Ep 4: Staying in Control with Tommi Papson

Episode 4 January 31, 2023 00:52:28
Ep 4: Staying in Control with Tommi Papson
Leaders in Life Sciences
Ep 4: Staying in Control with Tommi Papson

Jan 31 2023 | 00:52:28


Hosted By

Mike Ferletic

Show Notes

What makes a good corporate citizen, and what makes one less solid? Whose job is it to find out? Today’s guest will answer those questions and more.

Tommi Papson is the president of Regulatory Consultants Group. She’s also an ex-FDA investigator and Consumer Safety Officer, among other things. Both as an FDA investigator and now as a consultant, she works to ensure that companies play by the rules, but those two different roles require different approaches. 

Listen to the episode to learn more about Tommi, her role as an investigator for the FDA, and how it stacks up against her current consulting position. She discusses the different types of leaders she’s encountered, the challenges she’s faced in her career, and the differences between how she was received as an investigator vs. a consultant. 

Topics Discussed in Today’s Episode:


Tommi Papson


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Episode Transcript

Mike: Welcome to the Leaders in Life Sciences Podcast powered by Enterey Life Sciences Consulting. In this podcast, you'll hear from leaders in the life science community, how they grew into their current roles, the lessons they learned along the way, and advice from those aspiring to follow in their footsteps. I am the host. My name is Mike Ferletic, and I'm the CEO of Enterey Life Sciences Consulting. At Enterey, we help leaders orchestrate the positive change they want to see in their organizations. Are you ready to be recognized for your leadership success? Take a listen. Welcome, everybody, to the Leaders in Life Sciences podcast. It's great to be here. My name is Mike Ferletic. I'm the CEO of Enterey Life Sciences Consulting. I'm excited to have our guest today. We'll talk about her in just a moment, but first, I want to introduce our co-host, Courtney Boudreaux. How are you doing today, Courtney? Courtney: I'm good. How are you? Mike: I'm doing great. I see that we have a third person on the line helping us co-host today. Can you introduce our extra guest? Courtney: This is Rishi Raval. He is one of our co-workers at Enterey and is a wonderful consultant who has given up some of his day-to-day to be here to chat with us. Hi, Rishi. Rishi: Hey, how's it going, everyone? Happy to be here. Thanks for having me. Mike: How's it going, Rishi? Good to see you. Rishi: Thank you. You too. Mike: What's been going on lately, Courtney? It's been a while since we've been on the recording. Anything new? Courtney: Nothing much. I think last time, I was talking about Pickleball. I checked my Pickleball classes, and they were really fun. It was a new sport to learn and I still have to get my own paddle, but I can't wait to start playing Pickleball with people in the neighborhood, friends, and family. Rishi: Pickleball is great. Courtney: Yeah. How are you, Mike? What's new with you? Mike: Not so fun stuff. We've had a little bit of a project going on at home. Not a planned project, which is why it's not so fun stuff. A little bit of a minor overflow that is leading to some excitement in the house. We're trying to treat it like a little vacation, but we just have a little bit of some work to be done in the house. That's what's been going on. At the end of the day, it's all being taken care of, so we're thankful for that. We're going to get a little nicer bathroom out of it, let's just say that. Not intentional, but there are always some good things that come out of some troubling issues. Courtney: Who is the interior decorator in your family? Mike: Not me, although I would love to think I am. We're going to leave that to others. How about you, Rishi? What's going on with you? Rishi: Not much. Been to a couple of Suns games. We're doing well this year, so the games are more exciting. Our stadium is actually packed, which is always fun. We don't do too well all the time, so it's been fun. Good outings. Mike: Nice. I still remember—I'm dating myself here—the Charles Barkley days. That's when I was really following basketball a bit more closely. I do remember that they almost won the championship back then. They almost won it again recently, right? Rishi: Yeah. Lost to Jordan as did everyone, and then lost last year, but it's always a good time. Mike; Very true. It's great. Thank you both for being here. Looking forward to our conversation today. I'm going to go ahead, jump in, and introduce our guest. Our guest today is Tommi Papson. Tommi is the president of the Regulatory Consultants Group. She is an ex-FDA investigator, consumer safety officer, and member of the DHHS FDA International Cadre Investigations. After leaving the agency and having adventures of a lifetime and some experience with other firms, Tommi co-founded Regulatory Consultants Group along with other ex-FDA experts. The audits continued from cradle to grave to document review in the steps of a serious but fun mock FDA audit to remember. Working closely with the DOJ, FBI, OCI, and state and local government agencies, Officer Papson enjoys the challenge of escalated FDA 483s of OAI firms, warning letters, seizures, recalls, and civil and criminal money penalties. Her career spanned hundreds of investigative activities and inspections in bioresearch monitoring, pharmaceutical, medical device, consumer complaints, and whistleblowers from routine assignments to unannounced for-cause inspections. I'm sure those are fun. Hopefully, we'll hear about it. Violators were placed on the Application Integrity Policy List. In addition, the FDA's public health concerns, illness, life and death reports, and adverse events inspections were part of her day-to-day activity as an investigator. Outside the office, Tommi is a painter and a sculptor. She enjoys photography, global travel, and volunteering with professional organizations. She brings her FDA experience together with current regulators to industry groups like the Pacific Regional Chapter of the Society of Quality Assurance as their president and as a past president of the Orange County Regulatory Affairs Group. Tommi lives by the following advice that in the regulated world if it isn't documented, it doesn't exist. Let's welcome our guest, Tommi Papson. Welcome, Tommi. Tommi: Hello, everyone. Mike: Thank you so much for being here. That introduction, boy, I can't wait to hear more about your background and experience. It sounds pretty exciting. Tommi: Normally, the