Workshop Overview
Trainer: Dr. Raphael Nudelman
The scrutiny of drug impurities in regulatory review and inspections stems from their potential impact on patient safety. It
is imperative for pharmaceutical professionals to possess a thorough understanding of regulations and the ability to
implement effective strategies for minimizing impurities in their drug products.
This course is meticulously designed to offer a thorough comprehension of the challenges associated with establishing a
robust control strategy for various impurity types. The focus extends to critical areas, including impurity qualification,
mutagenic impurities, elemental impurities, extractives and leachables, and solvents, encompassing Nitrosamines as well.
Each module delves into practical approaches through case studies and exercises, providing clarity on existing and
evolving regulatory frameworks. Upon completion, participants will gain the confidence to adeptly navigate the regulatory
landscape encompassing EU, US, USP, and ICH regulations related to drug impurities