iSpeak Blog
When discussing manufacturing execution concepts and practices, it is useful to first take a top-down look at life sciences needs and the regulatory/guidance environment.
Paul J. Irving, BSc Hons
Northern Life Sciences Ltd.
Managing Director
Paul Irving has extensive experience as a Compliance and Validation Consultant with most major international pharmaceutical companies. He specializes in ERP, MES, risk management, 21 CFR Part 11 consultancy, IT infrastructure qualification, electronic archiving and quality management systems. Irving also has experience in all aspects of quality control including SPC and development of management information systems, gained whilst at Kimberley-Clark. As an active Member of ISPE and GAMP® Forum, a co-chair of GAMP Special Interest Group on manufacturing execution systems as well as a recognized Subject Matter Expert (SME). Over recent years, Irving has led a large program of compliance and validation for one of Poland's largest pharmaceutical companies. Currently Irving operates as a strategic consultant for Northern Life Sciences Ltd. within the UK, US and CEE, responsible for management consultancy and business development activities. Currently Irving is working in UK as part of global quality transformation team for one of the world’s leading pharmaceutical companies. Irving holds a BSC Honors Degree in applied statistics for business and industry from University Of Northumbria in England.
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