Speaker 1: I want to thank everybody for attending this presentation and overview of FDA do and don't do during an inspection. This presentation is given by Compliance Insight. If you have any questions, need additional information, want anything that we could possibly offer to you, I certainly recommend that you go to our website, that's www.compliance-insight.com, and you'll see this as we go through here, but just some do's and don'ts. This is a brief overview of some of the items that we've pulled together over time. When dealing with the FDA investigator, we, as a company, should demonstrate knowledge of and confidence in our quality system. This is not arrogance, nor is it defiance. There's a fine line between knowledge and confidence that our system works versus that we're arrogant that it can't get better, or we're defiant that our system is the best. There's a fine line to balance there between those. You want to come across as you are very knowledgeable in your system, and you're very confident in it. Never ever, ever give false data. Always tell the truth during an inspection. It's okay to say, I don't know the answer to that. Let me gather someone who can, or let me find the information for you. The investigator may ask the same question to different people at different times, and they're trying to understand the uniformity of the response. If you say, I do 1, 2, 3, and someone else says, I do 2, 3, 4, then there's a difference between your response. Be very aware that that is a common approach to asking questions during an inspection. Some tricks that are done, I don't want to use the word trick as in people trying to trip you up, but these are common don'ts during an inspection. They're used to try to pull more information from you. I'm asking you to be aware that they do go on, and you can sit there and understand what's happening. It's called the dome of silence type of approach. The tendency of people to fill a void in a conversation with more information. When they talk, they offer more info. They get in their mind that, ah, maybe I didn't give that person, the auditor, all the data that they wanted, therefore I'll give them some more info. I'll talk about it more and show how smart I am on this topic by adding more info. Don't fall for that, don't provide it. This is what I call the hmm factor. It's where I'm sitting there, I ask a question, I write it down, I can either shake my head as in that may not be right, I get a concerned look. People perceive this as a problem, and then they offer more info to me by saying, well, that's not exactly how we do it all the time, or, well, that's what the procedure says, but this is really, we go above and beyond the procedure by doing these things, and we know this, and this is how we do it. They try to fill in that gap. If an investigator asks you for some information, don't make them ask for it again. Don't wait to see if they forget about the request. Give them the data. Make sure that you have it reviewed, prepped, and ready for them. Don't sit there and expect them to forget it. Bring it in. Sometimes they do forget, but please, don't sit there and expect them to forget it. It only makes the investigator annoyed that they have to keep asking for data. It is not productive to argue with the investigator when responding to a question or observation. Tell you this, you're not there, you can discuss something with them to try to understand, to grasp where they're coming from. You never want to sit there and argue with them, well, I think you're wrong, or that's your opinion. Don't challenge the investigator. There's no need for it. It only motivates curiosity and more and more questions. Just understand, they're there doing a job, they're trying to gather data to see if you are in compliance, and there potentially are things where you could improve upon your compliance, and you just have to be able to understand what they're looking at and see where they're coming from so you can respond in a professional, courteous, but knowledged position. Don't stand around making faces, looking worried when the investigator is there talking or discussing things with people, and you're behind them, and you get this concerned look in your face. It only makes other people feel nervous. It may alert the investigator, if they see it on your face, that something may be wrong. Act confident and proud, but not defensive. If a fellow employee is being questioned, don't try to interrupt to help them answer that question. Don't give contradictory information. Let them finish with it, unless it is truly off. If they say, do you write with a pen, and they say, no, we always use pencils, and you know that for a fact as not being correct, you can say, well, wait, wait, I thought everyone used pens. Don't you use a pen? I've seen you use pens constantly. Maybe you misunderstood the question, and just try to intercede, but you have to be very, very careful with stuff like that. Don't interrupt the investigator or other employees while they're speaking. Let them speak. Be courteous. Don't talk loud or speak with others when the investigator is trying to concentrate, read, review documentation, or talk to other people. It is not your job to fill an uncomfortable silence or void with additional explanation. Again, that's a dome of silence. Do not keep offering data when there's silence. Just let it be silent. I can't stress this enough, and this goes to that sort of dome of silence type of thing. Loose lips sink ships. People talk. They like to talk. They like to show what they know. If you're in the hallway, if you're in the bathroom, even if you're off-site, they talk. They talk about the things. There's a story of FDA inspectors going to a facility, were going through, everything looked fine. They were going to approve this facility. At dinner one night, they overheard people in the table next to them talking about how stupid the investigators were from the FDA for not finding all the problems in this area, that area, in this area, in that area. So the next day, guess what? The inspectors came in, and they started asking for information about the areas that they had overheard that evening before. They were there, and they pounded this company for all the findings that they typically would not have found. It is very important that people understand it, that there are inspectors around. They should not be talking about the problems of the company. Things to remember during