DIT Postgrad wins best article of the Year in Journal of Validation Technology

In October 2007, DIT PhD student Mr. Kevin O'Donnell and his research supervisor Dr. Anne Greene were awarded the prestigious Article of the Year award by the Institute of Validation Technology in the United States.  This was for a research paper they wrote on Quality Risk Management that was published in the Journal of Validation Technology in February 2007.  (O'Donnell and Greene, 'Failure Modes: Simple Strategies for improving Qualitative Quality Risk Management Exercises during Qualification, Validation and Change Control Activities, Journal of Validation Technology,  Vol. 13, No. 2, February 2007)

The winning research paper was titled "Failure Modes - Simple Strategies for improving qualitative Quality Risk Management exercises during Qualification, Validation and Change Control Activities."  It has resulted from research that Mr. O'Donnell and Dr. Greene have been performing over the last three years on the application of Quality Risk Management in pharmaceutical manufacturing.  

The awards ceremony was held in Philadelphia on October 25th, 2007, at the annual Validation Week conference hosted by the Institute of Validation Technology.  Mr. O'Donnell attended the ceremony on behalf of Dr. Greene and himself, and he thanked the Institute for the award. Accepting the award, he stated that it was a great honour to receive such an award, and that he and Dr. Greene were delighted to accept it. 

The research being performed by Mr. O'Donnell and Dr. Greene is part of a PhD project that is co-sponsored by the Dublin Institute of Technology and the Irish Medicines Board.  This was the second time a research paper from this research work has been nominated for the Article of the Year award.  In 2006, their paper titled "A Risk Management solution designed to facilitate risk-based Qualification, Validation & Change Control activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU", as published by the Journal of GXP Compliance, July 2006, was also nominated.  (O'Donnell and Greene, 'A Risk Management Methodology designed to facilitate risk-based Qualification, Validation & Change Control activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU'  GMP Review, Vol. 5, No. 4, January 2007.)

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