Nuala Calnan

  PhotoI have over 20 years experience in the Pharmaceutical industry with a strong technical background in New Facility Design, Commissioning & Start Up and Regulatory Consultancy. My most recent industry role was with the PM Group as Principal Consultant for the Life Science business working with a broad range of international clients involved in large scale facility start up & design projects. Through these various roles I have developed a detailed operational working knowledge of the pharmaceutical regulatory cGMP environment, both FDA and EMA and have been involved in preparing several facilities for FDA and IMB inspections. In addition to my career experience I have been involved with the ISPE since 1996 and have held committee positions at Irish affiliate, European and International level. In 2007, I was elected to the ISPE International Board of Directors. A longtime member of the Steering Committee for the Commissioning and Qualification COP and a member of the UK and Ireland PAT COP. I was actively involved in responding to the recent initiatives within the regulatory environment and was a member of the Author Task Team which produced the ASTM E2500-07 International Standard on Commissioning and Qualification. I was also a member of the team which recently wrote the ISPE Guide for Science and Risk Based Approach for the delivery of Facilities, Systems & Equipment and the Good Practice Guide for Applied Risk Management for C&Q. I graduated in 1991 with a Batchelor of Science in Engineering (BSc Eng) degree and gained my MBA in 2002. My new challenge is to undertake a PhD to develop a practical methodology for implementing the recent ICH Q8 (R2), Q9 and Q10 regulatory guidance for the manufacturing sector of our industry. The research is seeking to provide a practical means for integrating science and risk based approaches to Product Development, Quality Risk Management and Pharmaceutical Quality Systems across the lifecycle activities involved in the manufacture of human drug products.