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Transcription: GMP Training Content Design: Proven Strategies for Improving Performance Expert Panel Discussion – Live Free Webcast

The following transcription is taken from The Windshire Group’s webcast GMP Training Content Design: Proven Strategies for Improving Performance Expert Panel Discussion”:

Terri Melvin: Welcome everyone to today’s webinar “GMP Training Content Design: Proven Strategies for Improving Performance Expert Panel Discussion. I’m Terri Melvin and I’ll be today’s moderator. We have with us today two expert panelists. They will first tell us a little bit about themselves then address some talking points in their particular areas of expertise, and then we will dive into your questions live. Our hope today is to make some new industry friends and acquaintances and to serve as an information resource for organizations by providing answers to some of your most pressing questions around this very important and timely topic.

Just a couple of house rules before we get started, please don’t ask anything that contains confidential information and also 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 our advice or opinions we express, and now I would like to turn it over to Danielle DeLucy for her self-introduction.

Danielle DeLucy: Thanks Terri. Hello everyone. My name is Danielle DeLucy and I am an independent consultant. I’ve been in the industry about 17 years specializing in the areas of quality assurance and quality systems. I began my pharma career as a pharmaceutical microbiologist, I am a lab rat at heart, love microbiology, love sterility assurance, but my career took a different path in the biologics and pharma industry when I became very interested in the areas of quality assurance. I held many positions such as director of product quality, batch release, sterility assurance and my last position was actually the quality head of the filling and packaging department at a noted biologics firm.

So I’ve done a lot of consent decree remediation, a lot of warning letter remediation and just basically remediation helping companies get their quality systems in a state of compliance with a lot of the regulation, so hopefully today we’ll be able to provide you with some help in the area of the quality system that is quite important and really the basis for a lot of our compliance and regulatory success and our inspections and that’s the quality system of training. I’ll turn it over to Dina, so she can tell you a little bit about herself as well.

Dina Maines: Thank You, Danielle.  Good morning folks, my name is Dina Maines and I’ve also been in the pharmaceutical industry for my entire career. I started in laboratory as a microbiologist just like Danielle I didn’t think we knew that about each other before; I spent about five years in the laboratory and then transitioned into pharmaceutical manufacturing and packaging operations. Spent about 17 years doing that ended up being laid off with a non-compete clause and ended up being called by former colleagues to do consulting work and I transitioned at that point into the quality and compliance venue.

I’ve been doing quality and compliance work now for almost twenty years and have a very strong background in inspection readiness and also remediation experience, I also have worked on consent decree work as well. Passionate about training I’m looking forward to the discussion on the topic and I’m always available any time if anyone wants to reach out, I’m on LinkedIn.

Terri:  Excellent, now we’re going to go to Danielle’s talking points.

Danielle:   Just a few today to get us started, basically when we’re talking about training I come from a very I guess I come from a background where I really I think hands-on training is really very important. In the beginning of my career I started at a contract laboratory fresh out of college, knew nothing about the pharma industry or biologics industry, and working at this contract laboratory I thought it was going to be like any other lab going in, doing the testing and going home. But I had about two weeks of quality assurance training which was really extremely beneficial to me; it really built the building blocks of how I looked at pharmaceutical and biological firms from then on. Training is really one of the most important quality systems and having that robust quality training and having a robust quality training department, that can really help individuals with some hands-on training; it really goes a long way.

Those two weeks of training where I learned about good documentation, about proper aseptic technique, about how to work in the laboratory and just really basic GMP training in general stuck with me again for the 17 years that I’ve been in the industry. So it’s very important to really kind of lay that foundation with your new employees or really with anyone who’s starting a new position or perhaps maybe just doing a new process, proper on-the-job training is really key with any type of critical process in manufacturing or in the laboratory. A lot of times what I’ve helped companies do is develop on-the-job training modules where they actually can do kind of a satellite training perhaps in one of their training laboratories, to get the people comfortable with what they’re working with, what they’re tinkering with, whether it be an aseptic connection on a tank or perhaps transferring broth under laminar flow hood, really the hands-on approach is really one of my biggest, I’m a big proponent of that.

