REMEDIATE Deficient Quality & Compliance Documentation

FDA-regulated companies communicate with FDA Investigators through their documents. Poorly written, confusing or disconnected documents can result in an Investigator not understanding your quality system and a poor inspection outcome. Improving your company’s writing skills and documents will significantly improve your inspection outcomes with the FDA.

Writing for Compliance® is FDA-regulated industry’s first formal workshop training program devoted to creating documents that will meet the expectations of the FDA, and FDA Investigators, during plant and facility inspections.

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Over 67% of attendees who took Compliance Architects® Writing for Compliance® course felt that lack of writing skills is a big problem in compliance-implicated documentation.