Nitrosamines After the Initial Assessment: When Does a Change Trigger Reassessment and How Should Impact Be Evaluated

A nitrosamine risk assessment is often straightforward when the process, materials, suppliers, and product remain unchanged. The truly difficult decisions begin during lifecycle management when something changes. A new supplier is introduced. A reagent is replaced. A manufacturing site is transferred. A formulation is modified. An unexpected analytical result is reported. Teams must determine whether the existing risk assessment remains scientifically defensible or whether a formal reassessment, confirmatory testing, or additional control strategies are required. This technical webinar focuses entirely on the critical decisions that follow post-approval change. Participants will learn how experienced pharmaceutical organizations evaluate reassessment triggers, determine the significance of supplier, process, formulation, and manufacturing modifications, and decide when physical testing is strictly warranted versus when a scientific rationale suffices. The session will deeply examine the application of ICH M7 purge assessments, the classification of Nitrosamine Drug Substance Related Impurities (NDSRIs) using CPCA principles, the justification of testing strategies, and the development of agile control approaches that remain fully compliant as products, processes, and international regulatory expectations continue to evolve. WHY YOU SHOULD ATTEND Few life science organizations still struggle with the initial phase of identifying potential nitrosamine risks. The greater, ongoing operational challenge is determining exactly what to do after a change occurs. The same high-stakes question repeatedly surfaces across Change Control reviews, technical assessments, supplier evaluations, deviation investigations, Annual Product Reviews (APR/PQR), and global regulatory submissions: Does this change require a nitrosamine reassessment? The answer is rarely obvious or binary. Some lifecycle changes necessitate immediate confirmatory testing, revised specifications, or a comprehensive overhaul of the regulatory dossier. Others require only a highly robust, documented scientific rationale. This webinar demystifies how those decisions are made. Participants will review the exact technical factors used to evaluate change impact, understand when a purge-based justification can bypass laboratory analysis, and assess whether existing control strategies remain resilient. The session also directly addresses the latest NDSRI categorization matrix, specification limit decisions, evolving Acceptable Intake (AI) calculations, and the practical, harmonized application of current USFDA, EMA, Health Canada, ANVISA, and TGA expectations. Code: FDB3537