How to Prepare for, Manage, and Follow-up to an FDA Inspection – GlobalCompliancePanel

hi everyone welcome to global compliance panel alive of webinar on how to prepare for manage and follow-up to and FDA inspection my name is level I'm going to rehearse today on behalf of the global compliance penalties I would like to thank you for being part of this event today's webinar will be presented by the check schedules Jeff Kellogg is RF ec2m and as the director of quality at megameters a leading manufacturer of endoscopy and colonoscopy devices where he oversees the operation of the quality system in this position Jeff is responsible for oversight of the document control system and if the primary relation with regulatory officials why do this Jeff spent 13 years at life-track incorporation as the director of regulatory affairs aware he was responsible for compliance of the corporate quality system just received as a regulatory affairs certification in 1996 and has quality management certification in 2013 we are honored to have such a distinguished person such as Jeff curse off with us for today to represent this webinar with us ladies and gentlemen before we begin I would like to inform you of the program on flying for this training session this webinar is for 60 minutes duration but Jasmine take you through today's webinar highlighting the area that would be covered and he would then share with you his reservation and also like to inform you that all participants once they're part of this teleconference they have been placed on mute and will remain so until the Q&A begins towards the end of this webinar this is for the purpose of avoiding any kind of discontinuity and for allowing to present it to speak clearly so that everyone was present in this webinar can take Maximus benefit I also request all to hold back your question until the Q and a window begins 10 minutes of time will be allotted for the clan death during which your questions will be answered and ladies and gentlemen if for any reason you get locked out of this training session or teleconference I request you all to follow the same procedure to join it again now that we are all ready to start I request Jeff to take it from here yes thank you so much for the introduction list let me welcome everybody to this webinar for those of you that have never attended webinars before I really think the only detriment the only downside you're going to see is that quite honestly I can't see you and and you can't see me the way I like to address that at the end of webinars that I believe has worked for me in the past is certainly will have a Q&A session but if you feel like you want to have that evolved into more of a discussion a give-and-take kind of hypothetical or actual discussion I'm more than happy to do that I just want each of each of y'all to leave knowing what you felt like you wanted to know when you attended this webinar well as you are all well aware today we're going to talk about the FDA inspection well i'm going to talk you're going to listen on quite honestly and you're not going to hear me use any glowing terms you know I can you're not going to hear me use any positive adjectives either let's be honest here the best you can hope for is a an inspection that is not unpleasant different inspectors have different techniques some are a little more combatives and others others maybe want to try to come off as friendly and they may be others are trying to make a name for themselves to get out of the field to be able to be focused in the office in the compliance office regardless of the inspector blaming your bad inspection report if you will on the inspector is like for those of you who have kids or for those of you who remember having kids when you could come some with a bad report card and you ask about that and your kid says well my teacher hates me that doesn't matter we have to perform just like your kid we have to perform at the end during the FDA inspection so whatever the reason for a negative outcome it's your negative outcome so we have to try to plan as best we can for the FDA inspection looking at the outline just the agenda if you will going to talk about the authority to inspect you know the FDA is going to come to your facility I like to provide a little background as far as what what gets them there and why they think they can come there quite honestly then we'll talk about the types of inspections there are different types of inspections and in understanding the type of inspection undergoing it'll help you understand the reason for the inspection and therefore what the inspector is looking for then we'll talk about pre-inspection preparation I'll mention this now because I like to make it a point to mention it at least once during my presentation about FDA inspection your pre-inspection preparations should be an ongoing practice I've worked at firms that where once a week that senior management on-site or at least mid-level management will take one SOP and do a kind of internal audit on it and when they have something that changes they'll change the SOP via dec or whatever your document control processes and that way you're performing a pre-inspection preparation throughout the entire year then we'll talk about the inspection itself they call or they don't and the inspector shows up and what to expect and some good recommended practices I think and we'll talk about the clothes that meeting the classic statement of which finally over is not actually applicable to the closeout meeting and we'll talk about that also and then post inspection activities much like pre-inspection preparation to some extent post inspection activities should be done throughout the year but specifically I'm going to talk about immediate postal inspection activities how to respond when to respond etc and then we'll have a summary and hopefully you agree that the summary ties everything nice and nicely and neatly together before getting into the inspection itself it's important to understand the FDA's I guess they're right to inspect your firm can the FDA show up at any time day or night would have huge feel like letting the inspector in for whatever reason well the FDA can enter and inspect at reasonable times the bottom line is that this isn't an issue to be two concerns about as often as many people grouse about how the FDA is trying to take advantage of them what's critical what's important to remember is that the FDA is a business just like yours they want to utilize their assets and personnel or resources to get maximum value sending an inspector to affirm at 7am or 5pm is really just asking for a failed attempt at beginning and inspection remember inspection is designed to get an accurate picture of your compliance and they can't do that if no one's there so the chances of them are trying to get one over on you a pretty pretty minimal the FDA can also inspect enter and can inspect at within reasonable limits in a reasonable manner you know what unfortunately the word reasonable is not defined here having said that though you know since the statute doesn't define reasonable the FDA is established establishment of section procedures say that their authority extends to what is reasonably necessary to achieve the objective of the inspection so going back again to what is it that they will be objective of the inspection is to get an accurate compliance snapshot of your firm therefore their utilization of the term reasonable is going to be one that makes sense you can refuse to allow the inspector to enter your firm I mean you can do anything some things of course we're not legal some things are not right but you can do it you can say the inspector you know it no I'm not feeling it I'm not letting you in today and the inspector will absolutely not fight you on it he or she will just not certainly ask you for your name and nod and leave and that's it it's going to be as non-confrontational as that unfortunately what's going to happen next is that the FAA inspector is going to come back with a search warrant and in some cases a magistrate to administer that search warrant to issue the warrant that's not something you want to do what I'll mention throughout the presentation is that quite a bit of the FDA inspection is mental it's all that perception if you begin an inspection by not allowing the inspector entry into your facility that's going to be a problem and what lets the FDA come in is when you list with the FDA as a medical device or a farmer or supplement or whatever manufacturer manufacturer you are you in essence allow them access to your facilities and your records so that's I guess what gives them the right to get in now moment ago we talked about refusing an inspection but you can certainly recommend to reschedule there may be instances in which your primary well and your second is using in your secondary FDA liaisons or absent in many cases this will be more true for a small to medium sized companies than a large company at which there were multiple levels of FDA liaison as opposed to refusing the inspector access we can't let you in because there's nobody here to show you our compliance system you can certainly recommend or more accurately request to reschedule you want to make sure that you have a procedure that accounts for this possibility so that somebody can come out even if it's not you are let's say regulatory and quality people who may be your to liaison so maybe have your rng guy for your vp of ops operations come out and show the inspector your procedure that says if both are absent the senior person on site will request a risk scheduling and that way you have a procedure you're able to show compliance to an internal procedure and this will increase your likelihood of the inspector saying you know what that sounds good we can certainly do this your procedure is going to have also in it who these liaisons are you don't want you don't want their when you're trying to appeal to the inspector you don't want there to be any gray area

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