BSoD-04_Process Validation - How to create robust Processes

In manufacturing biomedical products one important aspect has to be considered to
be in compliance to international guidelines: process validation. Especially in production
and analysis reliable and reproducible processes must be present to guarantee
maintenance of product quality. In GMP regulated environment validation is a must and
further gains inportant in electronic documentations via commercial software application.

Prospective project managers dealing with process validation have to follow strictly
international guidelines with specific demands to performance and maintenance of
biotech processes and included devices.

This seminar deals with validation parameters and its determination in accordance to
current directives. Also GMP validation procedure and software validation is demonstrated.