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Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons] Simone (George) Ammons
Yan Kugel is joined by Pavan Pasupulati, the Vice President of Manufacturing Excellence at Caliber Technologies. Here, he shares valuable insights into the future of pharmaceutical manufacturing. With over 25 years of experience in both the process and IT industries, Pavan has become a key figure in driving digital transformation within pharmaceutical manufacturing.
Table of Contents
Pavan emphasized the significance of electronic batch records in the pharmaceutical manufacturing process, highlighting the benefits of automation and digital solutions in improving productivity, reducing manual errors, and ensuring data integrity. As the crux of the entire manufacturing process, electronic batch records offer configurability and flexibility to address the complexities of different dosage types, ultimately improving the efficiency of shop floor operators and reducing transcription errors.
Pavan discussed the challenges faced by pharma companies when implementing Pharma 4.0 solutions, emphasizing the importance of change management and providing configurability in software applications to address complexities. He highlighted the need to make customers understand how digital solutions can simplify their job and improve productivity and efficiency. Pavan’s approach to navigating complexity involves engaging users, communicating the benefits of digital solutions, and drawing out a digital roadmap for customers to transition from paper-based systems to digital formats.
Pavan predicts that artificial intelligence, data analytics, digital twins, and connected devices will have a significant impact on pharmaceutical manufacturing in the coming years. He sees a future where modern equipment, IoT, and AI will play a crucial role in improving productivity and providing additional data insights. Pawan’s insights reflect the ongoing transformation in the pharmaceutical industry, with a focus on leveraging emerging technologies to drive innovation and efficiency.
Pavan offered valuable advice for aspiring pharma professionals to stay ahead of the future of manufacturing and excel in their careers. He emphasized the importance of staying updated on regulatory guidelines, learning about new technologies, including artificial intelligence and machine learning, and developing an understanding of the quality maturity model. Pavan’s advice serves as a guiding light for individuals seeking to make a meaningful impact in the pharmaceutical industry.
In conclusion, Pavan Pasupulati,s insights shed light on the evolving landscape of pharmaceutical manufacturing, the challenges and opportunities in implementing digital solutions, and the potential impact of emerging technologies on the industry. As the pharmaceutical industry continues to embrace digital transformation, Pavan’s expertise and experience serve as a guiding light for organizations seeking to navigate the complexities of Pharma 4.0 and beyond.
Episode Chapters:
Please be advised that this is an AI generated transcript and may contain errors.
00:27 – 01:13
Yan Kugel: Welcome to another exciting episode of the QualiTalks Podcast. Today, we have the pleasure of speaking with Pavan Pasupuliti, the Vice President of Manufacturing Excellence at Calibre Technologies. With over 25 years of experience in both the process and IT industries, Pavan has become a key figure in driving digital transformation within pharmaceutical manufacturing. His expertise in lab digitalization in industry 4.0 has not only shaped his career but also empowered countless organizations to change their operations. In this episode, we’ll explore Pavan ’s insights on the common challenges GMP professionals face when implementing industry 4.0 solutions, as well as the
01:13 – 01:28
Yan Kugel: emerging technologies poised to reshape the pharmaceutical landscape in Pavan ’s personal journey through impactful projects that have contributed to his success. So Pavan , welcome to the Equalitox Podcast.
01:30 – 01:36
Pavan Pasupulati: Hi, all well and it’s my pleasure actually to interact with you today.
01:37 – 01:58
Yan Kugel: Thank you, Pavan . And before we go to your journey and the projects, your job function at Calibri sounds very fascinating. Vice President of technology and excellence. So what does it stand, what do you do in the organization because it sounds so fascinating?
