Pharma Sprint 30 - OOS Skill Burst (eBook, ePUB) - Renganathan, Ragupathy
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Pharma Sprint 30 OOS Skill Burst is a comprehensive guide designed for pharmaceutical professionals to master Out of Specification (OOS) investigations, root cause analysis, CAPA implementation, and regulatory compliance. Covering 30 critical skills, this book provides actionable insights, practical examples, and step-by-step procedures to handle OOS deviations effectively. It equips QA, QC, production, and regulatory teams to maintain product quality, ensure patient safety, and achieve inspection readiness. Each skill is explained in detail, offering guidance on documentation, statistical…mehr

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Produktbeschreibung
Pharma Sprint 30 OOS Skill Burst is a comprehensive guide designed for pharmaceutical professionals to master Out of Specification (OOS) investigations, root cause analysis, CAPA implementation, and regulatory compliance. Covering 30 critical skills, this book provides actionable insights, practical examples, and step-by-step procedures to handle OOS deviations effectively. It equips QA, QC, production, and regulatory teams to maintain product quality, ensure patient safety, and achieve inspection readiness. Each skill is explained in detail, offering guidance on documentation, statistical analysis, trend monitoring, risk assessment, and cross-functional coordination. Suitable for beginners and experienced professionals, this book enhances career growth, strengthens organizational compliance, and prepares teams for regulatory scrutiny.

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