whole thing isn't read or discussed. When I worked for the FDA, I was known as Trudy Papson, so after leaving and starting my own company, it was like that name has a reputation, so I went by my grandmother's nickname. Mike: That's great. Interesting to hear. Tell us about that. How did you find your way to the FDA and then ultimately becoming an investigator? Tommi: Radiation. I was in the Air Force. I want to be a pilot. When I passed all of my tests, I went to Lackland Air Force Base to be a pilot. After I got through several weeks of boot camp, I said, oh, when do I start my flight training? They said, well, I'm sorry, you're too short to be a pilot. I said, I was the same height when I was recruited in Pittsburgh and when I took all my tests. Well, we're going to put you in something else. Instead of flying the planes, I got to watch them. I got to watch the radar and learn about radiation. Then after that, I got into the medical field and medical radiation. Of course, the medical world involving medical devices, pharmaceuticals, and all those wonderful things. Somebody came to me one day and said, you really write great SOPs. You got to work for the government. I went, oh, that sounds interesting. When the government came to the hospital I was at and said, would you like to work for this, I said, certainly. I started out basically at the state of California as an environmental health specialist writing procedures on what the state inspectors would look for at radiation facilities, [...] in hospitals and different areas such as that. Then, that went from the state to the federal government. Mike: That's pretty elaborate. It sounds like a pretty interesting path. Actually, I had no idea that you were in the Air Force. So excited to hear a little bit about that. Based on that though, you've spent time in the military, public sector, private sector, and now working with your own corporation. I'm curious from a leadership perspective if you've heard or experienced different things, characteristics, and types of leaders that you can highlight the differences. Do you notice any key differences among those different environments? Tommi: Absolutely. There's a difference in every one of the sectors that you mentioned at different levels, different strata, and different silos as I like to call them. If you're in one environment, there's a silo basically where your job is where the leaders come in, knock on the door of your silo, and then might go away. There are certain areas where the leaders are right in there with you, and then there are others which we all know that leaders sit at the top, but they don't know what goes on at the bottom. As far as the leadership world that I have interacted with, I've interacted with Fortune 500 CEOs that asked me if I had an appointment—which I probably didn't need one—to people that just started work and wanted to get into a career. Some of those people actually became leaders. It's always interesting to see somebody who's starting out not just as a student but as a worker where they seem to have that potential of leadership right in the beginning. If they can get with somebody that's going to mentor them or have a path to get there, you can almost feel that and see that. That's one of the thrilling things of being in the different areas I've been in to watch. Mike: Tommi, that's interesting stuff. What's really intriguing to me is when you refer to some newer employees or employees that are early in their career, you can recognize some of those leadership characteristics in them so that you are drawn to mentoring them. What are some of those things that you see in some of those individuals that you really are attracted to? Tommi: The passion for what it is they do versus wanting to go to work from 8:00 AM to 5:00 PM. You meet somebody that has that passion that wants to know about it, wants to understand it, wants to find out everything they can about it versus the person that's there for a job. I don't see them coming through the whole area of becoming into the leadership world. For people who seem to have a passion to want to do something, it doesn't matter what area they're in. It can be in receiving. They have a passion to do what they do. They're going to move up in the receiving world. They have a passion to do something in the front area as a receptionist. She can end up maybe as an administrative secretary doing everything she never thought she would do other than just answer the phone, but she's got a passion for sitting there and doing what it is she really loves to do. That mentality that I think is inbred in certain people is I have the desire to do something and I want to do it right. With the government, you do it right or you don't do it at all kind of thing. Growing up, I had that same feeling with people that I met and watched people grow and change. Usually, it's people that it's a monotonous life for them. That's not a leadership thing. Courtney: I know you're passionate about all types of nuclear medicine and then regulatory affairs. Can you tell us a little bit about what you've done after the FDA in terms of continuing with your passion with regulatory affairs? Tommi: One of the things I did, I retired. I left the agency when there was a commissioner that said, people were no longer volunteering. It wasn't specifically spelled out in your contracts with the agency, but it was, you're going to be somewhere for three months where they hate your guts, they don't want you to come, you're going to stay there in that country for three months, you're going to move around from one company to another, and then you can come home for several weeks, write up your reports, get your information together, and then go back to a different place. When that three-month ED came out, I said, I think it's time to leave. I basically retired on a Friday and started my own company on a Monday. Several other people did that same pipeline thing and went oops, we don't want to go there. We did that and started that. I went from knocking on doors of companies saying hi, I'm here, to now being paid to go to a company. I work for the government so you know. Now, I'm getting paid to go to companies to do what I did with the agency. It was like, come in and put my people through an inspection. Make it real and make them feel it. They need to understand the importance of our stock going downhill, our CEO having a penalty, and everybody getting fired because they're the scapegoat. We want you to put our company through that. Can you do that? I said, I love doing that. You're going to pay me to do