KENX INSIGHT

Donncadh J. Nagle, Validation Lead, EIRCHEM Pharma

Donncadh J. Nagle is a pharmaceutical industry professional based in Ireland and is a recent graduate from the masters degree programme, MSc. in Pharmaceutical Validation Technology, at the Technological University Dublin (TU Dublin). Donncadh is an experienced Validation Engineer with over eleven years of experience in all areas of validation including; Process/Product Validation, Equipment/Automation Qualification, Facilities Qualification, Computer System Validation, Test Method Validation, and Cleaning Validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device and pharmaceutical industries. Donncadh has ambitions to become an industry leader within the pharmaceutical industry and is the current Chair of the BPCI Validation group, Ireland. Donncadh is also a recent winner of the 2018 Thesis award presented by KENX at their C&Q and Data Integrity conference, in Dublin, Ireland.

Donncadh is also a published author with IVT/JVT, USA

Professor Anne Greene, Head, Pharmaceutical Regulatory Science Team (PRST), Technological University Dublin

Anne Greene leads the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin, where she is also a senior lecturer and director of the several MSc. and BSc. Pharmaceutical Programmes, including the TU Dublin MSc in Pharmaceutical Validation Technology. She has supervised several students to PhD awards in areas of Quality Risk Management, Knowledge Management, Operational Excellence and PAT. Prior to embarking on an academic career, Anne worked at a senior level for several years in the pharmaceutical sector in Validation and Technical Management roles. Anne has a PhD in Synthetic Organic Chemistry from University College Dublin, and is currently a member of committee of the Irish Chapter of PDA.

Anne is also on the Board of Directors of Regulatory Science Ireland (RSI) and is chair of the Corporate Development Committee

Dr. Kelly Waldron, Senior Consultant, ValSource

Dr. Kelly Waldron is currently a senior consultant with ValSource and a member of the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (formerly Dublin Institute of Technology) in Dublin, Ireland. She has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM) and has authored numerous industry and academic papers on the topic. Dr. Waldron’s expertise extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, data integrity, audit and inspection programs and response, and design control. She holds a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a Ph.D. in pharmaceutical regulatory science (thesis in QRM) from the Dublin Institute of Technology. She currently resides in New Jersey, USA and can be reached at kwaldron@valsource.com.

Lelia Scott, Executive Director, Global Quality Systems Charles River Laboratories

Ms. Scott is a senior management quality professional with over 15 years if progressively challenging QA experience within the pharmaceutical industry, and 7 years in analytical lab sciences. Her specializations include: data integrity, global process adoption, implementation of enterprise-wide quality systems, computer system validation, vendor quality, relationship building in cross-functional teams and development of innovative solutions to expedite business processes using electronic systems in compliance with global pharmaceutical regulations. She holds a Bachelor in Chemistry from the University of Western Ontario and an MBA in Pharmaceutical Management from Fairleigh Dickinson University.

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