A lot of times we don’t really seem to take the time to train our employees when we get the word that we can actually hire someone, I know as a director and a manager of a department where I’m constantly asking for resources because we’re so busy, you get that new person in and you really want to get them trained as quickly as possible. But you really want to make sure that they do have the appropriate window to complete his or her training, you don’t want to rush them into their training, you want to make sure that have a very good grasp of what they’re doing the topic, the actual science behind what they’re doing so that when you do sign them off and let them loose in the laboratory or the manufacturing area that you’re confident that they know what they’re doing and that even if they do still have some questions that you have built up that rapport with them as their trainer, that they feel comfortable to come to you and ask you for help.

Because obviously our process is just as good as the people who are actually helping it along, so it’s really in our best interest to make sure that our training systems are extremely robust. I guess we can switch over to Dina’s talking points on training at this time.

Dina:  Okay thank you, Danielle. I was really happy to see that your second bullet point was on-the-job training because it’s a particular area that I’m passionate about. The points that I wanted to talk about specifically associated with on the job training development is to start early and that I think you need to engage with your operators and your supervisors and your mechanics during the actual design phase. A lot of things take place in an GMP environment and then it’s thrown over the fence into an operation setting, sometimes never having actually scaled up and that the operators in GMP tend to operate differently than the operators in a commercial manufacturing environment.

So the earlier on you have input the better your output will be as you start to scale-up and commercialize, even when you’re starting to talk about your initial area facility, equipment, process, product design you want those operators to be engaged, so you want to invite them to the team kickoff meetings as your equipment engineers or your process engineers are meeting to update on the project process as it moves forward through the pipeline, that early engagement is critical. Now not every operator is going to engage in sitting in a team-based meeting like that but you will see a couple of them that their eyes will kind of light up, those are the operators that potentially can become your group leaders or shift leaders, because they’re engaging early on.

You have an opportunity during factory acceptance testing and tight acceptance testing to engage with the operating staff, I’ve noted that when you send operators overseas to the original equipment manufacturing sites they’ve been really good about input on where to put guarding, where to put emergency stops, the height of a human machine interface screen, they have input because this is going to be their machine so they should be allowed to have an input and say. During the commissioning and qualification activities, a lot of times companies will say well commissioning and qualification it’s not turned over yet so the operators don’t need to be there, I think that it’s just the opposite I think that you should have your operations staff working side-by-side during commissioning.

During commissioning is when you’re shaking down those machines and those processes at your site and a lot of good knowledge and learning can take place during the things that go wrong, especially during commissioning and the operators and mechanics will get an opportunity to look at troubleshooting. When you’re looking at calibration criticality assessments for your direct and your indirect impact systems, they need to understand what’s important as far as a control parameter for the equipment and the process, so that they understand that if something breaks or goes wrong whether or not it’s going to need to be calibrated again and the importance of that calibration, so sitting in during those assessments for criticality is an important activity. Obviously validation is also an important activity in that you want to have your operators engaged alongside your validation engineers, and then your unit operations training should be the foundation that you build your training program off of for on-the-job training.

I find that in many cases the operators know how to run the machines but don’t know what’s important about how those machines run, in other words reviewing the inputs from your development report into your commercial manufacturing record, I don’t see companies training on the development report, I don’t necessarily see commercial batch record training with the frequency that I’d like to see, so I think that’s an important element as well. Knowing what type of equipment you need is critical to purchase the right equipment and knowing the critical parameters of the process will provide the proper understanding of the needs for your equipment, so again I think it’s important to recognize the importance of getting the operators engaged early on, so that they not only can help build good strong SOPs but they can train on those SOPs as well.

Terri: Okay great. Thank you to both of our panelists for their overviews, we are now open for questions live.This is how we’re going to do it; simply type your questions into the question functionality box that you have on your go to webinar control panel, and then I will read the questions out loud and then I will open up to the panelist to answer the questions. So now I encourage you to take this opportunity to ask questions while we have these experts here today, I do have a couple of questions that were submitted ahead of time, one is,  How do I train someone to review a document that may not be a hands-on practice per say?

