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Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons] Simone (George) Ammons
Yan Kugel is joined by Jennifer Chang, a QA Intelligence Specialist at Blue Mountain. Yan and Jennifer discuss the impact of digital transformation on manufacturing processes, the challenges and benefits of compliance in the pharmaceutical industry, and companies’ struggles in keeping up with regulators and taking a risk-based approach. They also explore why companies switch to digitized solutions and the importance of continuous learning in the pharmaceutical industry.
Table of Contents
The choice of vendor plays a significant role in regulatory compliance. Jennifer discusses the implications of supply chain disruptions and the emergence of less reputable vendors during times of desperation. She stresses the importance of vendor management as an enforcement trend that will continue to be crucial in the pharmaceutical industry. The relationship with vendors and the support they provide are key factors in ensuring compliance and operational efficiency.
Jennifer delves into the reasons why companies seek digital solutions for asset management. The transition from paper-based to digital systems is driven by the need for digitalization, but it’s not a one-size-fits-all solution. She emphasizes the importance of optimizing processes and involving the right people in defining the desired process before implementing electronic systems. The flexibility of digital solutions, such as Blue Mountain RAM, allows for customized workflows that cater to specific needs.
The conversation shifts to the impact of manual labor and human errors on compliance. Jennifer highlights the potential for eliminating certain types of deviations and errors through electronic systems. She stresses the need for systems designed to prevent errors, especially in processes that rely heavily on manual interventions. The benefits of electronic systems in reducing errors and streamlining maintenance and calibration processes are evident, providing a significant advantage over traditional paper-based systems.
In evaluating electronic vendors, Jennifer emphasizes the importance of responsiveness and transparency. The ability of vendors to communicate, provide timely responses, and share documentation becomes critical in ensuring a collaborative and compliant partnership. She advises companies to conduct thorough research, seek reviews, and assess the transparency and urgency of potential vendors to make informed decisions.
As the conversation draws to a close, Jennifer shares valuable career insights and advice for aspiring professionals in the pharmaceutical industry. She emphasizes the continuous learning and adaptation required in the ever-evolving landscape of quality assurance and compliance. Jennifer’s message resonates with the importance of embracing a growth mindset and actively seeking learning opportunities to stay ahead in the industry.
In conclusion, Jennifer’s insights shed light on the pivotal role of vendor management in ensuring regulatory compliance and operational excellence in pharmaceutical equipment management. By prioritizing strong vendor relationships, embracing digital solutions, and staying proactive in addressing human errors, companies can navigate the complexities of compliance while striving for excellence in pharmaceutical equipment management.
Episode Chapters:
Please be advised that this is an AI generated transcript and may contain errors.
00:26 – 01:06
Yan Kugel: Welcome to our podcast episode focusing on quality assurance in Pharmaceutical Equipment Management. Today we have a special guest joining us, Jennifer Chang, who is currently serving as a QA Intelligence Specialist at Blue Mountain. With a wealth of experience in quality, assurance and compliance, Jennifer brings valuable insights into the realm of digitalization in pharma equipment management. We will be delving into her QA journey, discussing the impact of digital transformation on manufacturing processes and exploring the challenges and benefits of compliance in the pharmaceutical industry. Jennifer, welcome to the show.
01:07 – 01:11
Jennifer Chang: Hi, thank you for inviting me. I’m really excited to be part of this.
01:11 – 01:51
Yan Kugel: Yeah, I’m also excited to have you here. We also did a very interesting webinar together, So I remember all your passion to the topic. And I wanted to start with you by talking about your career path. This is something that I have been discussing with previous guests as well, because I find it very interesting when pharma professionals go and do and implement their skills in the different areas, especially when they’re, for example, moving to service providers. So it just shows that working in pharma and quality doesn’t mean you always have to stay there. There are so
01:51 – 02:01
Yan Kugel: many opportunities. So I’m very eager to hear a bit about your path in pharma, how it started, and how did you move to your current role?
02:02 – 02:08
Jennifer Chang: Sure. I could go back as far as my teenage years as a lifeguard, if you want, at the swimming pool.
02:08 – 02:11
Yan Kugel: If it’s a fascinating, I’m sure that will be nice.
