Maps, Mentors, and Learning: Professional and Personal Journeys, with Pratiksha Parekh

In this episode, Dori is joined by the awesome Pratiksha "Patti" Parekh! Join in on the conversation as they cover not only what is happening across our industry today, but also have a great discussion around the powerful effects that dedicating yourself to continuous learning, building nimble maps, and actively participating in giving and receiving supportive mentorship can have not just in our professional lives, but in our personal lives as well. 

Ms. Parekh is a biopharmaceutical, pharmaceutical & combination product consultant with a reputation of solving multifaceted product lifecycle challenges in single-product and multi-product facilities. Currently, she is a Principal Consultant at CAI, an organization that she has been with for almost 15 years.  

She has worked at over ten organizations across the globe and has supported bringing innovative therapies to patients, as well as continuous improvement of existing programs to maintain compliance with global regulations. A highlight in her career was being Deputy Director of Validation at a vaccine organization fulfilling government contracts. 

 Ms. Parekh holds a BS in Biochemical Engineering and a BA in Economics from Rutgers University; an MS in Chemical Engineering from Columbia University; and an MS in Regulatory Sciences from Johns Hopkins University.

Connect with Pratiksha on LinkedIn

*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

This is a joint Podcast production of ProcellaRX and KENX

Transcript

Jason Secola: 0:02

Welcome to another episode of women leading validation from for Celebrex, a life sciences strategic consulting firm whose mission is to rethink, reshape and remake the software quality and validation industry for the digital future. On today's episode, we welcome Patricia Patek, who also goes by Patti. Ms Patek is a biopharmaceutical, pharmaceutical and combination product consultant with a reputation of solving multifaceted product lifecycle challenges and single product and Multi Product facilities. Currently, she is a principal consultant at ca ai, an organization that she has been with for almost 15 years. She has worked at over 10 organizations across the globe and has supported bringing innovative therapies to patients as well as continuous improvement of existing programs to maintain compliance with global regulations. A highlight in her career was being deputy director of validation at a vaccine organization fulfilling government contracts. She holds a BS in Biochemical Engineering and a BA in economics from Rutgers University, an MS in chemical engineering from Columbia University and an MS in regulatory sciences from Johns Hopkins University. And now to get the episode started. Here's your host and for Celebrex, co founder and CEO Dori Gonzalez Azevedo.

Dori Gonzalez-Acevedo: 1:13

All right. Well, welcome, Patti. How are you today? Good. How are you? Good, good. Well, it was fresh off of a weekend. And so I'm anxious to have a great conversation with you on our women leading validation podcast. So thanks for joining us. Great. Happy to be here. All right, so let's dive right in. I'd love for folks to hear a little bit about your journey of, of where you came from, and how you came to be in this validation space today, and give a good context for our conversation.

Pratiksha Parekh: 1:45

So great, thanks. Um, so I've been in the industry 19 years. I was born and raised in New Jersey. I went to Rutgers University for my undergraduate education. I have a bachelor's in Biochemical Engineering, from the School of Engineering. And then I have a bachelor's in economics from Douglas College. So that was about 19 years ago. And since then, I've been in the biopharmaceutical pharmaceutical space. Coming out of school, I started working for a monoclonal antibody, monoclonal antibody, pharmaceutical manufacturer, and I started in operations and manufacturing on the floor, doing cell banking work, and purification work. So upstream and downstream work as well as harvest filtration and everything that comes along with it. And then, while and then from there, I went on to work in late stage process development on the purification side working on resin reuse, viral clearance, design of experiments work. While I had that opportunity, and I was working, I started my first master's degree in Chemical Engineering from Columbia University and I graduated, I went to school and I worked at the same time. So I it took me about three years to graduate. And from there, I went on to work for CI who I'm currently employed with. So I've been there about 15 years. CCI is integrated solutions provider, providing services to the pharmaceutical and biotech industry, in validation, qualification, commissioning, quality assurance, project management, compliance and regulatory affairs. So I'm working with CDI I've worked in process validation, cleaning, validation, equipment, validation, quality assurance, I've been deviation lead to a couple other do a couple of projects, which I may talk about a little bit later. And I've done some regulatory work with them as well. So I've got to see a bunch of novel technologies and novel therapies and products also help with some continuous improvement of processes. And then on top of that, I can't say this enough, I got to work at 12 different, you know, large, medium, large, medium, and small pharmaceutical and biopharmaceutical companies all over the world. So it's been it's been absolutely amazing to have this opportunity to work in this industry.

