2025

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AI GxP Practice: What’s Working, What’s Not, and What We Should Do Differently

From Pilot to Production: Operationalizing AI Assurance in GxP

AI | Validation

Speaker Hari Subramanian, Director, IT Compliance & Testing Services; Taha Jilani, Associate Director, IT Compliance; Otsuka Pharmaceuticals

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Audit Trail Management and Data Integrity Controls Practical interpretation of industry expectations using real-world examples

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Adaptive Stage 3 Process Validation Turning data into action using continued process verification

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End-to-End CSA Lifecycle Management From initial risk assessment to continuous assurance and monitoring

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