Скачать или смотреть Deviation Management in Pharma | Root Cause Analysis & CAPA Explained ✅

🔬 Welcome to Biopharma Guru!
In this video, we explore one of the most essential GMP concepts in the pharmaceutical and biopharma industry — Deviation Management.

Learn how deviations are identified, classified, investigated, and corrected using Root Cause Analysis (RCA) and CAPA (Corrective and Preventive Action) principles.

🎯 What You’ll Learn:
• What is a Deviation in Pharma? (Definition & Classification)
• Types of Deviations: Planned vs Unplanned
• Criticality Levels: Critical, Major, Minor
• How to perform Root Cause Analysis using Fishbone Diagram and 5 Whys
• Step-by-step Deviation Investigation Workflow
• How to implement CAPA effectively and prevent reoccurrence
• Real-world case studies: Out-of-calibration equipment, OOS results, facility changes

🧪 Why It Matters:
Deviation management is the backbone of a Quality Management System (QMS).
Proper documentation ensures data integrity, compliance with USFDA, EMA, WHO, and CDSCO, and continuous improvement in manufacturing quality.

⚙️ Who Should Watch:
• QA/QC professionals, production chemists, validation engineers
• Regulatory and compliance personnel preparing for GMP audits
• Students of life sciences and biotechnology learning about QMS processes

🏭 Topics Covered:
• Deviation Reporting & Classification
• Root Cause Analysis (Fishbone, 5 Whys)
• Corrective and Preventive Action (CAPA)
• Documentation & Review Process
• Common Pitfalls in Audit Observations

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📩 For help, support, or collaboration:
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💬 Comment below: Have you ever faced a deviation investigation or CAPA audit? What was your biggest learning?

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