Paul Smith

Compliance2425
Consultant, lecturer, mentor, presenter, problem solver, trainer and writer. Paul Smith is a Director of Compliance2425, an independent laboratory compliance consultancy based in the UK. Over his career, he “migrated” from a specialist in R&D, interpreting FT-IR and FT-Raman spectra (MSc Thesis - Chemometric Modelling of Polymer Properties), through to Analytical, Quality, Laboratory Management and Leadership roles. He has worked as a research scientist, in technical roles providing education and customer support and compliance service implementation, writing compliance content (e.g. QMS documentation, protocols and validation plans) and creating educational and thought leadership marketing activity related to compliance trends and requirements. His passion is in monitoring and leveraging regulatory trends and non-compliance findings. Consulting was a natural evolution of his people, technical and compliance work. He completed his first software validation in 1994. Paul is currently the Deputy Chair of the ISPE GAMP UK Community of Practice (CoP) Steering committee, contributes to evolution of GAMP Good Practice guides and has written, contributed and co-authored and reviewed many articles related to laboratory compliance, including FDA non-compliance findings and Instrument Qualification. He regularly presents on these subjects at conferences and events. He was an early adopter of Data Integrity (trained by Monica Cahilly and Peter Baker). He is currently a member of the Nominating Committee for the USP Council of Experts. Paul holds a BSc in Chemistry and an MSc in Analytical Chemistry (more information can be found in Paul’s Linked In profile https://www.linkedin.com/in/paulandrewsmith/