02:01 – 02:54
Pavan Pasupulati: Yes, and so as the vice-president of Manufacturing Excellence at Calibre, my role involves in cultivating a deep understanding of market trends, customer needs and emerging technologies to inspire and guide our product development process. I focus on developing and communicating a clear and compelling vision for our manufacturing products, just backed up by strong execution strategy. Building dynamic teams and concentrating on innovation are also key facets of my role. There are teams which are focused on business development, product engineering, project delivery, and the customer support which I oversee as part of my responsibility as vice president of manufacturing
02:54 – 03:07
Pavan Pasupulati: excellence. In a nutshell, my goal is to maintain a 360 degree overview of business growth, profitability, customer satisfaction, and associate engagement.
03:10 – 04:05
Yan Kugel: Yes. It sounds fascinating and complicated, challenging at once and I think it’s very rewarding role to have so much impact on the organization. So what brought you to this position? So that’s what I also want to explore with you. So you have been in the industry for over 25 years now, right? And you specialized in various functions in the manufacturing and quality like lab digitalization and implementing the industry 4.0. And you had so many great positions from your career, right? So what were the key milestones in your career that brought you to the position where you’re
04:05 – 04:06
Yan Kugel: at right now?
04:08 – 04:52
Pavan Pasupulati: It has been, as you rightly said, a very enriching learning experience that I had for the last 25 years and I’m continuing to learn as we speak. If I were to look back at my career, I can group that into 3 segments largely. First 5 years, it has been practicing the chemical engineering in the process industries. I have developed good understanding of the unit processes, unit operations in fertilizers and also in petrochemicals, refineries, pharmaceuticals during this period. This formed a strong foundation for me to get transitioned into the application engineering and IT. In the next 10
04:52 – 05:35
Pavan Pasupulati: years, I have been mainly focused on implementing laboratory information management systems, the manufacturing execution systems, innovation management systems, and several other IT applications which I had opportunity to implement for global customers. So during this particular time, I have learned that for any successful project, It is important to have very good domain understanding. So if I am delivering a project in a refinery, I would need to really have a good domain understanding of how the oil and gas domain works. And similarly, if I am implementing a project in petrochemicals or like in pharmaceuticals, I would need to
05:35 – 06:14
Pavan Pasupulati: understand the overall business process and the domain of the pharmaceuticals so that way I will be able to effectively make the communication and also like able to involve the users and develop the deep knowledge of that particular area and combine that with the application that is being implemented. So the learning what I had is to have a good blend of the domain expertise, the application expertise, so that we are able to effectively implement the project within the timelines. So this is 1 of the key learning that I had while I was doing the implementation of several
06:14 – 06:56
Pavan Pasupulati: projects. The last 10 years, I have been looking at consulting with the customers mainly in the field of the lab digitalization, the digitalization on the shop floor, and also looking at the latest technologies, how we can bring that value to the customers. So these are the things which actually have influenced my career and brought me to this particular position. So some of the key projects which have influenced my learnings in this journey, there are several of them. But if I were to call 3 of such programs, the implementation which I did for a global pharmaceutical customer
06:57 – 07:36
Pavan Pasupulati: way back in 2005, that is something like a rich had 4 different sites where I was responsible to develop a learning content of like about 50 hours, which was combination of web learning and also the classroom training. So I personally traveled to the different sites of the customer where I had opportunity to interact with the scientists who are actually working in the laboratories and then implemented the laboratory information management system. The second experience which I really like, I would like to call out, which had a great influence on me, is rolling out a manufacturing execution system
07:36 – 08:17
Pavan Pasupulati: for a semiconductor customer. So the entire process is completely different with discrete manufacturing. And we were collaborating with a product partner. So that was a kind of experience which really helped me to understand the different facets that are involved in implementing a solution on the shop floor. And the third 1, which I would like to call upon, is the laboratory transformation program where we had to construct the different test methods, basically like which are having the detailed execution of all the different steps within the execution of an experiment and put that into the system so that
08:17 – 08:52
Pavan Pasupulati: there is a method, the guided method execution, which the analysts are able to follow. So these are some of the programs which actually have helped me to interact very closely with the diverse teams and help to understand the user perspective so that we are really able to deliver the value. So to get into this position, these are some of the things which have really helped me. And I really thoroughly enjoy interacting with the customer, understanding their point points, and then trying to see how we can really make a put a solution that fits their needs.
