calidad

Nitrosamine Impurities: Present, Past and Future

This course presents how to perform the risk assessment of the presence of nitrosamine impurities.

*IVA incluido

Advanced

1 hour

Course Description

The presence of nitrosamines, potentially carcinogenic components, in some drugs has caused the withdrawal of several products from the market and has raised the alarm among regulatory agencies around the world.

This is what you are going to learn!

This course presents how to perform the risk assessment of the presence of these impurities in drugs in order to respond to the new requirements.
Mainly addressed to Quality assurance and Regulatory affairs managers.

Main Objetives

The most important objectives to be achieved with the progress of the course are listed below:
  • Understanding the chemical structure and the usual formation reactions in the family of nitrosamine compounds.
  • Knowing the toxicological profile of this type of compounds.
  • Learning the steps to be followed in a risk assessment.
  • Identifying critical points in a manufacturing process in relation to contamination by the presence of nitrosamines.
  • Understanding and developing the different root causes.
  • Learning how to elaborate a risk assessment rational according to the current guidelines.

Course contents