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Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons] Simone (George) Ammons
Yan Kugel is joined by Kelly Stanton, the Head of Quality Systems Improvement at Corden Pharma who discusses her transition back to the pharmaceutical industry after four years at Qualio, an eQMS provider. She also shares her improvement projects that make a real difference in her organization. Additionally, she shares insights on improving processes, the importance of regulatory compliance, and the impact of implementing changes within an organization. The conversation also delves into the benefits of using automated tools, making processes lean, and the significance of leveraging electronic tools to improve efficiency.
Table of Contents
Kelly’s return to the pharmaceutical industry at Corden Pharma marked a pivotal shift towards driving process improvements and system enhancements. She emphasized the importance of embracing lean processes and cutting out unnecessary complexities within quality systems. Here are some key takeaways from Kelly’s insights:
One of the key insights from Kelly’s experience was the value of simplification in quality systems. By cutting out unnecessary processes and focusing on essential requirements, organizations can drive efficiency and compliance. Here are some pivotal points to consider:
As Kelly continues to navigate the dynamic challenges within the quality systems of the pharmaceutical industry, her focus on process improvement and system enhancements serves as a driving force for ongoing advancements. Her experiences and insights underscore the ongoing need for driving quality and compliance in the ever-evolving landscape of pharmaceutical and GMP practices.
In conclusion, Kelly Stanton’s dedication to driving process improvements and system enhancements within the pharmaceutical industry highlights the transformative impact of embracing lean processes and leveraging automated tools. As organizations strive to streamline operations and prioritize essential requirements, the pursuit of quality and compliance remains at the forefront of industry advancements.
Episode Chapters:
Please be advised that this is an AI generated transcript and may contain errors.
00:27 – 01:10
Yan Kugel: Welcome to our podcast about pharma and GMP. Today we have Kelly Stanton joining us. Kelly’s career has been a fascinating journey from the heart of the pharmaceutical industry as a quality manager to a pivotal role as a quality director at Qualio and EQMS software company. And then now she’s back again to Pharma at the Corden Pharma. So get ready to dive into her unique experience as we uncover the highs and lows of each role and explore the dynamic challenges faced within the quality systems in the industry. So Kelly, welcome. It’s great to have you
01:10 – 01:11
Yan Kugel: on the show.
01:11 – 01:15
Kelly Stanton: Thanks a lot. Yan, it’s good to be back working with you again. Thank you.
01:16 – 02:05
Yan Kugel: Yes. So we did quite a lot of virtual events together. You were the speaker of various webinars and events when you were working at Qualio. And it’s quite a different experience working for a software provider, than for pharma. So how did you decide to change your position? So you were a quality manager at some point, then you did a complete change to a software provider and quality management system. So can you maybe elaborate about this career path and how it came to be?
02:05 – 02:45
Kelly Stanton: Sure, sure. Yeah, it was fun. It was kind of an interesting journey. I was actually working at a medical device company back in like 2014, 2015 and had decided to jump out on my own as a consultant. And through that journey, I had ended up with a couple of different clients. Some of them were device and some of them were pharma all in the startup space and It was a lot of fun, you know None of them were at a point really in their journey where they needed a full-time quality person and so It’s funny now.
02:45 – 03:22
Kelly Stanton: I see it on LinkedIn a lot people talk about fractional leadership right and this notion of you know you don’t really need a full-time maybe marketing person or a full-time operations person and so this idea of having a part-time QA because they’re early in their development journey. And through that, I was looking for a software tool that could do my quality system work that was not SharePoint, because I highly do not recommend SharePoint for quality system management. I know lots of people like to use it. It comes free with your Microsoft office subscription and lots of
03:22 – 04:02
Kelly Stanton: startups figure, oh, we can just do document control in SharePoint. But once you kind of reach that place where you need to really start building up the documentation that you’ve got to have behind your product as you’re starting your journey towards approval, whether that’s drug or device, either side, you really need to consider purpose-built software tools. And so I had gotten on, Capterra is a website we use here a lot in the States. I don’t know if it’s a worldwide tool, but it’s a great search engine for finding software for different purposes. And Qualio had come
04:02 – 04:39
Kelly Stanton: up in my search and I had had checked it out and it seemed like a great option and I had kind of gotten to know you know Rob Fenton the CEO through that journey And so had talked with the companies I was working with and convinced them, hey, you guys need to invest in this software. And through that relationship with Rob, kind of that grew into a bit of an advisory role to Qualio cause they were also a startup and also building out their software tool. And, you know, as startups are often want to do, you
04:39 – 05:21
Kelly Stanton: know, they’re kind of funded and then they’re kind of not funded and then they’re kind of funded and they’re kind of not funded. And so in In 2019, I had an opportunity to join Qualio full-time. They were working on their funding rounds and really looking to accelerate their software growth. And so it was a cool time to join, to join them and really help, you know, kind of build out their software platform from an advisory perspective, because obviously, I’m not a software engineer. I used to joke, I only play 1 on TV. But really help them
05:21 – 06:00
Kelly Stanton: understand more in depth. I mean, obviously Rob has a great background himself, you know, coming from industry as a pharmacist and a pharmaceutical, you know, he spent time in industry too, and kind of helped guide through the customer service experience and the engineering experience, etc., etc. And so became their head of quality for a while there. And that was, I spent nearly 4 years with them. Great organization, great software tool. It’s really fun to watch them and they’ve continued to grow. And I stepped away from there, it was a year ago this month actually that I
06:00 – 06:19
Kelly Stanton: decided to return to industry seemed like a good time. And yeah, so here I am now at Gordon Pharma doing quality system improvement projects. And it’s a little bit out of the frying pan back into the fire to be back at this pace. But it was a lot of fun.
