Nuala Calnan

Biopharm Excel Ltd
CEO
Nuala Calnan is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author, and commentator is directed toward the delivery of patient-focused excellence and has included research for the FDA, HPRA (Ireland), and other regulatory agencies on patient safety and product quality in the manufacture and distribution of drugs.

Her current areas of consultancy and research include quality risk management, building patient-focused quality cultures, data integrity, knowledge excellence, designing 'Metrics that Matter' and cost of quality. Nuala co-leads the ISPE Cultural Excellence Team, is a founding member of the ISPE/PQLI Task Team on Knowledge Management and was Technical Author of ISPE's Advancing Pharmaceutical Quality (APQ) Guide Series.

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Advancing Pharmaceutical Quality Cultural Excellence
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Advancing Pharmaceutical Quality Cultural Excellence

Cultural Excellence is the expressed and implied ways in which an organization operates. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. Culture determines quality outcomes by affecting the organization’s ability to identify and act upon near-miss shortages, ensuring the integrity of its data,...