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Process Validation

Creating robust processes

5
Genre: Diagnostics / Therapeutics
Length: 43 minutes
Keywords: Fast Track Validation, Software Validation, GMP

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.

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