Nitrosamine Impurities: Risk Assessment, Control & Regulatory Compliance

This programme provides a practical understanding of nitrosamine impurities in APIs and pharmaceutical products, covering their chemistry, formation mechanisms, toxicological significance, and regulatory implications. Participants will learn to conduct systematic nitrosamine risk assessments, differentiate conventional nitrosamines from NDSRIs, establish acceptable intake limits, develop analytical and testing strategies, and implement effective control and mitigation measures. The programme also addresses FDA and EMA expectations, investigations, deviations, OOS/OOT results, CAPA, regulatory documentation, and lifecycle management, reinforced through case studies and practical risk-assessment exercises.