This 2-day analytical method validation training course is aimed at analysts involved in the validation of methods used for the analysis of pharmaceuticals. The training course is delivered at your company’s site by the MTS trainer. A pre-training visit may be arranged during which the MTS trainer will discuss the content of the training course with you to ensure that the method validation training is fully tailored to your needs. 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.

The standard cost for this training course, charged per person, is GBP £600 + VAT, but significant discounts may be applied depending on the number of learners in the group being trained.

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. Refer to the full course description for details of the agenda on each of the 2 days of the training.

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.