06:20 – 06:43
Yan Kugel: So how is it for a quality person that is used to putting out fires suddenly to work in a company that is a software company but still been an advisor role on quality and so on. So how is the feeling? What is the differences between the opportunities and the positions?
06:45 – 07:21
Kelly Stanton: Well, certainly different kinds of fires, obviously. I mean, in a software organization, you’ve got the customers depending on the tool, right? To do the right thing and have their documentation be right there, be accessible all the time. I think it was an interesting journey as well. For me, my experiences prior to Qualio with software were not generally cloud-based software tools. And as an industry as a whole, I was in industry when Y2K happened and that was a whole big deal and everybody was so afraid of it, right? And turned out to be nothing. And now the
07:21 – 07:49
Kelly Stanton: industry as a whole, right, everybody’s still pretty skeptical of the idea of having all of their stuff in the cloud, right? And so I spent a lot of time helping people become comfortable with this idea of I’m going to put all my stuff in the cloud and I’m not going to have You know full control over every part of my data, right? How are we working through the regulatory aspects that apply to that and that sort of thing? And so a lot of my fires if you Will at Qualio involved having those conversations with customers, helping
07:49 – 08:36
Kelly Stanton: them really understand change management, right? We were changing the software a lot and how does that work? What does that look like? What’s really important from a regulatory perspective? Those were interesting conversations always. So yeah, now that I’m here at Corden, this place is amazing. It’s fun. We do some incredible products here. We’re primarily a peptide manufacturer, 1 of the largest by volume doing peptide and some high potency oligonucleotide, I can never say that word, oligonucleotide products and such things and really need to bring our technologies forward. And so there’s some parallels in that. Also dealing
08:36 – 08:52
Kelly Stanton: with a lot of software tools, trying to get those implemented and brought up to speed and really transform our processes. And so some parallel journeys there to the customers I was serving there at Qualio, but back on this side of the table again now.
08:54 – 09:27
Yan Kugel: Is the person who validates the set for the companies that qualifies the suppliers, right? So what key learnings or insight would you say that you could take from working at Qualio when you came back to Pharma? So first you came to Qualio with your insight from Pharma. Did you take something back from there which you could say, you know what, this can be implemented in pharma as well? This is such a shame we don’t do this or that as well in the pharma world.
09:28 – 10:11
Kelly Stanton: Well, definitely, you know, 1 of the things I think that pharma could learn from, and I often use this too, is design control in the medical device industry is also very parallel to like the software development lifecycle, right? And that journey of building incrementally and how you document it and test and roll it out in little pieces and doing things kind of almost snowball-like, right? And in pharma, it’s interesting because, you know, we’ve got to get the molecule to a place where we can have it complete enough to test in a person, in human, and then
10:11 – 10:54
Kelly Stanton: take those things forward to get all the way to commercialization. Here we’re a CDMO, a development and manufacturer. So a lot of the projects we work on here are early stage clinical, mid stage clinical, all the way through commercialization and fully commercial products that we do out of this site. And So it was interesting at my time in Qualio to really pull back the curtain in the software development space, understanding how things get built. And yeah, I think some of that learning is interesting here. And sometimes we joke about, okay, so the train has left the
10:54 – 11:30
Kelly Stanton: station and we’re rolling down the tracks, except we’re still building the train. Right? And here, this site has been here for many, many years. So the train is definitely way the heck down the station, except it’s an old steam engine and now we need to convert it to diesel. Right? And so, yeah, because we’ve got to scale up. You know, we’ve got some old infrastructure and some old processes and we’re converting them so that they can scale and we can support people here to continue to do their jobs and be better and more efficient and all
11:30 – 12:01
Kelly Stanton: of those things and do it well. And so yeah, it’s a fun challenge. I like those kinds of challenges. I love looking at a process and figuring out how to do it better and make it better, but also keeping all the regulatory things in mind, right? Of how are we going to defend this when the regulatory bodies come in and go, okay, so why is this product safe? We have to always keep that in mind as we’re changing things. So yeah, it’s an interesting challenge.
12:01 – 12:06
Yan Kugel: Why did you decide to come back to pharma? Did you miss the action?
