podcast_S.Niedelman-E.Henry

How can medical device companies be better prepared for remote and on-site inspections and audits? Practice, practice, practice so that you’re always audit-ready.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectively, within the FDA and Life Sciences division of their law firm, King & Spalding LLC.

Listen to this episode where Steven and Eric share their keen insights and knowledge from working in the global regulatory sector of the medical device industry and offer best practices and tips that will help you prepare for FDA inspections and other audit events.

 

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Some highlights of this episode include:

  • The FDA plans to resume remote inspections by focusing first on mission-critical inspections related to pandemic breakthrough products to play catch-up using a prioritized, risk-based approach.

  • Preparing for FDA inspections versus the Medical Device Single Audit Program (MDSAP) and other audits will differ based on type, such as for-cause and premarket inspections or warning letter re-inspections in the United States or European Union.

  • The QMS exemption was created to allow non-traditional device manufacturers to manufacture devices. These manufacturers must comply with 21 CFR Part 820 if they intend to keep their device in the US post-pandemic.

  • If you are new to the industry or have a QMS exemption that requires you to do significant remediation of your existing quality system for compliance with FDA QSR or ISO 13485:2016, follow these four steps:

    • Scope what QMS elements are needed. 

    • Conduct gap assessment.

    • Prioritize resolution of gaps to address compliance, safety, efficacy issues.

    • Execute comprehensive program plan and continue to update progress.

  • Medical device organizations preparing for an upcoming inspection should follow these best practices: 

    • Profile investigator.

    • Prepare opening presentations.

    • Stage accurate and up-to-date SOPs and records.

    • Staff appropriately for right roles and skill sets.

    • Have a front and back room.

    • Conduct dry runs and mock audit/inspection activities.

 

Links:

Steven Niedelman

Eric Henry

King & Spalding LLC

FDA and Life Sciences practice of King & Spalding

FDA Medical Device Single Audit Program (MDSAP)

European Union Medical Device Regulation (EU MDR)

European Union (EU) Notified Bodies

Medical Device Coordination Group Guidance Document — MDCG 2020-4

ISO 13485 - Medical Devices

FDA Review and Update of Device Establishment Inspection Processes and Standards - Guidance Document

FDA Premarket Approval (PMA)

FDA Emergency Use Authorization (EUA)

FDA Quality System Regulation - 21 CFR Part 820

564A - National Defense Authorization Act 

Personal Protective Equipment (PPE)

Post-pandemic Readiness - Global Medical Device Podcast episode

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes by Steven Niedelman & Eric Henry:

“It’s been quite some time since many firms have undergone some inspections and we felt it would be a good reminder for folks to get their house in shape once inspections resume.” Steven Niedelman

“You’ll need to provide more emphasis and more preparation and more drills for your technical and your clinical subject matter experts that are related to the design, the development, the clinical testing, the manufacturer of that particular product.” Eric Henry

“You really need to make sure that you’ve looked at issues systemically, and not just in isolated examples. Again, it’s all about making sure you have evidence to demonstrate that it’s been effective.” Steven Niedelman

“What does perfect look like within a quality system?” Eric Henry

“Keep things going so that you can answer the FDA’s questions in the most expert way possible and in the most expeditious way possible.” Eric Henry


Transcription:

Announcer: Welcome to the Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Jon Speer: Joining me on this episode of the Global Medical Device Podcast is Eric Henry and Steve Niedelman. Steve and Eric are both with King and Spalding's FDA and Life Sciences Practice and they provide a lot of insights and wisdom and practical tips for you as a medical device company on preparing for FDA inspections and, frankly, other outdoor activities as well. So, I hope you enjoy this episode of the Global Medical Device Podcast. Hello and welcome to another exciting episode of the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. And of course, we're all aware of everything that's happening in the world today. And quite a few episodes of the Global Medical Device Podcast we've talked about sort of the impact that things like COVID and the global pandemic have had on our industry. Joining me to chat a little bit about some of the things that we can do to better prepare as an industry are Steve Niedelman. Steve is the lead quality systems and compliance consultant to the FDA and life sciences practice team at King and Spalding. And also joining is Eric Henry. Eric is the Senior Quality Systems and Compliance Advisor with FDA and Life Sciences Practice at King and Spalding as well. So, gentlemen, welcome back to the Global Medical Device Podcast.

Steve Niedelman: Thank you, Jon.

Eric Henry: Yeah, great to be here.

