Digitization for data integrity and regulatory compliance
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About the webinar
Currently, many computerized systems in laboratories are standalone and run as hybrid systems. This is a disaster waiting to happen. How can we change this? We need to automate the laboratory to eliminate paper and ensure both data integrity and regulatory compliance, but most importantly, to deliver business value. This webinar will present a comprehensive 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 in the pharmaceutical industry and 28 years as a consultant to that industry. He has 35 years of experience in computer-based systems, primarily in the area of analytical systems and laboratory informatics. He received the LIMS Institute's LIMS Award in 1997 for advances and training in the field.
Bob co-authored the revision of USP -1058 on Analytical Instrument Qualification, which integrated instrument qualification and computerized system validation and was updated in 2017. Bob has also been involved in computerized system validation for 35 years and is the author of Validation of Chromatography Data Systems, 2nd Edition, published in 2017. His most recent book is Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories, published by the Royal Society of Chemistry in 2019. He is a member of the GAMP Data Integrity Special Interest Group and contributed to the 2017 Records and Data Integrity Guide 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 journals.
Currently, many computerized systems in laboratories are standalone and run as hybrid systems. This is a disaster waiting to happen. How can we change this? We need to automate the laboratory to eliminate paper and ensure both data integrity and regulatory compliance, but most importantly, to deliver business value. This webinar will present a comprehensive 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 in the pharmaceutical industry and 28 years as a consultant to that industry. He has 35 years of experience in computer-based systems, primarily in the area of analytical systems and laboratory informatics. He received the LIMS Institute's LIMS Award in 1997 for advances and training in the field.
Bob co-authored the revision of USP -1058 on Analytical Instrument Qualification, which integrated instrument qualification and computerized system validation and was updated in 2017. Bob has also been involved in computerized system validation for 35 years and is the author of Validation of Chromatography Data Systems, 2nd Edition, published in 2017. His most recent book is Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories, published by the Royal Society of Chemistry in 2019. He is a member of the GAMP Data Integrity Special Interest Group and contributed to the 2017 Records and Data Integrity Guide 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 journals.
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