This is Part 4 of our series on virtual agency inspections. In this part, former FDA investigator Ricki Chase provides her advice on how to host a virtual inspection. In Part 3, she provided insight into the best way to prepare for virtual inspections, including how to always be ready, how to review documents, and which documents FDA is likely to request for review.
In Part 1, former FDA executive Howard Sklamberg reviewed the current inspection landscape and what may trigger an inspection these days. In Part 2 we reviewed a state-of-the-art virtual inspection platform using mixed reality technology developed by Thermo Fisher Scientific that was presented at the ISPE Biopharmaceutical Manufacturing Conference held virtually in early June.
Sklamberg and Chase were both speakers at a mid-June webinar sponsored by the law firm Arnold & Porter, titled “FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for and Responding to FDA Virtual Inspections.”
Establishing and Practicing Behaviors
Chase began her remarks on hosting a virtual inspection by pointing out that we all know there are certain behaviors we should exercise when we have a live, in-person inspection. Those apply to virtual inspections as well.
“A great quality system ensures constant readiness,” she maintained. “This includes practicing your inspection management. You should follow your normal processes, the ones that you are familiar with. You need to practice and follow them. Where you need to adjust for the mode of communication, make your adjustments. But do not throw everything to the wind and start from scratch just because it is a virtual inspection. Stick with what you have practiced and what you know.”
Virtual Inspection Best Practices
Designate a single point of contact (POC) for the receipt of the questions and the document requests. If you are not doing a live inspection—for example, by video conferencing, WebEx, Zoom, or something like that—they are probably going to be sending questions and document requests to you via email. Make sure you have a single point of contact for that because you do not want anything to get lost. And just like any other type of inspection, you need to make sure that you understand the requests. If you do not, ask for clarification.
You should have a standard team that participates in an inspection.
Know who your subject matter experts (SMEs) are. Make sure that the SMEs are a part of the process. One thing to consider, if they are doing a video inspection with you, is whether you want the SMEs in the room on camera. “Do they present the best to FDA? Or do you want them in the back room supporting the person who is in the room and visibly in front of the FDA on the video conference? These are things that you should normally consider in your course of preparedness for any type of inspection,” Chase maintained.
However, you cannot be assured if it is a virtual inspection that FDA will only work with a single spokesperson. It is very possible that they will ask to speak to the person whose name is on the document—the person who authored it or the person who reviewed it. Just because it is a virtual inspection does not mean that you should not have the relevant personnel available.
“When you send a document in the room when FDA is on site, you would expect that the individuals responsible for that would be available in case they have a question. It is no different here. You need to make sure that they are available.”
When you send a document in the room when FDA is on site, you would expect that the individuals responsible for that would be available in case they have a question. It is no different here. You need to make sure that they are available.
As in your normal process, make sure you have an independent review of your documents prior to submitting them. If they are doing a video conference with you, you should be running that backroom the same way that you always do. They make a request. You review it. Remember, this is not the time to make changes to your documents.
If they have made a request to you in writing and asked you to submit certain documentation via email or standard mail, it is important that you do not go back and make changes in those documents. What you do want to do is review them and anticipate what the follow up questions may be so that you can immediately begin preparing answers for those anticipated follow up questions.
Communication is Key
It is also important when you are communicating via teleconference to remember that the investigator is listening to you, but not seeing you. Your tone and your delivery are extremely critical. You want to make sure you communicate clearly.
“I tend to be a fast speaker,” Chase said. “If you are as well, you may want to make sure that you are taking a breath and slowing yourself down, giving the investigator time to interject with questions. You want to make sure you watch your tone so that it does not seem that you are being defensive or that you are being irritated by the fact that they are trying to conduct a remote inspection.”
Finally, it is important if you are doing a video conference that you dress professionally. “We all know that it shows respect. It creates confidence in your abilities and in your organization. If you are going to be on video, make sure that you look the part of your role and responsibility.”
Make sure that if you communicate in writing—not just on the phone or on a video—that your words are chosen to be clear and concise and that you are not using any type of inflammatory language and you are not appearing to be argumentative.
“I would also like to point out that context is important,” Chase stressed. “Where you need to provide context, you should provide the context. Just ensure that you are not allowing the provision of context to now move into lengthy storytelling or unnecessary verbiage or the entire history of a situation which turns out to not be relevant or may be an overshare. Particularly if you are providing that context in writing, you need to have an extra layer of review to make sure that what you are communicating is clearly what you intend to communicate.”
Adjust Your Logistics
We have discussed having a virtual inspection, mailing/emailing documents, teleconferences, and video conferencing. These are not the normal ways that we usually work with FDA on inspections. “You need to think about what your logistics are. You need to make sure right now, today, before FDA calls you on the phone and says they are going to do an inspection, that you are ready.”
You need to make sure that you can provide the documents in a format and file type that FDA can receive and read them in. If you are using some type of proprietary internal software and you send them a digital data file and they cannot read it, that is very frustrating for them. You do not want to frustrate them. Make sure you are communicating and understanding what they have the capability to receive and what you have the capability to send.
You need to think about what your logistics are. You need to make sure right now, today, before FDA calls you on the phone and says they are going to do an inspection, that you are ready.
Be mindful of file sizes as well. Submit your records and your data the way that they specifically ask for them, e.g., if they give you identifiers, ask you specifically to write a question number on your reply or request you to restate the question that you are answering so that they can marry the documentation up with their information, follow the request. Help them be successful in conducting the inspection.