02:11 – 02:48
Jennifer Chang: I mean, it could be considered relevant, since even at that point, my main function was kind of enforcing preventative measures in the interest of public safety. But my professional career started after I graduated in 2009 and I actually started as a quality technician in a meat processing facility. So this was sort of my first introduction to a regulated environment, where I learned a lot about GMPs in general and standard operating procedures and good documentation and labeling practices, as well as kind of the crash course in how demanding the manufacturing world can be. So after I’d been
02:48 – 03:25
Jennifer Chang: there for a few years, I developed an interest in laboratory testing and microbiology and auditing. So in 2012, I shifted to the kind of parallel world of pharmaceutical manufacturing, where I started as a QC microbiologist in a laboratory. So I quickly took to kind of the more strictly controlled environment that’s required to manufacture sterile injectable products. And I really just started soaking in as much information as I could. I love to learn, that’s kind of what drives me and I kind of had, I was a kid in a candy store with all the different things that
03:25 – 04:07
Jennifer Chang: I could learn when I got there. The microbiology lab allowed me to really dig deeper into not only the testing and investigations, but the to kind of connect that with the applicable industry and regulatory requirements that dictated why, how, and when that kind of testing was done in pharmaceuticals. So from there, from the microbiology lab, I moved into the quality control incoming inspections group as a supervisor, where I became heavily involved in source materials and vendor management and supplier corrective actions, which I also found fascinating. So things like your specifications for every product or component or
04:07 – 04:44
Jennifer Chang: excipient that comes in, you have to have specifications and determining what is acceptable to use in your product. And also at this time, funnily enough, I was also using Calibration Manager from Blue Mountain, which is the predecessor to the modern regulatory asset manager, the RAM product that Blue Mountain offers today. Not realizing that I would come to know the Blue mountain company much, much better in the future. And since the organization I worked for was over 100 years old at the time, CalMAN was only 1 of a handful of electronic systems that our site had implemented.
04:44 – 05:27
Jennifer Chang: So We were primarily paper-based. Those systems had been working for a long time since our organization had been around so long. So CalMAN was actually 1 of the first electronic data capture systems that I really had worked intimately with. So After making my way back to the QC Microbiology Lab as a supervisor in 2016, I started becoming more involved with electronic systems implementation and administration. So starting in the laboratory, we had systems for environmental monitoring, personnel monitoring, data capture, particulate monitoring, sample tracking, endotoxin testing, and struggling with kind of dealing with the associated electronic systems taught
05:27 – 06:04
Jennifer Chang: me a lot about strategies and pitfalls. I learned a lot about what not to do with systems like that and where you can run into roadblocks with things like training and user management. Adversity is a really effective teacher and I was learning the lessons the hard way. So After I was in that role for a while, I moved to the quality assurance team, which was kind of another parallel move even within the organization. I was still focused on QC processes, so the laboratory, but Moving from quality control to quality assurance, it required me to adopt a
06:04 – 06:42
Jennifer Chang: new perspective on some of the same topics that I dealt with since I started in pharma. So I now had a more active role on the same topics. And I had a more active role in defending our processes and decisions and our documents during regulatory and customer audits. And I started to develop a sense for anticipating compliance concerns. I also kind of resumed my role with vendor management, albeit on the
06:42 – 06:42
Yan Kugel: quality assurance kind of that final approval side. It is a different responsibility to be kind of the last
06:42 – 07:18
Jennifer Chang: signature before we’re determining whether or not something’s acceptable or needs to be discounted. I got involved with a lot of initiatives that required QA input. And after a couple of years, my scope within QA further expanded to include all of the manufacturing and support activities. So kind of at each tier, it would open up a whole new world of things I needed to learn and kind of study and research into, which I really enjoy. But with all that I loved about it, pharmaceutical manufacturing can be grueling. I mean, It’s a stressful environment. It’s demanding. It’s unpredictable
07:19 – 07:59
Jennifer Chang: and can be really relentless sometimes. So, and end of 2022, I decided I needed to find a role that would better suit my needs and my family’s needs. So after a brief stint with some freelance and consulting roles, early last year, I came across Blue Mountain’s role for QA Intelligence Specialist. So, I actually wasn’t looking for a full-time role when I came across it, but I was interested right away. Here was a chance at kind of a unique opportunity for a career pivot that I hadn’t considered before. It’s almost like the role was created with my
07:59 – 08:38
Jennifer Chang: exact background in mind. So after pursuing it and I figured I wasn’t too old to transition to learn to adopt yet another new perspective amidst another parallel industry with a different yet still related set of best practices and standardized processes, as well as a fascinating interplay of different people and skills and departments and functions that have to coordinate to create a stellar product that’s stable. And after meeting the Blue Mountain teams that I would be working with, I knew that Blue Mountain had the supportive culture and the commitment to quality that would actually allow me to
08:38 – 09:10
Jennifer Chang: keep learning and improving myself while getting to offer the benefit of my experience in life sciences to improve our customers’ experience. So, it’s been tricky for sure. The world of software has a whole new language to learn, just like life sciences did when I got into that field. So I still have a long way to go. But to me, that’s not a dread, it’s an excitement. And I also, like I said, I’m excited to have a chance to leverage my past struggles to make things easier for their customers however we can.
09:11 – 09:47
Yan Kugel: All right, so that’s an interesting career path. And I think it’s fascinating to see the possibilities out there and to take upon opportunities when they present themselves, right? So congratulations on that because I think it’s quite fascinating indeed. And Before we go a bit more into compliance and what you do and asset management, can you tell us a bit, in short, what Blue Mountain does so we have the understanding of what we are talking about here?
