This course is intended for participants who need to know more about the types of systems used to manage a vast amount of information produced during product development. The curriculum provides a unique view of life science for professionals who need to understand the documents, data, and records required across the product development process. Information systems can be a broad area to explore so this course will focus on the process and regulations involved in using systems and producing the required outputs. Participants will understand the difference between an “informatics view” vs. a “technology view”.
Additionally, attendees will learn how to evaluate information challenges that include assessment of technology (EDM systems), regulations and their impact (FDA, ICH, other authorities), and business processes (how things need to work to leverage new technology) as well as the intersections of these areas.
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