Jon Speer: Well, last time that we spoke, we started to dive into a few different things where there's some adjustments and things that we need to be aware of or factor in to our lives, but also from a regulatory and from an FDA perspective. And I think one of you suggested, " Hey, might be a good time to kind of talk about what to do to prepare for an upcoming inspection. How to prepare for that." So we’ll dive into that for a little bit today. So I guess once live or probably for the foreseeable future, remote inspections resume, do we have any idea of where FDA is going to focus first?

Steve Niedelman: Yeah, Jon. FDA, as we mentioned during the last podcast, FDA has on July 20th, came out with a plan to resume inspections, albeit they are really rarely taking place. But they are going to focus, initially, on mission critical inspections. And their definition of a mission critical inspection would be a for cause inspection or compliance follow up, certainly a public health emergency, an imminent risk to health or pre-approval certainly that are focused right now on pandemic related breakthrough products. Those will be their targets initially because there will be a bunch of catch up that's necessary. So you can expect that if you've had a warning letter, if you have had some kind of correspondence from the agency, they're going to come in to verify corrections, determine your current status. And one of the concerns that Eric and I had in identifying this as a potential podcast item is it's been quite some time since many firms have undergone some inspections. And we felt it would be a good reminder for folks to get their house in shape once the inspections resume.

Jon Speer: All right, any other thoughts on that, Eric, before we dive into the next tidbit here?

Eric Henry: No. Well, just this, I think because the FDA is going to resume remote inspections in this prioritized way, this very risk based approach to when they begin to resume on site inspections, I think that even maybe more so than they have been in the past, the MDSAP inspections for those people that are part of the MDSAP program would be relied on for routine inspections to qualify as a routine inspection for the FDA. We had talked a little bit in the last podcast that we had about remote inspections and I think those will continue for some time both under the MDSAP program and the EU. I know we're talking a little bit about preparing for FDA inspections, but I think it's worth noting that onsite inspections are also a requirement under the EU medical device regulation. And in fact, the European Commission on January 11, so very, very recently published its comments on on- site inspections versus remote inspections. And they reiterated the importance of on- site inspections and that they are a requirement of the regulation. But also sort of following way late on the tail of the MDCG guidance allowing for remote inspections, said that they did concur that that was good rationale for those remote inspections but that they wanted to make sure that beyond the absolute lockdowns that COVID is requiring, that those on- site inspections resume as quickly as possible. And that regulatory competent authorities within the EU keep the European Commission informed on how those remote programs are going and any particular issues they might have with compliance to the regulation using that program.

Jon Speer: Okay. You bring up an interesting point on the MDSAP side of things. If I'm a firm that's going through that process, is my preparation for MDSAP going to be different than an FDA inspection? And I think to highlight some of the things that Steve mentioned as far as how FDA's going to prioritize and focus, sounds like there's going to be an emphasis put on maybe more for cause or firms that maybe have some previous observations or warning letter situations. Can you kind of compare and contrast my preparation as a firm with respect to FDA versus MDSAP or other types of audits?

Eric Henry: Yeah, sure can. So whether you're going through a notified body audit for compliance to the EU MDR or under the MDSAP program, keep in mind that the tone, the nature of those inspections and audits tends to be quite different than what the FDA will likely execute. Especially in the case of a for cause or a 43 warning letter follow up or even a pre- market inspection. So where the inspection is likely to be very broad, it covers all the contents using ISO 1345: 2016 as the fundamental basis for the MDSAP audit program with tailoring for the specific country regulations. It may deviate some from that. They'll hit each of those elements during the MDSAP audit. And so, preparation is pretty broad but also likely not quite as deep as you might get during a for cause, 43, pre- market type of inspection. So the way I see preparation differing is that in a 43 or warning letter or even for that matter, a for cause inspection, you going to have specific areas of exposure that you need to make sure are addressed in the inspection. So in a 43 and warning letter re inspection, you've likely already agreed with the FDA on a set of actions and how those need to be executed over a certain period of time. You've been giving them, likely, periodic updates on your progress. So during the re inspection need to show clear evidence that those actions have been completed. If you've done a quality management system remediation within your program, you need to show that those actions have been completed and tie those in as much as possible to those actions that you committed to the FDA. And I would recommend also that you pre- stage the warning letter or 483 you pre- stage all of the updates you've given to the FDA, the documentation that supported the completion of all the actions on a pretty wide basis. Meaning that not just the action that says this is complete, but associated processes, chart, progress indicators, program management plans and so on. For cause inspection, especially those likely unannounced in many cases but if you do get some warning, I'd recommend doing something like a heat map where you can understand clearly what your level of exposure is on each of these areas, the FDA's concerned about. And think about things like CAPA or other things that you can quickly move to execute or begin executing that show how committed you are to resolving those issues and provide those as for the FDA. In the case of a pre- market inspection, I think the preparation differs primarily in its focus. So an MDSAP covering the whole quality system in a pre market inspection from the FDA, you're going to look at product specific information records, data, clinical data, study data. You're going to do deep dives into the design history file and device master record for that particular device. If you're doing a manufacturing tour, as is common across audits and inspections, you'll need to tailor that specific... If your manufacturing, site manufactures more than one product, you'll have to tailor that tour and that route that you're going to plan ahead specifically for that product. And I would say that as you prepare your subject matter experts, you'll need to provide more emphasis and more preparation and more drills for your technical and your clinical subject matter experts that are related to the design, the development, the clinical testing, the manufacture of that particular product very deeply, more so than you would for an MDSAP inspection.