that, and I'm going to travel around the world. That's what I did afterward. That's been the passion I carried through it. It's still fun to do and I still get hired to just drop in and innocently come in to knock on your door. Courtney: You mentioned going places where people don't love that you're there. How do you stay resilient in the face of that, especially if it's thousands of people at a company and it's just you showing up? Tommi: I guess I have this little part of me that says if I know I'm sent there and I'm in there for a for-cause inspection, you hurt some innocent person. If I can say to myself, I know that you know you've hurt some innocent person and your company is proceeding to do that, that's not right. Let's see what we can do to find out if you can correct it. If you know about it, then let's put it together so that you can fix it, or the agency will fix it for you. The passion going in is you've got a problem, let's work together. I basically go in as an educator, not a hammer because I'm too short to be a hammer, but the effect is I'm here and let's see what we can do. I guess the way that I carry that through is there could be a table with six lawyers across from me saying, I'm sorry, you're not permitted to talk to anybody. That's okay. They don't need to talk to me. But it's June and I don't have vacation until December. I don't know where you're going, but I'm going to be here, so let's all talk. The interesting part of working through and doing that now is the same thing. It's let's play. Mike: That's great. I've got a curious question. You've gone to meet with people at companies as an FDA inspector, and you've gone to meet with people at companies as an external consultant preparing them to deal with FDA inspectors. I imagine you've seen the best of people and the worst of people perhaps in those experiences. Maybe they were either solid companies that had great compliance with regulations or maybe they had some issues, but that doesn't necessarily change how they act as leaders in the organization. I'm curious if you've seen different sides of these companies. What were some of the leadership characteristics of those that were solid corporate citizens versus not? Tommi: One of them would be to meet with the FDA. One of them is, oh, yeah, you're here and we'll respect the fact that the agency wants to know about us. There's leadership that doesn't ever want to see the FDA, and there's always a fall guy. Usually, somebody's the director of something or another. That's the leadership of a company that could be not running or operating as well and as safely as they could or should be. Courtney: How do you see leaders lead the people that they're essentially serving and their employees in those situations as well? Do you see them assisting? Sometimes, they turn and run a little because they're frightened for themselves. Tommi: A really good leader on inspections and mock inspections I've been on around the world wants to be part of it. They want to know what the staff is doing. It's not that they've dispensed with everything that is your responsibility, please go off, and do your job. You're paid to do your job. Really fantastic people want to sit in, watch, and see what it is not as an observer but as a participant in this is how I think our company should run and these are the people that I trust that are going to do that. If it's okay with them, is it okay if I sit in? Absolutely. A good leader is willing to sit in, go through, and watch what the staff is doing, not just walk in, sign a document, and say, yeah, we know you're here. Then, at the closing of the inspection, they're there. That's usually the leader that is going to receive a 483 at the end of the inspection because they do not want to participate in what has been going on. That's really just an indication for me right out of the get go. That is how it works. Mike: That's a great perspective. Wanting to be a part of it and knowing what's going on is what you described. The person that's just signing the document maybe either doesn't know or doesn't want to know what's happening and what it sounds like. Tommi: Many times, the person that is at the top of the organizational chart, whenever an agency inspection happens, one of the first things an investigator asks is the copy of the organizational chart. We're going to talk to this person down here, but I'm going to want to meet with this person, this person, and the top person because if there's an escalated action, that leader is the person that's going to answer to the Department of Justice, the FBI, and the Office of Criminal Investigation. It's not going to be the regulatory person, directors, managers, or vice president. It's going to be the leaders that are running a company that could be manufacturing, distributing, or doing something that they could be doing better. A good leader is in there to say, you know what, we're ready to do that better. We understand. We want to do that better. That's a great leader. They're willing to say I think you found something and we're going to address that before you leave today. Leadership can step up and say, we see this, and we'll take care of it. Mike: That's a great example. Curious about your additional insights into that one. I've worked with some various clients and supported some inspections, and one of the objectives was always, hey, if we can address this wall, our inspectors are here, let's get it, let's turn it around, and let's see if we can present it to them. They were always eager to do that. Tommi: That's a bonus. Mike: I was going to ask, do you like to see that? Tommi: If you're out there doing consulting and you're working with a company, one of the good pieces of advice I have is you really want to offer the FDA everything that you can do and say right there while the investigator is there because you got to remember, they only have a snapshot of time. They're taking that snapshot, they're taking that back, and that's your history for many, many years until somebody else comes back. If you're able to interact with them and have management, your leadership is sitting there saying, you know what, here, we're going to talk about this by tomorrow morning. Do you want to come back? We're going to address this tonight. Everybody's going to work over. And they really mean that. A good leader will say, what can we do? What is it you need? I can't act as a consultant. You can pay them, they can tell you what to do, or just ask your staff what they would recommend. I'll be back in the morning. Then, a good leader says, let's get