Pharma Sprint 30 - USFDA Skill Burst (eBook, ePUB) - Renganathan, Ragupathy
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  • Format: ePub

Pharma Sprint 30 - USFDA Skill Burst is a concise, high-impact guide for pharmaceutical professionals aiming to master USFDA regulations and compliance practices. Covering 30 essential skills, it provides practical strategies, real-world examples, and inspection-ready tips across areas such as GMP, electronic records, labelling, IND/NDA submissions, post-marketing surveillance, audits, warning letters, recalls, and CAPA integration. Designed for QA, RA, PV, and regulatory staff, the book equips readers with actionable knowledge to enhance compliance, ensure patient safety, and advance their…mehr

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Produktbeschreibung
Pharma Sprint 30 - USFDA Skill Burst is a concise, high-impact guide for pharmaceutical professionals aiming to master USFDA regulations and compliance practices. Covering 30 essential skills, it provides practical strategies, real-world examples, and inspection-ready tips across areas such as GMP, electronic records, labelling, IND/NDA submissions, post-marketing surveillance, audits, warning letters, recalls, and CAPA integration. Designed for QA, RA, PV, and regulatory staff, the book equips readers with actionable knowledge to enhance compliance, ensure patient safety, and advance their careers. Each skill is presented in a clear, step-by-step format, making complex regulations accessible and implementable. Suitable for both beginners and experienced professionals, this guide helps build confidence, operational excellence, and regulatory readiness in the U.S. pharmaceutical market.

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