April 28, 2023 • 46 mins
Welcome back to another episode! Today, Dori sits down with Sree K, a life sciences industry professional with over 18 years experience that spans roles in testing, validation, IT, Business, and Quality. As an expert in test automation, Sree is a huge advocate for automation in validation and modernizing our approaches to software compliance.
Sree is also very active on LinkedIn, providing his followers with unique and insightful life sciences related content, and illustrating what an exciting time it is to be a part of this industry.
You can follow Sree on LinkedIn here, but in the meantime, put in your earbuds and enjoy another great episode of Software Quality Today!
*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 production of ProcellaRX
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Episode Transcript
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Sree K (00:56):
Thank you very excited to be here.
Dori Gonzalez-Acevedo (01:35):
It's been a while since we chatted, so we
it's always nice to be able tocatch up to while we're doing
some of these podcasts. Yeah,you've been active in in, in
posting and doing some new liveLinkedIn stuff. So how was
things going? And I would liketo know how things going and
where you are and how you cameto be in this industry.
Sree K (01:56):
Okay, great questions. I think it's really exciting times
to be in this industry, I thinkI would start from there. People
who are looking to join thisside of work in our industry,
this is the best time to arrive.
And that's the message I've beentrying to portray in my when I
talk to new people, or I try toshare something LinkedIn, things
like that. Because I mean, I'vebeen in the industry for 18
(02:19):
years. And a lot of the time Ifelt, as I heard you also in
other podcasts and people saywhat you actually do is kind of
boring, or doing the same stuffover and over again. I think the
reason CSA guidance coming outit's exciting time to be in this
industry and make really somechange, right? I mean, some of
us have that in us. We didn'thave something to refer to, but
(02:41):
now you have something to refer.
So go make that change.
Dori Gonzalez-Acevedo (02:49):
Yeah, so it's, I know, you and I both
have been in the mindset ofdoing risk based approach for
many, many years. Right. But itwas a lot of resistance we had
had for folks that say, Well, isthis really going to be
accepted? Or is this going to beokay, and so what are your some
of your thoughts around the CSAguidance? And and how does that
(03:11):
does this help thatconversation?
Sree K (03:14):
It does, right? So I think one of the key aspect is
to understand the key players inthe game, right? Especially when
you talk about validation,you're dealing with three
schools of thought, you have abusiness team, you have an IT
team, and then you have thequality team or CSV if it is
part of that, right. So my earlyconversations has been like, you
(03:34):
know, people want to see howothers are doing wait and watch
and then implement our, youknow, last farm, especially
this, like, hey, we have enoughresources to do what we were
doing in the past, right? Theydon't need to change anything,
we have enough time we haveenough resources, but what they
miss is they could allocatetheir resources to more mission
(03:56):
critical activities, if theyapproached you to their space.
Right. I think that's the partwhich is missing. And I've been
very vocal about it. And alsoyou in some, in some cases, it
is about doing and showing itright. So luckily for me, I had
the good fortune of doing a lotof automation testing projects
before. And once the customersees that kind of savings, yes,
(04:16):
you have to invest a little bitin upfront, like the first year
or so. But then you see thevalues in the second 30. And you
don't have to keep the same teamor in all right. So that's one
of the big, big savings I'veseen. And also these days as I
write and talk to more people Isee a lot of acceptance from all
(04:39):
different angles, someone orwait and watch, but already some
use cases coming from the spaceapproach and how each of the
customers have been benefited.
Right. So people have startedreading those and then
especially my focus area rightnow is to work with small and
midsize farmers. So since youknow, in one way they're
disabled advantage is anadvantage because they don't
(05:01):
have the systems built in, theydon't have the linkage of, you
know, doing this in one way. Sothey're open, an open mindset,
they are ready to listen to whatis happening newness, try the
new stuff, because theirintelligence also get to the get
the product of the dog to themarket as fast as possible.