pizza. Rishi: Tommi, you mentioned this earlier. Can you talk about the differences in how you were received coming in as an FDA investigator compared to as a paid consultant to come do these mock audits? Tommi: There are certain companies that pay me to come in anonymously. Basically, I'm knocking on the door and saying, hi, I'm here with an agency. I'm basically sometimes told, do you have an appointment? I don't need one. As a consultant, a fun, really good thing to do is if you want to have a mock inspection, from your receptionist down to the CEO, they're involved. That involvement is going to put them through. I'm pretty much going to put them through getting all the way through with a walkthrough and with the documents. The entire thing that I would do is a small capsule of what an agency investigator is looking at. I'm able to walk in there and say, I'm here to do this and I want your cooperation. I don't want to say your companies pay me a lot of money to do this, but the end result of doing a paid consultant job versus going into an agency inspection needs to be the same thing for me. I hope it is for most consultants. You want to do what you can for that company that you're walking out with. You want to know when you walk out that you've done what you can that day in that area that you've been in because you don't want to go home and watch on the news tomorrow that all of a sudden, there was a recall, problem, or something in an area that you looked at, and you just were in a hurry, you got out, and you did it. That's not something I could ever have lived with. Mike: It seems like a common theme that you touch on is to have buy-in from top to bottom that creates the best client from either you coming in as an FDA investigator or from a consulting capacity. Courtney: It's all in the name of patient safety. That's the intention. That's what carries through. It's not done just despite some sort of company. It's these products are going into people, whether it's a device or a drug. Safety is the reason that they're there, so having companies who are compliant probably cared very much so about safety as opposed otherwise because unfortunately, there is a spectrum of that in the industry. Tommi: Courtney, you hit that right on the head. If you think about somebody who is doing the same thing every day and they're writing SOPs, doing submissions, or manufacturing, sometimes they lose sight of this widget is going to go into somebody or this sterile device that may not have a good seal is going to go into somebody. For somebody who's routinely doing the routine things over and over, good management and good leaders are going to walk in and say, everybody, what are we doing? Is there anything else we can do? Is there anything else we need? Good leaders are right in there. They're walking the floor. I've had companies where they said they've never seen their bosses. I was like, what? That shows later. Not that I would say that's intentional, but that does show up. Mike: It sounds like whether you are going in as an investigator from the FDA or as a mock audit leader, you encounter people who can demonstrate their leadership at all levels of the organization from the receptionist to the site head or the CEO, and everybody in that whole list of people that you would encounter have the chance to demonstrate their own leadership. Would you agree with that? Tommi: That's the way it should be. It should be that way on every inspection, every audit, and every consultation. Everything that you go through with an interaction with another company, another person, and the way they're doing something. By the time you're all done with the FDA, you're doing what's something that's called an investigation operations manual. You'll do a closeout every day. You'll sit down at the end of the day every day, and you will give less 30 minutes or so and a sandwich of here's what I saw today, here's an observation that I have, or here's an idea that I have. Tomorrow, I might be going to have a discussion about this area and this problem or concern. I'm going to have more questions, and I'll be back to discuss that. As a consultant, I would be doing the very same thing as I'm here, I see this, and I'd like to expand a little bit on that. Can you get somebody in to talk to me tomorrow? They'll have overnight. You guys all talk about it because here's an area I'm going to focus on tomorrow. I want everybody on the org chart that I have and everybody's signature. I see that he signed a training document, I'm going to ask to interview them tomorrow. I do that. I got their names, but one of the little things you do is say this person might be really fatigued at what they're doing, so let's bring him in. Let's give them a chance to talk about what it is they do and let them talk about that in front of a representative of their department or in front of somebody who's a consultant acting as an agent that could help them later or really hurt them later. The learning experience is when I walk out of there, I want everybody that I interacted with to know that the leader knows what it is you do, and they're going to appreciate what you do because after I'm done with them, they're going to be happy that you work for them. Mike: Hey, Courtney. A lot of our clients we work with have great ideas on how to improve their business, but they just run into challenges that seem to get in the way of accomplishing their goals. Have you ever seen that? Courtney: Yeah, of course, it happens all the time. I've seen clients struggle with a lack of visibility into all the work that's happening within their organization, I've seen clients that are focused on manual tasks, which takes away from focusing on the actual project work, and I've seen leadership struggle to make decisions due to lack of timely information. Mike: That's so true. It seems like just knowing the problems to fix is only half the battle. How do you help your clients address those challenges? Courtney: We of course first work with our client to design a structured management process that fits their culture and team. In a lot of situations, we bring in tools like Smartsheet to help the entire project team be more efficient. With the help of Smartsheet, we were able to create dashboards, automate routine tasks, and have the information ready in real time to help support leadership's decision-making. Mike: It sounds like you not only execute on the project but your work helps everyone get more done with less work. Courtney: I hope so. Smartsheet is a powerful tool, and my clients seem to be really happy with