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In-House Training

Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies

Tutors: Dr Andrew Teasdale

This 2 day course is aimed at providing a holistic understanding of the challenges and issues associated with implementing an effective control strategy for all impurity types. It will examine key areas, specifically, impurity qualification, mutagenic impurities, elemental impurities, extractives and leachables and solvents. In each case it will examine practical approaches through both case studies and practical exercises and in all instances provide clarity as to the current and emerging regulatory frameworks.

The course also looks at other impurity related areas such as shared facilities, both the guideline and recent Q&A document, finishing with a look to the future and the challenges associated with new modalities including Oligonucleotides and Antibody Drug Conjugates.

Course Outline

This 2 day course is aimed at providing a holistic understanding of the challenges and issues associated with implementing an effective control strategy for all impurity types. It will examine key areas, specifically, impurity qualification, mutagenic impurities, elemental impurities, extractives and leachables and solvents. In each case it will examine practical approaches through both case studies and practical exercises and in all instances provide clarity as to the current and emerging regulatory frameworks

Benefits of Attending

What will attendees gain from the course?
  • What are the key impurity classes and how they relate to the overall manufacturing process.
  • A clear understanding of the pivotal role played by chemists and analysts in the impurity management process.
  • How to effectively relate product quality to impurity qualification ensuring that qualification studies properly align to process capability.
  • How to align impurity management to the over process control strategy – to optimise effective control.
  • How to use effective impurity management to drive key process and regulatory decisions e.g. starting material definition and defence.

Who Should Attend

Scientists, managers and team leaders involved in the development of pharmaceuticals and Engineers.  This course is particularly relevant to process development chemists and analysts at all levels, but will also be of interest to late stage medicinal chemists who want to gain a greater understanding of the impact of impurities

What's Included

The course fee includes:

  • comprehensive course manual
  • coffee/tea refreshments breaks throughout each day
  • buffet lunch each day
  • course dinner on the first evening
  • course certificate