09:48 – 10:30
Jennifer Chang: Yeah, sure, absolutely. So Blue Mountain, it’s, like I said, the primary offering is regulatory asset manager, which is exactly what it says. So it is managing all of your equipment, your assets, your incubators, your balances, everything that you would need, all of the the assets that you need to manufacture product under GMP regulations. So not only will it help manage the maintenance, the calibration, events, the scheduling, all of that, it can help with parts, it can help with reporting, you can build workflows for things like periodic reviews, you can set up events, anything that you need
10:30 – 11:01
Jennifer Chang: to be recurring, you can capture in the system. So we have customers that use it to capture, you can capture claiming records on those pieces of equipment. And so it’s just a repository for all of those types of events that would impact your assets. And it’s all right at your fingertips. And you can look at everything related to an asset, just pulling up that record. I personally find the audit trail really helpful because you can get to that records audit trail from the main menu of any of the records. So yeah, so that’s just the broad
11:01 – 11:05
Jennifer Chang: overview, but I’m sure there are people that can explain it much better than I can.
11:06 – 11:54
Yan Kugel: No, I think you did it quite well. And just to understand where we stand in terms of the industry, right? So you mentioned that you came from a company that was established, was old, has been around for quite a while. And we know that such companies, they take time to change the way they’re doing things to update their system because sometimes they have established systems that sometimes they even build themselves before suppliers and service providers, software companies came in and created something more dynamic. So did you have such a system? So you mentioned that you did
11:54 – 12:15
Yan Kugel: work with Blue Mountain there, but did you have the system there with all the models? And also when you’re looking at the new clients that you have, would you say that most of the companies have some software that already manages the resources or a lot of it is manual?
12:16 – 12:52
Jennifer Chang: We get a wide variety of different types of customers and a surprising amount that are sort of a hybrid model. So it might be, you know, you generate a piece of paper, you print out a piece of form to complete a calibration and then that gets transcribed or moved into a different system. We might have customers who came from an older version of the system and they want to upgrade to benefit from the newest features. So we get a lot of those, a lot of different scenarios that come to us as a customer. And so our
12:52 – 13:20
Jennifer Chang: job is to try to meet our customers where they’re at and figure out the best way to implement it that is most beneficial, most, you know, effective and in the best, like a timely manner, but without being too disruptive to their current process. So it’s always trying to strike a balance. And that’s why we try to really understand what our customers biggest struggles are, what their biggest objectives are when we’re meeting with them to try to implement.
13:22 – 13:31
Yan Kugel: What do you find to be the biggest challenges that the companies face before they come to you with resource management?
13:33 – 14:05
Jennifer Chang: A lot of the challenges, again, it can vary a lot depending on the individual situation. So a startup company, they might have a lot of people, a lot of really smart people who know their product. But the manufacturing game might be new to them. They might not understand how to manage and schedule all that. So they might be leaning on us a little bit more than just the solution. So that’s where somebody like me can come in and kind of help with offering sort of a perspective on compliance when they’re trying to configure. Or you might
14:05 – 14:42
Jennifer Chang: have a company that they’re really good at what they do. They understand manufacturing and GMP, but they’re going through some growing pains. They might be starting a new facility or a new clean room project, new construction projects, they would have slightly different needs, but they could still, that’s where we could still offer insights from what we’ve learned through different implementations to kind of optimize how they would configure. So the biggest challenge is using solutions that you purchase in the most productive way, in the best way, in the most compliant way. And that’s where we can help
14:42 – 14:56
Jennifer Chang: because we’ve seen a lot. Blue Mountain, it’s not 100 years old, but it’s in its 30s. It’s 35 years old this year, and they’ve seen a lot of different scenarios and a lot of growth and changes within the pharmaceutical industry.
14:58 – 15:19
Yan Kugel: Yes, and What are also the biggest challenges of implementation of such systems? Do you find that the validation or the risk assessments, this is the biggest concern of quality and how do you usually deal with such events?
15:20 – 15:57
Jennifer Chang: We could hold an entire webinar on the challenges. There’s no shortage of those. Again, the biggest challenge is making sure that what you have, like your ultimate output, however it is implemented, that it fits your needs and that your end users understand it and they know how to work with it. So 1 of the big challenges is having the resources. So a lot of times the same resources, the people that you need to make your product day in and day out, to release it, to test it, to deal with things, to deal with issues as they
15:57 – 16:35
Jennifer Chang: pop up, those resources are the same resources you need to tap into when you’re rolling out a new system, because they’re going to understand what the real-world implications are going to be. But it’s really hard, because those same individuals, they have a lot of time constraints. They have a lot of other conflicting priorities. So that’s where kind of the management, the executive leadership buy-in, being able to support, giving those resources enough time, giving them the support they need to be able to think things through as they’re rolling out these electronic systems.
16:36 – 16:53
Yan Kugel: And do you work with the clients directly or you’re more involved in the back office of the quality intelligence of the system to make sure that it is up to the standard and up to the GMP regulations?