it. Mike: That's great. If somebody needs help on their project, what should they do? Courtney: They should check out enterey.com and schedule a call with us to see how we can help. Mike: Sounds like a great idea. Courtney. Thank you. We've talked about these situations where you show up on the doorstep, you're well-received, and people participate or not. What's one of the biggest challenges that you faced throughout the duration of your career? Tommi: I guess one of the biggest problems is knowing that I'm going in a for-cause inspection where there's been a death or a hazard, somebody's had surgery, or many people had surgery. If you're familiar with what's called a MedWatch report or MedSun report, companies, doctors, and nurses get to tell the agency something's wrong. If you're going through the country, the agency [...], and they're getting a report from Florida, Michigan, California, Hawaii, England, or Germany that there's been a problem, there was an investigator singling that out, and they're putting that together in a package. They will knock on the door and want to see what's been going on. When you're sent in to someplace like that, you're basically going in. You're not telling why you're there, but you're there to do something that the agency has sent you to do. The biggest challenge I had was a company that we knew there were things going on and the Department of Justice had a flare-up of a question about them. I was sent in and went in with a team of two other people. Normally, a good investigation or inspection of a good company is about three days, maybe four. If there's a lot of information and they're doing a lot of maybe class three devices, you might be there a week. If it's a class one or two, you might be there for 3–4 days. This company was doing things and we knew they were doing it. They had a lot of complaints, but they failed to tell the agency about the complaints and they failed to tell them about the adverse events. Basically, my job was to go in and find out that they knew that and they didn't want me at the door, told me I didn't have an appointment, and asked me to come back. Basically, you go back, but you're bringing the United States Marshal with you and it doesn't look good for everybody. You go into the lobby and you tell everybody, you might as well go home for the day. You don't really want to do that, so you want to try to get into the door and issue what's called the 482, which is Congress says you have the authority, you've taken an oath, you swore to go in, and treat them fairly, and then proceed and do what it is you need to do. The whole thing is to find evidence. An agency representative going in is to find evidence for prosecution. Like you mentioned, sometimes you're not received well. If you're going to accompany where you're sent and there's a for-cause, somebody's been hurt and the whole job is to find out why did you know about it, when did you know about it, and how many other people have been or could be affected tomorrow, the next day, and the next day? A company that met with me decided that the employees weren't going to talk to me. I basically spent three months at their [...]. Everybody accused me of having a trailer in the parking lot. I didn't have a trailer, I just drove down every day. It ended up in the paper that after an FDA audit, 85 people lost their jobs and a company went out of business. That was not the FDA's fault. The FDA found that there were children having their thyroids removed because this company's analyzers weren't accurate, their assays weren't accurate, and they were cheating on little lines that they were making. We spent some time trying to find out who knew that, how much they knew it, and how long they knew it. That became a criminal prosecution. That was one of the largest settlements in the history of the agency. It was a time-consuming thing and they didn't want me there, so they presented every day. Then, the president got a lawyer, and I would talk to the lawyer, not the president. The director and his regulatory staff would not be there. His lawyer would be there. I was talking to the lawyers asking them questions about things, lab journals, specific dates, and specific gravity of this. The lawyers were looking at me like, we just can't do this. We're getting paid to sit here to have you ask us these questions. We have no idea what you're talking about. I said, really, I'm not going anywhere. This is it. I'm here. Either I talk to them or you can keep asking the questions. It doesn't matter to me. Have you ever seen an FDA inspector with a green journal? That's a legal document. That's your diary. You take your little green journal, open it, sit back, take notes, and write your notes. Then, when you close that journal, it's like, I'm really done talking to you. Please get me somebody else that'll really respond because we really, really want to wrap this up this year. Probably one of the most challenging things was just face-to-face with lawyers because the leaders felt a penalty was coming and a penalty did hit them. Courtney: The Fifth Amendment protects your right to prevent self-incrimination. That probably does not apply in this situation, correct? Tommi: Correct. There's criminal activity. You're selling something you know is a problem. If it crosses a state line, it becomes federal. If you say you sent something in the mail, then you've involved another agency. That's how all these fines build up. In one of the cases, there was a whistleblower that we met at Denny's, and we met several times at Denny's. Basically, they tried to let this employee go because he was unhappy with something that was happening. He was charged with being a disgruntled employee and was put into a position of no leadership authority. He was bumped down. He was put aside and he kept saying, you got to do something. I can't watch this. You have to do something. He finally told the FDA, and the FDA did something. He got a very big million-dollar settlement out of that case because he was a whistleblower who knew facts about a company that had continued to do things that were not safe, and public health had been affected. That's the whole mission of the agency. If you know about it and if we find out about it, then that's where the bad guys are. There's a very small percentage of bad guys and there was a profit thing. They were making a lot of money. I can't name them, but it's in the press. The most challenging thing is to know that you know that something's wrong and find the evidence to prosecute them. It's like the police. They have to follow you until