Dori Gonzalez-Acevedo: 4:29

So I can imagine, though, when you were younger and going to school that you didn't really think you were going to be a validation kind of person. Right? That wasn't what you weren't signed up for. What did you want to be?

Pratiksha Parekh: 4:43

I knew I wanted to do something where I could make the world a little better than the way I came into it. And I think that that's really a driving factor in, in most of the decisions I make in my professional career, as well as my personal life, you know, I am a daughter of immigrants. And you know, that's, that's really something like a value that I grew up around that, you know, we, you know, we're there's a gratefulness for being here. And, and also, you know the opportunities here are wonderful and make the world a little bit better than the way you came into it. So I'm so lucky that I was able to do this through being invalidation.

Dori Gonzalez-Acevedo: 5:39

Do you think some of those skills that you did early on in the manufacturing area influenced that in your choice here? Or do you have some other learnings from from that time?

Pratiksha Parekh: 5:51

Sure. So absolutely, I think I think it created a core thought process that learning never stops. So it was working in operations, right out of school, you ever, there's, there's changing all the time, you can know your one facility can be changing products multiple times, and there can be different attributes that are critical or not critical or are less critical. So that, you know, knowing that there's a lot of changes involved, it's the frequency of knowing what's important, how to do certain operations differently, you know, if something in our case and monoclonal antibodies, you know, something could be an extracellular Maliau Mala, drug product, or intracellular drug product, and that our drug substances, those things, you know, really govern, how have operations take place to there's continuous learning, you could have a facility, especially in a Multi Product facility, because you'll see so many different things. So, yeah, no, I definitely did. It just it just fostered. What I already did was, I was learning before I was in college, I was learning and then it fostered the trend of learning made me want to go on to get my masters maybe want to do all these different jobs and projects and see AI maybe want to come and get my second master's. So definitely, absolutely. I'm so lucky that I started an operation.

Dori Gonzalez-Acevedo: 7:25

What do you think? Are some of the the trends and movements moving forward? Now in validation? Right? So, you know, it's different than it was 15 years ago, when you started, right? What are you what are you what are some of your observations around validation and how we were doing it today that is different than it was in the past, or maybe some of the things that we should be doing now, today, given that technology has changed?

Pratiksha Parekh: 7:51

You know, I think the biggest thing in this is as simple as it is, the evolution of single use technology, and how much it's being used now than it was maybe 20 years ago, and how that should be handled from a validation standpoint. And that could be different from each organization to another, you know, that that's definitely something to look at. From an analytical standpoint, obviously, you still have to do bioburden and endotoxin testing. But, you know, vendors are making, you know, making modifications and changes to some of the ways that to make this simpler for the end user, or us, or people in the industry to do these types of testings. And I think that that's, you know, that should be taken into account to maybe look at what potential risks may or may not be there or in within the validation scope. So, those are a couple of things. I also think, you know, from a product standpoint, like, I mean, cell and gene therapy, you know, up and coming, you know, and I think it's so fascinating, and last November, I was at a conference where Dr. Peter marks from CBRE spoke, and he spoke about the number of personalized medicine that were approved, even during the pandemic, which is remarkable, right. And I know that there's regulations around it and things but implementing those regulations into quality quality into validation, you know, you know, the downstream effect of it. I think that it's this is a very fluid, fluid process. But I still do believe in validation. My opinion is that you the process, knowing the process when you're working on validation is so important and the more you know about the process, the better validation or the easier Valley The issue can be, and that's what I that's how I that's actually been my mantra for my career, you know?