16:55 – 17:29
Jennifer Chang: A little bit of both. I’m not primarily, I’m not like a primary customer contact. We have an entire team, an implementation team, that is there to kind of walk alongside. But I might get called in if there’s, say, a specific compliance concern, a question. I kind of love these because they’re debates. They’re really interesting, and you might have a lot of different perspectives and none of them are exactly right. So a lot of times just having the conversation can be really helpful. But that’s usually when I get called in. My primary duties are just like all
17:29 – 17:56
Jennifer Chang: of the QA stuff, the audits, document control, training, validation, document review. I’m involved with all of that here, but it also, my specific role gives me jurisdiction to kind of track and monitor the ever-changing industry and the regulatory enforcement landscape and kind of digest the complex guidance documents and regulations into actionable advice that we can give both internally and to our customers.
17:57 – 18:13
Yan Kugel: Right, so you then responsible to make sure that the system operates within the requirements, right? So you need to keep updated on the latest standards of validation of computerized system and so on, right?
18:14 – 18:45
Jennifer Chang: Yeah, Yeah, I have to kind of keep myself up to date so that I can be offering the most up-to-date information. I mean, that’s the challenge in life sciences is the bar is always being raised. The standard is always to be improving. And that’s sort of the price to pay to even be in this business is you have to be, you have to approach it with a growth mindset. And I’m really fortunate that Blue Mountain does have that mindset. And that’s sort of the other piece of what I do is I kind of leverage my knowledge,
18:45 – 19:17
Jennifer Chang: my experience, and not just in what the regulations are, but in doing things like trying to standardize processes, trying to take information from people who are really knowledgeable, have been in this industry for a long time, and kind of turn that into training materials for a new set of people, a set of young skilled professionals that are coming in so that you can kind of transfer that knowledge and standardize it as much as possible. So that’s where I’m hoping I can help Blue Mountain as well.
19:20 – 19:33
Yan Kugel: So in terms of your role, you said you always need to keep up to date, so what are the best practices if you can share? How do you stay up to date?
19:35 – 20:17
Jennifer Chang: Yeah, sure. So the first off is read, watch. There’s so many great resources out there. I could fill a book with all of the references and resources, but The problem is actually having time to read them. But I happen to enjoy reading and interpreting all of the kind of boring regulatory guidance documents and try to piece together the kind of the bigger story that’s unfolding. But I mean, internally, people forget that there’s a lot of resources internally. So your own SOPs, your own work instructions, investigations are a gold mine of information Because sometimes the best way
20:17 – 20:51
Jennifer Chang: to understand a process is to see what happens when it goes wrong. So kind of like the gene knockout studies in genomics research. If you see kind of the output of how things go wrong, what the investigation process was, then you can get a much clearer understanding of why that process is so important and why that process is the way that it is. So yeah, there are a lot of good websites out there that offer free or paid, you know, things like webinars, things like Qualistry, where you can get webinars, you can get perspectives, you know,
20:51 – 21:28
Jennifer Chang: that, and even if there’s a lot of different information, you’re not going to absorb it all over time, you’ll kind of build your own ideas and it’ll at least get you to think about things or sometimes point you to a new resource. So really just read, watch, learn wherever you can. And also, I mean, going along with that too, in terms of finding mentors, find people who are good at things that you’re interested in. It’s unlikely that 1 single person will have the time or knowledge to impart everything you need to know. So find multiple people
21:28 – 21:49
Jennifer Chang: that are skilled or knowledgeable at something you want to learn. Learn what you can from them. Like I’ve had different mentors from everything from microbiology to root cause analysis to Microsoft Word or vendor management or electronic systems validation. So by doing this, you can kind of not only shore up your skills, but you’re also passively building the network that you can continue to learn from.
21:49 – 22:23
Yan Kugel: So I think this is a very good point, especially with mentors. I think some people are very lucky to get great ones. And sometimes it’s a bit difficult to find those. So you manage to find those in your company itself. And speaking of mentors, if somebody wants a mentor, what is your recommendation? How to identify good mentor people who are open to be a mentor, who are skilled enough and how to approach them so they become 1.
