What Are the Top 2-3 Skills That the Training & Learning Community Needs to Up-skill / Re-skill Their Staff to Support a Virtual Inspection or the Adaptation of the Audit Model?

Jack Garvey |

Question: Thanks, Jack. That was informative. 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 a virtual inspection or the adaptation of the audit model?

JG: 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.

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