Steve Niedelman: Let me just add very few additional thoughts to what Erica has very eloquently and really deeply articulated. You need to make sure you're going to have examples to be able to demonstrate it works. You're going to need illustrative examples to demonstrate that the SOPs have been applied, " And here are examples and here are the changes and this is what we've seen and here are products that we've manufactured to demonstrate that the issue has been addressed." I would suggest that they may come back and if it's not product specific, they may pick another product to see if you looked at across product lines to ensure that you were taking a holistic approach, especially if it's a quality system issue. You really need to make sure that you've looked at issues systemically and not just in isolated examples. And again, it's all about making sure you have evidence to demonstrate that it's been effective.

Eric Henry: Yeah. That systemic approach Jon, that's probably, in Steve's experience and mine as well, that's probably one of the biggest gotchas in inspections where the FDA is coming back after having looked at you before. Is that if they don't see evidence that you solved the problem systemically across your quality system, across your product lines, across your various organizational entities, and instead you're just trying to solve the specific example they cited, you can expect a repeat citation and maybe worse.

Jon Speer: For sure. What you guys are both talking about is probably why CAPA remains to be like the number one issue cited during FDA inspections. It seems like people or companies are very quick to kind of slap a band- aid on it, so to speak, and try to get through that CAPA exercise very quickly. But they could do a little bit better job to get to the true root cause and address it from more of a systemic issue perspective.

Steve Niedelman: Exactly. Sometimes there are so many are open, you need to prioritize. But just the signal that while we've opened up CAPA... I've been at firms, I'm sure Eric has been at firms, CAPAs have been open for two or three years and there's no activity. So the premise is you're going to address the root cause. You're going to determine an effective outcome and be able to demonstrate it through verification of effectiveness.

Jon Speer: For sure. The last time that the three of us spoke, we talked a little bit about some of the things that have happened as a result of pandemic, including things like UAs and 564As and just to remind folks, the 564A, companies that, I guess, were granted this... I don't know the right verb there is, but it was granted.

Steve Niedelman: Go ahead.

Jon Speer: I was just going to say that the 564 basically allow companies to proceed but gave them a QMS exemption. So obviously this is something that needs to be addressed on a go forward basis. So any thoughts about that?

Steve Niedelman: Absolutely. 554A was we have to demonstrate when we submit those applications on behalf of clients, we have to demonstrate some level of a quality system, whether it be 9001 whether it be the automotive quality system, aerospace, etc. But at the end of the day, as firms come out of these exemptions, at some point they're going to be expected to be compliant with 21 CFR part 820 or if at that time at some point in the future the agency adopts the ISO requirements which we are all anxiously awaiting for that announcement which will probably be coming at some point this year. But nonetheless, this exemption was created to allow nontraditional device manufacturers to manufacture devices. And so, coming out of this pandemic, as you referenced and we mentioned during our last podcast, that they need to be building their compliance with a 20 if they intend to stay in the device business.

Eric Henry: Yeah, I would say that and I think we mentioned this a little during the last podcast. I would encourage people to go back and reference that as well. But just to briefly restate, if you are new to the industry or have an exemption a QMS exemption that requires you to do significant remediation of your existing quality system to come into compliance with the quality system regulation or, in the future, 1345: 2016, you will need to look at this in four steps, in my view, in the way we're encouraging companies to do as well. Which is first of all to sort of scope what QMS elements you need to have. What does perfect look like within a quality system. And then do a gap assessment against what you already do to see where you're falling short of that quality system. And then a prioritized way, a risk based way, prioritize the resolution of the closure of those gaps so that you're hitting things that address significant compliance issues, safety issues, efficacy issues right up top immediately. And then you plan those the remediation or the closure of those gaps based on that risk of a priority. And finally, you execute against that plan. And that execution needs to be accompanied by a pretty comprehensive program plan that says, " Here's the full list of things we intend to do in priority order. When we're going to start and end up and who's responsible." And then keep those up to date with progress because it's one of those inevitable Murphy's Law kind of things if the FDA or MDSAP auditor is going to show up on your front door before you fully completed that quality system remediation program in full. And so because of that, it's important that you've handled the ones that they would be most concerned with first. And that you show progress against the remaining issues that you haven't yet gotten to, you have the gaps you haven't yet closed, to reduce the risk of findings or further enforcement actions because your quality system is not compliant.

