The PRST has developed a model for Employment/Field based PhDs in Regulatory Science, based on best academic practice.
A Selection of Publications
O’ Meara, A., Calnan N, Greene. A., & Kane, P., An Investment in Knowledge pays the Best Interest’, Journal of Validation Technology, Journal of GXP, September 2015.
Jones I., Greene A., & Cullen. P.J, ‘Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time Imaging’, Pharmaceutical Technology 39 (3), 2015
Waldron K., Greene A., & Calnan N., (2015). ‘Quality Risk Management: State of the Industry Part 1: Has Industry Realized the Full Value of ICH Q9’, Journal of Validation Technology (JVT), Vol. 20 ,(Issue 4), 2015
Greene A., & O Donnell K. (2014). ‘From Science to Knowledge: An Overview of the Evolution of Knowledge Management in Regulatory Guidance’, ISPE KM E-Journal, November 2014
Ryan D., Greene A., & Calnan, ‘Process Validation: Begin with the End in Mind – An Industry Survey on Continued Process Verification’, Journal of Validation Technology, March 2014
Calnan N., O Donnell K., & Greene A., ‘Enabling ICH Q10 Implementation – Part 1. Striving for Excellence by embracing ICH Q8 and Q9’, PDA J. Pharm. Sci. Technol, Nov-Dec 2013, Vol 67, No.6
O’Donnell K., Zwitkovits M., Greene A., & Calnan, N., ‘Quality Risk Management – Putting GMP Controls First’, PDA J. Pharm. Sci. Technol., May/June 2012, 66:243-261
Jones I., Cullen P.J., & Greene A. ‘The transition from Cleaning Process Validation to Continuous Cleaning Process Verification’ Journal of Validation Technology, January 2012
O’Leime C., O’Donnell K., & Greene A., ‘Moving Towards Risk-Informed Decision Making – a possible path for the EU GMP Environment’ Poster presented at ISPE Seminar, Cork, October 2010
Kelleher E., & Greene A., ‘Reduced Validation Effort – Approaches Used and Lessons Learned’ Journal Of Validation Technology, Vol 14, No.8, Autumn 2008
O'Donnell K., & Greene A., '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
[Won Journal of Validation Technology Paper of the Year Award for 2007]
O'Donnell K., & Greene A., '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.
Brady J. & Greene A., 'Education in Computer System Validation: 40 Hour Lesson Plan' Journal of Validation Technology, Vol. 13, No 1, November 2006.
O'Rourke D., & Greene A., ' Lean Manufacturing Practice in a cGMP Environment', Pharmaceutical Technology Europe', October 2006.
O'Donnell K., & Greene A., ' A Risk Management Solution designed to Facilitate Risk-based Qualification, Validation and Change Control Activities within GMP and Pharmaceutical Regulator Compliance Environments in the EU- Part II, Tool Scope, Structure, Limitations, Principle Findings and Novel Elements' Journal of GXP Compliance, Vol. 10, No. 4, July 2006.
[Nominated for award of Paper of the Year by IVT]
O'Donnell K., & Greene A., ' A Risk Management Solution designed to Facilitate Risk-based Qualification, Validation and Change Control Activities within GMP and Pharmaceutical Regulator Compliance Environments in the EU- Part I, Fundamental Principles, Design Criteria, Outline of Process' Journal of GXP Compliance, Vol. 10, No. 4, July 2006 [Nominated for award of Paper of the Year by IVT]
Calnan, N., Lipa, M., Kane, P., Menezes, J. C de, (publication due, 2016) Currently commissioned by Taylor & Francis as lead editor on Knowledge Management in the Pharmaceutical Industry book
Frieldli, T., Basu, P., Calnan, N., Mänder, C., (publication due, 2016) A book to be published by Elsevier Press in conjunction with St. Gallen University, Swiz., entitled 21st Quality Management in the Pharmaceutical Industry – Overcoming the Divide between Quality and Excellence
Calnan, N. (2014). The Know-How and the Know Why: An interview with Merck. ISPE KM E-Journal
Calnan, N. (2014). The 80/20 Rule of Knowledge. Pharmaceutical Engineering: Knowledge Management E-Supplement Edition. ISPE
Calnan, N. (2013) Book Chapter entitled Leading the advance in Regulatory Science in Bellm, D., Werani, J., & Friedli, T. (2013). Leading Pharmaceutical Operational Excellence – Outstanding Practices and Cases, Springer Press.
Calnan, N. (2013) Unlocking the Knowledge, Interview in Angle Magazine, April 2013,p.12-17 ISPE. (2013).
ISPE Proposals for FDA Quality Metrics Program - Whitepaper, 1–19. (Calnan, N. Author Team member)
Waldron K., Ramnarine E., & Hartman J, ‘Regulation Snapshot, PDA and Dublin Tech Institute to Collaborate on QRM’, PDA Letter, Oct 02, 2015
Waldron K., ‘Integration of Risk Management Principles into the Quality System: Risk-based Impact ‘, Journal of GXP Compliance Volume 17 Number 2, Spring 2015