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Transcription: Building a Sustainable Quality System for Emerging Companies: Expert Panel Discussion – Live Free Webcast

The following transcription is taken from The Windshire Group’s webcast Building a Sustainable Quality System for Emerging Companies: Expert Panel Discussion

Terri Melvin: Welcome everyone to today’s Webinar, Building a Sustainable Quality System for Emerging Companies: Expert Panel Discussion. I am Terri Melvin and I will be today’s moderator. We have with us today three expert panelists. They will first tell us a little bit about themselves and then address some talking points in their particular areas of expertise. Then we will dive into your questions live. I will now turn it over to our first panelist, Dr. James Blackwell.

Dr. James Blackwell:  Thanks Terri, and thanks to everyone in our audience for joining us. I am James Blackwell, president and principal consultant for The Windshire Group. Our hope today is to make new industry friends and acquaintances and to serve as an information resource for organizations by providing answers to some of our most pressing questions around this very important and timely topic. Just a couple of house rules before we get started. Please do not ask anything that contains confidential information. Also, for today’s webinar, we are not offering any specific advice for anyone’s particular situation and we are not responsible in any way for any use of the advise or opinions we express. After self-introductions, we will share a few of our personal thoughts about building a sustainable quality system and then we will get started with questions. I will then close our expert panel webinar with some concluding thoughts.

Prior to becoming a consultant, I held several senior technical positions within industry development and product companies. I have been an industry consultant for more than 12 years, assisting with CMC technical aspects for products in all major therapeutic classes at all stages of the product life cycle. More recently, due to the growth in this area, we have been doing significantly more work in the quality systems arena. All of all our panelists have significant experience in this area as well, and now I would like to now introduce Danielle DeLucy for her self introduction.

Danielle DeLucy: Thank you, Dr. Blackwell. I am Danielle DeLucy. I have been in the industry now for about 18 years. I had most of my training early on in the microbiology lab and then other quality systems dealing specifically with sterility assurance. I have held various positions in the quality management arena. So hopefully today you will be able to learn a lot of different topics and techniques and different things that we have been through with our experience. I will now hand it over to Ammon to talk about his background.

Ammon Eylath: Hello everyone. This is Ammon Eylath. I am head of quality with Karyopharm Therapeutics which is a biopharma company near Boston, Massachusetts . My experience really ranges from R&D through product development with both biotech and pharma. I think specifically my involvement with quality systems, as a quality person, goes all the way back earlier in my career when I had the opportunity to also deploy various quality system software packages. So, I am a user of quality systems and a person that has assessed and deployed them.

Terri: Thank, Panelists. We will now go to Dr. Blackwell for his talking points.

James:  Thank you, Terri. First off for the small companies, start simple and I think that works throughout the company lifecycle. I’d like to paraphrase Einstein here; “Your quality systems should be as simple as possible, but not one bit simpler.”

Smaller companies are stretched, even larger companies are stretched, for resources these days. So, know when to reach out for help. Electronic systems have made things much easier for companies to implement and get up to speed, but just having an electronic system obviously is not the complete answer to the challenges here. Some of these are cloud-based. So, they can be very cost effective. Everything used to be paper-based records and I think many of us know the challenges of being completely reliant on those.  Again the good news for all companies is that the offerings have really improved in this area.

In conclusion, I’d like to talk about releasing product to market. Especially companies who have developed their first product and now have that product on the market. This is a step change in responsibilities that you have. So your culture in management needs to adapt to that. There are examples of companies that never did and really got into trouble. Make sure that any gaps you have are filled at that point . Use metrics to ensure that your company is in control and improving. And learn from others. There are a lot of examples of mistakes others have made and there are experts out there in the industry that can really help.

I’d like to conclude by saying that quality truly is free. It takes the right management to see this, but it’s been proven time and time again in other industries and even within our industry. For example Amgen is a case study that improved their deviation and CAPA process and tracked their metrics around that improvement. It literally showed the tens of millions of dollars they were able to save through improvements in that system.

And now to Danielle for her talking points.