Dori Gonzalez-Acevedo: 10:08

Yeah, I think you're spot on on that. Yeah, I really do. I think I agree with you wholeheartedly in that in. And I say similar thing. And part of I think the disconnect is that that process was, so you were talking specifically about process validation, but whatever it is, whatever the thing is that we're validating, right, there are more people literally associated to that thing, or there's more parts or more parts of the organization or different organizations. Now, as part of that process, our the complexity of of that interaction, I think, has changed a lot. Right, where, you know, 10 years ago, a lot of stuff was all in house. Right. And we can extrapolate that to complete computerized systems as well, right? Like a lot of stuff we're done in house, right now, things are externally or you have CMOS, and CRO like you have all these different parts and vendors that are also super critical, and part of that supply chain, as well, on how they all connected it and the responsibilities that they need to be part of that conversation now, right? What is their part of the expertise that folks need to know so that the companies can make their own decisions based on whatever that is to? Right,

Pratiksha Parekh: 11:27

right. And to just to piggyback on what you just said, you know, multidisciplinary cross functional teams may not just be, you know, your people in house, it's also the relationship with your vendors, your relation, and, and more so now than ever, and I'm sure you can speak on this too. Supply chain is much more, you know, much more in play now. You know, quality control, maybe always present, but maybe you need analytical and microbial, you know, backgrounds in the in the conversation, you know, it's just a little bit more evolutionary now. So there's many more players in the game. I mean, I've sat with I think that's where both sides. Yeah,

Dori Gonzalez-Acevedo: 12:09

absolutely. Yeah, it makes it then the job of communication and what's what should be validated? What shouldn't be validated? Who's Who's Who's doing the, quote, unquote, validation? Is it the totality? Or is it individual parts in some of the parts, right? Like, it is more, it's more more, more complicated, more dynamic, and requires more thinking and skills that you were mentioning earlier? Right? Like, how do we now evolve what we do, rather than being static? And so one of the things I think about that, when I say that is, you know, validation, 4.0 and pharma 4.0. Right, and this continuous goal, right, to get to a level where we're continuously validating across the board, but how do we get there, right? Still, I think, if someone can solve that problem, that would be

Pratiksha Parekh: 13:02

sure. But and to your point, you know, that continuous, like, continuous part is, is super important. But the original part and the core of it, you know, for us to be better rate already, but to be more maybe robust. Is that an essential? What is the essential process knowledge about what what are the steps to make this a drug substance? What is important? What are your in process parameters? What are your controls that should be in place, you know, those those attributes. And like we said earlier, it's not, it's not just an operations thing. It's not just an engineering thing. It's not just a checkoff thing, it's just the process of it's a multifaceted, alright, and, and having worked in some way, shape, or form with or in all these different departments in or represented different organizations in different departments, I think it's always been really helpful to know. You know, what, what is? What is the important part here? What part of the process is being impacted by the decision that we're making here?

Dori Gonzalez-Acevedo: 14:18

Is that one of the things that you love about being as a service provider? Having all this? Yeah, tell me more. I

Pratiksha Parekh: 14:25

love that. So there's, there's couple things I love. Seeing, having had seen all these novel therapies has been awesome. You know, I think that that's pretty remarkable. Once again, we talked about the evolution of our industry, you know, talking about anything from an ice and I say something simple as, you know, single use technology. You also say a pharma four point out, you know, we're all talking about the evolution of our industry. But there's also a part of it that's That's professional, and it's very important, it's vital. But there's also a part of it, that's also personal. And, and I think that that's from my personal, genuine curiosity of the human spirit. And, you know, working together and learning from each other. And, you know, not every one everyone comes across is a is a forever mentor, you know, or none are some, but there are moments where we will all learn from each other. Something, you know, they know, and I believe, and there there really is, I am amazed at the way people think, and I think it has also blossomed the way I think as well.

Dori Gonzalez-Acevedo: 15:50

Do you think that's changed since COVID? Or do you think this is something that's

Pratiksha Parekh: 15:55

been going on all along? So I think that I think COVID Probably, it was probably there all along. But I do find conversations being a little bit more, you know, meaningful in? Or maybe I don't know, if you can find a better word than me.

Dori Gonzalez-Acevedo: 16:27

But a little bit more personal, a little bit more connected, maybe

Pratiksha Parekh: 16:32

connected? Yes. Because, because we a lot of us work in this virtual space. And, and we're able to be, we are to connect and still, you know, finish what we started or finish what we were supposed to do. But yes, absolutely. I think there's more knowledge, there is definitely more knowledge sharing since COVID. Or maybe even more, more meaningful knowledge sharing.