Danielle: I could talk to that Terri. I was a batch release director supervisor for about five years and that’s a question that we often we’re asked by FDA, how are you training your individuals to review documents such as batch records, they are extremely important documents, you want to make sure that everyone is looking at them the same way, that they’re finding any potential errors. And I’ve seen people do it really well and people do it not so well, and the people that do it well have a very robust training system as both Dina and I had mentioned in our talking points. When you’re reviewing a document you really want to make sure that the people first understand the process that the document is actually documenting, so one of the things I always like to do whether you’re reviewing a standard operating procedure and a batch record, even a laboratory method document, go out and take a look at the process first.

We all know that there’s different ways that people learn, some people learn by watching, some people learn by hands-on, some people learn by reading but I like to involve all of those different aspects of learning when I’m trying to train someone on how to review a document. Hopefully they have all the different skills that you need to review a document like being result oriented and knowing good documentation practices things like that, but the first step to review a document effectively is really knowing the process that you’re reviewing. So getting them out there looking at the process, watching it and kind of following along maybe with a blank document at first and then have them get familiar with that, with the batch record that’s always very helpful because then once they’re back at their desk and their cubicle reviewing it, looking at all the information they can kind of remember where they were in the document and what they’ve witnessed.

With a standard operating procedure the same thing, if you’re going to be asking multiple people usually have to review documents and in a lot of different industries, so you usually have an author or maybe a scientific reviewer, maybe a regulatory reviewer they’re all going to review for their specific section that they’re an expert for and then you come out with the quality reviewer who really has to take a look at that document holistically and look at all of the aspects of that document. So making sure that they understand the process and they need to understand a lot of the reasoning behind certain things are done or maybe the reason why the essay is done that way, they don’t have to be an expert or a scientist or a manufacturing engineer in the quality area but they do need to have some knowledge of that.

So that’s really the way I begin my training for a batch record just to kind of come full circle, usually what I would do is do a little test for them at the end, we do a mock batch record filled with different errors I would purposely fill it out with if ten to fifteen errors and I would give it to my trainee and say you know what why don’t you try to pick out the errors that are in here and we would have a certain number of errors that they would need to pick out in order for them to be considered quote-unquote qualified. Again it was a mock batch record; it was not anything that was utilized in the area. And that really seemed to go over very well with any of the regulatory inspections that I was in and it really does give you a nice piece of documentation for their training records. It’s always a hard question to figure out how to help people review because it isn’t hands-on, but those are just some of the things that I found successful in my experience with training people on how to review documents, so hopefully that helps.

Dina:   Terri, if I could elaborate on that, I agree with everything that Danielle said but I would also offer that for the first time through when you’re seeing a new commercial manufacturing record I would make sure that the batch record review people have read the product development report and have read the validation report, so that you come from a place of understanding and then walk the process. So I would just predicate that transfer aspect of learning and understanding and training on those new products and processes I would like to reiterate that, and reinforce that as a foundation before you start the actual batch manufacturer and batch record reviews on execution.

Terri:  Excellent point thank you, I think that answered the question if that did not answer your question please just type a follow-up question into the question box, but while you were speaking a couple more questions come through. So how long should a training period last?

Danielle:  I guess I could take a stab at that, a training period really should fit what the person is actually being trained on. So if you’re trying to teach aseptic connections or if you’re going into a clean room area and teaching gowning, how somebody can gown up into an aseptic processing area, it really should be prescribed in your standard operating procedure the process as to what the person has to go through, what prerequisites are needed.

It’s really difficult to answer that question with a firm training should last two weeks or training should last one month, it really depends on what process that they’re being trained upon, so sometimes training includes a few sessions like reviewing it or observing it a few times maybe then doing hands-on a few, so it’s hard I think to actually state that but certainly your training modules should prescribe what prerequisites you need and what different stages of the training are required in order for a person to be trained.

Dina:  Yes, I would come in behind that as well that you would not want to define a training period, but you do want to define your minimum training requirements and with that it comes along and remember it’s not just your employees that you’re talking about training it’s also your consultants and/or temporary people that you may be bringing in to support as well. You would want to establish via a curricula a specific minimum core set of training requirements that everyone would receive.

