[Recommended On-Demand Streaming] Implementation of CSV for Generative AI Systems and AI Literacy Education | Explanation of AI Validation and Risk Management Concepts Based on FDA CSA
As the utilization of generative AI in business progresses, the pharmaceutical and medical device industries are focusing on practical issues such as "Is generative AI subject to CSV (Computer System Validation)?" and "How should AI validation be conducted?"
In this content, we present on-demand sessions that explain CSV compliance and AI risk management in generative AI systems, based on the concepts of FDA CSA (Computer Software Assurance) from previously well-received webinars.
■Content
- Determining the applicability of CSV to generative AI systems
- Methods for conducting AI validation
- Key focus areas during inspections
- Points for ensuring data integrity
- AI literacy education and Human in the Loop
- Considerations for internal controls in the utilization of generative AI
*This content is based on information as of April 22, 2026.
*The information provided is intended for general informational purposes and does not guarantee specific actions or compliance.

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