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Limited Availability until June 7, 2024
The ever‐increasing use of computers within the life science industries draws the attention of the FDA and international regulatory agencies. In recent years we have moved from simple record-keeping systems to computer‐controlled processing, manufacturing, devices, and inventory systems. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers, trained users, skilled IT professionals, and involved management.
This accredited course is designed to provide an introduction and overview of key topics, regulations, tools, guidance, and foundational principles that guide computer system validation.
Topics include:
FDA, GAMP, MHRA, ISO, and MDD.
Upon completion of this course, you will be able to:
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This course is intended for professionals in the life science industries working in all facets of computer system validation. The course addresses the regulatory requirements and industry guidance that should drive the CSV efforts in the life science industries for the following personnel:
• System Users
• Project Managers
• IT Professionals
• Regulatory Staff
• Auditors
• System Vendors
• Validation Test Managers and Engineers
• Validation Managers and Engineers
• System Developers, Designers, and Integrators
• Quality Assurance and Control Staff
An overview and introduction for professionals who manage staff in any of these areas would also benefit from this course by gaining a better understanding of the current regulations and most recent issues.
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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