Terri:   Agreed thank you, I have another question here and I think it’s a follow-up to what you just said Dina, how much and what do you document for on-the-job training?

Dina:   Well, it’s a really interesting question because I don’t think most companies that I visit are doing enough with respect to on-the-job training, they basically will send somebody side by side with an operator for three days, they’ll watch the employee doing the work then the employee will watch the person doing the work and then the supervisor will watch the employee doing the work and sign off on a training form that they’re done, and that’s typically what I see in a lot of the companies that I go to for on-the-job training.

I think that you should have a prescribed training program that talks about what’s important about each unit operation, I think you should have a training program that would include what’s important about a compression process, what’s important about a coding process, what’s important about fluid bed technology, what’s important about packaging operations, what’s important about labeling I think you should have modules that based on what the employee is being assigned that they have not only their SOP training that says that you turn on switch A you interlock B that’s the task based, but you want to have a some training that talks about comprehension around those unit operations.

Terri: Danielle, anything to add?

Danielle:  No, I think Dina covered it. I think really making sure that that prescribed training module is documented and really highlighting everything that the trainee needs to do is really key to making sure that you do document enough training to consider the person completely qualified when they’re done.

Terri: Okay great, we have a follow-up question to this. So how do you measure training metrics and how often should you report them?

Dina: Well it depends on what your SOP says for your management review, it varies from company to company I’ve seen it as frequently as reporting monthly, to reporting quarterly, to semiannual, to annual. It depends on what you define based on what’s appropriate for your company, in other words larger more complex companies that have electronic solutions tend to do things more frequently than small paper-based companies that don’t have a lot of resources.

Terri: Danielle?

Danielle: I definitely have to agree with that.

Terri:   Okay, so this rolls into the trending of the training for root cause in event reporting and should you report that or review that?

Danielle: When you’re looking at trending for I guess for root cause and training, I think that’s something that you’d want to look at rather frequently, I would say that’s something I’ve been involved in a lot of quality management meetings with upper management and that’s one thing on at least a monthly basis that you want to kind of take a look at and say we’ve been having some training issues and really if they’re being highlighted I guess that’s the root cause of some issues that have been happening.

You kind of want to nip that in the bud rather quickly so that’s really showing that you have a systemic issue as opposed to just a one-off type of a situation, but again even as Dina mentioned previously you really need to have that listed in your standard operating procedure, I don’t think there’s no guidance on that but taking a look at that rather often in my opinion is in your best interest.

Dina:  And I think everyone is sensitive to the fact that most root causes end up being classified as operator or analyst error, and I think that just reiterates the importance of monitoring your event management system regularly and frequently and I encourage team-based reviews of those events. In other words get people in a room talking to each other and include the people that made the error in the discussion, because rarely do I find that it’s just an operator or an analyst error, typically there’s either a problem with a method or lack of understanding of the equipment or the instrument.

There’s other causes maybe the method isn’t well written, maybe the SOP isn’t well written, maybe if you’re doing just read and understood SOPs maybe that’s not enough at which may have led to someone making a mistake. So just get those foundational team-based reviews going when you are trending for training, retraining especially around operator our analyst error.

Terri: Okay, thank you, and should you include that in your management reviews, obviously right?

Dina: I would recommend it, yes.

Danielle:  Yes, definitely.

Terri: Next question – What are some of the key points an FDA inspector will look at for in terms of signs of quality (and they’re talking about during GMP inspection)?  I guess, what is FDA looking for when they’re inspecting for training?

Danielle: I was at a biologics firm few years ago and we actually had kind of an unprecedented inspection that just dealt with training, we had one inspector come and the only thing that she had when she sat down at the table she said I’m here and the only thing I’m going to look at is your training system. Which was very strange we were usually used to being audited for far and wide all of our quality systems on a yearly basis at that time, so just looking at training was pretty interesting and I can tell you just because she said she was looking at training she still did span all of the different quality systems. So they’re going to look to make sure that you have a training system, that you have people that are controlling it, that are monitoring it, they’re going to look at how you’re qualifying your individuals, how they’re being notified maybe that they’re not qualified anymore.

