—-Be prepared, the FDA cometh!

Preparing for the FDA is key and underpinning for success in navigating the inspection process.

Most important is to pick the right core team to help prepare the site for the process. After the fact, this team can also be helpful in maintaining processes so that things are always in a good state of readiness. This can prove to be a welcome bonus!

Important is to make sure that the team and its members are clear in terms of their responsibilities.

In preparing a good strategy,it is to important to spend a budgeted amount of time preparing for sample questions, so the team “knows” how to respond.

In preparing for an FDA audit it is always important to assure that the questions are clearly understood. This might sound motherhood as a point, but it’s so common that people don’t understand properly what they’re being asked and as a result they end up causing issues that could have been avoided.

Confidence is also another feature that the team needs to work on to be properly prepared. A confident presenter or SME contributor is far more valuable when questions are being asked than someone that is nervous and stumbling over themselves when answering. The downside of this behavior is that it may be interpreted that you may be hiding something. This will break trust, so that needs to be avoided.

Confidence comes from knowledge, and since you know more about the process than they do, you should be able to develop a measured response when asked questions.

In being asked questions, its always okay to ask for clarification to a question if you don’t understand or if a question is not clear.

In terms of your responses, it’s always a good tactic to be polite and professional with the inspectors and to generate a good rapport to build trust.

If things are not clear, then say” that’s a good question” and request clarification. Always be specific and precise with your answers. Try to be concise, keep answers short and only answer the specific question. Often elaborating on things that were not specifically asked for will get you into trouble and cause additional lines of questioning which may be totally unrelated to the question that was originally asked. So, be measured in your approaches to how you answer lines of inquiry by the inspectors. Along the same lines, never anticipate what you think the inspectors are saying. Let them ask questions and then answer them as concisely as possible. Again, always understand the questions and if necessary, clarify what they want. The key here is to ask again and again if you don’t understand. There are no prizes for guessing what you think that they meant.

As already indicated, a common mistake is trying to give too much information when answering questions. Understand that if they don’t get everything they’re looking for in your answer, they will ask a supplemental question. So, let them! Try to be authentic in your responses but always guarded.

Above all else, don’t be tricked into a friendly approach by the inspection team. They are there to do a job and to find out whether you are in compliance, so be measured in relation to how you respond.
Understand this, your systems should be under control and their line of questioning will be to probe for weaknesses.

They will look at entry points into your documentation to see if there are any potential issues. For example: will be looking for deviations in the process so they will look at your logbooks early in the inspection process. They will look for laboratory errors/deviation etc. and so these laboratory logs will also be examined. Change control records will be another key set of documents that will be reviewed to see what issues are going on.

From these and other records, the investigator will drill down to discover further issues or problems. Records looked at could be; investigations, CAPAs, training records to assure full competency, preventive maintenance/calibration logs, and analytical test records and batch records.

These are all simple points in the preparation process but done well can make a world of difference to helping to manage a successful site inspection.

Read Part 1 Here
Read Part 2 Here
Read Part 3 Here