Danielle: Companies that produce products with rigorous quality requirements face numerous challenges associated with meeting quality objectives. Organizations of all sizes and across all industries can easily fall prey to quality issues without effective information controls as a core component of their quality management systems. Without a centralized and organization-wide approach to managing their content, companies leave themselves vulnerable, because of the difficulty and complexity of managing critical and sensitive information and processes that affect quality and compliance.

The greatest resource of a quality company are its people, so strategies for managing both real and perceived change, or concerns and attitudes, should be addressed during the initial planning of the QMS. Be sure to include executive management in periodic updates and progress checks along the way to implementation

A company requiring GMP and/or ISO compliance must establish, document, implement and maintain a QMS, as well as maintain its effectiveness in accordance with the required compliance standard.

And Now I’d like to turn it over to Ammon for his talking points.

Ammon: My points or purposely high level items that people can discuss. For example, the benefit of manual vs electronic systems for the small company – pros and cons; and what they really mean to be compliant with the quality system. Especially for a small company or people starting up to not to overreach their abilities.

Second point is how to best assess an electronic QMS to be the right fit for your company – small or large. There are alot of factors related to this, like usability and the type of company one has – pharmaceutical, biotech, medical devices or cell therapy.

The third point I think is interesting and has come up in the past and is my desire to see how well we can integrate a learning management system with your eQMS and is this a good idea or not?

Terri: Thank you, panelists. We are now open for questions. Simply type your questions into the question functionality box on your control panel. Our goal today is to answer any and all questions live. However, if we do not get to your question live, we will promptly answer your question upon the end of this webinar.

Now for our first question: “What quality metrics do you consider most important and what should be implemented first?”

James: I think one secret tidbit I’d like to share around here from my experience is that I think it’s been one that has been a lost opportunity that may organizations really aren’t taking advantage of and that is obviously, you know, management would be tracking this in detail perhaps in aggregate, but if you can track true root cause um and you know have those true root causes mapped to different functional units or whatever. That could be a really good leading sign of problems in your organization. So that requires your QMS system to have, you can’t have only 7 or 8 categories for root cause. There’s no way a true root cause is man power, for example, um, that’s probably going to be 200 or more root causes, that are true root causes. What’s a true root cause? A true root cause is something that’s defined in actionable terms. So when you read that root cause it’s clear what action needs to be taken to prevent that or preventing recurrence. So a truly effective quality system will be preventing recurrence of the same root cause. So the only way you’re really going to know that is trend and monitor that. So , um , so that’s sort of one more advanced area. Again not terribly difficult to implement. But can be very effective to organizations to make sure especially their deviation CAPA system is really in top-notch form.

Terri: Thank you, that answers the question. Here is another one: In building a sustainable quality management system, an effective CAPA process is a critical component and frequent FDA inspection target. What advice can you offer related to implementing an effective CAPA process? That could be a webinar of its own. Anyone want to take that one?

“How do you handle, what is best practice in risk-based audit plans?”

Danielle:   For risk-based audit plan, one thing you want to consider when you’re looking at what risks you’re willing to accept with the supplier I guess is first and foremost I would say is; what I talked about a little bit in my points to consider; balancing that business aspect with compliance. So you may see a risk with the business that they have a great compliance program. However perhaps they aren’t very good on delivery or maybe they’re a little bit too expensive in the business. So you really have to balance that risk. Do you want to have a risk to the business or more of a risk to compliance? Now I’m a quality person through and through. So I would say I wouldn’t risk a lot of my quality aspects of this supplier auditing program or risk any of the compliance that I would expect from the supplier. But some companies do choose to do that. So I guess I would say you yourself have to take that into consideration when you’re working with management. How much risk you’re willing to accept, some companies actually you know they don’t really expect you know a lot of you know strict adherence to compliance with some of their suppliers. Some companies make sure that they have a functioning quality system. It’s working properly. They’re notified of any changes. And they’re satisfied you know maybe with just looking at past FDA inspections and saying that “yep, they’re good to go.” They’re going to give me my product in a timely manner. You know they are cost effective and it’s a product that I need and it’s going to make my process go that much more smoothly. So when you’re looking at risk based auditing it’s really up to the firm to see again how much risk you’re willing to accept. So I don’t know if James or Deborah, do you have any comments?

