Driving BioPharma Innovation
RESEARCH & PUBLICATIONS
Publications
21c Quality Management in the Pharmaceutical Industry: The Journey from Compliance to Excellence
Frieldli, T., Basu, P., Mänder, C., Calnan, N., (2018), Editio Cantor Verlag Aulendorf (ECV)
A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry
Calnan, N., Lipa, M., Kane, P., Menezes, J. C de, (2017), Taylor & Francis. ISBN 9781498750479.
Supply Chain Risk Mitigation -Addressing the Inherent Risks in an Increasingly Fragmented Supply Chain
Calnan, N., (2017) , Contract Pharma Online, September 2017.
De-risking Your Supply Chain: Considerations from a Supply Chain Maps Management Program
Kalska-Zimnicka, M., Calnan, N., O’Sullivan, F., (2017) , IVT Network, Institute of Validation Technology, September 2017.
Leading Indicators of Quality: Pinpointing Behaviours and Measuring Results
Calnan N. (2016), ISPE Pharmaceutical Engineering, Vol 36 No. No. 6, Nov-Dec 2016
Announcing FDA’s Pharmaceutical Manufacturing Quality Metrics Research
Frieldli, T., Basu, P., Calnan, N., (2016), ISPE Pharmaceutical Engineering, Vol 36 No. 6, Nov-Dec 2016
Cultural Excellence: Ensuring that “Culture of Quality” is more than just a slogan
Calnan N. (2016), ISPE Pharmaceutical Engineering, Vol 36 No. 1, Jan-Feb 2016
Has the Effort Been Commensurate with the Level of the Risk? A Review of Significant Publications Since Issue of ICH Q9
Calnan N., Greene A., Journal of Validation Technology, December 2015.
An Investment in Knowledge Pays the Best Interest – Are you leveraging you investment in your CTDs by using the knowledge?
O’ Meara, A., Calnan, N., Kane, P., Greene, A.,(2015), Journal of Validation, September 2015.
Thesis -Protecting the Patient: Enhancing the Quality of Pharmaceutical Products
Calnan, N. (2015). , DIT. February 2015.
Quality Risk Management: State of the Industry Part 1: Has Industry Realized the Full Value of ICH Q9
Waldron, K., Greene, A., & Calnan, N. (2015), Journal of Validation Technology (JVT), Vol. 20 ,(Issue 4), January 2015.
The 80/20 Rule of Knowledge. Pharmaceutical Engineering: Knowledge Management E-Supplement Edition.
Calnan, N. (2014), ISPE. May 2014.
The Know-How and the Know Why: An interview with Merck.
Calnan, N. (2014), ISPE KM E-Journal. May 2014.
Editor of Pharmaceutical Engineering: e-supplement on Knowledge Management – 11 article e-journal
(ISPE, Ed.). May 2014.
Enabling ICH Q10 Implementation--Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9.
Calnan, N., O’Donnell, K., & Greene, A. (2013), PDA Journal of Pharmaceutical Science and Technology / PDA, 67(6), 581–600. doi:10.5731/pdajpst.2013.00940
Leading the advance in Regulatory Science, book chapter from Leading Pharmaceutical Operational Excellence – Outstanding Practices and Cases
Calnan, N., Bellm, D., Werani, J., & Friedli, T. (2013), Springer Press. (2013)
Unlocking the Knowledge, Interview in Angle Magazine
Calnan, N., April 2013,p.12-17
ISPE Proposals for FDA Quality Metrics Program - Whitepaper, 1–19.
ISPE. (2013), (Author Team member)
Inside the Global Regulatory Dialogue (Vol. 4).
International Pharmaceutical Quality (IPQ) Journal (2013), Cited from conference proceeding.
Quality Risk Management: Putting GMP Controls First.
O’Donnell, K., Greene, A., Zwitkovits, M., & Calnan, N. (2012), PDA Journal of Pharmaceutical Science and Technology / PDA, 66(3), 243–61. doi:10.5731/pdajpst.2012.00859
ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment (FSE), 2011
Calnan, N., Member of the author team
ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
Calnan, N., Member of the author team
The FDA’s Draft Process Validation Guidance- A Perspective from Industry.
Calnan, N., Redmond, A., & O’Neill, S. (2009), Pharmaceutical Engineering, p8–16.
Commissioning, Qualification and Verification: A Review Solving the Terminology Conundrum.
Adamson, R., Calnan, N., Chew, R., & Wisniewski, S., (2008). Pharmaceutical Engineering, p60–66.