22:24 – 22:54
Jennifer Chang: Yeah, it’s hard. And I’ve kind of thought about this the last few days. You don’t always realize your mentor is your mentor until it’s a little farther down. And sometimes they don’t either. I mean, the first time I found myself where I was kind of mentoring someone, I didn’t realize it until after a year or 2 of working with them and they called me that and it sort of took a step back. But the way, like kind of looking back, the way I found a lot of the mentors, the people that have helped me learn and
22:54 – 23:27
Jennifer Chang: grow along the way, you start by helping them. Volunteer to help with the project, the task that nobody else wants to do. So not only does it just give you a really contextualized, hands-on experience learning something, you’re also gonna watch that person who is better than you at something. You’re gonna watch them struggle. You’re gonna see how they deal with it. And even if, I firmly believe that you can learn something from every single person that you meet. Sometimes that lesson is how you don’t want to behave or how you don’t want to make decisions. But
23:27 – 23:59
Jennifer Chang: even that is a lesson. So get involved. I mean, that that’s sort of my biggest piece of advice to somebody really trying to flesh out their knowledge in this industry. Get involved. Try to learn what you can and just sort of follow wherever the information is taking you. If something looks interesting, go read it. If you find something else, go, and even if I don’t read it right away, I kind of, I always have kept a folder of things that are just resources, or if I come across something, I might download it and save it and
23:59 – 24:19
Jennifer Chang: then go look at it later. Or what would happen is you would, I would end up in a situation where I would then remember, Oh, there was this really good article that was about, you know, a root cause analysis or some kind of microbial issue. And then you could go read it. And then that kind of puts it in the context. And for me, that’s sort of how I could cement my learning.
24:20 – 24:47
Yan Kugel: And from your current trying to stay up to date with everything, where do you feel that the industry is heading? Do you see changes that are happening or what are the current trends in, let’s say, with the validation of software, validation of cloud services? Is there anything new there?
24:49 – 25:26
Jennifer Chang: There’s always something new, but what I’m seeing right now the most is sort of a not a return to pre-COVID, you know, measures. It’s more of the enforcement actions. So during COVID, you know, it rocked everything and that included the FDA, the regulatory bodies. They were struggling to get inspections done. They were, they implemented a lot of tools like the remote inspections. What I’m seeing now is, and then, you know, the focus became a lot more on Like for enforcement actions warning letters that you saw a lot more that had to do with You know kovat
25:26 – 26:09
Jennifer Chang: treatments that were being mislabeled or misbranded. Whereas now what I’ve seen is there’s a return to onsite inspections. There’s sort of a return to more normal inspections. So you’re seeing a lot of the enforcement actions go up. So it’s, and companies, they were also deeply affected by COVID supply chain personnel shortages. People like me who decided to pursue other interests, a really knowledgeable set of professionals who are retiring. So what we’re struggling with now is trying to bring sort of the new, the young professionals up to speed while trying to deal with some of the fallout
26:09 – 26:46
Jennifer Chang: of issues that have happened with supply chain, with personnel, things that are really making the manufacturing process harder from the day to day. So that’s a really, that’s a struggle. But the message from the regulatory bodies really hasn’t changed that much. Overall, what I see time and time again is that they want a holistic risk-based approach showing that you understand your process, that your operations are driven by procedures and are in an overall state of control that’s designed for a product that is made right the first time. And that’s that’s something that we adopted Blue Mountain
26:46 – 26:50
Jennifer Chang: too. It’s what’s expected for our customers and that’s what we’re always going to strive for as well.
26:51 – 27:22
Yan Kugel: And where do you feel are the struggles of companies when we are talking about keeping with the regulators and taking the risk-based approach which is a bit newer. So it’s something that Dave Day strives to. So what challenges or mistakes that you see that the company do and do you have some advice how to avoid those mistakes and overcome those challenges?
27:23 – 28:01
Jennifer Chang: Yeah, that is a tricky 1 because instead of having really specifically prescribed, you have to do X, Y, and Z that was there before as the scope and the breadth of the types of products, the types of therapies, as that’s increasing, the regulators have to figure out how to broaden their guidance and their regulations without making it so vague that nobody knows what to do. So there’s a lot more leeway to justify doing things that may not be, you know, the same as it’s always been, but the the key there is you have to be able
28:01 – 28:34
Jennifer Chang: to justify it. So for companies you can’t just pick and choose and and not have any justification. What the the agencies want to see is that you have you fully understand your process, you have fully thought through whatever it is that you’re working on with the process, the changes, setting it up, you need to be able to demonstrate and then later to defend and adjust as needed. You need to be able to be prepared to do that for anything that’s going on at your company. It’s kind of the takeaway that I’ve seen there.
28:36 – 28:49
Yan Kugel: And do you see companies that don’t follow that path? And so what are they doing instead if you have some example like of things you should not do?
28:51 – 29:28
Jennifer Chang: Examples are just kind of cherry picking things that sound nice. And I don’t have a great example off the top of my head. The best kind of analogy, you know, the most, the 1 that comes up easiest to mind is with electronic systems implementation. So if you say, okay, well, the regulatory bodies, you know, they support CSA, they support software assurance instead of the old kind of CSV model. But if you’re doing that in the context where you don’t have a good partnership with your vendor, like where your vendor’s not doing the legwork to make sure
29:28 – 29:45
Jennifer Chang: that they have a reputable established process and you do less testing, do less of your own kind of vetting out of that without really any justification, you could kind of get in trouble. That’s sort of the first example that would come to my mind.
