Developed by Jack Garvey, a highly regarded attorney, and engineer with more than 38 years of experience in the FDA-regulated industry, Writing for Compliance provides practical strategies and insights to help your team improve their writing skills to significantly improve regulatory compliance outcomes. The program is designed to enhance the quality of written documentation and help your company navigate FDA inspections successfully.
Previously offered as an in-person, two-day training, Writing for Compliance is now available online through our advanced Learning Management System (LMS). Whether you’re a single employee, a department, or an entire company, we can help you improve your writing and boost your inspection outcomes.
The training includes practical exercises that allow participants to analyze common regulated document problems, identify key messaging elements, and spot issues that can and will lead to FDA Investigator inquiries. Through an in-depth study of the Writing for Compliance structured document writing process and rubric (available for free download!), attendees gain essential skills to recognize deficiencies in documents and rewrite them for better inspection outcomes.
Despite being one of the most regulated industries, and the need to communicate to aggressive regulators only through written documents, many FDA-regulated companies fail to invest in basic writing training. Technical personnel often struggle to communicate complex concepts clearly, and many documents are not prepared with the anticipation that FDA Investigators will scrutinize them for compliance during inspections.
Writing for Compliance was created to address this critical skill gap. It is the first industry-specific training program focused on improving writing skills that directly impact FDA inspection outcomes. This program will not only raise awareness about the importance of documentation in regulatory compliance but will also provide concrete methods that your operational and quality staff can apply to improve their writing and support better inspection results.
Given the vast amount of documentation created daily within FDA-regulated companies, even modest improvements in writing skills can lead to significant benefits during inspections. Investing in Writing for Compliance training for your staff can result in long-term savings by improving document acceptance rates by FDA Investigators, reducing the risk of enforcement actions, shortening inspection times, and minimizing remediation costs.
By applying the principles and techniques taught in Writing for Compliance, companies will be better equipped to create accurate, effective compliance documentation and improve their regulatory inspection outcomes.
Writing for Compliance is now available online via our cutting-edge Learning Management System (LMS), providing flexible access to the training whenever and wherever you need it.
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