your tail light goes out and you're like, oh my God, my tail light's been out. I didn't know that. Mike: I think it's a really interesting concept and thought process. We hear a lot about, oh, this person could go to jail. You actually have seen that. I've been fortunate in my career and working with various companies that the people that I've worked with have been very concerned about that not from their own safety or freedom per se but because they do care so much about patient safety and patient health. You got to experience the good and the bad, it sounds like. How frequent were those instances? How often did you find those companies that you had to stay for three months and that took away your ability to really expand the reach of the agency and make sure the broader industry is doing well? Tommi: As a bonus, I got to train people. I got to let them shadow me. As one of the bonuses of what I did, I see your people would be able to follow and see what are the techniques that we have. How is it that we get people to really go up to a chalkboard and write down where this thing short-circuited? You can draw that on the chalkboard for me? Sure, that'd be good. Then you see the camera comes out with the investigator and the company says, I'm sorry, you can't take pictures. Really, you don't want me to take pictures? Then, they call the lawyer. There's a whole long series of things that happen with the good things and the bad things. When you have the good things happening, it's a really exciting bonus. You get to enjoy that. Most of the people that I have worked with in the FDA and in the state of California really enjoy what they do not because you're finding a criminal offense but because you're out there to say, I have seen 100,000 things almost like yours and I bet you. I can give you an idea. I can walk in here in three hours and give you a tip on where it is I'm going to be tomorrow. Let's just talk about where I think it is. We may have a common ground where we may have a discussion where your management really would like to talk to us, or if they don't want to talk to us, that's okay because we'll be talking later. The good thing is you get into a good company and they're there. Let's do a walkthrough. One of the techniques I did—maybe as a consultant, you've seen this—is you can do an audit. The company walks you in, they sit you down in a conference room, give you coffee, and then they'll show you the slides of their company. I never did that. I walked right onto the floor. Open the doors and let me in, not in the lobby and not in your conference room. I'm going to walk in there right into the back and see what's going on. That's the fun part of it. Then, when it's a good company, they're going, yeah, over here. The other company is like, I'm sorry, we're doing manufacturing. If you still want to manufacture, then I need to go in there. Mike: You're taking all the great work that us consultants did in preparing slides and making it less useful. Tommi: I can tell you how to do it as a happy thing. You don't do it initially. You have discussions. They used to buy me chocolate donuts all the time. There was this rumor out there that Investigator Papson really likes chocolate donuts, so I go to a firm and there'd be chocolate donuts. The next day, there'd be chocolate donuts. They have profiles on the investigator. Rishi: Courtney, how many slide decks do we prepare? Courtney: I would say not too many. Only when they're necessary. Tommi: That's okay. You can do a slide deck as long as it's not impeding something. A lot of the slide decks are let's look at our rehab 3000-square feet. I'm looking at everything, and then 1 ½ hour later, I'm just bored to death. That's the way I am with classes. It's like, oh, another slideshow. Courtney: We emphasize adding value. Tommi: That's good news. Mike: At some point during that day, you'll want to see the overview, so we know it'll be used. Courtney: You're describing the situations where lawyers come in, and then there are roadblocks. Has a company ever won against you? Tommi: No. Courtney: That's what I thought. Tommi: When I issue a 483, which is the list of observations based on the Food, Drug, and Safety Act Code of Federal Regulation sections 800–1200, I know the law. It's just in my head. If I am at a firm and I give you an ultimatum, I'm going to say, this is what I see. If you can fix this and tell me it's okay, then you will not get this little observation. An observation starts out and it's a canned thing that the agency has. All the regulations that have this little can thing. Then, there's the next sentence where the investigator comes in and says, specifically, you did this at this time on this day with this person. That specifically points out what's happened. That's what the investigator has to do. Courtney: In our personal conversations, you've said that one of your favorite things is when people go to jail. I'm wondering if there is a favorite story you have. I know you mentioned the one about the thyroid device, but is there another story about somebody being convicted? I know you've posted some things recently on the OCRA page. Tommi: There have been some clinical researchers. There's a thing called the Application Integrity Policy. That's I caught you committing fraud. Fraud against the federal government is a really serious thing. There are doctors that have had jail cases. Their sentences get reduced sometimes, but they've been prosecuted and they can no longer work on any clinical trials. They can no longer work in a pharmacy or medical device company. They can no longer provide anything that's regulated by the FDA or the agency. Bear in mind that $0.25 on every dollar, Department of Health and Human Services touches somehow. Food, drugs, cosmetics, and everything in the world is the Department of Health and Human Services, which is the umbrella over the FDA. Everything gets touched by the FDA, so there you are, you don't want to just keep doing that. Application Integrity Policy is when doctors have seriously hurt somebody. An investigator's job is to find something that you can take to a jury. Pretty much, you want to take the evidence that a jury is going to understand. This is a lot of technical stuff, they've done all this research, they've done all these fun things, they've made a lot of money, and they have a lot of fun times, but here in the end is their signature when they knew somebody died. Here's their signature on a training manual. Here's their slideshow where they talked about, oh, there's only one death or maybe there were two deaths. If