08:55 – 09:28
Yan Kugel: Right. And a lot of those projects were establishing different digital solutions with the clients in pharma. And right now there is the general name for the digitalization the pharma 4.0, right? So there is a lot under this definition. So how do you define this in your words? What does it mean for you bringing the manufacturing facility to 4.0? What does it mean?
09:29 – 10:10
Pavan Pasupulati: Well, right, right. Okay. So I think like the industry 4.0 was predominantly the concept on how we came from generation 123, and then we are at 4. So we are actually blessed to be having the kind of a technology advancement that we are able to experience now. So if I were to look at the inheritance of the industry 4.0 for pharma, which we also call it as the pharma 4.0, the fundamental principles like which actually remain in terms of the interoperability of the connected devices, the decentralization making, visualization of the data, and then also trying to
10:10 – 10:49
Pavan Pasupulati: bring more of the insights from the data that actually is decided. So the way that I would look at for the formal perspective is how are we really able to utilize this in the manufacturing lines if I were to look at using the connected device, if I were to look at getting the insights of the batch production that would happen. The critical process parameters which are which really like have to be monitored so that we are able to like move towards a golden batch. So this is how that I interpret on inheriting the industry 4.0 concepts
10:49 – 11:01
Pavan Pasupulati: into pharma and our solutions also like a we have to be aligned to that to marry the advancements which are there in the technology and then provide that benefits back to the customers.
11:04 – 11:25
Yan Kugel: Right, And I have also seen at some point that people already speak about the Pharma 5.0. Is it something that you are familiar with? Is it something that is a far-fetched reality at the moment? Or is it actually that some companies already move into it and what does it mean actually?
11:27 – 12:05
Pavan Pasupulati: So, my understanding is that while we have 4.2, 5.1 then like subsequently some of the other things may really open. The way I really look at it is, we have already, if we look at the overall chain of how we sense the data, and then how we gather that particular data, and how we are able to visualize the data, and then how we are able to act on that particular data. So these are the fundamental principles which will still remain as part of the overall chain of the activities which any of the specific operations would typically
12:05 – 12:41
Pavan Pasupulati: constitute of. Then these are some things which are enriched by the technology components. Then we are able to bring the artificial intelligence machine learning, where we are able to use that for quick decision making. Now we are also looking at generative AI. So if we are going to call that also combining with the network speed and other things and like a look at the 5.0, then obviously there are steps that we are taking towards it and probably like some of the industry pioneers are also looking in that direction. But what I believe is to really like
12:41 – 13:01
Pavan Pasupulati: and look at what is coming next and then quickly bring that into address the challenges that are really faced in the shop floor. So that’s how I really like to see it and that’s my perspective on the next phases of the series that is 5.0 or the next subsequent
13:02 – 13:34
Yan Kugel: things. And can pharma companies go directly to the different stages? So let’s say some company is at the moment paper-based in a lot of functions. So is it possible to directly jump to the latest version of pharma by establishing the right function immediately or there are some steps to it that 1 has to go through first 4.0 then upgrade to 5.0 or is it something that can happen immediately?
13:36 – 14:13
Pavan Pasupulati: In my opinion, first I think we should definitely look at making from the paper the way which you stated. First to get that into a digital format. Say we bring that into the electronic format. There are certain information systems that which need to be in place. If we were to look at the digital maturity of each of the particular customer, we could be at different levels. The way I would think which we should approach that is to draw out a digital roadmap for the customer, depending on the state where they are, if they will have to
14:13 – 14:49
Pavan Pasupulati: go and take the first step of digitization, where you are able to make that electronic. Then you have information processing, where you are making in terms of digitalization, where you are also going to get the historical data and the current data. Then look at the digital transformation. So the digital transformation obviously like there you are using more of your knowledge. So the first 2 stages, you are looking at data and then like at the information, the third 1 you are looking at the knowledge. So I would not think that somebody could directly jump in without really
14:49 – 15:24
Pavan Pasupulati: having the strong foundation layer that’s built. In my opinion, it should be that the customer would need to take appropriate steps, especially if you look at the pharma perspective, that how do we move away from the manual and paper-based activities into electronic and then like use those systems to collect that particular information and then jump into the transformation where the information that’s collected becomes knowledge and that knowledge can be used to empower the decision. So that’s how I would see it in terms of the digital transformation.
