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Computer System Validation in the Cloud: Cloud Is Here Today and Here to Stay
Session Chair(s)
Frances Nolan, MBA
Independent Consultant
Independent Consulting, United States
Organizations developing and using computerized systems are benefiting from novel approaches to the development, validation, and deployment of such systems in a regulated environment. This session will provide real examples of how practices such as Agile software development, Software/Platform/Infrastructure as a Service, and cloud deployment are being used today to great effect. The session will also address what these practices mean to suppliers, sponsors and CROs, and regulators.
Learning Objective : Discuss how suppliers can leverage novel practices in their own development and deployment of systems, including making their computer system validation deliverables more accessible by their customers; Identify how sponsors and CROs can optimize their user acceptance testing (UAT) by leveraging supplier practices; Describe how regulators can consider changes in their inspection approach in order to assess the adoption of these novel practices.
Speaker(s)
Computerized System Validation in the Cloud
Frances Nolan, MBA
Independent Consulting, United States
Independent Consultant
CSV in the 21st Century: A Customer Perspective
Mark Connolly, MSc
ICON, Ireland
Vice President, Firecrest
CSV in the Cloud: Regulatory Perspective
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
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