12:08 – 12:46
Kelly Stanton: Why did I decide? Oh, jeez. Just felt like the right time, I guess, you know, software is fun. But that’s not that’s that’s not what I went, you know, my backgrounds in biology and chemistry, and you know, it’s not my core. You know, we certainly, at Qualio, it was a lot of fun to get to help so many customers bring products to market, but at some point, you know, our ability to do those things is limited to just their quality systems, right? And so, yeah, to be back in industry and get to be closer to that
12:46 – 12:49
Kelly Stanton: process again is really where my heart is.
12:49 – 13:00
Yan Kugel: Right, so how was it for you after, how was it for years, how was it to come back into the big shoes that you’re wearing right now as the head of quality systems?
13:02 – 13:14
Kelly Stanton: Well, a little shocking at first. I got here and a month later we had a regulatory inspection. So again, a little bit like you can come a fire hose.
13:14 – 13:16
Yan Kugel: Yeah, dive directly into the pool, right?
13:17 – 13:43
Kelly Stanton: Yeah. Yeah. You know, I had been talking about what it’s like to go through 1 of those for, you know, 3 and a half years and hadn’t done 1 in a while. I mean, we were ISO certified at Qualio. ISO is always a different pace than an actual regulator. So yeah, that was definitely very different. But yeah, it’s been fun.
13:46 – 14:09
Yan Kugel: So do you feel that things changed during your time away from the industry or does pharma move so slowly that it’s very difficult to miss this train? We know that the digitalization is still probably in the second shift only. That’s how it feels. Or do you feel it a bit differently?
14:10 – 14:58
Kelly Stanton: Pharma moves very slowly. Pharma’s, I think device moves a lot faster. Device is a little more open to change, open to risk taking. Pharma moves very slow. Pharma is very risk adverse. And that starts all the way up at the regulatory authorities. You don’t see the same… I used to joke with medical device regulations, it’s the same set of regulations that applies from band-aids to pacemakers and everything in between, right? And so you have to have a different sort of mindset in the ability to take the regulations and interpret and apply. On the pharma side, you
14:58 – 15:34
Kelly Stanton: know, it’s chemistry, right? And it’s always, there’s very much a sort of the chemistry is what it is and it either works or it doesn’t. And, you know, so, you know, you still see it’s interesting. You know, 1 of the things you wanted to talk about is challenges, right? And so 1 of the big challenges I see happening right now, for example, is around supplier quality. So in device, we’ve had this notion that we have to qualify our suppliers, we have to understand their quality systems, we have to have quality agreements in place. That’s been in
15:34 – 16:10
Kelly Stanton: place for years. That’s been an ISO requirement for years and years and years. On the pharma side, the FDA just came out with that guidance in 2017, which is not that long ago. And so we’re still seeing challenges where vendors are like, you want to do what? You want us to have a, we don’t need a quality agreement. We have our terms of service that’s good enough. And we’re like, oh no, no. And then they’re like, OK, well, sure, you can come audit. But you can, yeah, sure, have half a day. And you can come walk
16:10 – 16:47
Kelly Stanton: through. And SOPs, you want us to have SOPs? We do the things with the stuff. You don’t need, we’ve got a couple SOPs, sure. But like in this mindset of, you know, our suppliers are supposed to have quality systems and they’re supposed to have procedures and this negotiation around the quality agreement because we’re purchasing a product and we have to understand how they’re managing what happens if you change something in the product that we buy from you. We need to understand that change because then we have to determine does that have an impact on how we
16:47 – 17:20
Kelly Stanton: make a product? And if that has an impact on how we make a product, we have to notify our downstream customers, right? And there’s this whole domino effect. And we’re still, you know, how many years later? 2017, right? So it’s, let’s do that math. It’s 7 years, 8 years later. And these vendors are like, you know, it’s taking months to get quality agreements negotiated and put into place. Right. And right. Like That shouldn’t be a challenge all these years later, right? It’s a huge challenge.
17:21 – 18:03
Yan Kugel: And even huge companies that are used to it. So I remember doing vendor qualification myself and working even with the established company like Fisher Scientific, which is their, you know, their products that are natural sciences and pharma and steel, even with them, it took more than a year just to close these agreements because all the red tapes and everybody needs to take a look at this and these those lawyers and those lawyers and so that’s a crazy how long it takes even for established companies that there are not enough standardized you know there are the templates
18:03 – 18:23
Yan Kugel: right But still there is no industry standards what should be there. So each person or each quality manager just inputs there what he thinks to be the right. Because I think it’s more best practices, right? It is. And each person brings their own ideas there, right?
18:23 – 18:39
Kelly Stanton: They do. They do. And that is a big struggle. And then somebody like a Fisher Scientific, which is really just a distributor, right? And so if you’re buying any starting materials, now it isn’t just Fisher. I need to know who you actually bought that.
18:39 – 18:39
Yan Kugel: Like, who
18:39 – 18:40
Kelly Stanton: did you buy that from?
18:40 – 18:41
Yan Kugel: Yeah, that’s crazy.
18:41 – 18:43
Kelly Stanton: Right. I have to go upstream.
18:43 – 19:16
Yan Kugel: With China and then you need it And then you need the manufacturing certificates. And they don’t want to give it. And then when there are different companies, like in China, for example, they have their own tax optimizations options where they have different companies, shell companies, and there you need to find the right manufacturer because they give you something from a different address and you need to understand how their systems are working. So it can be so complex.
