Compliance Insight FDA Consulting



everyone for attending this presentation on compliance insight this is a very special presentation for me mainly because I'm the vice president and co-owner of the company I've got a lot of blood sweat and tears invested in compliance insight and and I can say this this is a very special company out there a lot of people we've worked for have given us an awful lot of very good feedback on our services we really strive to be value-added for the company and we we really try to be a little different than everyone else we really want to be a service provider to you that adds value resolves the issues get you back into work again and that being said let me let me just go through this introduction to you compliance insight we offer hands-on effective value-added compliance solutions we go above and beyond the call of duty to get stuff done we really work with you try to make things happen effectively efficiently and in compliance with the regulations we really focus on getting things done in a timely manner and a very proficient manner and try to get it done in compliance we have to balance all of those activities together we specialized in QA and are a services nationally and internationally for us FDA regulated industries we focus on quality regulatory in a variety of industries we deal with clinical operations and I'll talk about that a little bit here later and and that is really a new service that we've offered and we we really focus on FDA regulations and anything coming into the United States anything that's made in the United States we really try to help companies meet those requirements our services are practical they're straightforward and they're easily implement we really strive to be to that standard you're looking at here our company focus we try our best to be practical to meet your requirements and I can say if you really are interested in bringing us on board we're very open to give you names of people you want to talk to ask them what we do how we did it and and get some feedback from them we we have a quite a list of people that we work for some we we can't obviously give you the names and info for from confidentiality but we can certainly put you in contact with Lowe's that really like to discuss with you various things about what services we provided let me let me just continue on with this you see here a nice picture My partner and I had Cynthia iPAQ she is the one that started the company and went out there made that great leap of faith and very brave lady she went out there said I'm gonna do this I'm gonna get this thing started and brought me in to help out and we've worked together now for 13 years at at the time of this this recording and we have dealt quite a bit with a lot of things across the world the United States North America Europe and Asia and we really look at ourselves as we try to go anywhere in which there's a call for a need for our services our dedicated team and we have quite a few on our team now there's a it's time again of this recording we have about the thing about 10 people and we have about 10 to 20 other people that are at call that are contracted to us to serve with us overall we have well over a hundred and fifty years of combined knowledge and experience in FDA regulated industries the the one thing we look for with people are that they have to have hands-on practical experience and knowledge in the field in which they work we truly try not to get people that are theoretical that don't have that practical hands-on in the trenches dealing with the problems day in and day out that's the type of consultant we look forward to work for us and we really push them to make things happen in a compliant manner for you as the customer the client to make your company you a success so Cindy started this company in 2000 and really offered hands-on quality assurance and reg affair services to the pharma and medical device industries a year later she brought me on board I'm the co-owner and vice president troy Fugate I joined the company in 2001 and since that time we have grown just leaps and bounds because of our success model we really try our best to go out there offer people a value-added service we are not there to suck you dry of money we aren't there to build for hours upon hours we are there to try to make things work trust me when I say we will put in extra time just to make it right for you our recent addition been very dedicated people Julie Gary Locke for one very knowledgeable very very impressive young woman that I tell you she is absolutely fantastic in clinical area she she can discuss anything and everything with you if you have any clinical questions certainly by all means contact us and ask to speak to Julie she will give you the the straight narrow answer on clinical operations our value proposition to you I can tell you this every consultant we send to you is going to have 15 plus years experiences in the Frenchy's they have to be in the trench get their shirt dirty get their hands dirty understand what works what doesn't work why it didn't and really try to get in there and understand how to solve a problem not just to give you the theory that yeah this sounds good but it doesn't work when the rubber hits the pavement it just doesn't work we have a unique ability to get around some politics the chat or the roadblocks that typically get in the way of a quick response to any FDA issue and and I can say with that in mind our real forte is dealing with the US FDA trying to get companies out of problems and we we look at it in two factors reactive and proactive we can come in and try to help you get things fixed before they're found by the FDA or issues fall apart or as they fall apart and you have problems we can come in and fix those issues there as well so we have a great deal of experience in just getting by all the issues that would stop a typical group from getting stuff done we just get things done we try to work with the company we work very diligently with a variety of people but we really try to get by those things we offer workable options for you in order to get something