Trainings By Informa Markets

Impurities Qualification Workshop in Pharma Drug

27 Aug - 28 Aug 2024

Workshop Overview

Workshop 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.

Benefits of Attending

  • Get awareness and understanding of current regulatory guidelines, the similarities, and differences across guidelines, and their impact.
  • Appreciate the different types of impurities and when/how to control them
  • Understand current and future industry trends, including the forthcoming ICH
  • guidance - ICH M7 hazard assessment and risk characterization
  • Learn how to derive acceptable intake limits, and the challenges associated with this from both a technical and regulatory perspective
  • Qualification of Non-Mutagenic Impurities

Who Should Attend?


  • Quality Assurance
  • Quality Control
  • R&D
  • Production & Manufacturing
  • Regulatory
  • Packaging


  • Pharmaceuticals
  • Life sciences
  • Biopharmaceuticals
  • API Manufacturers


  • Vice Presidents
  • Associate Vice Presidents
  • Directors
  • Associate Directors
  • Head/ Plant Head
  • Deputy General Manager
  • Senior Scientist
  • General Manager
  • Senior Managers
  • Managers
  • Assistant Managers
  • Senior Executives

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