This webinar will discuss the lifecycle of computerized laboratory equipment, with some discussion of the similarities and differences to computer system validation, and the use of quality risk management to right-size the effort, based on complexity and risks to data integrity. The GAMP holistic approach to verification of computerized lab systems will be examined, along with the use of USP <1058> and this GPG to create a seamless quality standard that addresses all laboratory equipment, from mechanical to highly automated laboratory systems. In addition, the importance of supplier assessments: their purpose and benefits will be emphasized along with examples to illustrate supplier risks.
Mark is an independent consultant in laboratory informatics and data, data integrity, validation of computer systems/spreadsheets, analytical instruments and LIMS/ELN. He has 30+ years of pharmaceutical experience in QC Labs, computer systems validation and lab informatics. Mark co-lead Eli Lilly’s data integrity remediation program for QC Labs worldwide in 2012, consulted and audited several Lilly sites preparing for data-integrity focused inspections. He is a co-leader for the GAMP Data Integrity Special Interest Group and Chair of ISPE Global Documents Committee.
Paul has a passion for laboratory compliance. He started his career as an Infrared Spectroscopist, recording and interpreting infrared and Raman spectra and chemometric modeling of FT-IR, Raman and NIR data. He did his first software validation work in 1992, before moving into broader analytical chemistry and laboratory management roles. Overall, he spent 17 years in the pharmaceutical industry and has worked in laboratory consultancy roles for the last 17 years.
He has worked in Pharmaceutical R&D, New Product Introduction and Quality Assurance and has focused on compliance of laboratory instruments and harmonization of this compliance, writing articles, while papers and contributing to GAMP Good Practice Guides.
In his current Agilent role, he monitors laboratory compliance change and non-compliance trends, sharing this information with customers and colleagues.