James: I would add that as a scientist and engineer, I think it’s important to understand how their product fits into your product and where there may be some issues or problems in the past so that you can guide your auditor to focus on certain things. You know perhaps it was validation or deviations in those areas. And I think Danielle touched on it as well is doing some research and understanding the regulatory history and if there has been compliance issues and seeing what has been observed there in the past could also help focus you from a risk standpoint.

Terri: Ammon, do you have anything to add to this question?

Ammon: I think they’ve covered it quite well. Thank you.

Terri: Excellent. Great. Here’s the next question.

How do you deal with GMP versus ISO 9001 requirements?

Danielle: I’ll take that one. When looking at ISO 9001 and GMP, they’re not very dissimilar. They do require the same amount of preparation for our supplier audit, they do require that you do audit your suppliers. I would think that, you know, the GMP requirements actually go a little bit deeper when it comes to really auditing the actual process and the manufacturing piece of the audit. I know I’ve been involved in both of these types of audits and, you know, the ISO 9001 does achieve what you’re looking for when it comes to a supplier audit. It does mandate that you have this as part of a functioning quality system that you go out, you know, you take a look at your suppliers, you see what things that they could do better, you document things that you’re in agreement with. And then you provide that report to them. From a GDP perspective and in my experience I’m not sure how James and Deborah have experienced this but I believe I’ve gone a little bit deeper into the process. You know we’ve looked at a few more systems. We’ve looked intently at some deviations and CAPAs, and really see how they how they manage a lot of the different types of maybe issues and compliance concerns that kind of come about. So that it’s a little bit easier to understand their approach to quality. You know in the GMP audit as opposed to the ISO 9001 in my opinion it just seems like more of an on the surface type audit

Ammon: And to follow on with that, just because your vendor is ISO 9000 compatible, it doesn’t mean that you can’t go into the GMP types of assessments. In fact if they’re making a product or providing a service that supports GMP then absolutely I suggest going back to your scope and your agenda that you look at those areas, you may not have an ISO 9001 standard to reference but they also may just have SOPs in place to determine whether they’re following it. The important thing to know is how they are executing those steps that are critical to you, how they are documenting it and how they are communicating that to you and if you don’t have a GMP regulation to cite, you can still work out working with them to make sure that their actions are compatible with your needs.

James: The other thing I would add is that one of the biggest differences is in area of validation where that’s obviously something required by GMP and not in the ISO guidelines.

Terri: Well I think that rolls into the next question is;

How to set limits, is ISO 9001 sufficient?

Danielle: I would say it depends on what you were actually, you know, auditing for as Deborah and James have had said, you know, if you’re looking for. You know, as James said a little bit deeper into the validation of the methods or depending on what product that they’re making, you may want to, you know, go that GMP audit route instead of it’s just the ISO 9001.

James: I agree.

Terri: Okay great we all agree. Here’s the next question.

How do you manage suppliers who refuse to be audited with justification of having an ISO or GMP certification?

Ammon: I would be very leery of a supplier who refused anything upfront. Anybody who is certified, accredited knows that part of the process is verifying and if they are accredited by an ISO 9000 organization then they should understand that and if they don’t I would work very hard to work with them on explaining to them that it would be beneficial for both parties if they went ahead with the approval process.

Danielle: I would have to agree with Ammon. It really puts up a kind of a red flag when you are trying to do business with a potential supplier and they are, you know, refusing anything even if it is even, you know, compliance issues or any of their documentation that definitely does kind of put a bad taste in your mouth when you are trying to establish a business relationship with them. And as Deborah said working with them and trying to get them to understand, you know, if they work with you and you get them in a pretty good, you know, situation, this could be beneficial for them as a supplier bringing you on as, you know, as a potential business partner and could potentially open them up, you know, to more business for themselves.

