Process Validation in Biopharmaceutical Production

Short description

Process validation is the method to demonstrate that a pharmaceutical process is suitable to effectively and reproducibly produce a medicinal product of consistent quality.

Process Validation can be complicated, for instance in biopharmaceuticals many different process parameters affect the production process and different aspects should be part of the validation. Furthermore, biotechnological processes are prone to variability due to raw materials, the inherent variability of bioprocesses and the variability in test results.

In the last years the whole concept of process validation also dramatically changed:  the life-cycle approach was introduced and different new regulations have been issued.

This comprehensive, practical training will clarify the whole landscape of process validation and give tools on process validation in biopharmaceutical production.  During the training, the participants will be able to practice the theory using real biotech production equipment.

Objectives

• Understanding the different aspects critical for design and performance of process validations

• Understanding the regulatory expectations regarding process validations

• Setting up and organising different types of process validations

• Writing validation protocols and reports

Target group

• Production, QC , QA and RA persons working at a biopharmaceutical company.

• Personnel working in validation related functions.

• Personnel working in a (virtual) company outsourcing production activities.

• Reviews from participants: "The course gives you more background on how your process is structured". "Very instructive and fits in well with our daily work".