Jon Speer: Do you think that the QC guidance is a good tool for companies that have this 564A exemption?

Eric Henry: I think it is a good tool. There's a couple of tools I would actually recommend for the 564A. And again, I know that the FDA has not yet gone to ISO 1345: 2016. But if you look at the MDSAP and specifically they have a document called the MDSAP Audit Approach Policy that they published, I think third or fourth quarter last year, that outlines all the 1345 requirements and furthers into that, 21CFR820 requirements, which is the quality system regulation where they might differ from 1345. And I think if you're looking at a full quality system, what do I do. QC is good but QC focuses on a few areas, the heavy hitter areas that FDA would come in and hit during a quality system inspection. And it'll certainly cover the bulk of where you might have exposure in the quality system. But if you want to really see where all of the details are and where the full quality system is laid bare and presented in a way that you can develop action items on across the entire set of processes, I might encourage you to go to the MDSAP audit approach, even in preparation for an FDA inspection.

Jon Speer: It's a really good idea.

Steve Niedelman: Everybody needs to keep in mind conformance to a quality system is a baseline. It's not the gold standard. It's considered a minimal requirement. And what I would encourage firms that earn 564As, as we stated the last time, they need to... If they're planning on continuing to manufacture these devices post pandemic, as Eric mentioned and we have spoken in the past, the need to start moving towards compliance with these requirements.

Jon Speer: Terrific. Folks, I want to remind you that I'm talking with Steve Niedelman and Eric Henry. Both gentlemen are part of the FDA and life sciences practice at King and Spalding. Gentlemen, do you mind maybe sharing a few words about the FDA and Life sciences practice at King and Spalding and what types of services that you help medical device companies with?

Steve Niedelman: Gladly, the FDA and life science practice at King and Spalding has a significant amount of depth and expertise in all areas of FDA compliance, FDA requirements, as well as reimbursement and CMS requirements for those firms needing assistance with reimbursement issues, courting issues, etc. We have extremely knowledgeable attorneys as King and Spalding is a law firm, an international law firm with expertise in FDA practices all over the world. And our attorneys, many of which are former chief counsel attorneys, we have a number of other folks with deep industry experience. The depth of our knowledge of our attorneys is exceptional and have been recognized as, in the past many, many times as the FDA practice of the year by many organizations. We assist in all post market, pre market, clinical study areas. We assist with internal investigations, white collar issues, other types of investigations. Eric and I are part of a consulting group within the practice that assist firms with quality system remediation, hopefully, in a proactive way, but often they're found to assist firms that are reacting to FDA findings and FDA issues. We have a clinical staff on staff as well to assist with health hazard evaluations of renowned cardiovascular physician who has served as the chief medical officers, those familiar with FDA requirements and expectations for health hazard evaluation for recalls, etc... We really do provide all services that can be associated with any FDA regulated industry from conception all the way through. We work with firms to help them go out of business and retire registrations internationally. So, we are basically cradle to grave on all FDA activity.

Jon Speer: ...or service. Terrific. Thank you for sharing that. Folks, you can learn more certainly by going to kslaw. com. Want to remind you too that since we're talking about inspection prep, Greenlight Guru, we're here to help you as well. Greenlight Guru has the only medical device quality management system software platform in the industry. It's been designed specifically and exclusively for medical device companies by actual medical device professionals. Many of our, well, all of our customers frankly, are going through some sort of audit and inspection as part of their lifecycle as a medical device company. This is just standard course and standard operating procedure for any medical device company. And we hear stories all the time from our customers about how the Greenlight Guru medical device quality management system platform is making their audit activities much, much smoother even in times like we're in now where the need for remote inspection has become a thing, it's become a reality. So learn more by going to www.greenlight.guru we'll be happy to have a conversation with you. All right. So getting back to the conversation and I guess keeping in mind that as inspections resume, there's a pretty good chance that a lot of the companies that are going to be subject to inspection, this might be the first time or maybe it's been a long time. So what are some of the prep steps that you have in mind for companies that may be going through this FDA inspection for the first time or it's been a long time since the last one.