an FDA inspection. I'll go through this a bit more here, just stuff that you should bear in mind. Number one, number one rule of all documentation practices is if it is not documented, it does not exist. It doesn't matter what you've done, how great of a thought it was, you did the testing properly, but you didn't document it, you didn't record it. It doesn't matter. It didn't exist. It doesn't exist. In the FDA's world, it's great, it sounds good, but I have nothing to show for it. Number two, the investigator may read your body language, and be aware of your body language, that you're defensive, that you're guarded, that you're worried, you're concerned, and it's a two-way street. Read their body language as well, so understand if they're getting annoyed, or if they're getting defensive with things that you're doing. Just be aware of those types of things. During the inspection, observe and learn to read the investigator's body language. What I said before, make sure that you understand what the investigator is trying to tell you from how they are acting, and be aware that sometimes they may give you that, trying to see what you do in response to questions that are being given to you. Communications, very, very complex. Verbal communication is only 7% of all communication. There's paralinguistic, and there's nonverbal. 55% is nonverbal. How you cross your arms when you're talking to someone, how you stand, how you look at them, how you move your lips, your eyes, the brow on your head just getting wrinkled up because you're not liking what you hear, your eyes opening wide because you're shocked at what you're looking at, those are all nonverbal things that are great communicators, and it's a bulk of the communication that goes on out there. View orientation, understand when you're talking to someone or they're trying to get into your zone, these are things that you have to understand. There's an intimate zone, which is right next to you, to one and a half feet, and then about a foot and a half to four feet is a personal zone. You're there trying to be personal with that person and get some information. Personal zone goes out from four feet to 12 feet. Beyond that, you're just sort of off in the distance, but those are zones where if you're talking to the investigator, you don't want to be right into their zone. You want to give them a personal zone to a social zone, so the optimum place to be talking to someone is about four feet. It gives it right in that cusp where you're there being personal with them and giving them some room in which to function. Establish normal behavior patterns, interview techniques. What is it that you're normally doing? Do you stand? Do you shuffle your feet? Do you look away? Does your gaze break from the person? You have to be aware of behavior changes that tell you that something may be going on, that person may be uncomfortable, a person may be not telling you all the truth. I've given you some secrets here for how the interview techniques go on when you're an inspector. When I'm an inspector talking to you, I'm gathering all the information that you're telling me, and again, a lot of that is nonverbal. This is what I'm looking for as I'm establishing normal behavior patterns, and then I start asking questions so I understand what it is that you're trying to tell me. Truthful postures, upright, open, relaxed. You lean forward on occasion. You align with the investigator. Your body aligns with them. You have casual posture changes. You're comfortable, you're relaxed, you're truthful. Deceptive posture, you pull back, you retreat, you slouch. You become frozen, robotic almost. You're not aligned with them. You have a barrier posture. Barrier posture, you cross your arms. You are defensive, your defense shields come up. You have consistent posture changes, back and forth, back and forth. Your head, your body slump, you're defeated, you're deceptive. Nonverbal behaviors, you're composed, you're concerned, realistic, you're cooperative, you're direct, you're spontaneous, you're open, helpful, sincere, confident, persistent, consistent. Those are all things and behaviors that tell a person that you're being truthful. Conversely, to truthful is deceptive behaviors. You're overly anxious. Now, I understand as being an inspector that I know people will be anxious speaking to me. They'll be a little nervous. I understand that. What I'm looking for are people who are overly anxious. They're really hiding something. There's some deception going on. They're unconcerned, they're unrealistic. Only uncooperative or defensive is very much a defensive or deceptive behavior. That's something that I really get quite a bit of, just really defensive. So I think, what's going on? Why are you hiding this? Why are you so defensive of this? You're guarded, you're evasive, you're hesitant. You rationalize everything. Well, yeah, we do that, but if we didn't do that, we wouldn't make any money. Or everybody does that. We're not the only ones. Why don't you go down the street and talk to them? Why are you picking on us? You're insincere, you're defeated, you're apologetic, you're accepting of defeat, you're quiet. Now, sometimes people can be quiet just because they're nervous, anxious. Sometimes it's just in people's behavior patterns, they're just quiet. I understand that. So all of these things are tools that are used by me to understand deceptive behavior. None of these mean that they're being deceptive. It's just a tool that I can use to say, I need to look into this a little bit more. Breaking a gaze. If I look right, you're editing or fabricating something. If you look left, you're accessing your memory. Yeah, this is how it was done. 85% accuracy rate with this tool. Now there's some 15% in that ballpark where that's not the case. But that's where I establish a pattern. If I ask you what you did yesterday for dinner, you go back in your memory, you access that, I see which way your gaze is focused so that I understand that's a pattern. That's true. I'm doing that. So if you look the other way when I ask you a pharmaceutical or inspection-based question, I know then you're trying to make things up. What does the person expect me to say, therefore I'm going to give you that rather than what the truth is. Stick to the facts, not opinions. Do not give opinions. Well I think this should be this way. That's not a fact. That's an opinion. I'm not sure, but this is how I think it's done. In my