done me at remediation of an issue or getting things done proactively there's more than one way to solve a problem and it's certainly not my way or the highway we come in and we say look this is what we would have to do this is what we see and this is the issue and let's think about how we're going to get there what's an interim option that we can do to fix it right now to have it functional and then what's the long-term resolution how can we make these things work for you we look beyond the observation and try to get to other areas systems with within the entire company to make sure that it's not just focused in one area we say look this is a systemic issue we want to be able to go out and fix it across the board this is what we can do as an interim as an intermediate and a long-term fix at least give you the path to get to compliance taking into consideration that the firm needs to be operational as well as compliant we work extremely diligently to bring systems into compliance quickly efficiently effectively and as compliant as possible to make you a success you can't operate in a down situation you can't operate in a data analysis situation forever you have to have your systems in place you have to be able to move forward and that's what we're there to provide the ability to move forward capacity to speak to all levels of the firm be it from a CEO down to a mechanic we really work efficiently trying to deal across all layers in the company to talk to people on their level with an understanding that they need to be provided we have field experience to institute procedures company-wide that are compliant functional very important they're functional and really work as opposed to theoretical fixes things that look good things that look great in the office and don't work in the field we really bring that to the table our experience is multifaceted and continues to grow so what you see here is as of the time of this recording US FDA and e.u regulatory bodies we have quite a vast experience knowledge in that DEA experience USDA we have due diligence if if you are looking at buying a company or if you're looking at trying to understand what's going on we can perform due diligence new construction Greenfield what they would call that training validation I don't know list all these for you here you can see them just understand we continuously add to this list and provide you a variety of services and backgrounds we will not tell you we can do something go out and try to find the person to do it if we don't have the capacity to do it or the capability or the background and knowledge to be expertise in the field that you need then we will try to help you find someone and give them give you that reference for them and hopefully you can make a connection there continuing with some of the experience just more detailed parentals large and small volume parentals oral tablets capsules liquids joint mints api's finished products cosmetics healthcare foods biologics we deal a quite a wide variety of background field experience in these type of operations we really want to get a diverse background of people working for us so that we can understand what is needed in these areas and if you call with a particular question then we can give you the right expertise in that area our services the capabilities and unique benefits I can tell you this compliance insight is a group of highly trained QA and RA people professionals educated hands-on knowledgeable people that will come in for you and fix your problems we have proven track records in a variety of fda regulated industries we provide all sorts of issue resolution and these are just some of a partial list pre-approval inspection prep audits getting ready for the audit dealing with the issues after the audit supplier contract manufacturer audits CMOS we deal quite a bit with virtual companies that come in to say we have the knowledge to make it we have the background and the science and technology but we don't have the quality or we don't have the regulatory background we'd really don't want to hire people for that we really want to just contract that out we provide those types of services quite a bit GMP gap analysis to understand where your gaps are in your GMP compliance and that could be in a variety of industries but we really focus on gap analysis this is a proactive approach if you have an issue with an FDA audit 483 warning letter consent decree we can come in and provide the gap analysis of where are all the other issues while also helping you fix your FDA issues we can conduct laboratory audits we can again do due diligence things that company you're looking at buying maybe a product you're looking at buying we can come in there and look at the GMP compliance from that regulatory we can look at filings across the board I Andy's NDA's supplements in your reports quite a bit in the clinical aspect we deal with we can be your fda liaison we can ask the FDA questions with complete anonymity they don't have to know it is from you we can we can probe various areas in the FDA trying to understand what really the the proper response is to a question and approached you with the responses from that we can also deal with FDA problems for 83s warning letters consent decrees we can write it we can certainly provide the oversight when you get to a consent decree there's quite a bit more involved with that that deals with being assigned the responsibility by the court and we will certainly have to sit down with you after that to make sure that we follow what is being given to us by the court and also we like to have some firewalls in there between the people out there actually doing the consulting the providing you the input of how to fix the issues versus the group that would come in and actually verify that those systems being implemented are functioning in a compliant manner anyway we would have to go in depth with that one but we do provide those services additional services that we provide we can deal with quite a bit project management being one we can look at a compliance project and come in and give you management over those activities