Eric Henry: Yeah, just briefly and I'll pass it over to Steve. Both of us I think we could almost do an entire podcast just on this one question because there's not only some great fundamentals that every company needs to go through, but there's a wide variation in circumstances and in capabilities within companies that sort of drive how preparation occurs. But just to kind of go through a bullet list of things to think about. And obviously this would be tailored to your situation, your staff, your circumstances, what kind of inspection you're going through. But you might want to start off, especially if you get a notice of inspection, with doing things like profiling the investigator. There's a couple of tools out there you can use to do that, to determine what level of expertise the investigator has which might give you a sense of where they would focus their efforts, where their sweet spot is. What their personality is like? What are the nature and frequency of the observations that they make at companies. And again, that kind of intelligence can be had from a couple of sources out there. You need to do things like prepare opening presentations, not so much marketing your products but giving the investigator right up front, a sense of what your firm does. How many people there are, what kinds of products that you manufacture, maybe a high level overview of your quality system and your manufacturing process. Need to look at things like staging SOPs and records so that they're quickly available to the front room when necessary in an inspection. In some cases, in a case of something like a warning letter or re- inspection or pre- market inspection, there are certain documents you might even want to pre- stage in the front room itself instead of just having in the back room in reserve so that they can just reach back and grab them immediately on demand. You want to make sure that you're staffing appropriately with the right rolls and the right skill sets, both in the front room and in the back room and with your subject matter experts. You need to have a front room in a back room, the room where they are going to be, that's the front room where your host is. The back room where all the support staff are that manage the requests that are made, bring the subject matter expertize to bear, track all the documentation that's being moved into the front, keep things going and so that you can answer the FDA's questions in the most expert way possible and in the most expeditious way possible. You should do dry runs and maybe we'll talk a little bit more about how important those are later. And really it's two flavors of dry ones runs. One, to bet people that are going to be in the inspection and providing direct interface to the FDA so that you make sure you have the right people in the room. Sometimes the person who knows the most about a particular topic is not the person that should be saying what they know in front of the FDA. So you want to make sure you have the right people in the front and then also have a full dry run of the entire inspection so that you get the mechanics of that kind of worked out. And get the kinks worked out of the system of being able to respond to the FDA. Obviously, look at tools that you need for things like communication, managing question, scribing, determining what are you're going to provide, what systems you might provide, electronic records directly to an investigator versus paper records. Most companies still provide mostly paper records to the FDA during inspection but there is some migration occurring to electronic in certain cases. Get that workflow between the front room in the back room down. Prepare your site, do tours with predetermined paths, make those parts of your dry run. Have the clinical data that you need to support safety and efficacy available and easily accessible. And obviously, have an SOP that drives all this.

Jon Speer: Yeah, it's key.

Eric Henry: And make sure that you're following that so that it's not just reinventing the wheel every single time. And finally, what I'll say before I turn over to Steve, who I'm sure has a plethora of other ideas as well, because he's been through this many, many times on the other side of the table, the one asking the questions. And that is to sort of pre- structure what you anticipate might be custom report queries that are requested. So in many cases, they may ask for certain types of complaint records or certain lists of complaint records over certain periods of time for certain products or CAPA lists or whatever. And some of those a tool just churn out but in some cases, you may be asked to generate reports or lists of things with certain criteria or under certain parameters. And so, you need to be prepared to generate those queries and those reports to the FDA in a reasonable time. And sometimes that takes a little preparation as well.

