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Informa


Nitrosamine Impurities Forum - Americas

26 Aug - 27 Aug 2020   |   Virtual Course


Course Overview

Addressing Unwelcomed Guests in the Pharmaceutical World

Nitrosamines, or more correctly N-nitrosamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens. Although they are also present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable.

The U.S. Food and Drug Administration (USFDA) is investigating several potentially cancer-causing substances, called nitrosamine impurities, recently found in some drugs, including those used to treat elevated blood pressure, heartburn and acid reflux. Some of these drugs from certain manufacturers – including angiotensin II receptor blockers (ARBs), ranitidine, and nizatidine – have been recalled because of the presence of nitrosamine impurities.

In the European Union (EU), following an Article 31 review of sartans at risk of containing nitrosamine impurities (those containing a tetrazole ring), 9 manufacturers were asked to review and make changes to their manufacturing processes to minimize nitrosamine impurities to the extent practically possible. The problem of the presence of nitrosamine impurities has global implications and ramifications for the pharmaceutical industry & possess challenges related to:

  • Presence of a toxic impurity in API
  • Lack of product and process understanding
  • Inecient testing method/equipment
  • Inadequate risk assessment
  • Stability/storage issue

Objectives of Training

Understanding valsartan contamination in drug products and thier consequences
Understanding the global regulatory and toxicological limits to combat nitrosamine impurities
Sources of nitrosamine impurities and adopting correct methods available to avoid product recall
Strategies to identify these impurities at the right stage
Risk-based approach and key analytical techniques to identify these impurities
Analytical and Chemical assessment to address nitrosamine impurities

Benefits of Attending


Understanding the global regulatory norms and recent amendments to mitigate risk due to nitrosamine impurities

Comprehending the recent analytical tools and techniques to address these impurities

Strategizing the right techniques at right stage to eliminate the presence of these impurities in drug substances and drug products

Identifying the various sources and adopting accurate methods to avoid product recall

Who Should Attend?


INDUSTRIES

  • Pharmaceuticals
  • Life sciences
  • API Manufacturers
  • Bio-Pharmaceuticals

DEPARTMENT

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




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26 Aug - 27 Aug 2020

Virtual Course

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