Nitrosamines are a critical topic for regulators and the industry, due to recent safety recalls of several products that contain this impurity. This two-day course will provide participants with an understanding of current regulatory guidelines and the USP General Chapter <1469> Nitrosamine Impurities. The course will provide an overview of sources of nitrosamines, including their formation from the presence of other impurities and how to eliminate or reduce nitrosamine levels. Tools for evaluating and controlling nitrosamines in drugs and pharmaceuticals will also be covered, as well as in-depth analytical procedures in General Chapter <1469>, including the use of the USP Reference Standard and precautions to be taken during analytical procedures. The course will also cover risk assessment methodology as per ICH9, development of a control strategy, calculation of nitrosamine limits as per ICH M7, as well as performance characteristics of the test method.
Couse Duration (hh:mm:ss): 08:29:59
Amanda Guiraldelli – Scientific Affairs Manager – U.S. Pharmacopeia
Naiffer Romero – Scientific Affairs Manager – U.S. Pharmacopeia