Developed by an attorney with over 30 years of experience in FDA-regulated industry, and newly updated for 2016, Writing for Compliance® is a fast-paced, interactive workshop that is filled with practical information, insight, tips and approaches to defined approaches to help your company’s personnel improve their writing skills. The program is structured as a full-day, onsite, interactive workshop that includes six workshop exercises, each based on actual quality records and inspection-target documents commonly used within FDA-regulated companies. Each workshop exercise requires participants to analyze typical quality record structure and content, and improve the core messaging elements that the required documentation must contain to be effective. Using the Writing for Compliance® Structured Document Process and Rubric, 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.
The dynamic, interactive classroom training, combined with the participation-based workshop exercises, provide an exceptionally strong awareness of the importance of writing to regulated inspection success, and how incorporating even simple principles can yield significant improvements in compliance outcomes.
For more detailed information on the program, download our overview presentation: Introduction to Writing for Compliance®
Why Focus On Writing to Improve FDA Inspection Outcomes?
Despite being one of the most regulated industry sectors in the world, attention to and training on even basic writing practices within most FDA-regulated organizations is almost non-existent. With extensive requirements for bulletproof communication of complex technical and scientific concepts, and documentation required for almost every operational activity, highly-technical personnel struggle to write to the appropriate audiences, and to choose the proper writing styles and techniques to effectively support great compliance outcomes. Even more striking is that many documents are never written with the anticipation and knowledge that an FDA Investigator will likely read them in the future and evaluate them for deficiency during an FDA inspection!
In response to this broad industry knowledge gap, Writing for Compliance® was developed by Compliance Architects® founder Jack Garvey to be FDA-regulated industry’s first workshop training program intended specifically for Senior Professionals and Operating Staff within companies regulated by the US FDA. Until now, there has been no industry training program that comprehensively explores the extraordinary impact (positive or negative) that writing skills can have on compliance outcomes. Writing for Compliance® will not only raise awareness of the importance of writing to regulatory compliance outcomes, but will also provide defined, tangible approaches and concepts that industry personnel can apply consistently in their day-to-day work activities.
Maximum Return on Investment / Minimal Cost Expenditure
Given all the documentation developed day-to-day within FDA-regulated companies, even a small improvement in writing skills can result in immense positive improvements at inspection time. This relatively small investment in personnel training to focus on writing better documents can yield continual, significant returns down the road through reduced enforcement remediation costs and even shorter inspections.
Using the principles and approaches outlined during the Writing for Compliance® workshop, FDA-regulated companies will possess the tools to improve regulatory inspection outcomes and increase operational staff effectiveness in developing required compliance documentation.
Writing for Compliance® is delivered as a full-day, in-house training program within your organization. For maximum benefit, in-house training programs can incorporate your documents as examples within the course material, increasing the relevance of the course outcomes for your personnel.
For more detailed information on the program, download our overview presentation: Introduction to Writing for Compliance®
Please click here for further information about in-house training delivery options.
