Archived: VIRTUAL TRAINING EVENT | Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies

Virtual On line Course

Date: 22 September - 30 September 2020

Location: On-Line Event

Tutors: Dr Andrew Teasdale

This Virtual On Line 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.

The course will be split over four sessions as follows:

Tuesday, September 22nd | 2.00pm until 5.00pm BST and
Wednesday, September 23rd | 2.00pm until 5.00pm BST and

Tuesday, September 29th | 2.00pm until 5.00pm BST and
Wednesday, September 30th | 2.00pm until 5.00pm BST

If you would prefer this course LIVE, we are running it in Basel, Switzerland on December 7-8, 2020, click here for more details

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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:

  • all four sections of the course
  • course certificate at the end

You will have the option of buying a hard copy of the manual and this will be sent via the post to you.  Please note for on line courses no PDF version of the slides/manual will be sent via email and no recordings are available after the event.

 

Testimonials

Ferring Controlled Therapeutics Ltd

Informative, excellent presentations provided by a leading professional in impurities

Bayer AG

I enjoyed it very much and learned a lot about interpretation and implementation of the discussed guidelines; Thanks for sharing!

Grünenthal GmbH

This really was one of the best courses I have ever been on. Thanks a lot to Scientific Update for organising and to Dr Teasdale for this outstanding lectures!