there are more, then we may report those to the agency, but we think it might be the hospital or the doctor. The investigator's job is to find out and find the evidence. The evidence is just given to a judge. First, it's given to the Office of Criminal Investigations. It was right here in San Clemente. I used to spend lots of time down there with them at lunch. The Office of Criminal Investigations looks at it, and then they take it to prosecution or legal counsel. In that instance, that's the important part of somebody getting prosecuted, not because I like to see them go to jail. I like to see them pay the penalty for harming people. The fact that a doctor can ever work again I think is probably better than going to jail. Mike: That would be very devastating. I agree. Let's take another look at it. I want to ask the question of all the companies you've walked into either uninvited or invited, you've probably seen some really good things too. What would you say to those listening who are going to encounter inspections or are going to just want to do their job well from a regulatory compliance standpoint? What are some of the basic rules of the road and rules of the trade that you would tell anybody, hey, if you follow these rules, you're going to be in pretty darn good shape? Tommi: One of the crucial things for leadership to understand is that I talked earlier about the silo. You have regulatory people and you have manufacturing people. A really good program is everybody knows what everybody else is doing. You don't want marketing to run the company, you don't want regulatory to run the company, and just always just go by the book. Every department should be able to sit down and have time together. Everybody needs to know what everybody else does. That's very difficult in a company small or large to get somebody to understand why it is you want to sit there and read code books and why it is you want to know about these things versus why somebody in marketing wants to talk about something being the greatest, the best, treat this, and do this, but it's not really quite accurate. They don't understand why that regulatory person is sitting over here saying, you can't really say that because that's not true. If we say it's treating something, we have to have clinical studies that say that. For good management and a company that really works well, everybody knows what everybody else is doing. You see the posters together. Everybody's interacting together. I mentioned pizza. A lot of times, there are pizza parties after I leave. Everybody's getting together to celebrate. Whether they got 483 or not, they're together. A really good leadership program and management of companies is everybody knows a little bit about what everybody else does. But if they're siloed, then everybody is doing their specialty, not understanding. Marketing has to know when they're selling this product that the regulatory is saying, no, we don't do that and this doesn't do that. Manufacturing is saying, I changed this product. I'm doing this and this will be faster and speedier. Wait a minute, design control over here wasn't told. That's getting everybody together. A really good company and really good consultants will say, let's everybody get together. Every department head does a walkthrough all together. One of the things I really like to do when I'm doing a mock audit is I like the CEO with me and every department manager not in their suits and ties. We're going to come together one day and just going to walk through. We're going to do walk through just as another employee. I watch them and see if they talk to people and see if people talk to them. You need to know your employees, and the employees need to know you. They need to know that you care about them and that you're there for them. On your next consultation and consulting job, that's one of the things I would like to hear that this company does. Mike: Get to know people. Courtney: People drive results. Mike: There you go, dropping the slogan. Tommi: That's good. That's social media stuff. Mike: Excellent. We're pretty close to wrapping things up here. I heard the doorbell. Pizzas come in. I have to make four different trips here in our virtual world. Tommi: We did that one time at our board meeting. We were meeting virtually, and we just had Grubhub. Everybody got dinner at 6:00 PM. Mike: I think that's the beauty of these services. Everybody can still have dinner together. Tommi: We're trying to come out next week and be a real board and meet in person. Courtney: Is that next week? Tommi: Next Wednesday, 6:00 PM. Be there, be square. Courtney: It's right around the corner, Mike. Mike: It sounds really close to us. Tommi: Where are you? Mike: We're right in the Irvine Spectrum. Tommi: This is up at the district right at Jamboree right across from AMC Theater. Mile: Is that an OCRA event? Tommi: It's the board meeting event. Mike: Oh, not everybody's welcome. Tommi: No, I'm hearing that somebody else is going to have an event soon that they're going to give me information on. Courtney: Yeah. We're doing and organizing Chaos webinars with OCRA in April. Tommi and I were working on that and coordinating that. We have to fill out some paperwork. Tommi: It's just one page. It's really easy. I'll help you. Mike: If you don't write it down, Courtney. Courtney: I did. Mike: That was awesome. Tommi, I want to say thank you so much for being here and talking to us. Your stories are fascinating. I think we could probably keep talking for a lot longer, but in the interest of time, we're going to move on to our little game that Courtney has prepared. Afterward, we're going to capture some key takeaways from your thoughts too, but first, we'll do this game. Have a little fun. What do you think, Courtney? Courtney: Yeah, it should be fun. What we're going to do is like we do in some of our previous episodes. It's just rapid fire questions, Tommi. I'm going to ask you a series of 10-ish–12-ish questions and as quickly as you can answer is what we're looking for. First thing off the top of your head, and then I'll ask Rishi and then Mike. Let me know when you're ready. Tommi: I guess I'm ready. Courtney: Do you like cats or dogs better? Tommi: Cats. Courtney: Do you have a secret dish that you can cook? Tommi: Tuna noodle casserole. Courtney: What motivates you the most? Tommi: Flowers. Courtney: What is your favorite work memory? Tommi: New boots. Courtney: What's your favorite season? Tommi: Fall. Courtney: What do you have a hard time pronouncing? Tommi: Disestablishmentarianism. Courtney: What has been your favorite age so far? Tommi: Nineteen. Courtney: Would you rather fly or have super strength? Tommi: Super strength. Courtney: Do you own your own Netflix account or do you use somebody else's? Tommi: My own. Courtney: What is your go-to karaoke song? Tommi: You ain't nothin' but a hound dog. Courtney: Our last one. What is the last thing you searched on Google? Tommi: Your company. Mike: I was going to say Tommi Papson. Courtney: Tuna noodle casserole, huh? Tommi: It's the only thing I can cook. Mike: I have so many more questions. We have a whole other podcast to go through now that you've answered those questions. Rishi: Do we get the same questions, Courtney, or are they different? Courtney: They're different. That'd be too easy. Rishi: I was preparing answers in my own head. Tommi: If we've learned anything today, reading it [...]