DEVIATION WRITING 101: A Practical Guide to Crafting Clear, Compliant cGMP Investigations that Meet FDA and Global Regulatory Expectations
En stock
0.44 kg
Sí
Nuevo
Amazon
USA
- Deviation Writing 101 provides a clear and authoritative roadmap for deviation management as it utilizes a holistic approach that empowers quality professionals with a profound understanding of the foundational principles that underpin every successful investigation. The book meticulously defines the types of deviations and provides a structured lifecycle—from immediate actions to final approval; ensuring that deviation writers are not just completing a task but builds a robust and compliant quality system through a defined methodology. This book serves as a comprehensive guide with a detailed framework to understanding, investigating, and resolving these deviations by proactively identifying their root causes, and implementing robust corrective actions. Drawing on industry best practices, established methodologies, and real-world examples, this book will equip quality professionals, investigators, and managers with a resource guide to conduct thorough, compliant, and defensible deviation investigations.
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