Testimonials

“Deviation Writing 101 is a comprehensive training manual that distills over a decade of industry experience into a concise, must-have resource for regulated professionals, focusing on data integrity and ALCOA principles to build defensible audit trails.”
Curt Claussen

Sr. Director of Parenteral Operations

“This highly innovative book integrates AI as a powerful writing tool with human accountability for quality and compliance, trailblazing a shift toward a proactive state of continuous audit readiness via mock audits and a strong Quality Management System (QMS).”
Parangiri Nivas Rajaram

Sr. Manager - Sterile Filling

“Josephs possesses a rare gift for simplifying complex topics without sacrificing a single ounce of detail or accuracy. His writing style is direct and authoritative, making it easy to absorb critical information. He’s the kind of author who instills confidence in his readers, empowering them to tackle even the most critical deviations with a structured, professional approach.”
Quality Professional

“Josephs has created a foundational text for our industry. His insights on everything from root cause analysis to final report approval are both comprehensive and deeply considered. He’s an expert who empowers you to become one, and I have no doubt this book will be a permanent fixture in the field for years to come.”
Quality Professional

DEVIATION WRITING 101

A Practical Guide to Crafting Clear, Compliant cGMP Investigations that Meet FDA and Global Regulatory Expectations

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