Right. So
Dori Gonzalez-Acevedo (05:21):
because they're smaller, they're more
nimble. Right. And they're giventhat they're smaller, they're, I
think, we can make the logicalassumption that they're closer
to understanding the why theproduct is what it is, or when
why the urgency to get thingsdone. Right. Yeah. Whereas when
you get to the big enterprise,you know, organizations, that
(05:42):
journey to the end goal isfurther away and less tangible.
Sree K (05:47):
Yeah, I think there's good and bad to eat as well,
right. So you know, enough, thereality check I had in my career
was, I worked for Big Pharma for15 years. And then I wanted, I
did a lot of different roles inour major change, I thought, I
can make these kinds of changesin a smaller pharma faster, and
I can learn faster. But some ofthe challenges remaining small
(06:07):
farmers already you you feelwhen you go to small farmer,
you, you may be working with AI,ml, and all this new stuff. But
then I had this reality checkingoff my experience where they
were still paper based, right?
So there was not even a singletool for doing electronic
validation, for example, like,so. Yeah. I mean, they have
their own challenges. But Ithink from a philosophy
standpoint, right, it is easy tohave these kinds of
(06:30):
conversations about risk basedapproach, why we are seeing this
what kind of benefit you wouldsee there is a guidance to refer
to an FDA themselves have beenmore vocal thing I have seen in
the last couple of years aboutthis approach. They're working
very closely with our industry.
So it's not that the customer ishearing this story from one side
(06:50):
right now, just as consult, andyou bring that here, these are
the best practices for industry,they're also seeing that FDA is
agreeing to their approach, andthey themself are partnering a
little more. So I think it's awin win situation. That's why
I'm really excited about what'shappening right now.
Dori Gonzalez-Acevedo (07:06):
Yeah, so the, at the end of the day, one
of the things you mentioned isaround the the automation,
right, and that has thecapacity, we have the capacity
to be able to change that theefficiency with a CSA model,
right, if we truly apply that inthe way that it's intended.
(07:27):
Right. And, and I think there'sa hesitancy to to do that on a
grand scheme, because like,organizations can't have that
impact of that change from abusiness process perspective,
right? Because one thing is tosay, we're going to change the
(07:50):
methodology, right? Or, or orrefocus that. But then the other
part of that is how muchtraining that needs to happen in
order for that to to be done,right? What are the third
parties that interact with usthat already know our business
processes, and then that has tochange the tools and electronic
tools, right, or that need to bemodified according to like, it's
(08:13):
like a ripple effect, that whilethe upside and benefits could be
there, that you had said it wasa little push for, like
automation change, like,typically, a major automation
practice is a huge push. Right,that then diminishes over time?
I think the similar sort ofconundrum I think we're
(08:36):
struggling with is how much toinvest in doing a better
business process from the verybeginning. Right, or altering
that or changing that. So do youlike what are some of the things
we can communicate to folksabout the benefits of moving to
a newer approach?
Sree K (08:55):
Yeah, you're absolutely right. Right. But what I think
is, it's all in the thinkinginitially, without seeing,
right, that's where they havethe fear. Yes, consultants can
come and talk about, hey, wehave implemented this in this
area, or this customer. Andthese are the benefits, we can
show those in a super goodslides to show but the customer
(09:15):
believes would only come whenthey actually see. So I think
the best approach in myexperience is, you know, pick a
small project, maybe a GXP, orsmall, non GSP project, right?
