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Genotoxic Impurities - Strategies for Identification and Control

30 September - 1st October 2019

Radisson Blu Edwardian Grafton, London

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.

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.

This course is approved by the Royal Society of Chemistry, and is also available for studying online, check website for dates>>

  • Examining in detail the ICH guideline, its implications and its impact on  control strategies
  • 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

David Elder
David Elder studied chemistry at Newcastle-upon-Tyne (BSc, MSc), before moving to Edinburgh to study for a PhD in Crystallography. He is a visiting professor at King’s College, London. After 39 years of experience at a variety of companies, he recently retired from his role as Director within the product development group in GSK R&D. He is currently an independent CMC consultant.  

 

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
  • Regulatory Affairs
  • Safety Assessment
  • Toxicology

Specifications for Small Molecule Drug Products Webinar

Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry.

The webinar will cover: 
• Regulatory guidance (ICH, FDA, EMA) 
• Tests appropriate to different dosage forms 
• Dissolution specifications for immediate-release, modified-release and extended-release drug products 
• Dissolution specifications in the context of the biopharmaceutical classification system 
• Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination 
• Specifications for combination drug products 
• The role of specifications in maximizing drug product stability

Andrew Teasdale speaking about the EMEA Guideline on the limits of Genotoxic Impurities

rsc approved training

This course is approved by the Royal Society of Chemistry for the purpose of continuing professional development.

As the UK’s professional body for chemical scientists, the Royal Society of Chemistry supports professional development by listing excellent training opportunities on their database of approved courses. The approval process is one of peer review, involving assessment against set criteria by members that are expert in their field.

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