Dori Gonzalez-Acevedo: 17:00

Yeah. So I know, it's CII you guys have, cuz I've interviewed a couple folks from CIA, and I know, folks from CIA as well. But so how, how do you guys mentor each other? So here is your very large of service provider? Right? You guys got lots of consultants doing lots of different things at different companies? How are you? Is there a way of doing or sharing that knowledge internally that you guys are doing and cultivating best practices?

Pratiksha Parekh: 17:34

Yes, yes, there's definitely internal knowledge sharing we, we have programs in place for when an individual just starts with our organization. So that and that helps them. It's, it's actually, you know, more senior people or people that have been there longer will educate the newer employees on terminology on best practices on on current current events, even like, what's the, you know, even as far as like, you know, how a cell and gene therapy done, you know, quality, compliance or regulatory we have, we have systems in place for folks to flourish in whatever dynamic or whatever at, you know, whatever subject matter they choose to. So, it's, it's, it's, it's, that's one part of it. The other part is, is that, you know, we do, we do have mentorships you know, where we help each other. I, you know, sometimes they're, they can be formal and I don't mind informal, if someone comes to me and says to me, Hey, you know, Patti, I'd love to pick your brain about something or I like to talk to you about something, you know, I'm fine with that as well. So yeah, we do we do have a very encouraging environment. I mean, that's I think one of the reasons why I've probably been there for as long as I have you know, I've always I've always felt like there have been champions for me I've always felt endorsed there has been a lot of advocacy for me and But with all that also came like hey, why don't you try this? What did you think about this? You know, like yeah, this is this is a different area you can go look at you know, this is something different you can you can think about what about this and that and it gives me options along with the encouragement.

Dori Gonzalez-Acevedo: 19:47

Where do you go to get your mentorship?

Pratiksha Parekh: 19:50

Oh, I've had quite a few mentors through CII you know, some of them have you know, There have been some retirees, you know, people that have retired since but you know, there's never, there's never not someone else that I can go to, to speak to and talk to them about and get a good gut check from. And I also through school, when I did my master's program at Johns Hopkins, I have some mentors from there as well, which is nice. But most of mine are, are internal, I have a really nice support system within, I'm a Principal Consultant there, and I have a really great group within there that I that I work with it is really nice. And then I say, hey, what do you think of this? And, you know, it's conversational. I don't mind the formality of once a month we talk. But even I like the open door policy, that's, that's always worked for me. If someone else wants something else, that's fine, too.

Dori Gonzalez-Acevedo: 20:53

So you went back to school, two times after your original, your initial bachelor work? And each of those times, I'm guessing that there was some motivation for wanting to do that. And I'm curious of whether or not that has produced the effects that you wanted with those degrees?

Pratiksha Parekh: 21:15

Sure. So the first master's degree from Columbia, I think that I wanted more robust chemical engineering experience and knowledge. And that's, that's why I went for that. And I'm really glad I did, because there is a, a couple more, I personally needed a couple more years of, of formal education, to feel a little bit more in tune with my craft. And when it came to the second master's, that was by choice. And as I've mentioned, I worked in an operations, process development, quality control, validation, obviously, quality assurance, I just felt like Regulatory Affairs was an organic, was it like an organic move, I really, like next step, organic, I thought it was really interesting, you know, I love to have the opportunity. And I've had a few opportunities to put the story together, like all the other aspects, input into a dossier, that regulatory affairs, manages, and is approved by a marketing authority, you know, and brings a product to market or a current product and a different indication to market I think that that's really interesting. It's a

Dori Gonzalez-Acevedo: 22:47

different skill set. That's why I asked because it's very, and I've done some myself over the years, but it's not

Pratiksha Parekh: 22:56

very different. Very, very, is. It's, it's, it's different. And I'm excited, I'm excited, because especially, and I think where I shine the most would be in CMC, regulatory, based on what everything that I've done, and I want to be able to tell the story, you know, and I hope to be able to do that. And so,

Dori Gonzalez-Acevedo: 23:19

so, that's interesting. So can you for our listeners, can you explain what CMC means.

