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Genotoxic Impurities - Methods to Identify and Control

Genotoxic Impurities - Methods to Identify and Control

Practical advice for detecting, assessing and controlling genotoxic impurities to ensure regulatory compliance

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Course Highlights

  • Modules are released on a weekly basis

  • Learning with zero expense on travelling

  • Course is approved by the Royal Society of Chemistry UK

  • Live intercative sessions, 2 hours/week

Duration: 28 Days

Mode of learning: Online Classroom

Course Overview

Who should do this course ?
  • Professionals involved in identifying/analysing/controlling/reporting of GTIs.

What are the course deliverables ?
  • Examine in detail the ICH M7, EMA and FDA guidelines

  • Review implementation strategies of the ICH guideline for new chemical entities and generics

  • Explore common in silico systems used and evaluate their strengths and weaknesses

  • Discover methods to assess potential mutagenicity impurities

  • Discuss the In-Vitro and In-Vivo tests available to examine mutagenic impurities

  • Gain the knowledge to implement a successful strategic MI analysis with minimal impact on development times

More about this course
  • 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

  • Led by Andrew Teasdale, this 4 week course 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

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Curriculum

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