Regulatory requirements for nitrosamine impurities are evolving, and the long-running issue continues to present pharma manufacturers with significant risk assessment, confirmatory testing and control strategy implications.
As companies contend with the management of nitrosamine drug substance-related impurity (NDSRI) formation across a growing number of products, this session will cover:
- An update on testing deadlines and requirements from the US Food and Drug Administration (FDA)
- Ensuring precise testing and comprehensive compliance
- Staffing for success and building the right cross-functional team