15:25 – 15:55
Yan Kugel: Okay, that’s a good insight. It’s all about doing the right planning, right? You have been involved, as you said, in many such projects of implementing digital solutions. So what would you say are the biggest challenges that you’ve seen with your clients in pharma companies when it comes to implementing such pharma 4.0 solutions?
15:57 – 16:34
Pavan Pasupulati: The first and foremost challenge, which I think is very, almost I would say known to everyone, but still remains to be the first and foremost challenge in the inertia from the person who are involved in the project, to adopt the newer ways of working. That inertia is 1 of the key challenge in terms of the people element. Apprehensions which the typical users can have, what is it really like you’re going to impact? So am I really going to have my job or it’s going to go away? So these are first and foremost kind of challenges which
16:34 – 17:18
Pavan Pasupulati: are typically there. And this is something which almost experience in majority of the projects. But in that, so if we look at from the information systems, like the legacy systems especially, the legacy systems, which are like a golden technology and the ones which were developed in the past. So getting those talking to the newer systems, they pose kind of technical challenges. And then I looked at some of the projects which I personally have experienced where the equipments are legacy-made. So they may not be 21 CFR part 11 complYant. They may not offer the kind of sophistication
17:18 – 17:57
Pavan Pasupulati: in terms of integrating and getting the data. So those are some of the challenges from the equipment point of view and the legacy systems point of view. If we look at it to the operations point of view, especially when someone works in pharma, it could be different departments like you have the warehouse and then like you have the quality control, quality assurance, and then the manufacturing. So there are many lab log books which are maintained. So these log books are quite large in number. So there could be several formats which probably are the same, but still
17:57 – 18:31
Pavan Pasupulati: they are large in number because there is a duplication of all these logbooks. So that is 1 of the challenge which actually like it comes into picture for the users to understand, yes, I mean, how can we harmonize these logs, bring that number down and then like as still try to use that electronic system to get used to working with the newer ways of working. So that’s another challenge from the operational point of view. And if I look at the Batch records itself, there could be the Batch records which could be running into several hundred of
18:31 – 19:04
Pavan Pasupulati: pages, say like 100 pages and 100 decades, so on and so forth. So that’s something like a which probably like a need to be refined, not really like a compromising on any of the complYance aspect, but really like to see how we can optimize those records, making sure that there is no kind of a violation on the complYance aspect and also the process aspect of it. And then I can try to bring that into the electronics system. So these are some of the things which I felt in terms of the people, in terms of the process,
19:05 – 19:44
Pavan Pasupulati: in terms of the equipments, which have posed the challenges which I have experienced in some of the projects that I have delivered. And the other point, not the least, that the representation which is required to be there from various departments when a particular program is really like a being taking off. So that representation basically ensures that there is a collective thinking. At the same time, there is also some kind of nuances which can be addressed right at the beginning of the program. So these are some of the things which I experienced as challenges and of course
19:44 – 19:49
Pavan Pasupulati: like maybe I spoke some of the solutions but these are some of the challenges which I experienced.
19:51 – 20:31
Yan Kugel: Right, and you mentioned already some ideas for solutions, but what is your personal approach to navigating such complexity? So when you meet with clients that they have all those challenges and they might be anxious to start with transition from legacy system from paper because there is a lot to overcome, they need to keep themselves updated and comply with different GMP regulations and validations. So what is your roadmap to navigate those complexities? How do you start?
