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Planning Your Testing to Identify Unexpected Impurities in Medicines

Join our webinar to learn about the regulations surrounding impurities in medicines and how you can lessen the impact on your operations.

Throughout the drug production supply chain unexpected impurities can be created and then remain present in a product. These impurities can originate from raw materials or be introduced during production.

As per the regulation US FDA Guidance for Industry Q11 Development and Manufacture of Drug Substances, looking for impurities throughout the process is mandatory and acceptance levels need to be demonstrated. If companies only implement impurities detection at a late stage of a medicine’s development, it can have a significant financial impact.

Objective

The objective of this webinar is to provide a strategy for structure elucidation. We will present an introduction to impurities in drug production, what they are, how and where they can be introduced, as well as a case study and an overview on how to handle new unexpected impurities. We will help you to understand how to comply with regulations, define the level and content of impurities and conduct a toxicological assessment.

Agenda

  • Introduction
  • Where can unexpected impurities be found?
  • Case study on production of an oxazolidinone drug
  • Summary
  • Q&A

Audience

This webinar will benefit those working in drug development and quality control laboratories, as well as quality managers, laboratory managers/leaders and senior management.

For further information, please contact:

Aurelia Resines
Global Marketing Manager
t: +41 22 739 9623

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