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 Irving
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. An active Member of ISPE Pharma 4.0 CoP Steerco and Liaison Member of the GAMP® Global Steerco (in particular Validation 4.0 draft guidance development Stakeholder), also a former co-chair of GAMP® Special Interest Group on Manufacturing Execution Systems as well as a recognized Subject Matter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 large programs of compliance and validation for many Global Life Sciences companies including Central and Eastern Europe. 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. Irving holds a BSC Honors Degree in Applied Statistics for Business and Industry from University Of Northumbria in England, UK. Paul was part of the ISPE GAMP® 5 Second Edition Guidance Leadership Team and Chapter Lead for Electronic Production Records.
Related Articles
Features
Cloud computing can be described as networked access and utilization of configurable computing resources such as data and information storage, processing capabilities, applications, and other services on computerized systems provided and/or maintained by a remote organization. As life sciences companies consider the advantages and costs of utilizing cloud services, they first need to invest...