Drug product impurities attract scrutiny during regulatory review and inspection because of their potential impact on patient safety. It is crucial for pharmaceutical professionals to understand the regulations and how to implement strategies to minimise impurities in drug products.
This training course examines the different types of chemical impurity of concern to regulators in chemical drug products. In addition to ordinary organic degradation products, you will examine mutagenic impurities (including nitrosamines), residual solvents, elemental impurities and extractables/leachables. Once completed you will have the confidence to navigate the EU, US, USP and ICH regulations surrounding drug impurities.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.