Agenda items

QbD is a scientific, risk-based, holistic and proactive approach to product development with predefined objectives. It emphasizes product and process understanding and process control and is based on sound science and quality risk management. QbD is also about ensuring that products have the required safety and efficacy through process control using quality risk management and knowledge management. Building reliable, efficient, and robust cost saving methods supports product development, production, and evaluation to ensure that quality and safety standards are met.

Why QbD is Important for Analytical Methods

What are the drivers for adoption of QbD concepts in the Pharma Industry and how can these concepts be applied to help ensure analytical methods are developed that are robust and rugged. What are the implications QbD approaches have on how analytical methods are validated and why are some of the key concepts needed, including Analytical Target profile (ATP), the importance of management of variation and the key aspects involved in lifecycle management of analytical methods.


This eSeminar took place in two 2-2.5 hr sessions in May 2014. Click here for on-demand view: Registration

Quality by Design for analytical methods: why would you need QbD for analysis? What tools are available and how do you use them? How to set up an experimental design? What are the prerequisites for successful pharmaceutical analysis methods? What are pharmaceutical methods for anyhow? What is the impact of simple sample preparations steps such as pipetting and dilution? Is there a way of working that will keep the variation low and precision good? The course includes many practical examples.

Training on-site, on-the-job, if requested. For more information, costs, registration and planning,  please contact Kantisto.

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.


For whom

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


This course is an introduction to capillary electrophoresis for people with limited experience that would like to increase their knowledge and experience of CE practice. People who want a better insight in the separations principles of the CE modes, instrumentation & maintenance, quantitative CE and who want to learn good working routines.

Classroom course and/or hands-on training, in English, Dutch or Swedish. Training on-site, on-the-job, if requested. For more information, costs, registration and planning,  please contact Kantisto.

After this course the participant will be able to write a fit-for-purpose validation protocol, perform the validation and evaluate the results. The coupling between product specification, method development and validation is explained. Statistics form an important part of this training.

Training on-site, on-the-job, if requested. For more information, costs, registration and planning,  please contact Kantisto.