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Regulatory Requirements and Strategies for Nitrosamine Testing

Join our webinar to gain insight into how managing nitrosamine impurities in the manufacturing of pharmaceuticals can be addressed.

Overview

In this session we are going to look at how managing nitrosamine impurities in the manufacturing of pharmaceuticals can be addressed. We will be looking at the process and the methods involved in identifying nitrosamine impurities.

Objective

This webinar will explore unfamiliar territory, with the first FDA guidelines for identifying nitrosamine impurities having only been published in 2019. There is a lot to uncover here, and we welcome questions and comments during this live and interactive session with our SGS experts.

Agenda

  • Introduction
  • Why nitrosamine substances have become a concern in pharmaceutical manufacturing over the last few years
  • Why testing for these contaminants is crucial for current and existing products on the market
  • The consequences if nitrosamine impurities are discovered in pharmaceutical products
  • Precautions that need be taken to avoid the formation of nitrosamine impurities
  • How SGS can verify the status of your products, by identifying and quantifying all nitrosamine contaminants to protect patients
  • Conclusion
  • Q&A 

Target Audience: The webinar is aimed at all biopharmaceutical and pharmaceutical companies.

Language: English

For further information, please contact:

Sofia Nicolaou
Global Marketing Manager Drug Development
t: +44 (0) 7874 867837

Speakers

Paresh Thanki

Senior Manager Operations in Chemistry, SGS

Paresh Thanki

Bhavin Prajapati

Scientific Leader, SGS

Bhavin Prajapati

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