Episode 2 | GAMP 5 | CSV & CSA Practical Training | Risk-Based Validation | Tamil
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Episode 2 | GAMP 5 | CSV & CSA Practical Training | Risk-Based Validation | Tamil
58 просмотров · 2 недели назад
Royal Quality Pillars
155 подписчиков
58 просмотров · 2 недели назад
🎓 Royal Quality Pillars – 15 Days Practical CSV & CSA Training Series
Episode 2 – GAMP 5
இந்த Episode-ல் Pharmaceutical Industry-ல் பயன்படுத்தப்படும் Computerized Systems-க்கு GAMP 5 Risk-Based Approach எப்படி பயன்படுத்தப்படுகிறது என்பதை practical முறையில் பார்க்கிறோம்.
🔍 இந்த Episode-ல்:
✅ GAMP 5 என்றால் என்ன?
✅ GAMP 5 Lifecycle Approach
✅ Intended Use
✅ GxP Impact Assessment
✅ Risk-Based Approach
✅ Software Categorization
✅ Supplier Assessment
✅ Requirements & Specifications
✅ Risk Assessment / FMEA
✅ Verification & Testing
✅ Objective Evidence
✅ Data Integrity
✅ Lifecycle Management
💡 முக்கியமான கருத்து
GAMP Category மட்டும் Validation Effort-ஐ தீர்மானிக்காது.
Practical approach:
Intended Use → GxP Impact → Risk → Complexity → Novelty → Critical Functions → Appropriate Assurance
💻 Practical Pharmaceutical Systems
📄 DMS
🧪 LIMS
📊 QMS
💼 SAP / ERP
🏭 MES
⚙️ PLC / HMI / SCADA
🔄 GAMP 5 Practical Flow
Intended Use → Requirements → Risk Assessment → Specification → Verification → Objective Evidence → Release → Operation → Periodic Review → Retirement
📱 CSV / CSA Training & RoyalSnap-A Demo
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✅ New Episode Updates
✅ CSV / CSA Training Updates
✅ Practical Validation Discussions
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✅ Webinar & Workshop Information
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🚀 Episode 2 – GAMP 5 | Tamil is LIVE!
உங்கள் கருத்து என்ன?
GAMP Category முக்கியமா?
அல்லது Intended Use + GxP Risk முக்கியமா?
💬 உங்கள் practical experience-ஐ comment செய்யுங்கள்.
📱 WhatsApp: 9618948094
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🏷️ Tags
GAMP 5 Tamil, GAMP5 Tamil, GAMP 5 Training Tamil, CSV Tamil, CSA Tamil, CSV Training, CSA Training, Computerized System Validation, Computer Software Assurance, Pharma Validation, Pharmaceutical Software Validation, GxP, Risk Based Validation, Risk Assessment, FMEA, Data Integrity, ALCOA Plus, 21 CFR Part 11, EU Annex 11, Digital Validation, Royal Quality Pillars, RoyalSnapA
#️⃣ Hashtags
#GAMP5 #CSV #CSA #Tamil #PharmaValidation #ComputerizedSystemValidation #GxP #RiskBasedValidation #DataIntegrity #FMEA #DigitalValidation #RoyalQualityPillars #RoyalSnapA