19:17 – 19:53
Kelly Stanton: It is, it is. And it’s a huge challenge for sure. So that’s, I’ll be interested to see too. I haven’t been keeping up a whole lot with that legislation going on in our Congress as well on the Bio-Security Act, but that’s gonna be an interesting 1. Let’s see how that affects the whole supply chain and everything as well, right? Like that, again, you know, in this process of, you know, I don’t know where people think their raw materials are going to come from. But that’s always an interesting 1. We want cheap, we want fast,
19:54 – 19:55
Yan Kugel: and high quality. We don’t want environmental
19:59 – 20:13
Kelly Stanton: problems with manufacturing. Oh, but don’t buy it from China. Yeah. Okay. Well, then where do you think it’s going to come from? Yeah. Yeah. So yeah, that’s going to be an interesting 1 for sure.
20:13 – 20:52
Yan Kugel: Yeah. Yeah. And this is, but I think companies do try right now to have secondary and free even suppliers for the same materials when they can to keep the supply chain running. But it’s also a bit difficult because probably if you have a main supplier because they’re cheaper, they’re in China than you have 1 in Europe, which is more expensive, but you don’t buy from them. So they don’t want to commit to the quantities. So this is Like, why should we be the secondary? Where are we the number 2 player here? Right. So how do you
20:52 – 20:55
Yan Kugel: work around this? What’s your opinion here?
20:55 – 21:37
Kelly Stanton: Yeah. You know, I think, well, I mean, obviously you’ve got to work with your customers, because there’s regulatory impacts to them too. In the end, they have to manage their filings with the regulatory authorities and wherever they’re distributing the products. It’s a very complicated process on their side. And figuring out how to manage that as far as, okay, if we’re going here, we’re going here, we’re going here, we’ve got to balance all of that from a cost, from a material planning perspective. And yeah, all of those things have to figure into how are you planning? How
21:37 – 21:45
Kelly Stanton: are you pricing? Yeah, it’s a complicated thing and I’m glad I don’t work in purchasing.
21:47 – 22:29
Yan Kugel: That’s right. And so working in Qualio, you work with many clients in pharma, medical devices, people who sit or sit in the shoes where you’re at right now. Right. And you, you, you were able to work in both sides of the mattress. And, after working with so many clients and helping, you know, with all their challenges, Like each company has their own challenges. Now you need to establish new EQMS. Each company has a different way of doing things and now they have their own challenges. So what did you learn for this process where you can say,
22:29 – 22:57
Yan Kugel: you know what I learned for this process? You know, I have a toolkit which I can share and something that I learned that I can do now in your role when you’re qualifying a service provider or trying to establish new services, which you say, you know what, now that I went, did it for so many clients, I, you know, I have this framework. Is it, do you have something like this?
22:59 – 23:43
Kelly Stanton: Yeah. And I think, you know, again, I think 1 of the biggest things that I emphasized over and over when I was at Qualio was always just keep it simple, right? What is really required versus what’s nice to have versus what’s somebody’s opinion and what they’re used to seeing. I find even here myself very often, right, like a lot of the systems here have sort of grown out of lots of time and lots of, again, being a contract manufacturer or constantly having customers come in and tell us different things, right? We have a whole lot of
23:44 – 24:19
Kelly Stanton: various opinions that have been like, oh, you need to do this and you need to do it this way. Okay, cool. And so there’s a lot of layers over the years of things. And so what you end up with in a lot of years like that, and this is true anywhere, right? Is a whole lot of, is this really required? Is this really what’s needed? And so to get back to like, okay, here’s the regulations, here’s some guidance documents, right? Obviously, we’ve got to stay current and have a good view of the various markets that you’re
24:19 – 25:04
Kelly Stanton: dealing with, and then stripping things away. And as you start to strip them away, What other systems are you impacting when you do that? That can be a challenge. Things tend to get very interwoven and muddy over time. And so I think it was interesting in my time at Qualio to get to see so many different systems, right? And have that perspective of just the sheer volume. I mean, we were, oh geez, we were over 600 customers when I left. And, you know, it’s, I’ve been gone a year, so I’m sure they’ve continued to just progress
25:04 – 25:47
Kelly Stanton: on that number. But to get to see lots of different ideas on how things can be done is always, it’s good to have that perspective because when you then come into a new organization, especially when it’s been around for a long time, you have that perspective of here’s ways I’ve seen things work, here’s some that work well, here’s some that maybe work less well. And just to bring all of that to the table and as you’re sitting in a room with the stakeholders and trying to figure out, you know, as you’ve got the giant process map
25:47 – 26:27
Kelly Stanton: out there on the board, like, okay, what about this piece and what about this piece and being able to pull those from your experience and from the things that you’ve seen other places or other customers that have helped in the past, right? There were so many systems that we set up there at Qualio, and that was just such a huge benefit to be able to bring all of that perspective into now an improvements role, which is pretty unique. You know, You don’t see systems improvement roles very often in organizations. People tend to try to split process
26:27 – 26:57
Kelly Stanton: improvements or project improvements and put that into existing roles. Like, oh, here’s the quality systems manager and they can do these improvement projects also. The problem with that, and this is 1 of the things I talk about a lot when I try to explain to people what I do is that those folks are also so busy in the day-to-day, right? They’ve still got to keep the lights on and they’ve got to keep the products moving out the door. They don’t have time to focus on the system improvement stuff. And so it’s very hard to actually get
26:57 – 27:26
Kelly Stanton: anything done in that role because you’re always firefighting and you’re always trying to get the product out the door. And so the last thing you’re gonna focus on is process improvement. And if you don’t have that perspective, right, which again comes from seeing lots of other systems and you aren’t given the permission to just focus on the process improvements, right? You can’t bring all of that to the table and then make good improvements. Right. And so, yeah.