29:45 – 30:28
Yan Kugel: Right. So to really do the due diligence on the vendors that you’re picking and the risk analysis and good audits to understand whether those vendors are a good fit. And probably what I hear a lot also from a lot of discussions that I do is also the human connections, which are very important because sometimes you might find a good vendor on paper, but at the end, you need to deal with people, right? So as you mentioned, sometimes clients come with regulatory issues and the company needs to assist them and they need to make sure that the
30:28 – 30:42
Yan Kugel: farmer needs to ensure that the vendors have the people who can assist them in such situations that they have experienced people who can jump on board and give them the advice they need.
30:43 – 31:15
Jennifer Chang: Yeah, that’s a great point. And that is actually, I didn’t mention it before, that’s 1 of the roles at Quality Assurance. We might get a customer who has a question, they’re in the middle of an audit with a regulatory agency and they need backup data or they need a procedure or some kind of question that needs to be answered. And that’s where we can kind of jump in real time and help them. And as someone who’s hosted regulatory inspection, that is so valuable. It’s so helpful just to have that peace of mind of knowing if I
31:15 – 31:55
Jennifer Chang: contact this supplier, they’re going to respond to me in a timely manner. They’re going to help me out and they’re going to provide what I need. So yeah, kind of to your point, the way that you choose your vendor, your vendor matters, your relationship with your vendor matters. That’s sort of a whole other side topic as far as the landscape and regulated industries. Like I mentioned with COVID and the supply chain disruptions. Going along with that, you, we saw some less reputable vendors pop up. And as you get kind of desperate, if you’re running out, if
31:55 – 32:33
Jennifer Chang: your supplier for some kind of clean room garb, or even things like sterile isopropyl alcohol wipes, things like that. If you’re trying to scramble to find alternate suppliers, you could end up with a bad supplier. So vendor management has become another sort of enforcement trend that’s popping up and will continue to be more and more important as things get outsourced or as more and more materials are required to come up with your finished product. But just like with digital systems, your vendor matters as much as the solution you’re purchasing and the support that you get from
32:33 – 32:34
Jennifer Chang: your vendor matters.
32:35 – 33:15
Yan Kugel: And if we are talking about asset management, so you mentioned that there are companies from a variety of spectrum that come to you that some of them have some minimal system that they use or they need something more advanced. So what’s the biggest reason that the companies actually come to you and either switch systems or providers or look for something new. So do they feel they are getting deviations or do they feel they don’t have the process under control? So what pushes companies to look for a more digitized solution?
33:17 – 34:04
Jennifer Chang: Again, yeah, this could vary a lot depending on sort of the maturity of the company. But, yeah, to the point about if we’re focusing on switching from paper-based to digital solutions, the biggest point there is digitalization. It’s not a magic wand that will just completely eliminate all possible issues just by implementing that system. A bad electronic system or a poorly implemented electronic system is just as detrimental as a bad paper-based system. So, with our customers, what we try to do is sort of not just shift their exact paper-based system onto a digital system, because that can
34:04 – 34:37
Jennifer Chang: be tricky. And also every system needs to be optimized periodically. A paper-based system that was implemented 50 years ago might not be optimal before, you don’t wanna just transfer that over. You wanna take a hard look at it first. You want to optimize your processes, really get the right people in the room, think about what you want your process to look like, and then try to put that into your electronic system. And with Blue Mountain RAM, we do have a lot of flexibility in sort of how you can do that, because there are a lot of
34:37 – 34:43
Jennifer Chang: workflows and you can just choose to implement them in a way that fits, that serves your needs best.
34:43 – 35:16
Yan Kugel: And so do you feel it’s also comes from that people feel they’re spending too much time on manual labor or do they encounter many deviations because of human errors with paper. So I know we don’t like saying, okay, it’s a human error, but at the end, human error, the root cause can be, you know what, the paper system doesn’t really work, we need something, electronics. So do you encounter this, it actually, you know, hinders the production because people are on paper or with a big system?
35:17 – 35:55
Jennifer Chang: Absolutely, And I could go on for hours about how I personally have been impacted by those kinds of things. Yeah, I mean, there are certain types of deviations, certain types of the human errors that can be completely eliminated. You’re not going to have an illegible entry because somebody writes too small or because someone spills a cup of coffee onto a paper. So you can completely eliminate those. It’s more about just being mindful as you’re implementing. But the paper-based systems, they are, you can only improve the paper systems so much, and it’s still going to rely a
35:55 – 36:25
Jennifer Chang: lot on, like you said, the manual interventions. And coming from sort of the background in root cause analysis, anytime you have a lot of processes that are really manual or you have something where people just have to remember to do things a certain way, you’re going to end up with a higher likelihood for error. And it’s not because people don’t care, it’s not because they aren’t doing their job. And sometimes it’s not even because they aren’t trained properly. It’s because the system is not designed to prevent errors like that. And that’s where the electronic systems, the
36:25 – 36:28
Jennifer Chang: benefits of electronic systems can really come into play.