But certainly, you know, isn’t a very good way to begin a supplier audit relationship by them not, you know, being forthcoming with a lot of their documentation.

James: The other thing I would add is that I would start looking at alternative suppliers as a back up as soon as possible.

Terri: Great. Here’s another question;

Is the quality agreement mandatory for any supplier or could just a purchasing specification be sufficient for low risk material?

Danielle: I would say it depends on your level of comfort with the supplier, for low risk type of things I would say that’s fine- a purchasing specification, but if you’re going to be, you know, engaging and if they’re actually doing a service for you maybe such as a laboratory service or maybe they’re filling some of your product or giving you or providing you a critical piece maybe a critical reagent or component. You know, I would really recommend that you do go to quality technical agreement. As I said in my opening statement I really think that it’s a very good document and I used it before where they really have been very beneficial, when there’s issues, maybe when there’s some questions that arise between who does what. It’s a nice document to say who’s responsible for what. And you know kind of sets up your expectations on that supplier so that it’s in writing and you know it’s a nice document to refer to throughout the business relationship.

James: I would add it comes back to your risk assessment, if you have, for example, Pharmacopeia tested raw materials such as the sodium chloride, do you really need a quality agreement with that supplier? I don’t think so. So it’s determining where that line is between for example those types of suppliers and your critical raw materials in terms of again, as Danielle said, from your risk assessment what you’re comfortable with.

Ammon: And also the quality agreement for those suppliers that are ISO 9001, you can work in the GMP issues that you want to consider there with the supplier and the quality agreement. And so when you audit them, you’re auditing their ISO 9001 certification and you’re also auditing with compliance to the quality agreement that they’ve agreed to. So that’s how you would work if you’ve determined that the kind of service that they’re providing requires a quality agreement

Terri: That kind of wraps up that question. Here’s a really good question:

What if I have a component that is a critical piece of the process but there is only one supplier that can provide it? But they recently failed their supplier audit.

James: Well I would say it’s not a fun situation to be in. I think that’s an example of where you need to understand what it takes to address that criticality to my bullets at the beginning of the talk and work with them on it. It sounds like a situation where if you really need them, that may be a situation where they need additional support from you and you need to consider that because as the question had said, you don’t have a backup. And so you either stop manufacturing or you need to help them fix their problems and you need to work to that. The situation is going to be complex, there is going to be legal issues and so forth. But you know there’s no easy answer to a situation like that for sure.

Ammon: I was recently actually embedded with a supplier who didn’t sell their certification but they had an extensive observations on an audit with lots that needed to get fixed. The sponsor actually embedded me with a supplier to remediate all of their observations and get them ready for reinspection.

Danielle: And I actually lived through this as the sponsor. I’m trying to, you know, qualify the quote unquote failed supplier for a very critical element component of a certain product that we were working on. It took quite a long time but as James and Deborah said, you really need to have that supplier’s best interest in mind. And pretty much, you know, work with them to get them in a state of compliance because obviously it’s going to help you as well. You know, obviously when the FDA or any other regulators coming to your site, they’re going to be looking at, you know, what you’re doing to make sure that your suppliers are in good standing. So it’s definitely going to benefit you as the company who has the supplier onboard you know to get them in a state of compliance so that you yourself don’t get an observation for, you know, utilizing a subpar supplier.

Terri: Okay. Thank you. Now we have a question almost on the other end of the spectrum here.

How often should a supplier be audited if they’ve been an approved supplier for many years?

Ammon: I would say when you develop your supplier approval and monitoring SOP. You’re going to have different categories of criticality of the supplier and in that process of doing your risk assessment you will determine what suppliers need an onsite audit, what suppliers need a checklist. You will determine once they’re qualified the frequency of onsite audits and the frequency of updating their information. And you’ll also be monitoring them and keeping a file on them. And if they continue to comply with your quality agreement and it’s a good relationship then you determine how frequently you need to go in on site. If they’ve had any major changes in leadership or facilities you would probably go in. But in general it’s all part of doing your risk assessment of your suppliers and what the criticality of their service or supply is to your product.