27:26 – 28:09
Yan Kugel: So that’s the benefit of working in a big company that can afford having many QA people, right? So if you’re talking about midsize companies or even API manufacturers, they can have sometimes, for the whole plan, 5 QA people, which do everything from deviations to chain control and so on to bigger, but bigger companies you have for each, you have a team for each part of the quality system. Right. So I think this is 1 of the benefits of the, you know, the bigger companies who can afford having specialists doing such special projects, like the improvements. So
28:09 – 28:42
Yan Kugel: you mentioned that sometimes you need to explain to people what you do. So I wanted to ask, what do you improve? What is part of your job description? So do you look through your current systems? Did you come and learn how the process is working then that your job is to identify what can be approved or somebody tells you, okay, we want your target is to improve this part of the quality system or so on. So how does it work?
28:42 – 29:22
Kelly Stanton: Some of it is identified through, you know, through CAPA and corrective action, right? And so a lot of times I think, you know, sometimes as things fall down and we generate Kappa’s, right, that’s an area where, you know, we don’t always build in to capacity within, you know, the 5 people at the API plant, right? How much of their job is dedicated to correction? I don’t know that we build that in, right? And so part of my role, So I’m focused on systems improvements, right? And so there’s another counterpart that I have here who’s head of
29:22 – 29:59
Kelly Stanton: quality operations improvements projects. And he does a lot more of the things related to stuff on the floor. I’m doing things related to sort of infrastructure behind it to support it. So 1 of the first projects I worked on was training. Because we all love the day we started a new job and then we sign into our electronic document control system and we get 400 training emails because you’ve got all these SOPs to read. And so what tends to happen over time again is we write new SOPs and we look at it and go, yep, everybody
29:59 – 30:00
Kelly Stanton: should train on this.
30:00 – 30:16
Yan Kugel: Yeah, that’s the pain. Yeah. So that’s what is well for me, You come, you get, as you said, if you’re lucky, you get it on computers or otherwise somebody just kills several trees.
30:17 – 30:19
Kelly Stanton: Yeah, here’s your binder.
30:19 – 30:32
Yan Kugel: Here’s your binder. And then they’re like, what’s going on here? As if somebody can remember what you read there within a day or 2 or 3, how much you sit in there and just check in boxes, right?
30:32 – 30:37
Kelly Stanton: Yes, exactly. Exactly. Right. So that was 1 of my first projects was looking at our… So how
30:37 – 30:38
Yan Kugel: did you correct it?
30:39 – 31:19
Kelly Stanton: Well, I think, too, again, as we grew, we were still sort of bucketing… We just had 1 title for all QA, for example. And so all of quality was training to everything. But the reality is we have operations quality, we have quality systems, we have development quality, and then we have analytical QA, who is in charge of releasing all the data the QC unit generates and then we have the QC unit. And so everything was getting dumped into just the QA bucket, right? And then we have like everything getting dumped into the operations bucket. But really
31:19 – 31:57
Kelly Stanton: what really should be happening, right? Is the quality systems folks, we have some oversight of the operation stuff, but I don’t need to know how to run a tank. I don’t run tanks, right? So 1 of the first, yeah, so right off the bat, right? Operators, same thing, right? We have levels of operators and there’s a whole training progression that they go through. We do have a training department here. And so in conjunction with our training manager, we went through all of the procedures and striated out further, right? Nobody had had the time or taken the
31:57 – 32:09
Kelly Stanton: time to sit down and really assess who actually needs to train on all of this stuff. And we took our all employee bucket down from like, I think 160 procedures down to about 50.
32:11 – 32:11
Yan Kugel: That’s
32:11 – 32:24
Kelly Stanton: great. Right, because again, it’s like, and it’s 1 of those things too, anytime you write an SOP, and if you say all employees are responsible, what’s the expectation?
32:24 – 32:25
Yan Kugel: Nobody’s responsible.
32:26 – 32:31
Kelly Stanton: Well, and nobody is responsible and everybody has to train. Right.
32:33 – 32:35
Yan Kugel: It didn’t so much time wasted.
