The following information is taken from the February 2021 AGXPE New England Chapter live webinar. The portion below discusses the vitality of effective writing for an FDA virtual inspection.
The question asked in the webinar was “what would you consider to be the 2-3 top skills that the Training and Learning community needs to upskill / reskill their staff to support an FDA virtual inspection or the adaptation of the audit model?” The following article is Compliance Architects CEO Jack Garvey’s response to this question.
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Harnessing the Power of Effective Writing for an FDA Virtual Inspection
Sure, so this is not a shameless plug…or maybe it is. But, I’ve been passionate about writing for years. About 10 years ago, I developed a program called Writing for Compliance®. Look, this has been this way for a long time. A lot of people have felt for years that if they were really good at managing inspections, that that’s the way they were going to kind-of get through an inspection. I don’t believe that was ever an effective approach. But, now it’s probably twice as important. Your documents have to tell your story.
You’re not going to be able to essentially charm your way through an FDA inspection. And your documents have to tell a story that is strategic in nature. They need to tell the story of control, about how you approach your obligations of meeting the regulations, what your implementation phase is…
I’ll say, this is not new, but I think this new dynamic makes things, frankly, even more important. You better have people that can write. And you need to invest to make sure people in your organization can write good documents. And not just documents that you do because you have to. Documents that will tell the story of control for your organization such that an FDA investigator, or a team of expert investigators, can understand your program from afar just using your documents. I think that’s critically important.
Writing For Compliance
Writing for Compliance® is the 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.
The new Writing for Compliance® program covers a wide range of topics that are fundamental to writing for regulated industry purposes, including but not limited to:
- the one thing you must do to succeed in any FDA or other regulatory inspection;
- key principles of writing for regulators as a primary audience;
- representing data, statistics, and scientific information;
- focus on quality records and inspection-focus documents; and
- the incorporation of legal advocacy principles to maximize document effectiveness.
Learn more about Writing For Compliance here.
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