AI GMP-ல் தவறு செய்தால்… உங்கள் முழு Validation-ம் தவறாகிவிடுமா? | Episode 3 | Tamil
Royal Quality Pillars
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AI GMP-ல் தவறு செய்தால்… உங்கள் முழு Validation-ம் தவறாகிவிடுமா? | Episode 3 | Tamil
43 просмотра · 11 дней назад
Royal Quality Pillars
156 подписчиков
43 просмотра · 11 дней назад
🚀 Episode 3 – AI in GMP Compliance & Validation | Tamil Version
🤖 AI GMP-ல் தவறு செய்தால்… உங்கள் முழு Validation-ம் தவறாகிவிடுமா?
Pharmaceutical industries are increasingly exploring Artificial Intelligence (AI) for quality control, deviation investigations, data analysis, document review, and other GMP-related activities. But how do we ensure that AI-supported systems remain reliable, controlled, and compliant?
In this episode, we explore practical concepts for applying AI in pharmaceutical GMP environments.
📚 இந்த Episode-ல் நீங்கள் கற்றுக்கொள்வது:
✅ Traditional Computerized System Validation (CSV) vs AI Validation
✅ AI Systems-ன் Intended Use மற்றும் GxP Risk Assessment
✅ Static Models vs Dynamic Learning Models
✅ AI Explainability மற்றும் Black-Box Challenges
✅ Data Integrity மற்றும் Independent Test Data
✅ Confusion Matrix – True Positive, False Positive, True Negative, False Negative
✅ AI Confidence Thresholds மற்றும் Human Review
✅ Human-in-the-Loop (HITL) மற்றும் GMP Accountability
✅ AI Model Changes, Change Control மற்றும் Lifecycle Management
✅ AI Governance-ன் Six Pillars:
Intended Use
Risk-Based Control
Data Integrity
Human Oversight
Explainability
Lifecycle Control
🎯 Who should watch?
Pharmaceutical QA and QC Professionals
CSV / CSA Professionals
Validation Engineers and Consultants
IT and Automation Professionals
GMP Compliance and Data Integrity Teams
💡 Our objective: Understand how to assess AI risks and establish appropriate validation, oversight, monitoring, and change-control practices based on the system’s intended use and GxP impact.
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🎓 Royal Quality Pillars
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Educational content only. Validation and control requirements should be determined based on intended use, GxP impact, applicable regulations, and documented risk assessment.
#AIinGMP #AIValidation #CSV #CSA #GMPCompliance #DataIntegrity #PharmaValidation #TamilTraining #RoyalQualityPillars