Product Characterisation of Biological Products

This course focusses on all aspects which are relevant for the characterisation of biological products.

Duration
1 day
Course fee
€ 895 (excl. VAT)

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.

Program

 

• Introduction to product characterisation
• Overview of relevant guidelines
• Process of product characterisation studies
• Common analyses and techniques
• Writing of the characterisation section of a CTA/IND/MAA/BLA

Sign up

  • Keep me up to date

    Leave your e-mail address to receive a notification when new training dates become available.
    Your e-mail address will not be used for other purposes.

Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

Knowhow.
Know how.
Know why.

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

Thanks