­­­­The primary avenue for which FDA judges a company’s conformance to cGMPs and ultimately the approval of regulatory submissions is through their review of documentation.  The success or failure of an FDA-regulated company often comes down to the quality of these documents.  While most professionals have spent years learning and mastering their technical expertise, mastering quality writing is rarely a part of this development.

 Writing for Compliance® is a breakthrough workshop training that is FDA-regulated industry’s first and only formal training program devoted to improving FDA and regulatory inspection outcomes through improving writing skills within regulated companies. Writing for Compliance® is a fast-paced, interactive workshop that is filled with practical information, insight, tips and defined approaches to help your company’s personnel improve their writing skills.   This accredited program is structured as a twelve hour interactive workshop that includes five workshop exercises, each based on actual quality records and inspection-target documents commonly used within FDA-regulated companies.  Classroom materials provide background on the problem of writing, recognizing non-compliance documents, and the Writing for Compliance® structure document writing process. 

Using the Writing for Compliance® Structured Document Process attendees become acutely aware of what to look for in deficient documents and how to re-write these documents to minimize questions from FDA Investigators.