36:29 – 37:11
Yan Kugel: So I can just imagine how you trick maintenance or calibration of equipment if you just have to do it manually on the list right if you I think the amount of errors or missed deadlines is just gigantic so I know that when I’ve used to go on audits I always say look at the calibration schedules to see if the maintenance was on time. And I’ve seen also with my eyes quite some occasions that people worked with uncalibrated system because they just didn’t notice or didn’t even remember to put a sticker or even I’ve seen quite a
37:11 – 37:35
Yan Kugel: lot of stickers on machines that say calibration pending. But usually it is because people are just behind their work and the work just piles up because they don’t have a good system to track what they need to maintain and to calibrate and then everything just falls last minute, right? So this is a big issue, I assume.
37:36 – 38:17
Jennifer Chang: Yeah, yeah, there’s so much for the technicians, for the ground level technicians to have to worry about from a day to day basis. That it can, the easier, it’s a mutual benefit, You can make people’s jobs easier, make their life, their quality of life at work better. And you can also improve your compliance because yeah, the miss schedules, those are, that’s absolutely an issue. There are companies who come from using spreadsheets to going to fully digital systems. And as much as it is a real hurdle to kind of get people that work with it to mentally
38:17 – 38:24
Jennifer Chang: shift from the paper-based to a digital system. But if it’s done well, the benefits are enormous.
38:24 – 38:45
Yan Kugel: So what are your perspectives on how to choose the best vendors for the company? So I know that we mentioned, you know, there should be good communication and you should evaluate them, but how should you evaluate them? What would be your criteria when people evaluate their electronic vendor especially?
38:46 – 39:29
Jennifer Chang: Yeah, that’s a really important question and it doesn’t just apply to digital solutions. The biggest strategy or 1 of the biggest early indicators is responsiveness and transparency. So is your vendor, your potential vendor, are they willing to talk to you? What kind of response times are you getting? What kind of level of documentation are they providing? Are they trying to withhold or are they transparent? Are they sharing what’s going on? Because that becomes even more important as you start receiving the product or using the solution, eventually there will be some kind of issue or you will
39:29 – 40:00
Jennifer Chang: need something from them and you need to know that that they’re there for you and and that’s the expectation that the regulatory bodies have there too. There is a compliance aspect to having a good vendor. You can do research, you can go and find, At least for some of the bad actors, it becomes pretty apparent as you just kind of go on and search and look about different vendors, you can find reviews. And we’re in sort of the age of information where you can find out anything, you just need to have the right context to make
40:00 – 40:09
Jennifer Chang: sure that you’re taking in the big picture. So yeah, biggest things, transparency, sense of urgency, and a sense of transparency.
40:10 – 40:32
Yan Kugel: And you mentioned before that there were occasions where your client just called during an audit. So is it happens quite a lot that auditors come and they want to speak with the vendors or let’s say the auditors ask questions which the client cannot answer, they try to really quickly to reach you?
40:33 – 41:10
Jennifer Chang: Yeah, generally it’s not speaking directly to an agency. It’s a question that they’ve gotten and either they’re unsure, you know, sometimes they just want confirmation that they’re providing, you know, the right response. Or that a lot of times it’ll be sort of a, like the regulatory agencies, 1 of the common things that they’ll do is ask you for objective evidence that if you say that their data will be backed up at a certain frequency, the regulators might say, okay, show me that evidence. And then at that point, if we provide that to them very quickly, it
41:10 – 41:32
Jennifer Chang: pretty much closes off that channel of investigation of inquiry for the auditor, which again, if you’re hosting the audit, you get to breathe a sigh of relief because that means they’re satisfied. They can check off the box that says, yes, this system is a state of control. This vendor is appropriate and is supportive of the compliance needs.
41:33 – 41:59
Yan Kugel: And if we go back to your career path, right? How would you compare working in pharma manufacturing in QC and QA to going to work for a role where your skills are still the same, but it’s a startup or software company. What are the differences in the job, in the culture?
42:02 – 42:45
Jennifer Chang: The differences are vast. I mean, I’ve, in both situations, I’ve come across some incredibly smart, talented, skilled, compassionate, wonderful people in both industries, But just the biggest difference is I kind of have my brain back here. Anyone who’s ever worked in manufacturing, they know that you’re kind of always anticipating a new issue to pop up. You know, some kind of, some new problem, some investigation, and out of specification, some issues that you have to deal with. And, and here I get a chance to sort of take a step back and I get to read everything, digest
42:45 – 43:23
Jennifer Chang: things, and then sort of use that information to help people. So for my personal inclinations and things that I like to do, it seems to be a much better fit. But I’ll never forget sort of what that manufacturing is like. And it’s really, it’s an experience I would never want to give up, but I gotta say, I’m really enjoying the software industry. The, the nature of what we do is It just provides a lot more flexibility for things like being able to work remotely and to do webinars like this. I mean, it’s just I get a
43:23 – 43:30
Jennifer Chang: lot of different opportunities that I didn’t even realize that I wanted before in the position I’m in now.