20:33 – 21:11
Pavan Pasupulati: So while engaging at like at the way that I have approached probably like a few examples, which I would say is first making the customer understand on how this is really going to simplify the job and what are the improvements that we can see in terms of the productivity and in terms of the efficiency. And a lot of discussion that really will be helpful to put the return on investment, which actually makes the user or the customer to take that kind of a step to move from the current system. So that’s 1 thing which I would
21:11 – 21:57
Pavan Pasupulati: take as an approach, really navigating through the complexities. The second 1 is the pharma industry, as we all know, has direct influence from the regulatory guidelines and these are evolving continuously. So in my opinion, basically we need to provide more configurability in the software applications to address these complexities. So when we explain on how the platform is really going to give that kind of flexibility for them to figure out and adopt that particular features on the current ways of working, how that can be really brought in. So that really like a makes their job simpler. So
21:57 – 22:36
Pavan Pasupulati: which really pays the way for the project to move forward. And obviously the change management, which will have to happen at different levels. Once you have the bail from the leadership team, then the benefits will have to percolate to all the different levels. Then everybody sees the benefit that is going to come in. Eventually, that’s how we are able to navigate and then move forward. And engaging all the different users and making sure that we are able to communicate the benefits in terms of the uses of that solution will be my approach in navigating the complexities
22:36 – 22:38
Pavan Pasupulati: that we tend to get in the projects.
22:40 – 23:27
Yan Kugel: Great, thank you for sharing your road map and how you approach the solutions to those problems. So I do believe it sounds much simpler than it is because there is a lot of work and thinking and risk management and the zone involved. But that’s how you need to start looking at the big picture and then diving in and really analyzing each big and smaller changes within it. So I think that’s a very good approach to that. And looking overall on pharma, how it progresses, So what emerging technologies do you think that will have the most significant
23:27 – 23:32
Yan Kugel: impact on the pharmaceutical manufacturing, pharmaceutical quality in the next years?
23:35 – 24:16
Pavan Pasupulati: Very, very, very good question. And I think like a, there is a, I would say significant transformation that is coming our way. And that is what is the future of pharmaceutical manufacturing is. So if we keep like looking at the newer technologies which are coming into the market and how There are use cases which are available across the different industry verticals and the similar thing like which are the problems that need to be solved within pharma. The artificial intelligence is something like which is really like
24:16 – 24:16
Yan Kugel: a taking off.
24:16 – 24:57
Pavan Pasupulati: And we see already that many customers are really extensively using this problem like in the research and development. And there are also large use cases which are available even within the manufacturing as well. The data analytics and the digital twins, these are some of the things like which are definitely like going to have significant the contribution in the future of the pharmaceuticals. So The way I see the future in the US to come by, most of the newer lines, which are actually going to come into production, I believe that a lot of the modern equipment are
24:57 – 25:35
Pavan Pasupulati: going to come onto the sharpness. So it could be a rapid mixer granulator, it could be a compressing machine, it could be auto coating machine, it could be the packaging machines. So they are all really like are going to come very advanced for the newer lines which are going to come into production. And I also see that there will be an extensive use of the IoT and connected devices, which will provide the real-time data for monitoring the process parameters, thereby it is leading to the improved visibility. I would see digital twins playing a large role where
25:36 – 26:15
Pavan Pasupulati: we can really look at optimizing and also like a troubleshooting without impacting the production. The artificial intelligence, which I said, the genetic AI, there can be different use cases in terms of answering the questions which can come from the different users. And there could be object identification. And then there can be a kind of a summarization of the documents which are there, probably like which can be made more concise. There can be like a sum of the information that can come really like in a very quick way so that we are able to quickly take decisions.
26:16 – 26:49
Pavan Pasupulati: So within the Generated AI itself, like there will be many use cases that we can really look at. So net-net, to summarize, I would see that the artificial intelligence, especially the generative AI and the machine learning use cases, with the combination of the connected devices and the data insights are going to really play a very large role, basically to improve the productivity and providing additional data insights. So that’s how I see the future in the years to come.
