Seminar Nr. 15660
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This 2-day Master Class brings together well-experienced experts to discuss the latest expectations and requirements for Quality Metrics and KPIs and how they are linked to Continual Quality Improvement (CQI) and Business Continuity. This will support you turning your company’s quality excellence goals into reality.
To remain ‘regulatory compliant’ and to ensure the continuity of product supply in a cost-effective way, systems and processes must be evaluated and the respective processes simplified and controlled. Important tools in this context are accurate Quality Metrics, the right Key Performance Indicators (KPIs) and Continual Quality Improvement.
Quality Metrics in itself are not new, though. They have already been used in pharmaceutical industry for years – even though mainly internally to measure operational performance. But quality can be measured on different levels and for many processes. Done in the right way, Quality Metrics can enable companies to reach a high quality performance. They will benefit from a continuous improvement in both operational performance and GMP compliance. And both are important for the continuity of business and product supply.
Now, the U.S. FDA has set up an initiative to use Quality Metrics for risk based inspections and published a draft Guidance for Industry in July 2015. In Europe agencies also use Quality Metrics. They are aiming to help regulators to separate manufacturing sites with poor standards from those continuously working on quality improvement.
In the end Quality Metrics will enable companies and regulators to benefit from a continuous investment in GMP to guarantee a high quality performance and the continuity of quality product supply.
Managers and Executives from pharmaceutical Quality Assurance and Quality Management but also Business Executives and Production Managers and those involved managing the continuity of product supply.
Quality Metrics and beyond