CE Fundamentals and Operation - Method Development - Method Validation - Troubleshooting
The course modules provide you with Capillary Electrophoresis (CE) fundamentals and operating modes, as well as practical tips to obtain fit-for-purpose methods. The method validation module focuses on the ICH Q2 guideline, with many real-life examples from the pharmaceutical and biotech industry. Although the focus is on (bio)pharmaceuticals, the principles apply for most CE methods.
This course aims for both starting and experienced analytical scientists and technicians and lab managers who want a better understanding of the CE techniques and practical tips for method development and validation, good working practices and troubleshooting.
Contents & Learning outcome
After this course, you will understand the fundamentals and be able to couple method development and validation to the purpose of your analysis. You will be better able to develop robust, precise and sensitive methods and will have a better understanding about the critical parameters, Quality by Design and good working practice of CE. You will have a good understanding on the validation parameters from a CE point of view as well as from a patient safety perspective. After this module you will be able to make a to-the-point validation protocol. Your gain in knowledge will reduce the amount of troubleshooting needed in daily practice, but if needed, you’ll have a good understanding of where to start and what to look for.
At the end of the course, all participants will receive a Training Certificate for their personal training record.
Module 1 – CE Fundamentals and Operation
- Electrophoresis and electro-osmosis: the separation mechanism
- Different modes of CE
- Daily operation and maintenance
Module 2 – CE Method Development
- General principles
- Quality by Design
- Many tips for developing robust, precise and sensitive methods
- Multiple examples from industry
Module 3 – CE Method Validation
- Method validation purpose and phase-related approach
- Validation protocol and procedure
- ICH Q2 guideline for analytical method validation
- Method application and transfer
Module 4 – Troubleshooting
- Troubleshooting strategy
- Many examples from industry
- Preventing the need for troubleshooting
- CE for routine use