Nitrosamine impurities have become a critical and ongoing challenge for the pharmaceutical industry. Regulatory expectations continue to evolve, acceptable exposure limits (AELs) are being reassessed based on evolving toxicological evidence.

In this webinar, our experts will explain why nitrosamines should remain a priority for pharmaceutical organizations and how the regulatory framework is shaping current and future compliance requirements.

You will gain clear insight into the data and inputs needed to perform an effective nitrosamine risk assessment (NRA). We will also explore the critical factors that influence nitrosamine formation and how to interpret assessment outcomes to define appropriate actions.

The session concludes with practical case studies and mitigation strategies, helping you translate regulatory and toxicological concepts into actionable steps for risk minimization.

What you'll learn

• Understand what nitrosamine impurities are and why they pose a critical risk to pharmaceutical products.

• Explore the regulatory landscape, including past developments, current expectations, and upcoming trends.

• Identify the key data and inputs required for an effective nitrosamine risk assessment.

• Evaluate critical risk factors and interpret assessment outcomes to support decision-making.

• Discover practical case studies illustrating strategies to prevent and mitigate nitrosamine formation.

Register now and strengthen your approach to nitrosamine risk management.