Digitalization for Data Integrity & Regulatory Compliance

12 Просмотры
Издатель
About the Webinar
Currently, many computerised systems in laboratories are standalone and operate as hybrid systems.This is a disaster waiting to happen. How should we change this? We need to automate the laboratory with the aim of removing paper, ensuring both data integrity and regulatory compliance but above all business benefit. This webinar will present an overall laboratory automation strategy and how it should be implemented with Practical examples and advice from case studies.
About Bob McDowall Ph.D.
Bob McDowall is an analytical chemist with nearly 50 years of experience, including 15 years working in the pharmaceutical industry, followed by 28 years working for the industry as a consultant. He has 35 years’ experience in computerised systems mainly within involving analytical systems and laboratory informatics. He is the 1997 LIMS Awardee from the LIMS Institute presented for advances and training in the subject.
Bob was a co-author of the revision of USP -1058 on Analytical Instrument Qualification that integrated instrument qualification and computerised system validation that was updated in 2017. Bob has also been involved with the validation of computerised systems for 35 years and is the author of Validation of Chromatography Data Systems, 2nd Edition published in 2017. His latest book is Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories was published in 2019 by the Royal Society of Chemistry. He is a member of the GAMP Data Integrity Special Interest Group, contributing to the Records and Data Integrity Guide in 2017 and two Good Practice Guides on Data Integrity Key Concepts and Data Integrity by Design. Bob is also the author of the “Questions of Quality” and “Focus on Quality” columns in LCGC Europe and Spectroscopy magazines, respectively.
Категория
Демотиваторы
Комментариев нет.