32:36 – 33:02
Kelly Stanton: Yeah. And then is that a process? Right. So the reality is though, is… Right. Deviation. There’s a perfect example. Is everybody really entering a deviation in the system or is everybody need to be aware that if they deviate from a process they need to escalate and then some people are responsible for Creating the deviations and entering those in the system and writing them up properly.
33:03 – 33:48
Yan Kugel: This is a great point. So I conducted audits last year. I was on an audit. And there was a situation like you described. SOP says everybody who encounters the deviation might write it down, but when you speak with the operators, they say, no, we don’t do it. We don’t know how to do it. And then you are in a direct deviation from your own procedures, which is a direct finding because you are not following your own procedures, right? And if it’s, okay, GMP audit, it’s not that crazy. It doesn’t impact maybe the lives, but if you’re
33:48 – 34:14
Yan Kugel: doing an ISO audit, this is critical as an ISO organization and different levels. And I see that this issue quite a lot that the responsibility is spread. You just said, you know, everybody’s responsible for different things, but the people on the ground, it’s not the reality for them. And then it’s not followed because they just follow the best practices then, right? So this is an issue.
34:14 – 34:56
Kelly Stanton: Yeah, Definitely, definitely. And it’s funny because that’s also 1 of those places where the conservative thinking will bite you too. Right? So there’s this expectation that like, okay, well, if everybody’s responsible for deviation, right? Everybody then has to have trained to the full SOP, even though the reality is that all the operator is doing is raising their issue and saying, hey, supervisor, I have this problem. And then the super because what’s happening in reality is the supervisor intervenes, right? They figure out what’s going on. The supervisor then notifies quality, right? Who gets involved. The 2 of
34:56 – 35:35
Kelly Stanton: them get together, figure it out. And then they go off and raise the deviation. From there, that operator, they’ll get interviewed later, but they’re never going to see it again. They don’t work in the system. Also, they don’t need that very expensive software license Because the reality is that the operator is reading and understanding SOPs in our software system. And that’s it. Right? They don’t need a full license to go, you know, edit and create deviation records. Right? So, so, you know, there’s there’s so many pieces to that. So then what you should really be doing,
35:35 – 35:52
Kelly Stanton: right? And this, again, this comes back to, this was a training issue, right? Everybody was training on the deviation SOP. The deviation SOP is really, really long and really, really complicated. And the operators are like, why am I doing this? Right? Like, it’s not relevant to them. Yeah. Yeah.
35:52 – 36:32
Yan Kugel: Yeah. So either they read it and they don’t understand it, but they just sign as if they read it and understood it, or they spend so much time reading and understanding something they don’t really need to understand instead of concentrating their efforts on the less but more important for them. So it’s better for them to read and really understand the 30 SOPs that are important for them than 150 SOPs that 70% have nothing to do with them, which is time wasted, energy wasted, motivation goes down, and your attention is spread across things you don’t really need,
36:32 – 36:32
Yan Kugel: right?
36:32 – 37:11
Kelly Stanton: Yeah, no. And that’s where, you know, so in conjunction with that training group, right, we have our monthly operator focus trainings. And we do absolutely emphasize things like GMP training, GMP thinking, including, you know, like, okay, follow your batch record. If something goes wrong, what do you do? Right? You raise the issue, you grab a supervisor, you guys determine, you know, is this, is this a deviation? And then what happens from there? But that doesn’t mean that everyone trains on the deviation SOP. So we’ve removed that from their curriculum, right? So that’s 1 less thing they
37:11 – 37:57
Kelly Stanton: have to go read and understand every time it updates. And then you can really focus their training in on more interactive, more interesting, more relevant to their role, you know, and that allows you also to, you know, a lot of times the education level of the operators that we’re hiring, right? Those guys aren’t, they’re not required to have college degrees. They’re not required to read and understand 30 page documents. That right. Like, and so, so you can, you can really make that training powerful and relevant to them. It’s not SOP based. Everybody’s understanding goes up. Everybody’s
37:58 – 38:12
Kelly Stanton: time is better spent, right? All of those things contribute to training improvement, GMP compliance, quality culture being better, all of that ties together. And that all works really well.
38:13 – 38:50
Yan Kugel: Right. And I think it also, if you really specify who is responsible for things, it also reduces conflict that you shouldn’t have. Like if somebody who is not responsible in the logistics to write a deviation And usually the QA says, okay, we’ll do it for you. But at some point they might be busy and say, you know what it says in the SOP, you should do it. And then there are conflicts. I’ve seen those conflicts that they’re the best practices, but sometimes somebody says, okay, you know what, it’s in the SOP, you know, if somebody stepped
38:50 – 39:08
Yan Kugel: on the wrong toe, then, you know, suddenly, okay, you need to follow it. And then everything crashes down, right? So did you finish this process already with really thinning down the SOPs that people need to learn? So it’s finished, right?
