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.

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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

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

CPHI Milan Announces 2024 CPHI Pharma Award Finalists

Published: October 28th 2024 | Updated: November 21st 2024

Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development

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Published: November 6th 2024 | Updated: November 21st 2024

Automate Aseptic Filling: Closing the System at Full Modularity

Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com

Published: November 5th 2024 | Updated: November 21st 2024

Untethered Data: Unifying and Contextualizing Drug Discovery Data

Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com

Published: November 8th 2024 | Updated: November 21st 2024

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification

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