Steve Niedelman: Let me give you some fine points to what Eric has already articulated and has provided an excellent summary of what needs to be done. It's important during your opening presentation, you have current tables of organizations that are available to show lines of responsibility, management responsibility. And since it's been quite some time since the last inspections, you might want to make sure they're updated and fresh. There may have been some personnel changes over this period of time. Make sure that the SOPs that you have prepared for the investigator, that they're being followed. It's not uncommon for an investigator to ask as they're given a tour of the floor, " Show me in your SOP what you're doing." And if they have to dig all the way down at the bottom of the fourth drawer of their desk, it does not present a very favorable approach. They need to have current SOPs or the SOP that they're following is four versions late. So you need to be careful about that too. So make sure everything is fresh, make sure everything is up to date and is inspection ready. Make sure the employees know their roles and responsibilities from the security guards and the receptionist when the FDA walks in and shows their credentials and or badge both. Some may have badges if they're from the field, those that come from the center do not. They need to sit and wait and make sure notice of inspection has been issued before any inspection begins. Make sure on your SOP that your ordered SOP in your opening presentation articulate your policies with regard to, as Eric mentioned, the availability of electronic records. And if you do make electronic records available or you give them access to electronic records, make sure that you don't have availability to your entire system, it's a scrub computer. It just provides the information they are getting, they can search elsewhere. Make sure it's very limited in the scope of what they're able to do and be able to access during that inspection. SMEs need to be made to be also be audit friendly and audit ready. As Eric mentioned, I've been in front of expert SOPs who when I challenged them in preparation for an inspection, will tell me it's the stupidest question they ever heard. That does not go over well. So not everybody is audit ready. That opening presentation should clearly articulate your availability. I mentioned the photographs and other things so that it doesn't look like it was an ad hoc decision if the FDA asks to do something that you do not want to share, such as signing of affidavits. So that you want to say you're not in conflict with your audit procedures. As Eric said, the front room and back room are critical, front room being the audit facing room, the backroom is the glue that keeps an inspection on track. Most important, make sure IT is ready. I've been at firms where, all of a sudden FDA shows up and they clear out a conference room. IT is nowhere to be found. There are coffee breaks. They can't get the equipment ready. They don't know where the computers are for scribing, etc. IT needs to be ready and that's where these mock audits and mock inspections help to get them ready and know what their roles are. Everybody needs to sort of know their roles. There should be a call down list. When FDA shows up so that everybody's aware that FDA it's on the premises. And it's important to ensure success by having daily updates and addressing any issues that may be found during the day that may be identified, should be identified by the investigator at the conclusion of each day, potential for three items etc.

Jon Speer: Yeah, that's great tips. A couple of things, hearing both of your comments certainly emphasizes the importance of doing some dry run and mock inspection activities as preparation. And I think a lot of times, unfortunately, what I experience or hear from companies is that when they get notice of an FDA inspection, it's like everybody's scrambling and it's like, " Time out. This is the normal." It should be normal everyday business, the fact that FDA is coming for an inspection. Okay, that's a little abnormal from the normal flow of day to day activities. But nonetheless, the FDA doesn't have to give you advance notice that they're coming, nor does an ISO order. So, we should be prepared for this all the time. So this is probably something that companies should think about as part of their internal auditing program. Is do more dry runs and mock inspections, make sure that IT is set up. I think IT is really important, especially now, considering that a lot of these audit and inspection activities are probably going to have a remote component to it, which is going to have some sort of technology involved in some way, shape or form. But talking about dry runs and inspections, what other things do you think are really important about this that the company should be considering?

Steve Niedelman: I've done a number of mock audits, mock inspections, just leading FDA. And one of the biggest challenges sounds stupid, but just the entry to the firm. And walking in, identifying yourself as an FDA investigator with credentials and or a badge and the secretary receptionist has no idea what to do, where to go, who to call. " Oh, who are you here to see? What are you here to do? Oh, well, why don't you go down the hall and go see so and so." There should be a formal process from very get go. And everybody in that chain needs to know their role and need to know their responsibilities. And these mock audits are critical. The old adage, " How to get to Carnegie Hall? Practice, practice, practice." To your point, everybody should be audit ready at all times. People should also be familiar with the relatively recent FDA guidance on inspections. Well, not for cause but for generally other inspections. For most, they will give you five days notice. They have a time frame for conducting inspections. But of course, they also have the right to stay longer if there are issues associated with recalls, complaints, etc. But generally, most inspections will now last, they're sort of predictive in three to five days. And they are to provide you daily updates so that you know where you stand. Which they should have been doing all along anyhow. Some investigators, unfortunately, don't like to follow those rules but everybody should certainly be, as you mentioned, audit ready, to go. And the best way to get there is through these mock audits. Internal audits should be identifying everything FDA finds. It always surprises me when I go to a firm that's had 14 or 15 observations from FDA, they get a warning letter or they're about to be conducting the last internal audit, " Oh, we found two or three things." Then your internal audit program is not adequate. It's an opportunity for you to self identify with no consequence. And they need to be as robust as FDA inspections.

Jon Speer: I would even go a step further. I think companies should consider their internal auditing should be way more robust than any FDA inspection.

Steve Niedelman: Exactly.

