The December 2013 edition of The Silver Sheet® includes an interview with Compliance Architects® Founder and Chief Executive Officer, Jack Garvey, about why writing is so important to improving compliance outcomes with the US Food and Drug Administration. Jack is the developer of Writing for Compliance®, the only dedicated course on improving the writing skills of individuals working within FDA-regulated companies.
In the article, Jack talks about the importance of “controlling the dialogue” during an FDA inspection by providing documents that are thorough and help to minimize Investigator questions, and how compliance documents can be improved by “telling your story” and ensuring that you are always focusing on the regulators’ intent and expectations. The article is reprinted here with the permission of The Silver Sheet®. Please click here for additional information on The Silver Sheet®. Please click here to learn more about Writing for Compliance® and how to improve your FDA-regulated company’s enforcement outcomes.