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In the ever-evolving world of pharmaceutical manufacturing, staying compliant isn't optional; it's mission-critical.
Regulatory Roadmap: Navigating Compliance in the Pharmaceutical Industry is a must-have guide for professionals navigating the complex terrain of Good Manufacturing Practices (GMP), FDA/EMA regulations, and quality assurance in the pharmaceutical industry. Drawing from years of hands-on experience, the author breaks down global regulatory expectations and translates them into actionable strategies that ensure inspection readiness and sustainable compliance.
This book delivers clear guidance on:

• Building a compliant pharmaceutical quality system
• Mastering GMP documentation and data integrity
• Handling inspections, audits, and CAPAs with confidence
• Implementing risk-based thinking and continuous improvement
• Bridging the gaps between regulatory theory and production floor realities

Whether you're a QA/QC expert, regulatory affairs professional, GMP auditor, or manufacturing leader, this book equips you with the tools to streamline compliance, avoid costly missteps, and foster a culture of excellence.

Parametre knihy

• Celý názov: Regulatory Roadmap
• Podnázov: Navigating Compliance in the Pharmaceutical Industry
• Autor: Mirela Gorjanu
• Jazyk: Angličtina
• Väzba: Brožovaná
• Počet strán: 80
• EAN: 9798285590583
• ID: 50674762
• Nakladateľ: Independently published
• Hmotnosť: 121 g
• Rozmery: 229 × 152 × 4 mm
• Dátum vydania: 28. May 2025

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