Pratiksha Parekh: 23:25

So that's chemistry, manufacturing and controls. So that will be part of the part of the dossier where we talk about pretty much the process development the manufacturing and all and the commercial both most of the commercial operational parts of the of bringing manufacturing a drug so so that's what it's about my most of my interests would be like in the in the three to p and the three to three, two s in the three to P section, which is the drug substance, but product section is really what I would be the most interested in to writing into because it has pharmaceutical development, and it talks about cleaning validation. I've talked about sterility, sterilization, validation and, and all those different aspects of it to bring it to market. So that's so yeah,

Dori Gonzalez-Acevedo: 24:22

and thanks for sharing that because I think it's really important for most folks don't realize how nuanced different parts of the submissions are, right? And so even when some of the more now we've gotten to more complex combined mixed products, right. So you might have drug product with a medical device with a software as medical device and each of those components actually takes a different lens and how it needs to be looked at and regulated and and proposed to the final combination product, right. Yeah, which Again, then that's bringing cross disciplines together, right, which historically, we worked in a silo, right? We, we often did our, you know, single drug component versus a medical device, etc. So now we're, we're in a different playing field, right, we're in a Bolyard, that has multiple things going on. So the teams that have to compile the information in order to get approval are more complicated teams, different endpoints and such. So I find that super exciting. Um, and now even more, so where we're getting into the, the evolution of AI and machine learning and algorithms that are going to have that are going for approvals, right. So it's, it's changing rapidly, right? And all of the underlying operational things that you were talking about earlier need to evolve in order to get to that, that level of change that we want to do, from a product perspective to cool stuff coming out. But if you don't have the underlying operations to support it, it's not going to get produced

Pratiksha Parekh: 26:12

right now. And the underlying operations and, and, you know, involving people from the beginning as those operations are being developed, you know, once again, not we talked about multidisciplinary cross functional teams, having those, the engineering and the, in the process development, and the analytical folks all involved in the beginning. So those processes can be, you know, in a good place to, and then, at the same time, implement all the things you just spoke about, which are very important with AI and computer system validation. Yeah.

Dori Gonzalez-Acevedo: 26:52

So can we pivot a little bit to the personal event? Okay, so tell me, um, tell me a little bit about your, your upbringing and kind of how you became a female chemists that so? I'm a little bit older than you. And that's was rare for, for me, also, probably pretty rare for you. How did that come to be?

Pratiksha Parekh: 27:14

So, so when I went into college, I didn't know what I wanted to do. I was one of the billions at school, you know, first year, I took a couple of biology classes, I took a couple chemistry classes. And then I took a physics class, and, and my eyes lit up, and I and I was like, oh, that's the importance of a ladder. A lot of, you know, it's putting everything together. And as, as silly as it sounds, it really did learning physics really got me interested in to go into engineering. I, the school, I went to Rutgers had all the different, you know, engineering disciplines. I chose Biochemical Engineering, because I wanted to do chemical. And then I said, Oh, this is neat. I can learn about cells, too. I really liked biology. And so you know, there's there's biophysics involved, and biochemistry and, and all those things. And you could say those, those are still parts of the conversation, but they're also in the chemical engineering platform. And then I learned about purification. And I thought that was really neat to like separation technology, and all that. And then, and that's how I became a chemical engineering. Did I know that I was going to be sitting here so many years later, and saying, how happy and grateful I am for all the things I've seen, and, and done. I couldn't, I couldn't even I couldn't even fathom that back then. But I'd love it. That when it came to like classmates and the number, you know, females and I, recently, last year, last year, I attended the records engineering graduation, and I did see you know, more than there were than when I graduated to that. That's wonderful to see. And I look forward to I am involved with some of the Alumni Associations through a couple of my colleges. And I look forward to seeing what comes of it, you know, and who I can we can all work together with because I'm more than willing to learn from them. You know, it's not a one way street.

Dori Gonzalez-Acevedo: 29:37

It's a two way street. Do you have any female mentors or have in your life that you you really drew from?

Pratiksha Parekh: 29:47

Yes, I had quite a few. Early on in my career. I had a couple of professors that I worked for because they work during the summer, who were female at the at the engineering school. In the biotechnology school at Rutgers, and so they were very, you know, very well are well articulate, well, well spoken women, you know, and they were, you know, able to tell, you know, helped me figure out what's important and what's not. And I mean that in an almost as, like, they helped me think scientifically, with the nurture me at the same time, I don't know if that makes any sense. But there was a, it was like a nurturing environment where they helped me learn science. And that was, that was pretty important back then. Even today, I have quite a few female mentors that I go to. So throughout my career I've had female, as well as male, many all different mentors. And, and I can actually go to them for anything. You know, it was it was really kind of neat, you know, you could just learn from anyone in that, in that environment. Yeah, it's been really neat.

