26 June, 2012
The Dorsett Hotel, Kuala Lumpur, Malaysia
Price: US$795
Who should take this course?
Analytical scientists and technicians who are responsible for validating capillary electrophoresis methods. The course is also useful for managers and QA staff involved in the method validation process. For workers who develop, but do not validate methods, this course will give insight into how to develop methods that will be easier to validate. No prior CE experience is needed, although those with practical CE experience and those who attended the CE method development course will certainly benefit more than those with no experience at all.
What does it cover?
This course is devoted to CE analytical method validation, focusing on the ICH Q2(R1) guideline, with many real-life examples, and follows on to the CE Method Development course. The examples in this course come from pharmaceutical analysis methods, i.e. methods for drug substance and drug products. Bioanalytical methods (drugs in body liquids or tissue) will not be discussed. Although the focus is on pharmaceuticals, the principles apply for most quantitative CE methods.
Learning Outcome – What will I get from this course?
After this training, you will be able to couple method development and validation to the purpose of your analysis. You will have a good understanding what the validation parameters are and you will be able to make a to-the-point validation protocol.
If you are a lab manager, QA or CMC-regulatory assessors, you will be able to review CE methods and data.
At the end of the course, all participants will receive a Training Certificate for their personal training record.
Course outline
- Myths and facts about CE for routine use
- Method purpose and requirements and the impacts on method development
- Method validation purpose
- Phase-related approach
- Validation protocol and procedure
- Method validation and Quality by Design
- ICH Q2(R1) guideline for analytical method validation
o Specificity
o Linearity
o Range
o Accuracy
o Precision
o Detection and Quantitation limits
- Robustness
- System suitability testing
- Method application and transfer
About the Instructor
Cari Sänger has more than 20 years of experience in pharmaceutical and chemical analysis. Her aim is to stimulate people to keep growing and learning, striving to get the best out of themselves. Cari is an independent, reliable, scientific people-manager and a globally recognized expert on separation science, especially within the capillary electrophoretic techniques. Cari’s focus is primarily on implementation, knowledge transfer and good working practices.