BioPharm Excel

Nuala Calnan has over 20 years experience in the biopharmaceutical industry across operations, new product introduction and facility start-up and manufacturing.

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Nuala’s current focus is on the integration of Knowledge Excellence, Operational Excellence, & Cultural Excellence in delivering enhanced quality outcomes for the patient. 

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Nuala works across the BioPharma and Medtech industries, as well as service providers to these industries, delivering research, consultancy and training that drives innovation. She works closely with industry in assisting organisations to deliver quality excellence, designing metrics that matter to the patient and the business, good data governance programs and implementing behaviour based quality through cultural excellence programs.

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Nuala has led a recent Irish Industry research study examining the Product Recall and Quality Defect data at the Irish medicines regulator, HPRA.  She is currently a member of the team conducting research on behalf of the FDA examining the role of Quality Metrics in driving enhanced quality performance. 

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Nuala co-leads the ISPE Quality Culture Team that published the recent ISPE Cultural Excellence Report and the ISPE/ PQLI Task Team on Knowledge Management.  She was also lead editor on a recent knowledge management book entitled A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry, CRC Press 2017.

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Nuala is currently an Adjunct Research Fellow with the Pharmaceutical Regulatory Science Team at DIT, Ireland, where she teaches and leads a number of patient-focused regulatory science research projects at Masters and PhD level.

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You can LinkIn with Nuala here.