Nuala Calnan

Nuala has over 19 years experience in the Pharmaceutical industry with a strong technical background in New Facility Design, Commissioning & Start Up and Regulatory Consultancy. Her 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 she has developed a detailed operational working knowledge of the pharmaceutical regulatory cGMP environment, both FDA and EMA and has been involved in preparing several facilities for FDA and IMB inspections.
In addition to her career experience she has been involved with the ISPE since 1996 and has held committee positions at Irish affiliate, European and International level. In 2007 she 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. She 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.
She was also a member of the team which 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 .
She graduated in 1991 with a Batchelor of Science in Engineering (BSc Eng) degree and achieved her MBA in 2002.
Her new challenge is to undertake a PhD to develop a methodology for implementing the recent ICH Q8 (R2), Q9 and Q10 regulatory guidance providing an integrated science and risk based approach to Product Development, Quality Risk Management and Pharmaceutical Quality Systems used in the production of human drug products.
More info: http://www.linkedin.com/pub/nuala-calnan/7/606/a34