39:08 – 39:50
Kelly Stanton: We did. Yeah. So the procedural side of things is handled and done. And then the rest of the improvements around the on the job and that sort of stuff is ongoing and back within the training department. And then I just continue to participate as a bit of an advisor and sort of their QA brain they can bounce ideas off of when they need help. And certainly, you know, any of the… I review a lot of the stuff that they build and help with infusing, you know, again, sort of quality culture, GMP speak, if you will, but
39:50 – 40:24
Kelly Stanton: always with that mindset of, you know, how do we drive that ownership in, into the operations, into that organization, and having it come, you know, again, very much from them, so that it’s not just something coming from QA, which if you’re pushing out too many SOPs to read, that’s what it feels like, right? It’s like, oh, God, what does quality want us to read now, right? This doesn’t matter. And so they are literally just like click, sign it off, you know, click, sign it off.
40:24 – 40:33
Yan Kugel: Yeah, it doesn’t make sense, right? Because then they will do it also for things that they actually need to read, Right? So this is the precedent. Yeah, because
40:33 – 40:35
Kelly Stanton: none of it’s relevant at that point. Right.
40:35 – 41:00
Yan Kugel: Right. So they need to feel, you know, that it really means something to read the SOP, because they actually do it. And do you see already the results of this change? Do you see the impact on people’s time and job satisfaction even? Is it measurable for you?
41:00 – 41:46
Kelly Stanton: Well certainly we see in the training metrics, we see the improvement as far as the compliance. Obviously we’re KPIs, right? Everybody wants their KPIs from the various areas. And so we’ve been measuring the compliance to train completeness on the read and understand side of things, right? Cause obviously it’s done in a database and so we can get at those numbers. And so definitely seeing that improvement for sure. As far as I think the word of mouth is that it’s better. Certainly people who’ve been here longer have noticed that they’re getting less and less of things that
41:47 – 42:14
Kelly Stanton: they’re spending less time or they’re getting less because, you know, the system we use here and I’ll just stay agnostic as to which systems they are. But they, you know, you get lots of emails from the system. And then if you’re late, your boss gets emails. And so, you know, it’s nice to, to see less of those kinds of emails about you know all your overdue training you know so it’s nice to to see less of those and and we do get feedback that that’s better so that’s good.
42:15 – 42:45
Yan Kugel: Right so So you mentioned that there is also this responsibility of quality that you want to spread across the organisation, so they understand some from 1 side they don’t need to read any SOP because that doesn’t make sense, but they still need to understand the total quality, they need to understand why, what they’re doing. It’s so important on a higher level, right? So how do you shape it?
42:46 – 43:17
Kelly Stanton: Well, again, so I think I mentioned that we do, you know, there’s a lot of that monthly operator training that goes on here. And so that’s always the direction we’re coming at it from, you know, like all pharma, good pharma organizations are doing our annual GMP training. And that gives us the opportunity as well to talk about the why, you know, why are we doing these things? Why is this important? And trying to level that up really and get beyond, you know, I think, you know, certainly I wasn’t here in the past to know what that
43:17 – 44:00
Kelly Stanton: was like, but other places I’ve been where you get your hour or 2 of somebody droning on to the PowerPoint slides of here’s 21 CFR Part 211, and here’s this regulation, and here’s this regulation, and everybody kind of glazes over, and then we all click the button that we saw it at the end. And so we’re really moving more in a direction of pulling in a lot more, here’s a real life example of from the news. Here’s a problem with GMP. And here’s illustrative examples of why those things are important. You know, another training that the
44:00 – 44:37
Kelly Stanton: organization put on last year was 4 hours around data integrity. And those things were customized to the different areas of the organization. So the operators got an operations focused 1, the QA unit got a quality focused 1, right? And by focus, I mean the examples and the interaction and the exercises that we had to do, right? And so those were put together by, you know, some other folks in the training unit and another operations person who was involved. Operations person who was involved. And then I helped again with that from a quality perspective on, yeah, here’s
44:37 – 45:19
Kelly Stanton: some great content. Here’s some examples I know of where data integrity is absolutely the reason for these failures. 1 of them was a supply chain problem where, you know, folks in the supply chain were falsifying certificates of analysis, right, that ultimately resulted in bad raw materials ending up in a product that then caused patient harm, right? And so bringing those things into the trainings and illustrating like, you know, so as you’re filling out your batch record and if you falsify this, right? Like this, these are the kinds of things that matter. And here’s why those things
45:19 – 45:36
Kelly Stanton: matter. And when you bring it all, really bring it all home, we’re bringing that kind of stuff into our training programs here and really trying to level up everybody’s understanding and understand the why and make it real and bring it home.
45:37 – 45:41
Yan Kugel: So learning from real world examples, I think that’s very important.
45:43 – 45:52
Speaker 4: Even if we look at the reward in letters, there isn’t so much from the community about what should be done.
45:54 – 46:03
Yan Kugel: So what are your next improvement projects? What do you think? Is there else to improve? Can you share it?
