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

Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies is organized by Scientific Update Ltd and will be held from Sep 19 - 20, 2018 at Elite Palace Hotel, Stockholm, Sweden.

The target audience for this medical event is 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.

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 to 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.

Price:
Course Fee: EUR 1700

Speakers: Dr Andrew Teasdale

Additional details will be posted as soon as they are available.