Approved training courses

Course description

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 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, 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.

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

Additional info

Included in the course fees: Comprehensive course hand-outs (the training book is provided as an electronic copy in pdf format); and Post training support (attendees can contact the trainer with questions after the training).

Training provider

Mourne Training Services Ltd

Email

oona@mournetrainingservices.co.uk

Tel

+44 (0) 28 3083 4938