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Limited Availability until April 25, 2024
For decades, the FDA and International regulatory agencies have been very concerned about the increased use of computer systems for reporting, clinical trial analysis, and communication.
Early validation guidance is focused on processing and reporting. However, today the industry is dependent on the use of computer systems. Developments in areas such as Artificial Intelligence, computer-controlled processing, manufacturing, devices, and inventory systems require sophisticated computers, trained users, skilled IT professionals, and involved management.
This training will include the most recent 2022 FDA draft guidance Computer Software Assurance for Production and Quality System Software. This program provides both national and international requirements and the techniques needed to meet today’s challenging environment. Topics include FDA, GAMP, ISO, MDD, Risk analysis, and more.
This intensive, accredited course is designed to provide an overview of the various aspects of computer validation including best practices, US and International regulations, and Industry expectations. It addresses the rules, tools, and techniques to develop and provide the basis for compliance and implementation for a single system or a company‐wide program and process.
Upon completion of this course, you will be able to:
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This course is intended for professionals in the pharmaceutical and other life science industries working in all facets of computer systems. The course addresses the responsibilities, roles, tasks, and acceptable techniques associated with the following personnel:
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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