we can certainly give you consultation on new construction what should you do what shouldn't you do have us look at it very basic standpoint we could at least look at it and say yeah this is something I would say would be okay or you may be you need to think about X Y & Z we can approach you with Capon investigation issues two very closely related items that have quite a bit of potential problem with the FDA viral studies looking at the data cleaning validation validation planning itself across the board SOPs risk analysis QbD type approach viral lot release type of questions and evaluations of data and also Nicolle studies clinical data clinical audits and we provide those types of services as well GMP GCP GLP all fall under something called GXP just to cover everything and there's all sorts of things out there from good documentation practices good distribution practices both of which by the way our GT GDP and Clinical Laboratory manufacturing anything that you think of that would be good X practices we can certainly provide you some services on that we provide in-house training we provide annual training we can provide new employee training to give you the tools and resources to educate and bring up to speed new employees we can deal with biosafety consulting on looking at clients with the expertise needed to design develop global regulatory testing strategies we also have an accreditation program is typically a 20 week program if you do one class per week that can be certainly changed based upon your particular requirements and we have had quite a few students come through that and we've had people actually visit us on site and go through these things very quickly we've had groups of people attend this this is a program in which you set the tone for how you want to be trained we will train you to those standards you just have to let us know what it is you want and how you want us to train you these are customized so there's no running program with this you just call us up and we will send you the application and details of this and at that point call us talk to us we'll answer all your questions and try to get you enrolled in this firms without regulatory issues in firm with regulatory issues these are the reactive versus proactive approach firms with regulatory issues 43 warning letters consent decree whatever it is our firm has the ability to contain the situation to provide you with interim controls to bring you back into operation have you in a state of compliance satisfy the FDA compliance issues and then deal with long-term issue resolution our main goal there is definitely to reestablish the firm's credibility with the FDA we want to make you compliant we want to make sure that you have a successful future and our our goal becomes your goal firms without regulatory issues we deal with them on a variety of topics providing short-term gap resolution to any specific project that might involve GMP compliance we can serve as your trained and experienced workforce on an as-needed basis we've had several people myself included actually serve in companies as they're part-time workforce until they were able to acquire the director the manager whatever it is to fill that position and we served in that basis just to make sure things were moving forward and there was no drop of services from the company our goal is to maintain your compliance status with the FDA understand the difference between those last two bullet points on both of these columns one is reestablishing it one is going to maintain it above all else we strive to be value added to your firm if we are not value added to your firm then we have an issue I can say this from my experience with this we will call we will try to set up conference calls emails whatever it is face-to-face visits to make sure that you are completely satisfied with our services we want to be a value to you if we aren't again we have an issue and we need to fix it and we will go to great lengths to make sure whatever the issue is that we resolve it some of our success stories I'll go through some of these briefly here and there would be more detail on some of these and some other presentations but this one dealt with a cosmetic and customer and a consumer products company as a major healthcare product company in the Midwest they had a major contract and we served as their temporary QA department for this firm to go through resolve all the issues we actively worked on internal issues deviations unplanned incidents external issues customer complaints outside audits that were going on we dealt with a lot of internal audits we performed all areas of operations in the plant manufacturing packaging warehousing just to name a few we dealt with a lot of CAPA items we followed up on these corrective and preventative actions to ensure that they were complete and the effectiveness checks were performed we executed changes to increase the company's quality score by 40% we saved that company from a catastrophic financial downfall and loss of a major client they appreciated this to the nth degree they really had a problem we came in quickly and we resolved it this is talking about a medical device firm there was a warning letter that the firm received we were contacted by this company to help with a warning letter there were a number of significant GMP and observations abroad provided in this and and they had a real issue going on the following steps we took to reestablish the regulatory compliance we prepared the warning letter response with a timeline to complete those activities we provided periodic status updates to the FDA for each of those observations in notification of remedial actions that were taken for each of those cases we trained all the employees on quality system regulations we established quality systems at all levels of the organization you can understand the depth and breadth of the work involved with this we prepared and implemented procedures per the quality system regs we communicated with the FDA on a continual basis to ensure that all those pending issues were addressed in a satisfactory manner the follow-up inspection by the