Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies
Event overview
This 2 and a half 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.
The course will finish after lunch on the third day.
Course Outline
This 2.5 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 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
Other Information
General Information
Each course includes:
- Refreshments & lunch daily
- Dinner on the first evening*
- The comprehensive Course Manual
- Course Certificate
Please refer to the course brochure for detailed timings.
*Not every course includes dinner please refer to the course brochures for detailed information on what’s included.
Course Certificate
At the end of each course participants receive a Certificate of Attendance – signed by your tutor.
Accommodation
Depending on venues we either reserve a limited number of bedrooms at a special rate for you or we will provide a list of recommended hotels close by to the course venue. More information on rates and booking forms will be provided upon booking. All rooms will need to booked directly with the hotel.
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 author of the book ‘Mutagenic Impurities’ published by Wiley. They are offering a 20% discount, for more information please read our blog post.
Brochure
View brochure
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