Writing for Compliance^®

Companies regulated by the US FDA or similar global health regulators tell their stories of quality products and regulatory compliance through documents. Delivered for years as a training course, the new computer-based training Writing for Compliance course offers clear examples, and practical exercises, and introduces a structured writing methodology to help create better inspection-ready documents that will result in greatly improved FDA inspection outcomes.

Developed with extensive insights from former FDA investigators and feedback from seasoned professionals at top FDA-regulated firms, the program addresses an often-overlooked but costly issue: poor writing. Ineffective, poorly-conceived, un-focused writing in quality record documentation has cost companies millions of dollars in enforcement actions, yet it remains largely unaddressed—until now.

Survey data obtained over the ten years of delivering the training has revealed that 60-80+% of life science professionals who have some responsibility for writing compliance-implicated documents have only received one or fewer college writing courses, and only one or fewer business writing courses. No wonder quality records and other regulated documents perform so poorly during inspections!

With over a decade of successful delivery to FDA-regulated organizations, Writing for Compliance has trained more than 300 mid-to-senior-level managers. Among them, 95% confirmed the training’s relevance to their daily work, and 94% would recommend it to a colleague.