FDA was a resounding success and the firm went on to be very successful we're talking about here is Canadian medical device license dealt with a 510 K in a Canadian license application foreign manufacturer of Class two in vitro diagnostics we're trying to get their market products into the US and Canada they turn to us for assistance we worked closely with the clients u.s. agent we prepared and submitted a number of 510k applications we submitted those to the FDA and Health Canada we took the following approach to make sure everything was satisfactory in both countries we identified the appropriate predicate devices for those 510 K applications we obtained and reviewed necessary documentation from the client we develop protocol for clinical studies needed to demonstrate substantial equivalence we participated in the coordination management and review of additional clinical studies required by the FDA and we successfully prepared and filed submissions to both the FDA and Health Canada the client now legally markets a number of in vitro diagnostic devices in those two countries United States and Canada and very successful at that endeavor API compliance this is dealing with an active pharmaceutical ingredient company they were going from ISO 9000 compliance or requirements to a q7 a IC H the client was a medium-sized chemical company they wish to produce an API for sale in the EU they already supplied chemicals to numerous pharma companies under an ISO standard they needed site wide training to close the gap between those ISO 9000 requirements and the IC hq7 a good manufacturing practice for aap is we went in implemented a training program to understand so to teach the people to understand what the differences were so they could understand q7a that was a big item all employees had to receive that and understanding what the FDA requirements were subsequently the company's quality systems were reviewed we establish ort and long-term corrective action to close those gaps between ISO and q7a and there were some that were back and forth the client successfully completed the implementation of that program Global Pharma manufacturing complaints this is a European manufacturing facility a US firm acquired a manufacturing facility in Europe all systems at the facility had to be evaluated and variances from the current GMP s in the United States had to be remediated the project spanned two and a half years during which a significant undertaking was was put forth and involved these items pointed out here plus I can tell you hundreds of more mainly I can tell you because I was the one that was involved quite a bit in this we audited remediated the USP purified water system there were several anomalies we trained all people across all systems on how to get into GMP compliance where the investigation system was brought to current FDA standards validation program was completely overhauled and implemented HVAC controls were established put in place monitored and check systems put in place for those the facility design the flow of material all those things had to be evaluated understood modified and improved to verify everything was in control the laboratory systems were evaluated streamlined the warehouse system was modernized to GMP compliance there was a lot of work a lot of activity there I can tell you this we we strive to get things done and it just took this amount of time to get this activity implemented we actually were involved with the FDA audit the company hosted that FDA audit which we worked in responding to the initial list of 43 s and we effectively gained approval for the manufacture and distribution of their products in the United States a pharmaceutical consent decree resolution this is a massive success story I can tell you this was very tough anyone dealing with the consent decree will understand this it was a large Midwestern solid oral dosage form company contacted us for help in compliance with meeting US FDA consent decree requirements we went in and actually worked quite a bit we were on site QA plant managers for two years really worked on site trying to provide a service to the company we completed quality operation utility facility and warehouse system overhauls completely all procedures all documentation we had direct contact with FDA during audits during this period of time we provided options and viable paths to be compliant this is really where our ability to be flexible and understand the variety of ways to meet compliance came into play we didn't just look at this is our way or the highway we said wait there's more than one way to be compliant with this let's understand it let's see what our options are and let's understand before we make a selection and move forward what we're going to deal with and make sure we're going down the right path we did not overwhelm the firm with auditors and consultants I've certainly seen this companies come in they have problems and auditors come in like a like a just a plague of locusts they come in they're everywhere they there's too many of them to deal with they suck the company dry of money and and then they pull back that's not what we deal with we really focus on getting in there with the right number of people working with the services that you have the capabilities that you have and approaching and working with you to make sure that we're all going down the right path we met all required dates for compliance activities we served one year as the operations QA oversight to assist with continual improvement processes we implemented new investigation processes and Campa programs and we served short period of time as the interim quality director and I can tell you compliance provided quality oversight for the first product to be approved for manufacture and shipment post consent decree it was a major undertaking and it was a major success for the company and for us as well we put a lot of hard work into this and I'm not going to understate anyone's efforts that went into this and it was really a major effort compliance completed the project with the system functioning within acceptable parameters and we continue to