The new process Validation life cycle is now split up into 3 stages:
1. Process design
2. Process Qualification
3. Continued Process Verification
The new “catchword” is process understanding. Trends should be evaluated in the Stage 3.
One element to show process understanding and to monitor trends can be Statistical Process Control.
On the one hand the seminar will explain the theory of control charts e.g. how to calculate and read them. On the other hand the seminar will explore how to practically apply Control Charts, e.g. implementing control charts in production or QC and setting up a good review process. This balance of class room sessions and exercises supports a hands-on approach to manage and use Control Charts in different environments, like validation and process improvement.
Examples and case studies from the experience of the speakers will give evidence of the success and possibilities the use of Control Charts adds to your enterprise. Additionally, there is a view on the software for SPC and its GMP relevance.