Dori Gonzalez-Acevedo: 31:09

What are some of the things that you think either young women or minorities need to come in to, to the space and might need today? And how can we help them or mine the gap there in order to make sure everyone's voices are heard at the table?

Pratiksha Parekh: 31:29

Sure. So I think for anyone coming into the industry, I think it's really, it's really nice to make a map, you know, say this is, this is the path I want to go about, this is what I think I want to do. Now, with the caveat, that map could change, you know, that, you know, so I could have said, Hey, I did operations, I did process development, I did my masters, I can go for the next scientists. You know, and that was my intent probably to give the next, you know, development scientists or scientists, whatever it may be, or I could try something new, and go into this organization that does validation, and do some validation work. And then validation, you know, like, I went into quality, quality I went into, you know, it just, it just evolved into so many different things. And so, having a map is important, but understanding the importance, and that it's okay, to deviate on the map, it's fine to, you know, and to be open, and to, you know, really, there are some things you're going to absolutely love. And then there's some things and you want to do over and over and over again. And there's some things you're going to absolutely love and say, You know what, I did it, I'm good with it. And that's, you know, I would rather do the first thing instead, you know, and, and that's fine. But don't close yourself out to new experiences and, and new opportunities. I know, I know, your background and CSV, I have coated in as in delta V control studio. I, you know, so I've done quite a bit now a lot of it, but enough of it. And, and I love it, and I respect it. You know, Can I do it again? Absolutely. But you know, I can maybe do something else, too, you know, it's just depends on what, where everything goes and, and giving yourself the option to be open to every

Dori Gonzalez-Acevedo: 33:54

I like that. So having a map and knowing that it's navigatable or changeable, and being open, open and curious, and what are some of those? Are there anything that you would have done differently along the way, or things that you are now looking forward to doing perhaps different?

Pratiksha Parekh: 34:21

I don't know if I'd have done anything differently. I think I would, I would if I'm looking back, there may have been in my case, a slight hesitation like, Oh, what if I maybe I shouldn't apply to this school or tried to pursue this program? Or, you know, I think that was more on the learning side of my life, you know, you know, things don't get in there. You know, like there is a little bit of that but, but just try and go different places and see what you like and see what the programs are if if you choose to go back to school, or even if you're doing some professional development learning you You know, see, see what's out there, you know and try everything, you know? What am I looking forward to? I really am looking forward to I guess leading by example. And the reason I say this is because funny enough. Last week, I spoke to a person who used to used to work for me, I was a validation lead on a project. And this engineer was out of fresh out of school and just starting her own revalidation career. And this is months ago, and now, last week, we spoke and she said, You know, I really look up to you, you know, you, you know, you your work ethic means a lot to me, because it made me feel like I was in the right field, and I and I really appreciate that and, and so on and so forth. And I wasn't her mentor, anyway, Dory, I was just doing my job. But the eggs I, your entire audience, whether they're mentors or Mentees and mentors more. So we do they do see us, you know, we do that we do lead by example.

Dori Gonzalez-Acevedo: 36:16

We really do. Yeah, so I was at Connects last week. And it was a great conversation, it was very targeted on the topic of part 11 and CSA, right, which was not the general validation university that we do, or the DMP University. And so, I found it really interesting, and that, when we had a very targeted conversation, a lot more in depth conversation was, was allowed to happen, right, because we're focusing on that one thing. And so, you know, I wonder, in particular areas around validation, if we need to have more dedicated focus time on, you know, specific parts, like cleaning validation, and really, really getting in depth of some of the stuff that has been changing, like single use in that, like, how that ripples effects and how that all impacts, like, there's lots of changes that have happened to have more some more dedicated time from folks like yourself, but that have been in the industry for some time. And we have some learnings there. I'm giving it with unity. Yeah, like keeping back to, you know, because the knowledge again, these are things are not taught in school, right, even though you had a very, very specific education in chemical Biochemical Engineering, like that was, but you're not taught cleaning, validation, you're not taught in the sterilization, you know, in that sort of rigor in the ways in which we have to do it. And so the only avenue to learn is either being in a big organization that has time to train and teach the new folks coming in, or organizations that connects that provide some some guidance and learnings. Because some of those things are not proprietary. Obviously, there are each company makes their own chemicals and compounds and all that sort of stuff. But the principles behind them is not not different, right?

