Kevin ODonnell

Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority.

Articles

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QRM, Knowledge Management, and the Importance of ICH Q9(R1)

July 8th 2024

This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment.

risk management and risk assessment concept | Image Credit: janews094 - stock.adobe.com

Quality Quartets in Risk-Based Qualification:

Kevin ODonnell ;Cliff Campbell

January 15th 2024

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

Latest Updated Articles

Published: October 11th 2024 | Updated: October 18th 2024

Buy, Sell, Hold: Cell and Gene Therapy - Part 1

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

Published: September 10th 2024 | Updated: September 18th 2024

CPHI Milan Announces 2024 CPHI Pharma Award Finalists

Published: February 23rd 2024 | Updated: December 22nd 2024

Europa Perspectives: Helping to Navigate the Regulatory System

Published: December 13th 2024 | Updated: December 22nd 2024

FDA Creates CDER Center for Real-World Evidence Innovation

Close-up of a microscope lens examining microarray slides, a crucial tool in genomic research and medical diagnostics | Image Credit: © Varunee - Stock.Adobe.com

Published: December 5th 2024 | Updated: December 22nd 2024

Leveraging Advancements in Bioanalytical Testing

Lipid nanoparticle siRNA antiviral delivery system, 3D illustration | Image Credit: © Dr_Microbe - © Dr_Microbe - stock.adobe.com

Published: December 7th 2024 | Updated: December 22nd 2024

Exploring Opportunities for LNP Delivery in mRNA

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