James: For critical suppliers, it’s usually every year in most quality agreements I’ve seen. And then you should have a clause in there that you can go in for cause. So if there’s problems, if there’s regulatory filings there that impact your product then you’re allowed to go in

Danielle: I think they covered it Terri.

Terri: Okay excellent. We’re going to go back. I have another question here, we’re going to go back to people failing audits.

If a supplier refuses an audit or failed an audit and they provide a critical component, could additional measures be implemented to ensure the quality of the product from the customer’s end? How would those measures differ from the measures that the customer would have otherwise implemented and the supplier agreed to or passed the audit?

James: That’s an ugly question. I think, I hate to say it depends, but you know it’s kind of hard. It’s almost like testing quality into a product and it sounds like, and you can’t do that. So if there’s issues there at the supplier and I have to talk about the case of a critical supplier, if there’s issues there and it can’t produce a GMP product or that meets GMP classifications if it needs to, then there’s nothing you can do about that because if they’re not meeting the GMPs, then the FDA considers the product adulterated. There’s nothing you can do to undo that. So I think that’s the spirit of the question. It sounds like they’re not meeting GMP requirements and in which case I don’t think there’s a lot that you could do other than going back to what we said before. If they have issues and you’re highly dependent on them, the fact is that you may have to help them address those issues.

Danielle: I agree.

Terri: Okay please let me know if that answered your question or if you have a follow up question to that. Here’s another question.

Are FDA investigators allowed to view supplier audit reports?

Danielle: It certainly, they can take a look at those. No problem, and they have.

Ammon: Yeah. It’s their objective evidence that your supplier approval and monitoring program is activated and effective.

James: That that’s part of your quality system and that’s part of GMPs.

Terri: So yes well that answers that question, just yes. Here’s another question.

How do we evaluate a quality system if the supplier tells us that we cannot look at the system records like deviations and complaints to protect the proprietary information of their other clients?

Ammon: I’ve actually had this situation frequently with auditors especially if it’s a new supplier and you do not yet have your own records with that supplier. You may not be able to see actual execution of let’s say a deviation or a CAPA for an OOS for in-process QC on a production line. But you can look at their SOPs, the forms that they use to fill it out. You also would be looking at their management reviews in their data on how many deviations they’ve had the time to close them. You can look at change control aggregate data, you can look at a lot of their quality management system information and data without having to look at the individual records in forms of a particular case.

James: Ammon I have a question about that, I haven’t done as many audits as you and I haven’t come across this. But could you ask for what I would say verbally redact that deviation so that they’re reading from it but not sharing any confidential information but nonetheless you get the essential and important details. Could you ask for that to be done?

Ammon: I suppose you could. But you have to first of all it depends on whether they have a hard copy or an electronic system and how much time you feel that you need to spend on that. I have had looked at supply rooms that had quarantine supplies from different clients and they’ve actually put screens up around the other clients and I only looked it on my client’s product. So yes in some cases I’ve asked them to shield the other clients. It really depends on how much you can find out without looking at the record and how much time you want to spend on it. Usually you get a good sense if they’re managing by the other data.

Danielle: And another thing that I’ve done on some of my supplier audits is if they do trending with different types of deviation categories, you can see how many human error deviations or, you know, processing deviations they’ve had. You know, it just gives you kind of a snapshot into, you know, what where they have kind of where their heavy hitter issues if you will. So that is another way to kind of along with what Deborah and James said to kind of take a look at how they’re managing their quality systems as a whole.

Terri: Okay. I have another interesting question here. If you have a question about a controlled process, should a supplier offer to actually make a change to the process during the audit?

Ammon: This happened to me too. I know it was a packaging supplier and I was questioning the pagination of their batch record and they actually sat down at the computer and offered to change the batch record based on my question. I asked them to stop. And of course discuss the control process of their batch record but he told me that they frequently have made changes because the client has asked them to make a change. So that was definitely a red flag for their control and their change control process. But any time anybody tries to change something or fix something while I’m there I always advise them not to do it but if they choose to do it they have to follow their control process. In most regulated or controlled organizations don’t make the change in one day. So no, don’t have them do it.