Pratiksha Parekh: 38:15

Yeah, no, no, that's a really, that's a really interesting and, and, again, it's a combination of will, one thing learning, right? Dedicated learning to a specific topic, to your point, maybe cleaning validation or process validation, so and so for me, the other part of it is also, you know, we have new engineers joining our workforce every day. So maybe developing some mentorship, you know, relationships, and then also maybe not as prevalent, but what I learned last week, learning by example, or leading by example, and now and I think that and, and, and I think all three of those can be accomplished in those in that type of form. I mean, is you agree, or?

Dori Gonzalez-Acevedo: 39:07

Yeah, I do. I think it's really important. I think it's, and that's one of the things what we're trying to accomplish and women leaving validation, obviously, as part of the larger broader quality connects sort of movement, right, is that we want to have a place where folks can feel free enough to ask those questions that they're they're either worried about raising particular internal environments or even external environments where they don't feel like they're going to get the support for you know, no one wants to ask a quote unquote stupid question and I and and yet, we are not doing a great job at cultivating an environment where they're not stupid questions, right, quote, unquote, right? They're just questions, right? Making it pretty be normal and normalize the fact that we II as humans, one can't possibly know everything. And it's okay to ask for help.

Pratiksha Parekh: 40:05

If right, and it's so Okay, Dory, I, I'm more than fine telling someone, let me get back to you. And you know, go let me find the answer. Let me get back to you. And I don't know it's okay to, you know.

Dori Gonzalez-Acevedo: 40:18

Yeah. And I think that's still, you know, there's certain Kab caveats in that in whether it's women or minority and right in the in the fact that if we raise those questions, is it possible to be seen as asking too much needing too much out? Like, there's a lot of shoulds that we put on ourselves in those contexts? Because it's not a normalized activity, right? Because there's still a lot of judgment in the room. And so that doesn't cultivate a, a culture of learning, right to what you were talking about before, right? We want to be we want to be learning all the time. But if we don't, yeah, as leaders walk the walk in that right, and lead by example, that any question is not a stupid question. Heck, there might be questions that are asked repeatedly. And maybe that's an indication of some other issue, right? If if the same questions being asked and answered multiple times, that perhaps a actual learning issue, right, rather than a knowledge gap issue, and and I think that that also needs to be parsed out, right, because one thing I've noticed through COVID, is that it's just much, we need to be much more aware of how one learns to like, because we all don't learn in the same way. Right? What am I noticing is, is I absolutely need folks to draw things out for me, right?

Pratiksha Parekh: 41:54

Visually, rather than no is

Dori Gonzalez-Acevedo: 41:56

my go to. Okay, yeah, and, and so, a couple of reasons. One, I'm dyslexic. And I didn't recognize that until later in life, which is just really, you know, confusing when you see all of what I've accomplished, and all of what I've done today, and then say, but, you know, but so, I'm not alone. Right? And there's plenty of other things around that, right. So one might be more visual one might be more audio one might be more, you know, reading it as the context. You know, my kid needs subtitles for everything. And so might everyone else on our on our business meetings, but we're doing these video calls in ways in which suit some some, some needs, but maybe not all the needs, right? And so how to bridge those gaps and how to make all of that just more normal. Right, rather than feeling it's a one off, or it's a sort of commendation just for for one party or one sector where it's actually just, it is who we are. As humans, we're complex

Pratiksha Parekh: 42:59

people. There's a place for everyone in this world, Dory, is a place for everyone in this in this everyone in this world, in this industry, if they so choose to, you know, I think that that, that Yeah. And if we have these conversations of it's okay to ask this question. I think that that can be beautiful thing to be able to do, you know, so that we can cultivate minds think, gather up understand more, understand more. I also think this and I don't, I hear it a lot in some of the more recent, you know, recent graduates becoming coming into our industry. And I've actually been, I've been doing this myself, I said, Well, what I'm, I am trying to understand, I am trying to do this, I am trying and and I, I'm someone recently brought this to my attention, one of my mentors, said, You're not trying try, you're doing you're doing. And I and I see the smile on your face because it's true, right. It's, we are we are doing and yeah, and to give ourselves credit for that, to give ourselves acknowledgement of that. And maybe even those questions that you're asked, you're, you're doing you're getting up there and asking the question, so yeah, you know, it's it is

