91AV

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. The content will also prepare you for the expected changes in regulatory expectations, and in particular, the update of ICH Q2.

This course is approved by the 91AV 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.

Learning Objectives:

1. Understand the purpose of analytical method validation and the principles of measurement uncertainty.
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 transfer as per available guidance from EMA, USP, FDA and WHO.
6. Review analytical procedures in terms of transfer to another laboratory and identify potential problems.

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.

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 interpret the data generated.
For example: 

• Analytical chemists
• Laboratory managers/ supervisors
• Quality control analysts/ managers
• Quality assurance managers
• Regulatory affairs managers

Included in the course fees:

• Comprehensive course hand-outs - The training book is posted to the attendee prior to the event.
• Certificate of Attendance
• Optional post training assessment (accessed in e-MTS) 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.

Course Agenda
The agenda for this live online training option is spread over 4 days (typically 09:00 to 15:00 each day). The time zone for live online courses is based on BST (UTC+1) from April to October.

It is possible to attend just the method validation parts of the courses if transfer and verification are not relevant for you. This would consist of approximately the first 2.5 days only.

United Kingdom