ISPE – Sağlık Bilimleri Derneği

ISPE - Sağlık Bilimleri Derneği
10 Nisan 2009
PQLI Eğitim Semineri Konuşmacı Özgeçmişleri

John Nichols

John Nichols has more than 35 years’ experience in the chemical engineering field, and is an expert in the areas of high containment, and process design having facilitated and coordinated multi-national teams for biochemical, fine chemical and pharmaceutical projects. He recently retired from his role as Director of Pharmaceutical Technology at Foster Wheeler after more than 25 years. In this role, he was responsible for global technology coordination and consulting to facilities for specific clients and projects, as well as being a Director of Britest. Previously, Nichols was a Director of Carlisle Consulting and Engineering Director for Extract Technology Ltd. a manufacturer of a wide variety of containment equipment. He is also former Manager of Pharmaceutical Engineering for Foster Wheeler’s Reading Office, where he was responsible for the staff involved in the design of bulk pharmaceuticals, biochemicals and secondary finishing facilities. Prior to that, he had 10 years experience in design, commissioning, and plant management of various batch and continuous fine chemical facilities.

Nichols is a Chartered Chemical Engineer and a Fellow of the Institution of Chemical Engineers. He has a BSc in Chemical Engineering from Imperial College, London, and a Diploma in Management from Thames Polytechnic, London. He was formerly a member of ISPE’s International Board and member of various committees, and he is a member of the EFCE Working Party on Process Intensification.

Bruce Davis

Bruce Davis is a professional engineer and has many years of experience in the pharmaceutical industry. He has been involved in pharmaceutical engineering projects for API, secondary manufacturing and packaging for AstraZeneca. He led engineering teams in these areas, from early business thinking to concept development to project delivery and managed the global capital programme.

He has a wide international knowledge and has carried out business/engineering studies for new plants and new developments internationally.

He has led cross-functional Quality by Design (QbD)workshops.
For ISPE, he is the 2008 Chairman.

He a major contributor and leader of ISPE's Product Quality Lifecycle Implementation (PQLI) initiative, he also co-leads the Control Strategy team, which has brought new thinking into delivering Control Strategies to meet ICHQ8/Q9/Q10 requirements. He has also had involvement in many other ISPE matters, including chairing the Sterile Baseline® Guide task team.

He is secretary to ASTM E55.03 Committee on General Pharmaceutical Standards. As of the beginning of 2009, he is running his own consultancy in Engineering for QbD.

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