Product Characterisation of Biological Products

Short description

This one-day course focusses on the different aspects which are relevant for the characterisation of biological products according to regulatory guidelines. The course encompasses the entire process from writing of the characterisation plan to the writing of regulatory documentation. Current guidelines, determination of quality attributes and the writing of the characterisation section for a regulatory submission will be discussed.

This course has been developed for analytical and regulatory personnel. No specific analytical expertise is required. It is expected that participants have some knowledge about biologics.

The aim of the course is to enable you to develop and execute a solid characterisation strategy and be able to describe this in line with regulatory guidelines.

Objectives

• Understand the different aspects for characterisation of biological products
• Become acquainted with regulatory guidelines and expectations
• Become familiar with the tasks and responsibilities for analytical and regulatory staff. 

Target group

This training is suitable for junior and experienced analytical and regulatory personnel. In addition, it is also valuable for personnel in related fields such as research and development, quality control and process development.