Make sure your telephone and conferencing and videoconferencing equipment works. If you do not have I.T. on your team, engage with I.T. and start getting them in the practice of doing this and being immediately available, looking at your systems and ensuring these systems would be adequate for this type of inspection.
You want to make sure that you have your printing, scanning, and copying functions available. We take these for granted. But occasionally these things break down and you cannot get a serviceperson in there. You need to know what you have available at your fingertips to get this job done.
“Make sure that your email is considered part of the official record,” Chase advised. “And be incredibly careful about your e-mail communication. Anything that you send to the agency can become part of the official record. This includes text messages. I would strongly recommend that you do not get into a text messaging habit with your investigators. Keep it in a format which can be maintained and be official.”
Remember that when you do send an email that your email can be altered and the context could be changed. “We would never presume that anybody would do that. But we also want to protect ourselves and make sure that we are not providing opportunities. So perhaps the email says, ‘please see the enclosed.’
The context that you need to provide or the description of your documents might exist in a word document that has been approved by your team. Put that conversation or context along with the documents in a PDF format so that it is secure and becomes part of the official record,” she advised.
Finally, just like in any other type of inspection, do not record your investigator or the inspection. “If you feel so strongly that you need to do that, you certainly need to have that conversation with the investigator before things happen, because if you do they are required by policy to record as well. My recommendation is do not record. It makes things awkward and uncomfortable.”
Do not record your investigator or the inspection. ‘If you feel so strongly that you need to do that, you certainly need to have that conversation with the investigator before things happen, because if you do they are required by policy to record as well. My recommendation is do not record. It makes things awkward and uncomfortable.’
You need to maintain an inspection binder just like in any inspection. Include all the submissions to FDA at their request. Ensure that every document is cross-referenced to any electronic file or correspondence that you have provided context for so that your record is complete. The investigators should be able to easily understand what you submitted to them. And they should understand which inquiry your response marries up to. You want to make it easy for them to follow what you sent them in response to their request.
If you are the point of contact, “now is not the time to get a little behind on your email. Make sure that you are monitoring your email and that you are very attentive to any communication you get from FDA so that you can respond in a timely way,” Chase recommended. “Minimize your email traffic internally. Make sure that you answer your telephone.” If they must call you because they are not clear about something and it is easier to discuss on the phone, you need to pick up the phone and have that conversation with them.
“You should handle this like you would any other inspection,” Chase advised. “If you have a request and the team is working in the backroom—which is where they should be—then be in the backroom or be in your conference room managing the inspection the way you normally would rather than and each of you sitting at your desk and sending a lot of email traffic around. That creates a record. It also can be challenging to communicate via email. So have your backroom and run it like you normally would.”
Say you get through your inspection and you have had a great virtual inspection. You have given all the requested documents. You have answered all the questions. And now it is time for your closeout.
“We would hope that if you are having a virtual inspection and there is going to be a 483 issued that you are going to get a closeout meeting. I certainly would not expect them to put a 483 in the mail or the email with no discussion.”
To prepare for the closeout meeting:
- Assume that you are going to get a closeout meeting. (You want to make sure only those who are necessary are in the room. They are going to want to issue the 483 to the most responsible individual at the site. That person must be around to receive the 483 if one is issued.)
- Make sure you know who is going to be in the room.
- Make sure you are taking accurate notes.
During the Meeting
Listen closely, particularly, if they are giving you verbal warnings or discussing items that are not written on the 483 for you to go back and refer to. You want to make sure you have a really good record of that so that you can address those as well.
“Again, do not argue an observation,” Chase recommended. “Now is not the time to be argumentative. If the 483 contains incorrect information, politely tell them you think that there is a mistake. For example, ‘I think it is supposed to be lot number one, two, three, not X, Y, Z.’ That way they can change it. There is nothing wrong with doing that. You do not want the 483 to be incorrect. They do not want it to be either.”
‘Again, do not argue an observation,’ Chase recommended. ‘Now is not the time to be argumentative. If the 483 contains incorrect information, politely tell them you think that there is a mistake.’
If you do disagree with an observation, you can state why you disagree. But do not be argumentative. Just clearly state why you do not think the investigator is right. Do you not expect the investigator to change the 483. “They might listen to you. They might take notes on it. They might report it in their Establishment Inspection Report (EIR). But it does not mean that they are going to go back and change the 483. Be aware of that.”
Follow your policy for responding to a 483 if one is issued. You must ensure that your team and your leadership receive the 483 as soon as the inspection is over. You have a deadline. You want to hit that 15 business day deadline with a solid response. Make sure that you communicate very quickly with your team and your leadership so that you can get started on that if you do get a 483.
If you made some corrections during the inspection it is perfectly fine to ask if you can present those during the closeout. Hopefully, the investigator will be open to that. They will take some notes and put that in the report.
“Finally, do not ask the investigator what they are recommending—for example, voluntary action indicated (VAI) or official action indicated (OAI). By policy, they do not have the authority to answer that question. So do not ask them.”
There are many options for FDA when they conduct a virtual inspection and there are a lot of ways that they can communicate with you. The key to being successful are the same things as previous in-person inspections:
- You need a solid program of continuous quality improvement.
- You need to make sure that you have ongoing inspection preparedness.
- You need to train and practice with your team.
- You need to anticipate where the pinch points are; we all know our weaknesses.
- Make sure that your communication is clear, concise, and professional.
- Practice your inspection process and follow your routine process so that it seems more natural to you.
“Communications and logistics are probably going to be your biggest challenges because this is just a whole new way of doing business,” Chase commented. “It is important that you check those things out now and that you are prepared and are not dealing with those problems when you get a virtual inspection.”
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