. Courtney: Rishi, you're up next with new questions. Are you ready? Rishi: Sure. Let's go for it. Courtney: What was your last impulse buy? Rishi: Phone. Courtney: Which celebrity annoys you the most? Rishi: All of them. Courtney: What mythical creature would you believe was real? Rishi: Zeus. Courtney: What's your favorite pun? Rishi: I don't know. Courtney: What is humanity's worst quality? Rishi: Importance of materialistic things. Courtney: Where do you live? Rishi: Phoenix, Arizona. Courtney: Who is your favorite boss? Rishi: Mike Ferletic. Courtney: What's your favorite holiday? Rishi: Christmas. Courtney: Would you travel to the past or the future? Rishi: Past. Courtney: Okay, the end. Good job. Mike: Rish, why did the mushroom walk into the bar? Rishi: I don't know. Why did it walk into the bar? Mike: He's a fun guy. Rishi: What's funny is I really love puns, but I couldn't think of any on the spot. I follow a bunch of pun accounts on Instagram and I just couldn't think of any on the spot. Mike: Sitting here observing, we have a lot of time to think, so we'll fill in the gap. All right, Courtney, I'm ready for you. Courtney: Are you sure? Mike: Yup. Courtney: All right. What's your favorite number and why? Mike: Eight. It's my birthday. Courtney: What is your favorite cake flavor? Mike: White cake. Courtney: What subject were you best at in school? Mike: Math. Courtney: What scares you the most? Mike: There are a lot of things. Probably bugs inside. Bugs outside are fine, but bugs inside, no. Courtney: Cats or dogs? Mike: Dogs 100%. Sorry. Courtney: I have both. It's fine. Tommi: I have both. Courtney: What's your hobby? Mike: Right now, I've learned to sail, so sailing is a hobby. My wife has learned to sail, not just me. Courtney: What is your favorite beverage? Mike: Red wine. Courtney: Then one more, if you had to be a Disney character. Who would you be? Mike: Oh my goodness, my favorite character having two kids growing up, I think is Tigger. He’s the guy just because he's always happy and always having fun. Rishi: Good answer. Courtney: That's awesome. That's all I have in terms of the game. Thank you all for playing. I think one of these days, Mike, you need to flip the tables here. Mike: I know. I was just thinking that. We're going to get to ask you some questions one of these days. That was awesome. I actually really enjoyed learning about our guest. Tommi: I could do that right off the cuff. Courtney: That would scare me, Tommi. Mike: I really enjoyed the game, Courtney. It was great at learning about Tommi and learning about Rishi and getting to participate as well. Let's move on to some key takeaways. As I mentioned, just great conversation. Tommi, thank you. What did you take away from this, Courtney? What can you share with us? Courtney: I really think that leadership, being able to stand by the people that they lead throughout these difficult times for instance such as an FDA investigation, is really critical to be a good leader from Tommi's experience in what she said. That's such an excellent takeaway. Leadership characteristic is just being able to stick by your people, educate and support them, and not leave them to their own devices or play the blame game. I think that that information has been excellent to hear. Mike: What do you think of Rishi? Rishi: Courtney took my first one, so I'll skip that one. That was my initial answer. The other one I had was you mentioned that good leaders often start off as either students or workers before they become a leader of a large organization or a large group of people, which I thought was really interesting. It leads me to believe that they're able to have that same mindset as the rest of the people in their company and it ties into what Courtney just mentioned. I would say that that's my second biggest takeaway. Mike: That's awesome. I think there were a lot of takeaways. Since I'm going last here, I'm going to mention two. One that really stuck with me, Tommi, was as Rishi was mentioning, some of these people that are new to the workforce are growing in their career. As a leader, having the willingness to reach out and mentor individuals is what helps those individuals grow in their career and become great leaders. That was just really insightful. It's a simple thing that's leading others in a way that may or may not get noticed visibly, but it's something that helps grow people in your organization, whether they stay there or they move on to other bigger, better things. The other thing that I wanted to mention—actually, I think Rishi, you confirm this from Tommi—is that top-to-bottom buy-in. Leaders really look to get that buy-in in their organization. Getting that buy-in and making sure people are on board and on the same page may not always agree, but they get buy-in and people know why they made decisions the way they make it. That was a great insight as well. Thank you so much, Tommi. We really appreciate you being a part of this and for hanging on for our extracurriculars here as well. Tommi: I loved the game. Mike: We have a little fun here while we're at it. This was awesome. Thanks so much. Again, Tommi Papson, our guest today, on the Leaders in Life Sciences Podcast. We'll look forward to talking to you next time. Take care, everybody. All right, let's wrap this up. If you like this podcast, please don't forget to subscribe. That really helps us out. Also, leave us a five-star rating. That's a big help too. If you like, please feel free to share your thoughts in the comments as well. Thank you for listening and hope to see you next time on The Leaders in Life Sciences Podcast powered by Enterey Life Sciences Consulting where people drive results. Take care.

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