I mentioned gowning before how are you qualifying your aseptic operators and gowning, how are you reminding them if they need to requalify, what if they fail a set of gown plates how do you address it then, how do you let them know that they did fail. So a lot of those different pieces they’re going to look at your process and see if it’s working, if it’s under control, if your quality unit is actually on board with making sure that people are trained, they’re going to look at your batch records and see if you touch on training there, who is actually doing the work, are they trained as quality checking that. Looking at your laboratory staff making sure that they have even as simple as resumes, CVs that they have the experience on file for working in the laboratory, things such as that.

When they’re looking at training in an inspection they’re looking to make sure that the people have the experience that quality is making sure that that training system is controlled, and that the modules that you put together the training program you put together is robust enough to make sure that these individuals can perform their job effectively. Because you can’t blame the operator if their training was poor or if the training program was poor it didn’t set them up for success, so they’re really going to be looking for that.

And again beware when they’re on their tours in the areas, they’re talking to individuals, I’ve had so many inspections that I’ve been involved with on the inspection teams the walkthroughs, I’ve been scribe, I’ve been team lead, I’ve been a coach of and everything, but one thing I can tell you that they are very consistent with is if they talk to any individual along the line whether it be an aseptic cleaner, a supervisor maybe in a manufacturing area or maybe just let’s say someone who is running the dishwashing area in the laboratory, they want their name and then they usually ask for their training on the actual tasks that they witnessed them doing. So they are very concerned with making sure that the individuals are properly trained and that your training program is as robust and effective.

Dina:  Yes, I can add a little bit to that too, in that when typically the investigators come in they’ll start with your organization chart; they’ll be looking at the backgrounds of some of your key individuals so it’s always good to have your CVS on hand. The next thing they look for is the person or individuals job titles, below the job titles you should have a position description or a job description that they’re going to look for to see what the tasks are for the individual based on their title, and then from the job description they’re going to look for a training matrix. There’s some type of an overview of the training requirements for the individual based on the work that they’re being assigned and then they’re going to look for evidence of training, conduct of training through the assigned procedures or records that are associated with the person actually conducting the work.

So that’s how they basically will start during the inspection and walk through your training system, I wanted to reiterate something that Danielle said and I can’t emphasize this enough having gone through this personally. One of your biggest risks during a regulatory inspection is during the walkthrough and the operators not knowing the content in their SOPs, they need to be able to speak to what the SOP requirements are that are associated with their particular job description and they should know the SOP name or number and the content of where to go if they’re asked questions during the walkthrough.

I know a lot of small companies use read and understood training which is fine it’s still done quite prevalently throughout the industry, however I can’t emphasize enough to do mock inspections and to have people come in and ask your operators to speak about what they’re doing and then ask them well where is that in your SOP or batch record, practice makes perfect.

Terri:  Very good. Now that you mentioned the mock inspection let’s turn it into a mock inspection, let’s say if a mock inspection is conducted or an audit is conducted by a third party and its recorded would that be acceptable?

Dina: Absolutely. In fact most robust compliance programs are established whereby you alternate years, like one year you’ll do internal audits the next year you’ll bring in a third party to audit your systems independently, that way you don’t drink your own wine is what my old boss used to tell me. In other words if you totally self-inspect then you start to lose your efficiency over the course of time, because everybody starts to normalize within an organization. So I really heavily encourage that as part of your overall compliance program with some period or frequency, you use that independent assessment just to make sure that you’re not all in groupthink.

Terri: I have another general question here, I think it goes back to documentation and training, but how can you demonstrate GMP compliance for training?

Dina: Training records, you’ve got to have some type of standardized form or even if you don’t have a form you can do just a memo to file and have it signed by the individual, their supervisor in QA.

Terri: Right, yes, I think training is probably one of the easiest quality systems to set up like Dina had said just a form and writing down what they’re actually training on and the trainee signature, the trainer and then quality and then that gets filed, in today’s day and age there’s also software systems that can track and trend this for you as well so there’s lots of options. Okay how do you demonstrate competency in specific areas especially manufacturing and equipment?

