Overview
Today’s quality landscape is incredibly complex with multiple data analysis, informatics, and enterprise systems. To ensure quality results, regulators across industries are focusing on data integrity, data security and consistent laboratory practices. This increased regulatory focus is driving many laboratories to leverage digital technology to automate their laboratory operations. This digital transformation of the lab is doing more than just ensuring compliance with the latest regulatory guidelines. It is driving laboratory productivity and enabling faster decision making by streamlining workflows. This seminar will describe the data integrity guidance documents from the MHRA, FDA, EMA and WHO and the recent changes that were implemented in ISO/IEC 17025:2017. It will also explain how today’s informatics solutions can help lab managers ensure compliance, drive efficiency and productivity and transform the lab.
Learning Objectives:
- Learn how instrument technology is responding to the digital transformation of the laboratory through cloud connectivity and increased speed and performance
- Learn how informatics solutions can enforce laboratory best practices as defined by GxP and ISO 17025
- Learn how, through integration and automation technology, laboratories are enabling faster decision making and improving laboratory productivity
- Learn how digital technology has the potential to change how science is performed
Speakers:
Bob Poole
Director of Sales, Thermo Fisher Scientific
Bob has now been in the position of Director of Sales of the EMEA (Europe, Middle East and Africa) region for more than 7 years and has worked in the field of laboratory informatics for over 16 years. He has a wealth of experience in technical software and applying a consultative approach to best understand client requirements. Bob‘s background, working in Chemistry and laboratories afford him a unique insight into customer and business issues including data integrity and regulatory compliance. Bob has worked with Thermo Fisher Scientific LIMS clients across multiple industries including oil and gas, pharma and biopharma, food and beverage, chem and petrochem, contract testing and water and environmental.
Nick Arnold
Senior LIMS Consultant, Thermo Fisher Scientific
Nick Arnold is a Senior LIMS Consultant at Thermo Fisher Scientific and has been involved in laboratory automation for over 35 years. Nick has been responsible for implementing LIMS systems in a wide variety of industries; pharmaceutical, chemical & petrochemical, forensic, environmental and food & beverage – both as a customer and as a consultant working for Thermo Fisher Scientific.
For the past fifteen years, Nick has project managed numerous LIMS projects from initial scoping and requirements gathering to go-live and roll-out, often involving multiple sites internationally and employing global teams.
Nick is a qualified ISO9000 Lead Assessor and PRINCE2 Practitioner and has in the past spoken at conferences on aspects of LIMS implementation.
He holds BSc and PhD degrees in Chemistry from Nottingham University
Felicity Thomas (HOST)
Editor, EPM magazine
After graduating with a Master of Chemistry degree in 2005, Felicity joined the world of scientific B2B publishing working across various industry sectors including those of chromatography and ophthalmology. Having taken on the role of editor of EPM magazine — the authoritative voice of pharmaceutical manufacturing — in 2017, she has become immersed in the subject matter, disseminating thought-provoking content across multiple platforms in this vitally important and enthralling sector.
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