So they're the amount ofvalidation you do is
comparatively little lesserthan, let's say, critical three
parter. So your turnaround timeis less. So you could
(09:37):
immediately show the benefits,right? In terms of percentages
when you show that, hey, you'reusing a, let's say, example of
cloud software. And softwareproduct vendor has three
releases per year, right. So youhave a set of regression test
cases, let's say you're notplanning to do any
announcements, right? are alittle bit of announcement like
10%. So in those cases, if youhave a regression suit, to
(09:59):
Today, you may be using fivetesters, I mean, those
regressions sold for four for amonth every month. So you're
basically spending three monthsof your year five testers
engaged, right? The actual workis nothing but just re running
the existing scripts. But if youautomate, you can reduce the
number of testers to in thisexample, write one tester. And
(10:20):
then the execution itself isreduced from, you know, one
month to a few weeks or a fewdays right. Now, the, the
hindrance I have seen in thiskind of exercise is more from to
be harnessed, right, fromquality essential because they,
in some cases, they are not upto date on the technological
advancements, to be fair tothem, right, because not so much
(10:44):
of education and training hasbeen focused in that part of the
group or they're busy in auditand other stuff. But what I have
seen is, in my experience, whenI worked with the quality team,
it's also because they don'thave an automation procedure,
right how to do automation. Sohumans typically always have a
CSV, or a testing procedure, butnot automate so. So what I did
(11:05):
was we brought experts fromoutside and helped write
something and then they coulduse it for a small pilot
project. So if you did a small,and then build a bridge that
showed recourse, the otherorganization showed them the
benefit and smaller GXP projectscame into picture, and then the
big gap. So now, I because Istill have contacts in those
(11:28):
organizations today. And then Istill hear from that, you know,
a lot of benefits they arereaping from that exercise,
which was done like five yearsback. So I think the initial
assistance will be there. But Ithink you need to pick a small
project as a case study. And,you know, when that confidence
that the your experience fromoutside may not, you know, may
(11:48):
not give get give the game, givethem the full confidence to go
out with that. But if you dothat the smaller one, I think
you can still win.
Dori Gonzalez-Acevedo (11:57):
Yeah.
Makes some interesting points.
But tree, let's circle backaround. So how did you even come
into this industry? Like, thisis not something you go to
school for? So what's yourjourney here?
Sree K (12:08):
Yeah, so I did not know anything about validation. So I
graduated as a computer scienceand engineering. So I did a
little bit of programminginitially for back in Sector
back in India. So I graduatedIndia. And then I traveled to
Germany for an assignment to do.
But it was a pharma company whowas doing sample oriented
pipetting, the blood tests, so Iwas writing software for them.
(12:29):
And since I was only one intheir office in Germany, you
know, I had to do some testingaround it. And they asked me to
do system testing, that's when Iget into the testing part of
things. And then an opportunitycame in the US with a big farm.
And then I came here becausethey show they wanted both
development and the testingexperience. And then the
testing. Organization was partof the quality group that time
(12:54):
and the statics and bandleaderredeposit, they said, Hey, you
have testing, we have thisprocess, learn this process,
everybody attesting to that,and, you know, we call it
validation, understand theseregulations, you know, study
these, right and follow theseapproaches. So I did that. And,
you know, I came to actuallystart a testing center of
excellence to that customer.
That was the first one and thenwe grew to more than 100 people
(13:17):
over over 10 years. So it doesmean that, but I think I'm an
accidental revelation person.
But eventually what happened wasthat I started loving the team I
was working with, and then italso gave me a lot of
opportunity to as I mentionedbefore, right? There are three
organizations you always workwith, you can work with ITT, we
can work with the business team,we can also work with the
(13:37):
quality and so these are threepillars of any farmer
organization, right. So theexposure you get, and the
learning you can, if you'rewilling and open minded, is
tremendous. What has happened tome was as part of quality of
research for a while, then movedto IT side, and then also the
business lead for a bit byimplementation. So I was able to
(14:00):
step into those shoes and seehow they think. So that's when
I, you know, when I became aconsultant, myself, and I was
able to think, you know, now myconversations are more
accommodating, I would callbecause I kind of understand
where they come from, right? Whythis ask for something, you
know, they ask for things likethat. But so yeah, so there was
(14:22):
also the creative side ofMidori, which always thought
okay, yes, you do the validationfor two years right and you keep
repeating like the you justwidened. Basically you started
with one point and you're doingtemperance but we're not doing
going deep enough you're only Irealized this when I came out,
started reading this actual FDAvalidation documents ESA
(14:45):
guidance doc Gam documents, notmany people read they just
picked something from thisslide. No, no, I myself question
was how did I survive in thisindustry? By not really reading
the actual Bible? Right. So Now,that's something which I tried
to embed into the team askingthem to read. You don't have to
read these documents in entiretyevery day. But as a daily
(15:07):
practice, what I do is I readthis guidance every day, at
least one page one page everyday is because every time I
reread it, there is some somenew person in new, which is
having a better understanding ofwhat they are trying to see.
