Å·ÃÀAV

This course will provide you with the requisite scientific knowledge and understanding of analytical method validation, verification, and transfer to allow informed interpretation of current regulatory guidance from ICH, EMA and FDA.

This course is approved by the Å·ÃÀAV for purposes of continuing professional development.

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. 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. The course will focus on anaytical methodology used for biopharmaceuticals, which are typically biomolecules.

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 parameters used for method validation, i.e., the validation characteristics as per ICH Q2(R1) of specificity, accuracy, range, linearity, precision, detection limit, quantitation limit and robustness.
3. Generate a validation, verification, or transfer protocol, as appropriate, including practically relevant experiments and 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.

Course Delivery

This 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. Total learning time is 20 hours. The time zone is BST (UTC+1).

The agenda and full schedule of all dates is available on the MTS website.

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 (approximately) only, resulting in a total learning time of 14 hours.

This course is suitable for

Anyone who needs to understand how methods are validated, verified, or transferred, either to design and carry out the investigation, or to review and interpret the data generated.
For example: 

• Development/Quality Control (QC) analytical chemists
• Development/Quality Control (QC) managers/ supervisors
• Quality Assurance personnel
• Regulatory affairs personnel
• Assessors and Inspectors from regulatory authorities

Included in the course fees

• Comprehensive course hand-outs - The training book is provided as an electronic copy (pdf) for both live online and classroom based options.
• Certificate of Attendance
• Optional post training assessment (accessed in e-MTS, our learning management system) which leads to a Certificate of Training.
• Access to training materials via e-MTS
• Post training support – Attendees can contact the trainer with questions that may occur when they apply their learning to real life situations.