Navigating changes in regulated software environments
Does regulated laboratory software use in a modern software ecosystem have to be complex?
Join us for our latest webinar to unlock insights into the intricacies of regulated laboratory software. We will discuss the changing regulatory landscapes, observations, and considerations when aligning software records with ALCOA+ principles as well as the essentials of requirements, qualification and validation for laboratory software. If you work in QC, or are working in a regulated laboratory, you do not want to miss this!
Learning Objectives:
Review the dynamics of regulatory changes impacting modern software ecosystems
Discover the significance of aligning software records with ALCOA+ principles for data integrity and compliance
Identify and gain insights into the requirements, qualification, and validation processes essential for effective laboratory software management
Presenter: Joe Ault (Sr. Product Marketing Manager, Thermo Fisher Scientific)
Joe Ault has a diverse professional background in pharma, having contributed significantly to validation campaigns for both small-scale, gene therapy startups and large pharma firms. Previously, Joe was a senior manager of computerized system validation at a cell and gene therapy startup, where his focus was on commercialization. He has also held roles as a computerized system validation engineer focused on laboratory and manufacturing systems. In addition to his roles at pharmaceutical firms, Joe has served as a validation consultant for industry leaders specializing in chromatography data systems. In this capacity, he played a crucial role in ensuring the validation and compliance of these systems, contributing to the reliability and accuracy of critical data for regulated customers. With a career spanning commercialization in startups and validation expertise of chromatography data systems, Joe is now focused on the creation and delivery of validation services in support of Thermo Fisher Scientific customers of enterprise software products.