provide services to the company as they need it and our real goal out of these type of issues are to work ourselves out of a job we are there to provide a temporary service on projects or issues we feel that if we do a good job then we get worked out of a job right there but if there's something else that comes up you'll look at us as the people that you want to be brought back in and to help you with future issues global API compliance this is a major undertaking by complaints there was a new API facility in China we were hired to establish Quality Systems file all the regulatory submissions and manage validation activities the facility was constructed in rural China the project spanned one and a half years and which time we did the following the facilities utilities the manufacturing equipment the API processes were all successfully qualified and validated all the quality systems were established put in place work out all the bugs and make sure everything functions appropriately we provided GMP training for multiple subjects including q7 a validation documentation practices distribution practices API processes we had drug master files that were written submitted and accepted we were able to work with the language cultural and regulatory differences to the complete satisfaction of everybody involved the prior approval supplement for use of the API manufactured at the facility was approved subsequently by the FDA the S FDA that's the Chinese FDA invited us to actually hold an IC hq7 a training for Asian industries interested in marketing to the United States that was a major request from the Chinese FDA we actually conducted that training and certainly if you're interested in anything like that give us a call we can certainly help you with that dietary supplement issues going on there was a lawsuit compliance was engaged by a law firm to conduct audits and investigations on international facilities to remediate a potential cause for contamination we had to work quickly effectively efficiently looking for specific items we perform GAAP assessments of 26 contract manufacturers and contract labs around the globe and internationally I can tell you it was a major undertaking by a number of people compliance investigated potential contamination of the dietary supplement ingest it by an end-user all 26 facilities were evaluated and findings shared with the law firm there were probable sources identified and they were certainly subsequently handled processed computer and cleaning validation providing oversight and aid in those areas compliance was engaged by a very large international firm due to FDA compliance issues regarding valid ferm needed to re-execute a majority of process equipment method computer facility utility and cleaning validation protocols they had to be evaluated if they were deficient they had to be reacts acute 'add we reviewed all those protocols for GMP requirements we established protocol formats we corrected the deficient parameters in the protocols we completely reformulated the cleaning program implemented it's validation that was a major undertaking just in that line-item alone we performed all those tasks in the timeframes that were established all the protocols were successfully executed the firm has passed subsequent FDA inspections there's been no other issues with regard to this the implemented cleaning program was successful to such a degree that the firm forwarded that process to other sites in their organization that was a major feather in our cap and we took great pride in having that done once we get started we're not just going to come in and get started and leave you hanging in limbo we will have periodic conferences to discuss the status whatever you arrange for and you're comfortable with certainly depends a lot on the topic the issue that we're they're working on it could be daily it could be weekly it could be monthly whatever it is we work with you to make sure you're in the loop timelines are established and agreed upon we have due dates we have milestones we want to make sure that we track these things if you say we want to have a complete GMP overhaul by the end of the day tomorrow we can tell you upfront that's not going to be able to be done we will work with you on establishing something that is meaningful that is something that yes we might have to stretch a lot of people and to get these things done in the timeline that we say we can do it but we will agree with you that yeah we can get this stuff done this is what we'll need to get it done we provide final written reports to you as needed on anything that you ask of us we will certainly help you find the issues and provide the solutions or give you a lot of options in which you can go in and understand what the best best path is for you why choose us I'm asked this constantly why would I choose you over X company why would I even think about you like I can tell you this we make certain that compliance issues are properly resolved everyone can do that yes but we're there to look at what you need in the time lane you need it and we're there to work with you to get it done in a program in a process in a system that functions in your company with your unique situation I can't go into a large multinational international firm and say here's a program that works for them and try to implement the same thing for a small 50 person company it doesn't work like that the concepts are there you just have to make those things fit for you we work with you we work for you we work to make sure you're completely satisfied we value our integrity I can tell you if you can hear just the passion in my voice going through this we are very compassionate about what we do compliance be a quality regulatory or clinical we deal with compliance and we're compassionate about doing it and doing it right we're committed to you we don't come in and say all right here's team a and we're going to be okay with this and then we're going to pull the rug out from under you and go to team B that's not what we do your success is our main goal you will see the results

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