Danielle: Agreed.

James: Yeah that was a good idea to me.

Terri: Okay, I have another question here.

What should the statement of all audit observations include?

Ammon: Okay I’ll take this one too. It seems like I have these life experiences. Your observations statement in the best case needs to reference the reg or the standard or a line in the quality agreement or line in the SOP. And just state the non compliance with the wording in that reference. Just recently again, I had a company I wasn’t auditing them. I was doing another kind of review with them and they said a previous auditor told them that they had to have the names of their employees on the organizational chart as an observation, and I asked them what standard that came from and they couldn’t answer it. I would not recommend writing an observation that was an opinion or a best practice. The observations should have a good solid reference and only state the objective evidence of how they’re not meeting that reference. Anything like names on organizational charts should go in a comment section if you choose to have that in your audit report.

Terri: Danielle or James anything to add to that?

James: Ya, Ammon is right. You always want to do that where possible. However I have seen a few exceptions to that where they saw practices that you probably couldn’t codify exactly like that because it didn’t exactly speak to the CFR. But nevertheless they were practices that most organizations wouldn’t perform as a part of cGMPs.

Terri: Okay, I have a question about what is best practice. We’ve heard some people have a grading system for suppliers. Do you have an approach to institute a grading system for suppliers?

Danielle: I’ve worked with this quite a bit. And a few of the firms that I’ve worked with and consulted with, it isn’t mandatory to have, you know, a specific grading system. It really is up to the organization. You know, basically the audit report really should say if you are going to use a supplier or not use the supplier, but in some respects the grading system is used to help upper management and some of the business part of the firm decide whether or not they’re going to, you know, if they want to do business with the supplier. So usually if you’re going to use a calculation, you know, a big chunk of the calculation is devoted to quality and then sometimes people add a delivery and a service type of a category of parameter as well. So it is, you know, based just like a report card maybe 90 percent or above would be considered your satisfactory suppliers and then you would then, you know, kind of scroll down after that, you’d have maybe a bucket that would be conditionally approved meaning maybe they have fallen down, you know, on a few of the parameters and then, you know, you might need to go back and check on them. And then there is the other bucket of, you know, not approved which you were, you know, definitely had some compliance and business concerns. So it is a nice, you know, quantitative way to kind of, you know, get a quick look at it how your suppliers are fairing, how they’re doing. But I mean it’s not necessary but it has been, you know, gaining some momentum at some of the firms that I have been consulting with because of the ease of, you know, metrics and showing how suppliers are doing, you know, to those that really aren’t, you know, right in the thick of things such as, you know, the upper management of the quality group.

James: I agree. I think it could be a good practice but I don’t think it’s required.

Terri: Yes. Okay. Ammon do you have anything?

Ammon: I’m just agreeing.

Terri: Yea I have a question about what should you include in a pre audit questionnaire?

Danielle: I guess a pre audit questionnaire can do a lot of things for you. You can pretty much ask a number of things, a lot of things I like to ask, the number of people in their quality unit, you know, if they have a quality plan, a mission statement, maybe a quality, you know, what their culture quality really is. It’s always a nice way to determine you know their commitment to quality, seeing how many people really are in their quality group as opposed to, you know, that ratio versus, you know, the manufacturing group, You can ask them for their last, you know, FDA inspection or regulatory inspection. When it, you know, when it has occurred and how it fared, you know, a lot of different things, you could really make it very personal to what you want to know. And also, you know, really kind of customize it for a lot of the different things that you might be going over there, you know, to audit themselves. I’m sure Deborah probably can add a few other things as well and James. I’ve done a few of them but probably not as many as Deborah has with the amount of supplier audits that she has conducted

Ammon: The questionnaire is really a good baseline for all the demographics you’ll have. What you have what have on their websites which are not always up to date, so it’ll give some facilities information, you’ll get, as Danielle said any registrations and certifications they have and last inspections and whether or not there were observations. [Unintelligible] If a new company that you are qualifying, to give good baseline for the qualification file and you can ask specific other questions about their processes too. And if they choose not to answer, that’s okay. I’ve had one company the one that was audited every day who had their own questionnaire filled out that they provided which was easier for them to fill in each individual took all require client questionnaire and made one big one and submitted and that was really pretty awesome.

