Validation of Analytical Methods for Pharmaceutical Analysis.

6 - 7 May 2013, Berlin, Germany

Introduction

The data generated using analytical methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the reliability of this data it is crucial that the methods are fit for purpose. Analytical method validation is the process of demonstrating that a method is suitable for its intended use. This two day course from Mourne Training Services provides a detailed explanation of how analytical methods are validated, enabling a full understanding of method performance characteristics and associated statistics, and how they are applied to the techniques used for analysing drug related samples. This knowledge will enable informed interpretation of the regulatory guidance on validation, namely ICH Q2(R1) and guidance from FDA and EMA on bioanalytical methods.