Dori Gonzalez-Acevedo: 44:39

some of those subtle words it's some of those subtle words are have kept us historically in our lanes, right? It has it is a conscious effort to drop them. Right it's I've noticed that not just in verbal but in written language as well, right? And so, you know, that is one of the ways and maybe we should do a whole other podcast on this I, I interviewed someone around this and talked about it because it's, it's very unique to women too, right. So there's this whole way in which we caveat, a ton, right? Some of our very natural and just instinctual that we don't even realize that we're doing. And so it's not until you have someone else on the other side say exactly what that mentor said to you that you actually said, Holy cow. Like that's what I've been doing. Like really? Yeah.

Pratiksha Parekh: 45:39

Well, the way it came out was I was saying something. So I'm trying to do this and just like not

Dori Gonzalez-Acevedo: 45:44

apologizing to people to like, that's the other thing. Like we say, I'm sorry, all the time.

Pratiksha Parekh: 45:49

Well, this was I'm trying, I'm trying. And then the person's like, Okay, you're, you're, you're not. I guess the person almost asked him, What are you trying to prove to me? And I said, the same time? And they say, No, you're doing? Yeah, you're

Dori Gonzalez-Acevedo: 46:10

Yeah, it's our, it's our trying to prove to ourselves that we're, we're worthy. We're, you know, we're, we've got it like all of those things stuff.

Pratiksha Parekh: 46:21

But I don't know. I just thought it was me. But then I realized, no, it's not, you know, and then I'm like, Okay, fine. But it's also like, a lot of people, I see this more during New Year's time, like changing the language like people's New Year's resolutions. Like, sorry, I took so long, and instead of saying that you say thank you for waiting for me. And I'm like, well,

Dori Gonzalez-Acevedo: 46:52

but no, yeah, that's funny.

Pratiksha Parekh: 46:55

And I, and I mentor, anyone who wants to be mentored? You know, I don't all right. I speak to anyone who wants to speak to me, you know, regardless of whoever they are, you know, there's young, and young engineers if they monitor young chemists or young biologists, regardless of gender, gender or anything, but I do hear that, now that I know that I'm saying, I stopped saying I'm trying, you start saying, I, you know, or you rephrase it, to say I an action I'm doing, you know, an action of doing so. Yeah, it's pretty interesting. And, yeah, I just, I just thought that if I was nothing, I'm improving on as well. Yeah, absolutely. Always Learning.

Dori Gonzalez-Acevedo: 47:41

Absolutely. So Patti, we're going to close out here in a few Is there things that you want to leave folks with, as, you know, something to look forward to, or part of what your message is for our community in general?

Pratiksha Parekh: 47:56

You know, I'm I think, feeling there's a feeling of when you're creating something good. And that is why I why I joined this industry is one part, but how I stayed this long, is because I've always felt like I'm creating something good. And I've been able to help organizations, whether it be with when I was I said before, novel therapies or continuous improvement, or whatever the case may be, but, you know, you're always creating something good. There's always an opportunity to learn. You are enough. You know, I think that's, that's important to tell your audience to hear, and, you know, safe, effective, quality products to our patients. You know, we are all have a hand in that. And it's pretty remarkable. It's pretty amazing and pretty remarkable. And, you know, whatever path you choose, you know, we hope you enjoy your time here, like I have. It's very sweet.

Dori Gonzalez-Acevedo: 49:25

Very sweet. Thank you, Patti. I appreciate you. Thank you for your time today. And hopefully, I actually am trying to schedule a meetup in Jersey, so I think we can figure that out getting together in person.

Pratiksha Parekh: 49:41

Just exit. Just tell me what you absolutely.

Dori Gonzalez-Acevedo: 49:44

That sounds good. Yeah. Perfect. Well have a wonderful afternoon.