Right? Because FDA always saysit is their current
understanding, they are not thatprescriptive. So you can make
things out of it. And you know,yeah, that's right. And so the
(15:29):
prescriptive part, which is whypart of why Priscilla X is
originally is prescription forsoftware quality? Because it is,
is an interpretation, right?
Even doctors, right? Do you donot, there's not one set answer,
you can ask, you know, variousdoctors all skilled within their
there, but they have differentapproaches to how to solve a
(15:52):
patient's ailments, it's thesame thing. Obviously, yes,
there are some go to things inlife critical situations where
you're going to prescribesomething, something specific,
but other things, you know,daily kind of maintenance and
health and well being can beachieved in many, many different
ways. And it doesn't work foreverybody. Right? So, you know,
(16:15):
I like what you're saying, andalso taking part of education,
even in a in a trusted advisorlike yourself, right, that
knows, kind of the basicprinciples is doing a daily
practice of reaching, reachingout and educating yourself, and
then seeing how that applies.
You know, that is also part ofan enriching culture of
(16:37):
learning. And in so when I hearyou say something to the effect
of, you know, so it's not oftenI hear this often, right, that
the quality team often is theones that perhaps need some
guidance, or education or somekind of dialogue, right? It's,
(16:57):
it's how to how to have thatdialogue in a learning sort of
mindset, right? It's not thatall it are right, or not all
business people are right, orquality people. Right, right.
But how do we have thisdialogue? Right, where we have
different perspectives? Yeah,everyone comes to it from from
(17:18):
different parts of theorganization or different, you
know, histories, right? So youwere in a pharma, and now you're
out, you're like, some do theopposite. Some are only ever
been, you know, in one place orthe other. And having, not being
forced to try on differentperspectives, really limit our
(17:39):
way of thinking. And I think oneof the, you know, the critical
thinking piece that, that thethe new camp guidance has come
out with, is is important,right? Because I think that that
was missing from the originalkind of risk based approach. We
said, We want a risk basedapproach. But what did we see?
(18:00):
We saw a bunch of checklistscome out and not getting down to
some details, right. And so whatdo you think the future of, of
this is given? We're in anindustry that is typically, you
know, again, generalization, buttypically slow to do change in
(18:22):
these sorts of operationalchanges that we're talking
about?
Yeah. What do you see is future?
Yeah, I mean, as I mentionedbefore, at least now I see the
future is really bright foranyone who is trying to enter
into this industry, right? AndI'm also not generalizing right.
When I say quality needs somekind of exposure, I will given a
class example, in my personallife. So I went to MIT meet
(18:45):
this. So initially, when Istarted my career, right, in
validation, I used to get thisFedEx packages from India, like
test is excellent in the bigpacket. So I was the evaluation
lead. So my role was to takethese packets, take a shuttle go
around the buildings in thecampus and get into a quality
person. So I go to this site,carry one laptop, right? So I
(19:08):
don't have an external monitorat that point of time. So I go
to this quality person, he hasgot two big monitors, and well
qualified persons. And I askedhim what I do. And he said, you
know, comparing these documentswith just send us a soft copy,
like basically looking from mydocument, the other admin
matting, and I said, Okay, fine.
(19:28):
So, when he left the company,after 1015 years, I went back to
this person to say goodbye. Hewas doing the same. Instead of
two, he just had four monitors.
