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Genotoxic Impurities – Strategies for Identification and Control

Course Objectives

The control of genotoxic impurities is crucial for ensuring regulatory compliance. With the implementation of increasingly stringent regulations for impurity levels, it is more important than ever for drug manufacturers to employ effective strategies for identifying, analysing and controlling GIs in their products.

This exciting new course - led by Andrew Teasdale, AstraZeneca - will provide you with the latest updates on regulatory expectations, clarifying any grey areas to outline your responsibilities as the manufacturer. It will also advise on crucial aspects of risk assessments and safety testing.

Using a combination of theory and practical case studies, the course will allow delegates to develop the knowledge needed to overcome everyday problems and enhance performance, ensuring you are employing the most appropriate analytical strategies for your products.

Why you should attend

  • Clarifying current guidelines and requirements for reporting genotoxic impurities
  • Learning about current methods for assessing the risk posed by genotoxic impurities
  • Exploring crucial strategies for safety testing
  • Reviewing strategies for genotoxic impurity analysis
  • Practical advice for overcoming everyday problems through the use of case studies and practical exercises

Who Should Attend

This course is relevant to anyone involved in identifying/analysing/ controlling/reporting of GTIs including those working in:

  • Analytical Chemistry/Validation/R&D
  • CMC
  • Development Chemistry
  • Genetic Toxicology
  • Impurities
  • Laboratory Management
  • Pharmaceutical Development
  • Safety Assessment
  • Regulatory Affairs
  • Toxicology

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(updated 22 May 2012)

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Dates and Venues

06 Sep 2012 - 07 Sep 2012

Hotel le Plaza, Brussels, Belgium

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Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals 

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