines Workshop designed to deepen participant knowledge of regulatory requirements, industry practices, and risk management strategies. This hands-on program explores current global guidelines, including those from the FDA and EMA, and helps participants interpret updates and emerging expectations. Each session is structured to provide practical knowledge that supports daily responsibilities in regulatory affairs, QA, QC, and manufacturing. Through real-life case studies, interactive exercises, and guided discussions, our workshop empowers professionals to better understand, manage, and comply with nitrosamine impurity regulations in pharmaceutical products.
The Nitrosamines Workshop begins with a comprehensive review of the global regulatory landscape surrounding nitrosamine impurities. Participants explore critical guidance from regulatory bodies such as the FDA, EMA, and national agencies. Discussions focus on key updates, evolving requirements, and how different agencies interpret and enforce nitrosamine risk mitigation strategies. The session emphasizes not only understanding the letter of the regulations but also their intent. Participants gain clarity on timelines, expectations for documentation, and inspection readiness—equipping them with the insight needed to navigate compliance with confidence and authority in their own roles.
Our Nitrosamines Workshop offers detailed instruction on the methodologies used for risk assessment specific to nitrosamines. Attendees learn how to identify hazards, evaluate exposure levels, and design appropriate control strategies. Practical exercises simulate real-world assessments, encouraging participants to apply structured approaches under expert supervision. Risk scoring, prioritization, and mitigation planning are covered extensively. This module is ideal for quality professionals, toxicologists, and regulatory leads seeking to strengthen their knowledge of impurity evaluation in the context of ICH M7. By the end, attendees can confidently contribute to internal and external risk reviews and submissions.
The final module of the Nitrosamines Workshop focuses on translating theory into action. Participants examine implementation strategies for mitigating nitrosamine formation and contamination in pharmaceutical processes. The session includes case studies from global companies that successfully applied best practices to overcome challenges in detection, documentation, and control. By reviewing what worked—and what didn’t—attendees leave with a realistic perspective on execution. They also gain tools to adapt strategies for their specific manufacturing environments. This practical insight supports decision-making and boosts preparedness for inspections and long-term regulatory sustainability.
Our strategic approach to ensure Nitrosamine compliance is based on global and holistic experience, and can be perfectly adapted to your reality. We address the latest regulations and risk assessments, helping you manage and mitigate potential risks specific to your products and processes.
Zamann stays ahead of the evolving Nitrosamine requirements, providing expert guidance to ensure compliance with confidence. Our proactive and senior approach helps protect product integrity and patient safety, securing your operations against regulatory risks.