Dina:   Well, as I said earlier most companies just put an operator with another operator for a number of days and then sign-off that they’ve observed and that the operator is capable of running the equipment, that’s typically done by the operator and the supervisor will counter sign and then that record comes to QA, QA will sign it. But to my previous point about building in a level of understanding is kind of the next step that needs to happen, in other words everybody’s familiar with technology transfers where you bring something in from another company and bring it into your company, and you transfer your methods, you transfer your process.

That’s typically done from one company or one laboratory to an RND group, either an analytical or a process RND and then what we lose is tech transfer to the commercial operations aspect and capturing that training, so capturing the transfer and the training on those master records on the product development report, on the validation report is a good thing to do and then training that’s built specifically around a particular product process or unit operation is like another step beyond that to demonstrate competency. So the operator can be able to talk about defects, because one of the things that I find is the operator when questioned during an FDA inspection couldn’t explain what kind of defects they were looking for. So visual aids and technical understanding all together will strengthen the operator’s ability to answer questions during an inspection.

Terri:   Okay great, we have a question about human error, we know we’re all human but how do you determine if it’s a competency issue or just discover that it was simply a one-time error if they made an error and when do you initiate a retraining or a retraining program if you find out it was a competency issue and how do you document it?

Danielle: Well, really first and foremost what you have to do is it’s a robust root cause investigation, most of the time when there’s a human error deviation everybody just says well just retrain them and let’s close out the deviation and be on our way, and a lot of times that’s really a quick and easy way to get out of it. But if it is a true competency issue you’ll see trends with the individual, you’ll look back you want to make sure that this isn’t just a one-off, interviewing that person and seeing how much he or she understands about the process that he or she was doing. You can usually tell from a supervisor perspective or an investigative perspective if it was an issue with the process or the document or if it really is a true competency issue.

Getting the person involved with the investigation, having them help you along I always found is very helpful getting them involved, making sure that they realize it’s not a cumulative action, a lot of times helping out with the deviation could be considered punishment for them doing what mistake has been made or error has been made, but really getting them kind of on board with it I really think that’s helpful and interviewing them, finding out what they know about the test or the manufacturing process that really should show you true competency or if they’re lacking a little bit. And to document that I’ve had many times where I’ve had to say that it was a lack of understanding of a particular method, the person has been removed from this manufacturing process for a full retraining and then you can outline maybe a little bit more training than the training module requires, you can add kind of ad hoc training to the individual just so you can see what will help them.

It’s kind of like the same thing we do in schools when somebody has some issues with reading or with math we give them some extra help, and sometimes it could be just that the person can’t grasp the concept, we’ve had a few individuals where they just can’t, I talk about gowning a lot because I’ve had a lot of gowning experience, but they just can’t get the gowning process down, they just can never pass. So it’s not like we fire them we just give them a different job to do, we say listen this isn’t the best fit for you let’s move you to this area of the manufacturing practice, but documenting that as diplomatically as possible, they’re trying to really demonize the person for the error just basically saying that it’s a lack of process understanding and here’s what we’re going to do.

Dina:  I think it’s a tricky ground when you’re actually dealing with a degree of competency, I think it’s really important though to really take a deep dive, nobody comes into work wanting to screw up, nobody comes into work every day wanting to fail, nobody comes into work every day wanting to make mistakes and if they do or they have there’s a reason beyond which operator error or analyst error, either maybe a method isn’t written well, maybe training wasn’t conducted as thoroughly as it could have been, maybe they didn’t have long enough cross over time on the training with another person, there’s usually a driver behind why somebody makes a mistake.

On the other hand you do run into competency issues whereby analysts may be forgetting to write down the information on their set of parameters in their lab notebook and that you need to partner with your HR people when you really talking competency, because it’s a very sensitive issue.

Terri: Yes, it can be a very sensitive issue, so if you do determine like a competency test or what would you consider a passing score I guess is the follow-up question?