26:50 – 27:34
Yan Kugel: Right. So thank you for those insights. So I do think that AI will play a huge role and it is to be seen what hurdles will be there from the regulatory perspectives and how we can overcome it. But I do think this will be really a game changer. And we do see a lot of software companies starting to implement AI, for example, in QMS, and different, I think, even in limbs and such, regard and then risk management and so on. So I do think it will play a huge role. So I think we are in a
27:34 – 28:29
Yan Kugel: dawn of AI and we cannot run from it. We need to embrace it and see how we use it in full potential. And For the past almost 3 years, you have been working at Calibre and Calibre specializes in electronic batch records. So, and batch records are a huge deal in pharma. A lot of companies are still using paper, for example. So where do you think this comes handy, those automation and electronic batch records. So how does establishing such processes and such tools can change the way pharmaceutical manufacturing works? And in which ways, like from time saving,
28:30 – 28:39
Yan Kugel: regulation, being much more audit ready? So what is from your perspective in working with your clients so far? What do you see in this regard?
28:41 – 29:21
Pavan Pasupulati: Yeah, I think the electronic batch record is the crux of the entire manufacturing. So a batch right from the issuance till the closure of the batch after the production. So the entire batch lifecycle is something like which is addressed by the caliber solution, which is the electronic batch record. So the taper-based batch records, which are currently being made, so we can really look at in a stage manner or like we can look at a kind of a holistic manner. So Basically, it could be of any dosage type. It can be the water solid dosage, or it
29:21 – 30:04
Pavan Pasupulati: could be injectables, or ointments, or the natural spray. There can be different dosage types, but all of those process segments and other things, the configurability is that something which is there within the solution that we have. And this basically improves the productivity of the shop floor operators. It also can make sure that the manual errors, the transcription errors, the data integrity issues. Those are some things which are tremendously reduced. And we really have several examples where we deliver some product to the customers. And in terms of the audit files, so each and every aspect of any
30:04 – 30:39
Pavan Pasupulati: change like which is made, that is something like which you will have the audit for each of those activities which are done within the system. And also, someone can try really validating the batches before it is really like a run-on reproduction. So those are some of the things which are there as part of the features. And it is also something which we can do within Stainless. So first, we can look at paper on glass. Then we can look at the electronic logs, which can be coming into the digitization, and then the in-process quality checks, and then
30:39 – 31:09
Pavan Pasupulati: the entire batch records. So it can be a staged approach, and it can be a holistic approach. So that’s something we can really help. From the complYance point of view, So all that data which is required to be presented as part of the batch dose here, so that gets directly generated from the system. So There are several features and other things which are there as part of the solution. And this is really well accepted and being used by several customers.
31:11 – 31:15
Yan Kugel: And do you see also AI being part of it in the future?
31:18 – 31:53
Pavan Pasupulati: Thank you so much for asking that question. Yes, we do. We are going to bring a general AI component on top of the solution. So basically, that is something like which is going to be there within the applications. There is some kind of an approval that need to be taken. If the user would need to, if the particular manager need to have some data that’s available before he takes the decision, so those are something like which it can bring it. And it also will have several other use cases which is going to be. So I will
31:54 – 32:09
Pavan Pasupulati: probably like reveal more of this when we are going to launch it. But yes, as you rightly asked, This is there on the cards and we are going to bring that into each of the caliber product that we offer in the market.
32:10 – 32:56
Yan Kugel: Okay, that sounds exciting. So I’m looking forward to the release and looking at the capabilities of it because I’m very interested to see AI in playing every part of the manufacturing. And I’m always trying to research and see where it has been used and how, and really get inspired from what’s happening right now and predict where we are heading in this regard. So looking forward to it, Pavan indeed. And Pavan , tell me something. So what inspires you at the moment in your profession? So you are already in 1 of the highest positions that 1 can achieve
32:56 – 33:10
Yan Kugel: working in a company. So What are your aspirations? How are you looking to drive innovation in the future? And how are you doing this?
