Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies
Event overview
This online 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 in UK time:
Tuesday, April 16 | 1.30pm – 5.30pm BST
Wednesday, April 17 | 1.30pm – 5.30pm BST
Tuesday, April 23 | 1.30pm – 5.30pm BST
Wednesday, April 24 | 1.30pm – 5.30pm BST
Course Outline
This 4 session online 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 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:
- Link to watch all four live sessions
- Electronic version of the course manual*
- Course certificate
For this on line course, there will be no recordings available and *the e reader manual is NOT printable or downloadable (due to copyright). If you prefer a hard copy of the manual you will have the opportunity of purchasing a professionally printed hard copy during the booking process.
Other Information
Discounts
1st delegate = full price
2nd delegate = 5% off
3rd delegate = 10% off
4 or more delegates = 15% off
For more information on discounts do give us a call on 44 1435 873 062
Wiley Book Discount
Andrew is the author of the book ‘Mutagenic Impurities’ published by Wiley. They are offering a 20% discount – see more information on our blog post.
Registration
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