Regulatory Roadmap: Navigating Compliance in the Pharmaceutical Industry

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 systemMastering GMP documentation and data integrityHandling inspections, audits, and CAPAs with confidenceImplementing risk-based thinking and continuous improvementBridging the gaps between regulatory theory and production floor realitiesWhether 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.

• | Author: Mirela Gorjanu
• | Publisher: Independently Published
• | Publication Date: May 28, 2025
• | Number of Pages: 00080 pages
• | Binding: Paperback or Softback
• | ISBN-10: NA
• | ISBN-13: 9798285590583