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This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle, which includes the activities of validation, verification, and transfer, to allow informed interpretation of current regulatory guidance from ICH, EMA and FDA, and in particular, ICH Q2 and Q14.

This course is approved by the ÂÜÀòÉç for purposes of continuing professional development.

The course is available in two versions. This version is the 'Biopharmaceutical Analysis' version, which is aimed at test methods used for large molecules, typically derived from biological or biotechnology processes. (Note: A 'Pharmaceutical Analysis' version is also available, which is aimed at test methods used for small molecules ).

Course overview

The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that the methods are fit for purpose throughout their lifecycle. To demonstrate that a method is fit for purpose will require either a validation, verification or transfer study, depending on the source of the method in question.

This course provides a detailed explanation of how these studies are performed, 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.

Attendees are invited to bring along any real life examples that they would like advice on during the training. These may be discussed during group exercises, or, where intellectual property is an issue, privately with the trainer.

Learning Objectives

1. Understand the purpose of analytical method validation, the principles of analytical error and measurement uncertainty, and how they link to acceptance criteria.
2. Define the performance characteristics evaluated during method lifecycle studies, i.e., robustness, specificity/selectivity, accuracy and precision, and working range, including lower range limits of detection limit and quantitation limit, where relevant.
3. Generate a validation, verification, or transfer protocol, as appropriate, including practically relevant experiments and suitable acceptance criteria.
4. Interpret the results of validation, verification and transfer studies using appropriate statistics.
5. Understand the different possible approaches that may be used for analytical method verification and transfer as per available guidance.
6. Review analytical procedures in terms of verification and transfer and identify potential problems.

Delivery

The course is delivered as a 4 day ‘virtual’ live online training event which is delivered over a 6 hour period on each day, from 9am to 3pm, including a short break. The time zone is typically based on GMT (UTC) from November to March, and BST (UTC+1) from April to October.

It is possible to attend just the method validation part of the course, if transfer and verification are not relevant. This would consist of the first 3 days only (approximately).

Course Fees

Validation, verification and transfer ( 4 days): £1,225 GBP or €1,475 EUR
Validation only (approx. 3 days): £925 GBP or €1,095 EUR