46:06 – 46:42
Kelly Stanton: Goodness. Well, so, you know, I think next steps working on… You know, I think… So this was 1, I think, that was near and dear to my heart at Qualio 2, right? Is implementing document control systems. And when you go off of paper and you implement document control, You don’t always, sometimes you’re in a hurry and you don’t always necessarily think about like how could I actually streamline the system and then put it in? Sometimes you just take all your documents like I’ve just got to get it in here and we’ve just got to get it
46:42 – 47:12
Kelly Stanton: up and running. Right? And once you’ve been in it for a while and you’ve used it for a while and everybody kind of starts to understand how to use it, then you go, you know, I wish I’d configured this differently. This would work better if, or you know, we’ve got these core documents, but maybe we should split these out and manage these a little bit differently. And so some of the stuff I’m working on now has to do with helping efficiencies within the documents that we control electronically, and then looking for ways to expand our use
47:12 – 47:45
Kelly Stanton: around that. Electronic batch records is always a hot topic. Everybody wants to do those electronically. Those are a huge lift for any organization. There’s so much, obviously there’s no, I think, I mean, SOPs are important. Don’t get me wrong, but there is no more critical document we do in industry than the document that is how you make your product, right? Would like to get there, but we’re not quite there yet. Move in that direction. So yeah.
47:45 – 48:17
Yan Kugel: So for companies that haven’t started, maybe they don’t have a head of quality system improvement, but they want to try to improve. So how would you rank the most important projects that you would say, you know what I see in a lot of companies, and to improve efficiency and quality and the culture, how would you rank the project that you would approach from the most important?
48:22 – 48:27
Kelly Stanton: Well, I think like within document control specifically, or just in general, because I think- Feel
48:27 – 48:29
Yan Kugel: free to talk in general, yeah.
48:29 – 49:05
Kelly Stanton: Okay, well, you know, like, well, so in doc control specifically, I would say, you know, a lot of times what I see people 1 of the big mistakes I see people make over and over again and this was true in my time at Qualio as well is people keep a lot of processes in place forms workflows steps and workflows that exist because they were doing it on paper. And you don’t have to do those things in an electronic system. The electronic system captures those steps for you. And so it is an opportunity to rework your processes
49:05 – 49:48
Kelly Stanton: if you take it electronic. And so now that’s the kinds of efficiencies we’re looking for. It really, you know, you don’t need a log book about SOPs for example, because the system checks the numbers out for you, right? There’s a base example. So if you can make how you capture and file your information everywhere in your whole facility simple, that will really improve efficiency for everyone. I think people don’t realize how much time they spend writing stuff down. And we have to document everything, right? Everybody said 1 of those famous sayings in the industry, right? If
49:48 – 50:27
Kelly Stanton: you don’t write it down, it didn’t happen. Everybody loves to say that, right? We always have to produce those records for any inspector or audit that happens. And so wherever you can make those things efficient, And you don’t need as many sign-offs and checks as what you had on paper because the system accomplishes that for you. So wherever you can make those things efficient and use, leverage the electronic tools that you have, definitely do that. And certainly there are controls you have to put in place around them, checking your audit logs and some of that kind
50:27 – 50:48
Kelly Stanton: of stuff all has to happen, but That’s a huge 1. I think everything you can make electronic, everything you can get off of paper, do it, you know, absolutely do it because the time and the money you spend dealing with paper around your facility is just such a waste. It is just such a waste.
50:49 – 51:20
Yan Kugel: Right, right. So people who the main hour, the workers hours that go into documenting and correcting and checking paper and companies might think, okay, taking a QMS system will cost us so much money, but probably it can save you the work of several people doing the same thing or wasting their time on those papers when they can do more important projects like improvement, right?
51:20 – 51:21
Kelly Stanton: Yeah, yeah.
51:22 – 51:58
Yan Kugel: Trying to find other ways to make their processes lean, right? So basically, I think 1 of the main takeaways from our talk as well in improvement is try to have your processes as lean as possible, cut everywhere you can because at the end it saves you the time. If you’re talking about the SOPs that you don’t need to read or that are not relevant, cut them away, cut out processes that you don’t need, right? And use automated tools. I think this is a great summary from the case studies that you brought us today.
51:59 – 52:17
Kelly Stanton: Yes, absolutely. Yeah, more checklists and more doc, you know, oh, let’s just have them sign off this extra stuff. You’re not really adding any value with that. You really aren’t. You’re just slowing things down.
52:18 – 52:59
Yan Kugel: Right. So as long as you have the right checkpoints that are most important and others don’t matter, then you can skip that, right? Yep. Indeed. Good, Kelly. So thank you very much for the fascinating conversation. I think it was so enlightening, so interesting to hear about your transitions for your career and all the insights you have on improving processes and how important it is and how you do the changes and the impact in your organization. So that’s just great. So thank you very much for sharing this with us.
53:00 – 53:08
Kelly Stanton: Yeah, well, thanks for inviting me. It’s good to it’s good to work with you again, Jan. And, you know, anytime happy to happy to jump on again.
53:08 – 53:10
Yan Kugel: Yeah, for me as well. Thank you very much.
53:11 – 53:11
Kelly Stanton: Thanks.
In this podcast episode, Nagesh Nama shares his expertise in incorporating AI into validated processes within the pharmaceutical industry. He discusses the benefits, challenges, and best practices of using AI […]
