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Genotoxic Impurities - Methods to Identify and Control 

  • Offered byPTI

Genotoxic Impurities - Methods to Identify and Control
 at 
PTI 
Overview

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

Duration

4 weeks

Mode of learning

Online

Schedule type

Self paced

Difficulty level

Intermediate

Credential

Certificate

Genotoxic Impurities - Methods to Identify and Control
Table of content
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  • Overview
  • Highlights
  • Course Details
  • Curriculum

Genotoxic Impurities - Methods to Identify and Control
 at 
PTI 
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 interactive sessions, 2 hours/week
Read more
Details Icon

Genotoxic Impurities - Methods to Identify and Control
 at 
PTI 
Course details

Skills you will learn
Software TestingCompliance
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

Genotoxic Impurities - Methods to Identify and Control
 at 
PTI 
Curriculum

Historical perspective on the development of guidelines relating to genotoxic impurities and their relevance/relationship to ICH M7

What does ICH M7 mean? Should I be worried?

Practical implementation

Structural analysis of impurities and data interpretation

Safety testing ?? pre-clinical evaluation of MI related risk

Establishment of acceptable daily intakes for mutagenic carcinogens

How to efficiently analyse mutagenic impurities ?? strategies to minimise development times and appropriate focus of testing

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Genotoxic Impurities - Methods to Identify and Control
 at 
PTI 

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