43:31 – 44:18
Yan Kugel: Right. It makes sense. So when you work in pharma, a lot of, especially in QA, a lot of your, from your job tasks involves putting out fires. Although we always say, you know, It should be risk-based, you should anticipate, but this is not the way always things go. There are always deviations. And when you work in QA, you need to love putting out fires. You need to love the chaos that you usually have there. So I myself, as you, I was in the QC. I was in the QA. So I know that each of the departments
44:18 – 45:00
Yan Kugel: has its own pressure. So when you work in the QC, it’s more straightforward. You get your analysis, but then you have you need to be really quick and, you know, and you need to finish those and those tests and because we need to release this, this page and you’re, you know, staying hours just to complete the test that some of them, you know, you need to wait 4 hours for some chemical reaction to happen, you need to continue, right? And in the QA, it’s the same, but in terms of the paper trail, something happens, a deviation
45:01 – 45:43
Yan Kugel: in QC deviation in the manufacturing, but they still want to release the batch, then you need to quickly to analyze and assess the issue to see if the gravity of it, right? And so it’s quite chaotic. So I think people who love it, who love always to have adrenaline, this is the right place, right? And if you want to work a bit more in your pace, as you said, right, it’s a good place to do something with those skills, but maybe not directly in pharma, I guess. For me, it was quite similar in my shift as
45:43 – 45:59
Yan Kugel: well, but It’s a bit different. But I think you’re to the point. And you’re, I think, very happy with your situation because it really fits the family situation and the stress, I guess.
46:00 – 46:20
Jennifer Chang: Yeah, that was very well put. And yeah, a lot of the learning, the early on, kind of immersing myself in everything, It was a lot easier to do that before I had children. So so yeah that it it can be The chaos can be you know kind of it if you don’t get bored when you’re working in a manufacturing.
46:20 – 46:21
Yan Kugel: Yeah, for sure.
46:21 – 46:52
Jennifer Chang: And yeah, with QC, like you say, QC, even between QC and QA, I always used to say, you know, QC finds the problems and then QA has to deal with them. That was it’s a really it’s interesting to have those those roles. And yeah, with with quality assurance in kind of the software industry, I get to be more of the kind of guiding, kind of helping a guiding voice instead of sort of a compliance officer, like the police officer or trying to, I don’t, I don’t have to be the bad guy as often when I’m here.
46:53 – 47:02
Yan Kugel: Yeah, yeah. So people actually are thankful for every, they are happy when the QA enters the office, let’s say, right?
47:02 – 47:05
Jennifer Chang: Right, right, they don’t cringe or roll their eyes and say, oh, QA is here.
47:05 – 47:28
Yan Kugel: Oh no, yeah, hide the notes. Yeah. Yeah, so that’s great. So Jennifer, is there anything else that you feel you would like to share about your career or asset management that we haven’t discussed yet, but you feel it’s important to share before we finalize this great session?
47:31 – 48:04
Jennifer Chang: I think I’ve said quite a bit already. I feel like you learned a lot about me. But my short takeaway version of sort of the advice is learn everything you can about anything you can. And This could work for anyone at any field or any stage of your career. And I guess the last part, if you were trying to, that I would want someone to know who’s kind of aspiring to get into this field is, it’s really easy to be intimidated kind of going into this field where there’s such a vast body of knowledge. So the
48:04 – 48:37
Jennifer Chang: kind of secret I would want to share, I would have wanted my younger self to know, is that no 1 truly knows what they’re doing. And before, you know, I know that sounds really alarming before you question this entire conversation. Let me clarify, I’m not saying that no 1 is qualified to be performing their roles in the industry. That’s not the case. There are just countless throngs of experienced, dedicated professionals with a deep understanding of their current working knowledge that’s considered to be best practice. And they work tirelessly on behalf of patient outcomes. But my point
48:37 – 49:17
Jennifer Chang: is just that knowledge is always changing because continuous improvement is sort of your cost of entry to do business here. And the message is mostly just to remember that that even the experts don’t know everything. And we’re all trying to figure this out together. So while the sort of ever-raising standards that are in life sciences can be frustrating because you’re never going to be finished developing your understanding, it’s also a good opportunity and kind of comforting to know that it’s never a bad time to kind of jump into this game and start learning. Because, and as
49:17 – 49:41
Jennifer Chang: older expectations and best practices are replaced by the newest, the current ones, once we get new information, more and more you’ll start to notice that your knowledge, your opinions, they can stack up with the rest of them. So I guess the message there is just there’s never a bad time to start learning more about it because eventually you’re going to catch up just with the nature of how things continuously improve in this industry.
49:41 – 49:45
Yan Kugel: Thank you for coming to the show. It was a pleasure having this chat with you.
49:45 – 49:52
Jennifer Chang: I really appreciated the conversation. Like everything, I think I learned something just from talking to you. So thank you.
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