James: In addition to what I’ve heard, I always like to see the table of contents for their quality system for policies procedures and SOPs.

Terri: Okay I have one more question here. Any advice or best practices or anything you can tell us about your experience in closing out a supplier audit?

Danielle: First and foremost, I always like to, you know, always end with a thank you to the supplier. I know that sounds kind of silly and obvious but they do usually, you know, put a lot of effort into hosting you and making sure that all the documentation that you have is adequate. So you’re thanking them, listing some of the positive things that you’ve seen. Making sure that they know that, you know, even though you might have a number of observations that there are some positive things that you did see and, you know, then I always say this as part of the webinar associated with this topic. Make sure that there isn’t a whole lot of people in the close out meeting for some reason. You know, those meetings can be very very large and you really want just the most important people to be there. The subject matter experts maybe some of the heads of those departments and just so that they understand, you know, what you’ve found and how you’re going to address it. Also make sure that they know what you expect, how long they have to respond making sure that you know how you want it formatted when they themselves can expect the report from you as well. So let a timeline discussion should occur along with any, you know, elaboration on any of the observations that you may have found. If they have any questions or need a little bit more, you know, dialogue to understand them. That’s the place to do that. I do try to shy away from any type of confrontation about the observations. Usually if you’re there long enough, if they have any questions they can kind of do that before the closing audit. I like to kind of do a quick wrap up every day before I leave, so that any of those observations really aren’t a shock for them during the close out meetings. So those are just a few things that I like to do in the close out.

James: Yeah the only thing I would add is that if you’re an auditor who knows what you’re doing, you should be able to summarize for them what your key observations were because you don’t want any surprises when they get your report.

Ammon: And I would add that most of my close out meetings take about 15 minutes. And one other thing that you should have is who the point of contact is for the report and responsibility for responding. And if you’re talking about closing the audit at your company I would also add that when they reply to any observations that you noted that you very carefully look at their reply to make sure that they answered the observation. I’ve audited several companies that the client had accepted the reply to the previous observations and it really was a [unintelligible] statement. What they did with no understanding if he had really corrected anything done in effect So I would say communicate with them after the report is sent out to make sure that you’re satisfied with the actions they took.

Terri: Great. That’s all the questions that we’ve had submitted. I think we answered everything. Any final thoughts or thoughts I thought we had some great questions today. Danielle, anything you want to add? James?

Danielle: I would just say that make sure that your supplier auditing program is a key part of your quality system. A lot of times some of the Quality Assurance groups kind of get watered down because of the amount of activities that they do with deviations and change controls, document reviews you name it. A lot of the quality people are really kind of maxed with a lot of different things they have to do but make sure that even though you might be a little bit overwhelmed with your own internal, you know, forms and documentation that you don’t forget about those suppliers because, you know, I’ve been through quite a number of FDA audits where it has been, you know, quite a few day discussion on the supplier audit program. So give it the attention that it definitely deserves.

James: But I’d like to tee off Danielle’s point. If you are overwhelmed or you need additional expertise. I know a very good consulting firm that can help.

Terri: Well I just want to thank everyone for all your great questions today and thank you panelists for your expert answers. If you think of the question later we’re always available call us, e-mail us, smoke signals work too, we’ll answer your questions anytime or contact information is on the last slide here to you and I’d like to turn it over to Dr. Blackwell for some closing remarks.

James: Thanks everyone for attending and we hope you came away today with some useful insights and a greater understanding of doing supplier audits. If anyone has any specific consulting needs on this or another topic, we would like to know how we can help. Please reach out using our contact information on the slide. We’d love to hear from you. The Windshire Group looks forward to sharing our expertise with you in the future. Bye everyone.

Terri: Bye everyone. Thank you for attending. Ending the webinar now.

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