opinion, again that's definitely an opinion, what you're saying is not true. This is really how things are done. You have to have a real fact on that and understand it. You say honestly, this is the way we typically do it, usually, usually, you have to do it all the time this way. Again, in the pharmaceutical industry, we do things consistently every time. It's not usually or typically or as I recall, Senator, this is what happened. That's an opinion. Listen to the questions carefully. Answer only what is asked of you. Do not volunteer more information than what is asked of you. Clarify if you don't understand some question before you answer that. When a question is too broad, ask for specifics. Can you provide me with the data results for your water testing? Yes, I can certainly do that. Why don't I give you the past six months worth of data? Is that acceptable? Oh, yeah, yeah, that's fine. You ask for specifics. Otherwise, you could have given them two years worth of data. There's no idea when it may have ended. It's too broad of a question. If you don't know the answer, say so. It's all right to say, I need to go out, I'll look into this, I'll come back and answer that for you, unless it's something very basic, such as what is your name? You can't say, well, let me go find out. You can't say, I'm a subject matter expert in this, and say, well, how do you do this? And say, let me get back to you with that. You can say, it's in the procedure here. Let me pull the procedure out. That's fine. Do not guess if you're not sure of the answer. Don't say, I think this is the way we do it, but let me check. Go out and check first. If you're not an SME for a question asked, do not answer the question, and explain to the FDA, I will have to get the right person in here to do that. Sometimes people that are there, scribes or people that are hosting the inspection will say, oh, yeah, this is the way this is done, but you're thinking that's the way I think it's done. And they like to answer because people like to be knowledgeable in the subject matter of the company. They don't like to be there just as an employee, a paper pusher, a manager that doesn't know what goes on with their people in the department. You have to sit there and say, I will get the right people in to do it. Sometimes people like to answer those questions. You've got to refrain from that. Sometimes I've threatened to put duct tape on people's mouths just to say, don't answer it. Don't answer this thing. Don't provide any input. If you think the investigator has misunderstood something, say so immediately. Do it in a professional, courteous, kind manner. Say wait, wait, let me get this straight. This is what you asked, right? And this is what you said as a response, correct? You said something, I think you may have misunderstood what he said, am I right with this? You're trying to make sure the inspector gets the true information, all the facts straight. Remember this, investigators are people too. They will make mistakes. They will misunderstand something. You're there to try to help out. Refrain from saying things such as these, and I've heard all of these things in my career. That's the way we've always done it. Well, what do you mean? This is the way we've always done it. Well, great, but it's wrong. Or to say, you know, off the record, nothing's off the record. Are you crazy? I probably shouldn't say this, but I'm going to tell you anyway. And someone actually said to me, who, me? To do that? Oh, no, never. Or someone, I go through things and they say, uh-oh, that means defeat. That means, yeah, there's something wrong. Or people in there say, you know, this is probably a mistake. Probably, what are you talking about? Find the facts before you say it. Let me check on this. Let me understand what happened here before I comment on this. If we would do it that way, we'd never get anything done. I've actually had people say that to me. I'd look at it and say, you need to document these activities because there's no documentation of it. And I'd say, well, if we had to document all these things, we'd never get anything done. This is a pharmaceutical industry. You're not making tennis shoes. You're not making bowling balls. You're making pharmaceuticals. It's a requirement that you document this stuff. We don't have enough time or resources to follow that procedure. Actually have people tell me that. Then don't have the procedure. Don't make the product. I'd do it in a different way because the procedure is not good. If you think that's bad, you should see over there, we fixed that problem by firing the person. No, you have to fix the problem systemically. It's not my fault. It's the previous supervisor. Various things. I'm not going to go through the rest of these. You can look at these things. Some of them are kind of funny. Documents and records the FDA can look at and shouldn't be able to look at. I'm not going to go through the stuff that they can look at. Some of the stuff they can't look at, internal audit reports, research, really far back research data, sales, pricing, personal records such as training, type of items, and any type of thing like that they can look at. But when you get back to personnel types of things, be very careful with that. Just some frequent questions. What happens if the investigator finds something wrong? Just go through these things. Look at it. This is here provided for you to get these things done. Just understand, have a well-knowledge person there to help you. Continue with this. What do you do if they find something wrong? Just continue with it. You'll get a 483. You effectively respond to that. You do systemic inspection type of responses. Make sure you approach this thing with someone who's well-knowledged, and if you need help with that, certainly call us. Here is the phone number. I suggest highly you go to the website. There's a lot of data there that can help you out, compliance-insight.com. Give us a call on this if you have anything really going on. We offer a free phone consultation. Get a hold of us. We'll set something up if we have to with the right people in the right area, and we'll help you out. We offer this free of charge. You've gone through this. Give us a call. We will certainly try to help you out. Thank you very much for going through this with me. I appreciate you going through this. Check out our website. There's a lot of good data there, a lot of good things for you to have. Thanks.