Validation of Analytical Methods for Pharmaceutical Analysis
Training Course - Dublin, Ireland
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 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 current regulatory guidance on validation, namely ICH Q2 and guidance from FDA and EMA on bioanalytical methods.
The approach of this course is to focus on the principles of method validation thereby enabling application to different types of samples and analytical techniques. Case studies are employed to allow consideration of real life scenarios. Examples relating to small molecule drug substances and formulated products; to physiochemical methods for biotechnological/biological products; and to bioanalysis are included. Particular attention is paid to the most common analytical techniques used for pharmaceutical analysis, e.g., High Performance Liquid Chromatography (HPLC).
Suitable for:
Anyone who needs to understand how methods are validated, either to design and carry out the investigation, or to interpret the data generated. For example: Analytical chemists, laboratory managers/supervisors, quality control analysts/managers, quality assurance managers, and regulatory affairs managers.
(Courtesy of Pharmaceuticals, via seal-analytical.com)
Wesite: http://www.mournetrainingservices.co.uk/course_list.html
Wed, Jun 05, 2013 - Thu, Jun 06, 2013
Metro Hotel Dublin Airport, Dublin, Ireland
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