John Lee, Video 9 of 9
This 9th video (out of 9 in total) focuses on Preparing for an effective FDA Inspection.
The video is recorded in 2018 in Copenhagen in Confederation of Danish Industry (Dansk Industri), where we invited John into a build-up studio and talked about FDA Enforcement trends and also differences between domestic FDA Inspections as compared to FDA Inspections abroad. The video is thus a re-premiere.
In the US, the inspection strategy for a pharmaceutical company is to give the FDA what they ask for with a prompt response. In the US, the FDA has no time limit. So, no time is used on e.g. executive management presentations. For comparison, in Europe and Japan, lengthy presentations are provided by executive management in what is called an opening meeting when starting the FDA inspection. The FDA has limited time on these inspection trips abroad; they cannot stay as long as they want. Companies need to respect that. This means that the FDA investigator might cut off the management presentation to ensure time for the inspection.
Also, be aware of that these presentations eventually could be an unintended way of providing the FDA with a checklist! Overall, these presentations could ultimately be harmful to a company, even though this was not at all the intention in the first place. So, carefully consider the structure and content of these presentations.
In terms of preparing for the FDA investigator’s review of recent qualification and validation protocols and report remember to organize your this beforehand for presentation!
At the end of the interview, you will find a slide deck for inspiration, which in general could be used for pro-actively preparing for an effective FDA inspection. This is the model and methodology, that Genau & More applies when supporting pharmaceutical companies in FDA inspections.