33:12 – 33:59
Pavan Pasupulati: So 1 thing that clearly motivates me is that we are really in a, I would say, intersection point of serving the mankind and also like using the technology for this. So we’re like, we are in such a kind of sweet spot, I would say. So what I would think of what really inspires me is that we are really able to offer a safe and affordable medicine, which can be produced by the pharma manufacturers. We providing our solutions, really enabling them to do that. This is something which really inspires me and then keeps me motivated to constantly
34:00 – 34:36
Pavan Pasupulati: think on what new solutions that we can bring out of the table. In line with that, so we are constantly looking at, how are we going to minimize the effort that the users are putting? Say for example, the users are taking time to put in the master data. So how can we really simplify this? And in typical, any product which you run in Pharma, there is a validation of that particular computer system that takes place. So how can we bring down this effort of validation? So probably like we can look at the pre-validated kits that can
34:36 – 35:10
Pavan Pasupulati: go along with the solution. And how can we tailor that these are really like as something which we can look at as the computer software assurance, which again, like is being really advocated in the industry. And how can we bring some of the solutions on top of what we currently have? Say like, for example, like we have a LIMS product or we have the BatchRecord management solution. So if we bring another solution on top of it, so probably like that combination really like provides a much higher value. So maybe you are not really looking at any
35:10 – 35:27
Pavan Pasupulati: components, but look at life rate components. So these are certain things which we constantly think and try to innovate and see how it’s really like a bring the actual value to the users on the shop floor and like in the world of the pharma value chain of the quality management.
35:28 – 36:04
Yan Kugel: Great. So very inspiring to see the thought behind the innovation. And lastly, Epavan, based on your impressive journey and career, what advice can you give aspiring pharma professionals to stay ahead of the future of manufacturing and excel in their career. What set of mind should they have to really bring their career to the best potential that they can?
36:06 – 36:50
Pavan Pasupulati: I have really 2 sets to say. 1 is constantly stay updated with all the information that’s available. In the current days or like in the current situation the information is really abundantly available Like we can just like get the information through all the channels that are really available currently. So 1 specific thing is to stay updated on what are the newer things which are there, especially the regulatory guidelines which are really like a coming from FDA and other regulatory bodies, and also learn about the new technologies which are coming in the market. So we are getting
36:50 – 37:24
Pavan Pasupulati: to see the newer ways and what it used to take so much effort in the past, like we are able to do it in a very short time being this. So that is something which is possible because of the technology. And we are all using those technologies in day in, day out of our day-to-day life. So the GMP professionals should really make a constantly look at keeping themselves updated on the regulatory guidelines, learn about the latest technology, including artificial intelligence, machine learning, and not to really like a thing saying that like, this is not probably something
37:24 – 38:01
Pavan Pasupulati: that’s relevant to us, rather, time spent, time may not be like going in too much of a depth, but definitely like having the knowledge of how that can impact or how that can benefit the activities that we do, that I think like will greatly help. And also looking at developing the understanding on the quality maturity model. So the quality maturity model is a concept which probably like is something which is really evolving and a lot of people have started practicing that. So if the understanding is further developed on this and then like in the each individual
38:01 – 38:32
Pavan Pasupulati: capacity that we are really able to adopt more of this. I’m sure that the organization goals are going to be aligned, and the guys can really contribute to the organization goals, and the success can be really seen by the respective organization. So my kind of to summarize, I would say the guys to stay really updated with all the information, learn the new technologies and then develop the understanding and the quality of it.
38:34 – 38:52
Yan Kugel: Great. Thank you for this incredible advice. I think many people will find it very useful and hopefully they will follow it. So thank you very much for this insightful talk and I wish you best of luck to you and Calibre and their future endeavors.
38:54 – 39:13
Pavan Pasupulati: Thank you, Yan. It was a really pleasure interacting with you and that questions which really have been very insightful and it helped me to reflect some of the experiences like which I have gone through and thank you so much for again bringing out this from me. Thank you.
Yan Kugel is joined by Vincent Cafiso, the Director of Quality and Regulatory Services at CREO Consultancy and a former FDA investigator. Vincent shares invaluable advice on things never to […]
