Approved training courses

Course description

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 is available in two versions; choose from either the pharmaceutical version (test methods used for small molecules) or the biopharmaceutical version (test methods used for large molecules, typically derived from biological or biotechnology processes).

The analytical techniques used to test traditional small molecule pharmaceuticals are typically different to those used for testing biopharmaceuticals, also known as biotherapeutics. Therefore, the key difference between the two versions of this course is that the examples and case studies used in the course are tailored to these different types of medicinal products. Additionally, since the typical acceptance criteria which is applied to each type differs, the most relevant guidance can be provided to attendees.

Learning Objectives:
1. Understand the purpose of analytical method validation and the principles of analytical error and measurement uncertainty, and how they link to acceptance criteria.
2. Define the performance characteristics evaluated during method lifecycle management studies, i.e., robustness, specificity/selectivity, range (including response and lower range limits), accuracy and precision.
3. Generate a suitable protocol for analytical method lifecycle management studies (i.e., validation, verification, transfer, and post-approval changes), including practically relevant experiments and suitable acceptance criteria.
4. Interpret the results of analytical method lifecycle management studies using appropriate statistics and statistical tools.
5. Be able to perform risk assessments associated with analytical method lifecycle management studies.

Delivery options for this course:
This course is available either as an open enrolment option, where anyone can book onto the course, or as an in-house option where the course is run for employees in a specific company. It is possible to attend just the method validation part of the course, if transfer and verification are not relevant.

The open enrolment option 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.

The detailed agenda and the full schedule of dates are available on the MTS website.
The in-house option may be delivered either in the live online format or in a classroom-based format at your site. It is possible to attend just the method validation part of the course, if transfer and verification are not relevant.

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

Pre-requisites

On request from training provider

Training provider

Mourne Training Services Ltd

Email

oona@mournetrainingservices.co.uk

Tel

+44 (0) 28 3083 4938