Validation of analytical (separation) methods

Prof. Yvan vander Heyden
Department of Analytical Chemistry
Applied Chemometrics and Molecular Modelling
Vrije Universiteit Brussel
Brussels, Belgium

General description

The validation of analytic methods is an important part of the quality assurance plan in an analytical laboratory. This validation requires that several quality parameters, such as precision, trueness (accuracy), linearity, detection and quantification limits, and robustness, are determined. The goal of this workshop is to discuss these parameters and the way they can be determined in practice.

A few words about the workshop leader

Prof. Yvan Vander Heyden graduated as PhD in Pharmaceutical Sciences in 1998 at the Vrije Universiteit Brussels, Belgium. At present he is heading a research group on chemometrics and separation science in the same University. The mission statement of his group is: “The rational use of new techniques in pharmaceutical analysis”, where analysis techniques refer both to separation and data-analysis. In separation science, research is performed by means of different techniques CE, NPLC, RPLC, POSC, SFC, UHPLC and CEC. The data analysis aspects of the research mainly are conducted on separation science data. They comprise, for instance, multivariate calibration aspects and similarity analysis on fingerprint data (usually from herbal samples) or the construction of predictive Quantitative Structure-Property Relationships.
He is author or co-author of about 380 papers, 260 oral and 390 communications in national and international meetings.

Scope of the workshop

1. Precision
• Evaluation of different precision components: repeatability, intermediate precision, reproducibility
• Robustness testing
2. Calibration and regression:
• Evaluation of linearity: lack-of-fit test
• Applications of regression in method validation
3. Trueness (bias)
4. Detection and quantification limits
5. Accuracy profiles – total error approach


14:00 – 15:00 Lunch

15:00 – 16:30 Course – part 1

16:30 – 17:00 Coffee refreshment

17:00 – 18:30 Course – part 2

19:00 – 20:00 Dinner