Pharmaceutical Quality Risk

Can we predict adverse regulatory inspection outcomes for you?

Based on our work for the FDA, we want to use our knowledge on operational stability and the link to inspection outcomes. We aim to identify patterns and correlations of your operational KPIs. Your goal is to identify the sites within your network that require extra attention and perhaps corporate assistance to successfully complete GMP inspections. Together we want to discuss with you how to include these in your quality management dashboards.

Get in touch to learn from our research and design a tailored project to optimize your quality risk management approach.

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For more detailed information and to join forces on this matter, please get in touch!

SEI
Steffen Eich
Research Associate & PhD Candidate