Eric Henry: Yeah, I would say just going back to the mock piece and again, you can use mock inspections if you want to do that sort of full up front room, back room as part of your internal audit program. That's a great way to kill two birds with one stone if the timing aligns. I would say just a couple of extra points on dry runs or mock inspections. First of all, realize that they do take time, resources and money. Understand that you're going to be taking people away from their normal day jobs. You're going to have to speed up some things. You're going to have to allocate space, take people and tools, put those together, assemble those in ways that actually do have some cost and some impact to other work that you're doing. So recognize that up front but also realize that up to a certain degree, there's value to that. I mean, you can overdo anything, you can overspend on any of these preparation activities but there's value to that to a certain point. And I would say that those dry runs too should come in a couple of flavors. First of all, especially for organizations that are new to getting these kinds of inspections and they really don't know. The people have never been through them. And I've been through a lot of this where I'm talking to people that have never been in front of the FDA. And even in the mock, they're scared to death. They don't know how to conduct themselves. They don't know if they're going to say too much or too little. They've heard these horrible war stories from people about horrible things that have happened in front rooms. And so, those first few sessions need to be very gentle. They need to be more coaching. If I was the FDA and I was to ask you this, how would you answer or just answer between us and let's work on the wording after you... Say it how you would say it if we were just over a beer. And then, let's talk about how you might reword that if you were asked in a more formal setting. So be very coachy, very mentor- like and approach them like that. And then, the next the second or third or fourth time through this, then you begin to say, " Okay, I'm going to put my FDA hat on and I'm going to be very much like what I think an FDA investigator would be like." Or you're going to get an expert in who's been through those or who's done those who doesn't know your people and could be a little more assertive and be an outside person that they won't recognize. And so they'll be a little bit more formal by nature and by instinct. And get that down and then have those hats on moments. But then when something goes wrong or somebody doesn't say something or you just want to go through a few topics and get some feedback then say, " Okay, now my FDA hat is off, let's recap. Let's look at some ways we can reword these things." So I think just having that formal and informal sort of stages and types of dry runs is very important. And I also think that those dry runs can provide input to sort of story boarding or laying outlines or scripting responses to areas that, as you do them, you see are very tricky. Where you might have an area where you've got more explaining to do or where there's some compliance gaps that you need to kind of work around and tell them how you progress through it, but it is not an easy explanation. Because maybe you're using terminology or concepts or multiple locations and it can get confusing. So you lay those out in a clear storyboard and it gives you indicators where that's going to fall apart in the front room. So just a couple of things on that dry run front.

Jon Speer: Yeah. It's important. I've been through enough of these. I know both of you have as well, that sometimes the person being subject to the inspection or the audit they're terrified. And that fear really becomes an impediment to good progress during an inspection. I think that's why these dry runs or mock inspections are really key so that people who are going to be part of this activity, that their minds are at ease a little bit, that they've kind of rehearsed it, so to speak. And I don't mean it to sound like it's rehearsing something to try to hide something. It's really about rhythm. And I remember the first FDA inspection I sat in, I was absolutely terrified and I didn't have coaching and we didn't do a mock inspection. And the little bit of advice that I was given is, " Don't say too much, just answer the question directly." So these dry runs and mock inspections, I think, can be really helpful.

Steve Niedelman: Let me just...

Jon Speer: Yeah, sure.

Steve Niedelman: Let me just say a couple of thoughts there. So, especially concerning is during tours and FDA questions or asks people that are doing their job on the line. Those guys are totally petrified. These are many times hourly workers. They don't know the big picture. They don't know everything that's going on. And sometimes they misstate information not because they're intentionally doing it, they just get flustered. They have no idea. They have no clue. And before you know it, it becomes a rabbit hole. Because then their story conflicts with what management is saying. And before you know it, there are suspicions, etc. That's why these mock audits of getting these folks, everybody gets up in the morning, the FDA investigator is no different than anybody else. They're human beings and it's really concerning... I was in a mock audit where FDA started to draw Title 18 conclusions because the person they spoke to on the floor conflicted what was stated in the office. So you got to be really careful. And sometimes, quite frankly, there's a lot of value to having third parties come in to do these mock audits so that it's not somebody you're always buddy- buddy with. And so, they get accustomed to strange faces asking questions, probing questions and getting familiar with those kind of situations.

Eric Henry: I think that's a really good tip. I mean, sometimes that third party objectivity does two things. It's somebody from the outside coming in who, you as the auditee are sort of in that hot seat, so to speak but needed to present information to satisfy the questions that are being asked. It's a fresh lens, but also gets the person going through the audit used to and familiar with people that they don't work with on an everyday basis, asking those questions. So I think that's a really good point.

Steve Niedelman: Exactly. And as you said, it's a fresh set of eyes that sometimes will highlight issues that are unbiased. And familiarity breeds contempt. Sometimes you're blinded by what you see every day. So sometimes there's a lot of value for us or anybody else to come and do some of these mock audits.

Jon Speer: I mean, this is what the two of you do for a living. So and you do it for a lot of companies of all shapes and sizes all over the place. So you have a lot more context for sure. So I guess as we start to work toward wrapping up today's conversation. Questions, so should my inspection preparation include preparing for remote inspections? Or should I assume that the FDA will not be resuming inspections until they can be onsite for the entire time?

