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Ensuring Patient Safety: Analytical Strategies for Nitrosamines & Genotoxic Impurities

Nitrosamines and other genotoxic impurities present a significant challenge to the pharmaceutical industry, as even trace levels can pose serious safety risks to patients. Their detection and control demand rigorous scientific, regulatory and manufacturing strategies to ensure product quality and compliance.

Join our webinar for a comprehensive overview of nitrosamine and genotoxic impurity management, with a focus on practical approaches and real-world case studies. The session will highlight the importance of nitrosamine drug screening for patient safety and explore how storage conditions and large-scale testing can influence N-Nitrosodibutylamine (NDBA) contamination. You will also gain insights into best practice strategies for nitrosamine mitigation to strengthen both regulatory compliance and product quality.

For professionals seeking to enhance their understanding of impurity risks and regulatory expectations, this webinar offers a unique opportunity to gain practical knowledge and expert perspectives.

Agenda:


  • Introduction
  • Drug substance and product testing – why nitrosamine screening matters and effective mitigation strategies
  • NDBA contamination – impact of storage conditions and the role of large-scale testing
  • Q&A

Who should attend:

This webinar will be of interest to pharmaceutical professionals, including QC/QA managers, analytical chemists, production/process managers, R&D scientists and specialists from biotech firms, CROs, academic institutions and regulatory bodies.

This event will take place on October 21, 2025, at 2:00 pm (BST)

Register now

Presenters:

Romain Simon

Operations Manager

Dr. Romain

Simon

Romain joined SGS in 2015 and is Operations Manager in Geneva, where he leads the analytical department. His career has focused on method development for the quantitative analysis of small molecules and proteins by LC-MS.
Paresh Thanki

Senior Manager, Laboratory Operations – Chemistry

Paresh

Thanki


Paresh brings over 23 years of experience in the pharmaceutical industry, with leadership roles in QA, QC, regulatory affairs, validation functions and auditing. He specializes in testing and releasing packaging, raw materials and finished products, and has extensive experience in coordinating and developing stability studies.

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