Dina: It’s my rule, a general rule of thumb what I’ve written into my SOPs has been that a minimum score of 80 percent, however based on a particular individual and the job that they’re doing I may require a hundred percent, in other words they have to keep retesting until they get that hundred percent score.

Danielle:  I’d have to agree definitely especially with critical type of tasks that they’re doing, I would definitely say a hundred percent but documentation is lesser type of processes eighty percent I definitely agree.

Terri:  Okay, I’m not sure if we answered this question but somebody wants some clarification on this, how do you handle trending of training for a root cause and event reporting and how should you report that or review that and should it be part of the management reviews as well?

Dina:  Well the answer to the last question yes, training trending should be part of your management review, and you said how do you trend I think you need to look at your aggregate of anything that’s associated with any type of error by a human, look at the aggregate first, look at all of it because it’s going to point to a potential underlying issue with either your operating system, your controls, your documentation system, you’ve got to look at the aggregate.

I mean if you’re getting on a number of retraining you should be looking at total number of training events or retraining events during a period and look at whether that number goes up or goes down across the periods, whatever that period you define to be but look at the aggregate first it’s going to tell you where you may have some material weaknesses.

Danielle: I’d have to agree, yes.

Terri:  Okay great, how can data for the risk be assessed, I guess for training or root cause is what they’re following up on guess you answered that already. Well it looks like I don’t have any other questions, this has been a great interaction it’s ten to twelve if you have any questions please type them in now, any summary comments?

Danielle:  No, I just want to thank everyone for attending today’s free webcast; hopefully we helped you out with some of your training questions. Again I guess as a lasting comment from my experience, just make sure that your training program is constantly assessed, is really robust sometimes we kind of forget about our training people that are in our training department, they work super hard in making sure all the documents are updated and we call upon them during inspections quite a lot.

So make sure that they have the appropriate resources that they need as well to make sure that your training program is effective and compliance, and again most of all my favorite word when it comes to training is robust, so I’ll turn it over to Dina for her closing comments as well.

Dina: Yes, I’d like to thank everyone for the questions, I think that they’re good questions; I think that the answer that you got for most of them well that depends, because everything has to be within the context of your particular business and what’s appropriate for the size of your business and the resources that you have available. And other than that I think it’s always a good topic to talk about training because I think a lot of companies don’t pay a lot of attention to their training programs, they’re so busy that they forget if they invest in training early on, you don’t end up with as many events later on.

Terri: Excellent, well thank you everyone for attending and especially Danielle and Dina for your expert answers. I know people hate to say well it depends but it does depend on your individual situation, oh I have one more question that just came through, how do you prove QA training in the small company they only have one QA staff member?

Dina:  I’m not quite sure if I understand the question, it almost sounds like they’re asking is one individual associated with training in a small company considered adequate. I actually work in a small organization where we don’t have an individual that’s specifically assigned to training, I end up doing most of the training myself or my lab director does the training.

So you don’t need to necessarily have an individual that’s just a trainer, I think though that you do want to define your minimum training requirements for our company, GMP training is annually, I typically train more frequency on every incident that is investigated, I build training that’s associated with the incident so that that’s a corrective action as well, to try to prevent additional incidents happening by general awareness, but you don’t need an individual specifically assigned with the title of trainer.

Terri:  Okay excellent, hopefully that answered your question, Danielle do you have anything to add, what’s a small company and you have one person buy?

Danielle:  No, as long as you have someone taking a look at it preferably in the quality group that should be fine, I come from your company so that’s why I always, I have been spoiled in my career to have a training department to help me out but certainly as long as someone’s taking a look at it and performing it and doing those texts you should be fine.

Terri: Okay excellent, well thank you everyone for today we hope you come away with insights and a greater understanding of training, if you have any other consulting needs on this or any other topic please reach out to us, our information is on this slide we’d love to hear from you and Danielle and Dina can help you as well. So let us know if you have any questions after the webinar concludes and we’d be happy to help you, I want to especially thank Dina and Danielle today for your expert answers; I’m going to be ending the webinar now, have a great day and a great weekend everyone.

Dina:  Thanks, Terri.

Danielle: Thank you.



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