MSI4

Validation of analytical methods according to ICH Q2 (R1)

Objectives :

Understand the requirements of ICH Q2(R1) for the validation of analytical procedures. Know how to choose the experimental designs to be applied and analyze the results. MSG3 or equivalent training is recommended as prerequisite.

Level of trainees :

All sectors technicians or engineers.

Duration and location :

Duration : 14 hours over 2 days
Location : Soladis training center in Paris or Lyon (to consult the calendar, click on “Sign up”) or directly in your office (minimum of 4 people)

Training fee :

In Soladis office : 1150€ tax-free per trainee
Other : Contact us for an offer adapted to your company.

Pedagogical Manager: Catherine TUDAL

« Validation of analytical methods is a broad topic. It is approached in this training with an operational way so that validation is not seen as a regulatory constraint but as a tool to better understand and exploit the results generated on a daily basis. »

Soladis invites you to take part of this training course called “Validation of analytical methods”, which aim is, on the one hand, to help you set up a test protocol and, on the other hand, to train you on the statistical interpretation of results. This training addresses laboratory engineers and technicians who have to qualify and validate their methods / products or operators.

Training Schedule

REMINDERS ON INFERENTIAL STATISTICAL METHODS

Statistical approach
Review of the concepts of hypothesis, significance, p-value, …

VALIDATION STRATEGY

Life cycle of a method
Approach and practical implementation of a validation process
Characteristics to be validated
Acceptability Criteria

VALIDATION OF AN ANALYTICAL METHOD ACCORDING TO ICH Q2 (R1)

Accuracy
Reliability (repeatability, intermediate Reliability, reproducibility
Specificity
Limit of detection, of quantification
Linearity, measuring range

DAILY USE AND VALIDATION OF THE METHOD, PRACTICAL APPLICATION

Practice on case study using XLSTAT

Do not hesitate to contact us for more information about this training, which can be organized in our training center (dates provided on our website) or directly in your premises, according to your preferences.

Soladis - France (headquarter)
6-8 rue Bellecombe
69006 LYON - FRANCE
Tél: +33(0)4.72.83.86.70

Soladis GmbH - Switzerland
Lange Gasse 15
CH-4052 Basel
Phone: +41(0)58.258.15.80

Soladis Inc. - USA
185 Alewife Brook Pkwy, Unit 210
Cambridge, MA 02138-1100
Phone: (+1)857.675.1189