Steve Niedelman: I would prepare in a hybrid fashion. There's really no authority for FDA to conduct virtual inspections for devices, although they're working. We understand that there's initiatives ongoing to consider trying to develop some kind of a program. It requires some legal finagling along the way. If the FDA can't issue a notice of inspection, it's not an inspection. So we have heard situations, we've heard examples of where firms, FDA have shown up, issued a notice of inspection, left then did the rest of it virtually so that they were covered. Because if they uncover any evidence or any information without a notice of inspection, it's totally inadmissible. They can't do anything with it. So the notice of inspection is critical. They're trying to develop something to do a virtual. As Eric indicated, MDSAP inspections are being conducted virtually. So for those in the MDSAP program, you need to continue to be prepared to conduct them virtually. I would suggest that if, as time goes on and vaccines start to roll out, that you will start seeing more the greater possibility of FDA on site inspections. And in preparation for that, I would still expect firms that might not have considered this in the past to be well prepared with PPE, protective gear. I think there will be a period of time where FDA will expect you to continue to follow those, to have that available, that they will certainly follow all CDC guidance and guidelines on that. For those of you who do combination products that are in the pharma world as well, they are exercising... FDA is utilizing their 704A authority to collect information, records requests that they are using and reviewing and helping to prioritize future inspections. And they have indicated to me that information collected during those 704A requests for documentation, if they see it's problematic, they will be issuing if noted, I don't know if they've actually done it, untitled and warning letters to those firms where they felt that information was not adequate. So I think the answer is, it depends. And I think timing is going to be the issue. Obviously, the pandemic is still quite significant and it seems to be getting worse, not better, at least for the short term. Hopefully, vaccines will help start bringing us into control over the next period of time. But if you're under the MDSAP inspection, European inspections, EU inspections, they're virtual. So, I think as more and more firms become MDSAP oriented they should be prepared for that, for the virtual concept. FDA, I think it's a little up in the air.

Eric Henry: Jon, I won't talk too much about this topic. I think there's a lot to be said about remote inspections and how they'll happen and when. And how the regulatory world is going to progress in that direction or not. I'll just give this one piece, this one little tidbit piece of advice if you are preparing a remote inspection, just kind of as a throw away for free. If you plan for remote inspections, pay particular attention to how the remote inspection will work during a manufacturing floor tour. How are you going to state position the cameras? What tools are you going to use to be able to walk around and continue to scribe and also provide commentary? What technology are you going to use? And also, does the signal strength of your wifi or however you're going to provide connectivity, does it maintain its strength and availability for the entire route that you have planned for your floor tour? Oftentimes on many of these manufacturing floors, especially for where there's a lot of heavy metal and in the case of imaging equipment, you have a lot of lead lined rooms and it kind of get in the way of these signals and you'll have a lot of dead spots. So I'd pay particular attention to remote inspection preparations and how you would conduct a floor tour.

Steve Niedelman: Let me introduce a little bit of a sidebar here. Many firms, if you're a manufacturer, you still have a requirement to have supplier quality oversight. Many firms have established remote supplier audit procedures, including virtual inspection capability with their suppliers to ensure the quality of the products they're getting. So some firms are set up with this. And I know I have been approached by at least three companies looking to establish virtual inspection capabilities that they feel will be as effective as an onsite inspection. So I know there's a lot of movement in this area. Some firms, like I said, if they're doing virtual supplier audits and there are a number of companies that are out there providing that service and I think many of them are overbooked already. But I think the virtual world is here for quite a while and I think it's something that need to be prepared for.

Jon Speer: Yeah, I totally agree. Gentlemen, I know we're just scratching the surface on this topic of inspection preparation and I appreciate all the tidbits and practical advice that you've provided today. So, Eric Henry, Senior Quality Systems and Compliance Adviser. And Steve Niedelman, Lead Quality Systems and Compliance Consultant, both with the FDA and life sciences practice team at King and Spalding. Gentlemen, thank you so much for sharing your insights and wisdom on this particular topic today.

Eric Henry: Thank you. It's quite crosstalk

Steve Niedelman: Thank you for having us.

Jon Speer: Absolutely. And folks, as I've mentioned earlier, we're here to help at Greenlight Guru as well. If you'd like to learn more about the Greenlight Guru medical device quality management system software platform, please go to www.greenlight.guru to learn more. As always, thank you for being loyal listeners. It's because of you the Global Medical Device Podcast continues to be the number one podcast in the medical device industry. As always, this is your host and founder at Greenlight Guru, Jon Speer. And you have been listening to the Global Medical Device Podcast.


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