This analytical method validation training course is aimed at analysts involved in the validation of methods used for the analysis of pharmaceuticals. The training is delivered using live web-based training, where the MTS trainer and the learner communicate over the internet. A broadband connection to the internet and a telephone is required. The course is split into 8 sessions, each of approximately  45 minutes in length. The timing for the delivery of the sessions is arranged to suit the learner. For example, a popular choice is to deliver two sessions in a day over a total period of four days. MTS will make every effort to fit in with the schedule that suits you.

Every attendee on a MTS course is asked to fill in a brief survey on their previous experience and training expectations to ensure that the training is optimised for their learning needs.

Synopsis

The pharmaceutical industry is very heavily regulated due to the nature of its products. This method validation training course provides a thorough treatment of analytical method validation following current regulatory guidelines. The validation process of planning a study, executing the study, and interpretation and reporting of the results is described fully. The theory regarding the purpose of validation and the practical aspect of performing a study are combined in this course.

The definitive reference for this topic is the guideline produced by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Q2(R1) ‘Validation of Analytical Procedures: Text and Methodology’. Sections of the guideline have been reproduced in the training materials associated with this course with the kind permission of the ICH Secretariat. All ICH guidelines are available via the website, www.ich.org.