Our workshops provide pharmaceutical companies with practical training on implementing nitrosamine and NDSRI compliance programmes in accordance with ICH M7, EMA, and FDA guidance. Each workshop is tailored to the client’s products, processes and level of experience, combining regulatory expectations with practical implementation strategies.
Providing an overview of the current nitrosamine regulatory landscape, including ICH M7, EMA and FDA expectations. Participants gain an understanding of nitrosamine and NDSRI formation mechanisms, evolving regulatory requirements and the scientific principles that support compliant risk management.
Hands-on training covering the complete risk assessment process, including Drug Substance, Drug Product, API Supplier and NDSRI assessments. Participants learn how to apply structured assessment methodologies, document scientifically justified conclusions and consistently evaluate potential nitrosamine risks.
Supporting the practical implementation of nitrosamine programmes through real-life examples, case studies and best practices. Workshops cover lifecycle management, supplier changes, analytical strategies, documentation requirements and common inspection findings to help organizations establish sustainable and inspection-ready processes.
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.