He said, Yes, my right. So Ifelt bad. But I think that's one
of the user persona, right? Imean, when you talk about the
future, right, I think the it inthat aspect, I believe, again,
I'm talking from my experience,you know, not to generalize
(19:50):
right has been lucky in where toget exposed to these new
technologies, right? Same withbusiness, right. So so they have
a legacy. A system, they maymove into clouds. So the other
festivals to start engaging inthe quality typically comes at
the last, I think there's basedapproaches one very, very good
way of getting this quality upin the discussion. And I'll tell
(20:13):
you an in class example,recently, when I'm doing this
risk based approach, right, thefirst thing I do is do a
brainstorming session wherequality is also involved. And we
talked about them, right, hey,this is a stimulus. These are
the requirements. These are theimpact of product quality, and
patient safety. And now wecategory. So this exercise we do
as a team, including quality,they always have this feeling,
(20:35):
at least in my experience thatHey, you come to me at the last
moment, saying that somebody hasclassified this is high, medium
low, and you're giving me thisevidence, I'm not happy about
it, right? Or you're giving meonly five days to do my review.
I think, at least in my recent,my recent experience has been
positive that the organizationrealize that quality has to be
upfront in those discussions. Sothat's a welcome change. Because
(20:59):
when we do that, they also getto know the technology, right?
So in my example, I told before,that person may get to know what
the team is trying to do fromday one and start putting his or
her perspectives. And that couldactually give them a better
compliance after the end of theday. Right. So it's a welcome
change. And that's one of thereason I also encourage my
(21:20):
friends or whoever reaches outto me earlier, as I told you,
right, and somebody asked forvalidation. You know, it's kind
of a boring, not people.
Because, as you mentioned, it'sa slow. In our industry, it's
considered slow perceived toother industries. Because, yes,
typically, our drug would takeanywhere between 10 to 15 years.
Yes. Why? And then they canCOVID has changed things a
(21:42):
little bit, which is good. Andthat's where we are going ahead,
right. But there are still inolder ways of doing it. So I
think, yeah, the perceptionchanging is one of the thing we
all as consultant, Kenyan,especially, that's something
which I tried to portray in theLinkedIn or try to draw some
cartoon just to show that youcan also have fun.
Dori Gonzalez-Acevedo (22:01):
Yeah, so tell us about our cartoon, the
cartoons. You're an artist. Sotell us a little bit.
Sree K (22:07):
Yeah, I mean, I don't call myself an artist. So it's
something which I used to doearlier drawing. And then I
started this doing intentionallywhen I started training my team,
because after a while, as youknow, it's also part of a
leadership style, right? So yousee a team doing the same
mundane routine stuff, and theyget bored easily, right. And
(22:29):
they also have a question inthemselves, Hey, I see all those
technological automation AMLhappened there, I want to be
there. But I'm stuck here,right? A lot of my team members
used to feel that I used to drawcartoons to show them the
evolution of the foundation,right and show them, hey, the
future is bright, things havechanged, at least Yes, the pace
of the changes, and it will slowcompared to what you see
(22:51):
outside. But the other way tolook at is this industry is
really strong, right? Itactually doesn't fluctuate that
much, if you look at therecession, or the other things
happening across our industry.
So you know, if you're lookingfor a stable, secure carrier,
this is a really good industryto be in, you just need to keep
an open mind also tight adaptfrom outside what you can bring
(23:11):
in. But it's a very stableindustry.
Dori Gonzalez-Acevedo (23:16):
It is it's very exciting. And I know
that ways in which people learnalso matter, right? And so I
love what you're saying aboutyour team and trying to engage
them in different ways. I'vebeen trying to do similar stuff,
right? Because over my years ofunderstanding folks, we all have
(23:38):
different strengths, right? Andso in ways of comprehending
information, and being able tohandle that, and our judgments,
or unconscious biases that wehave, right, and so how to
engage our teams in a way that,especially as consultants,
right, to elicit moreinformation from our customers,
(24:01):
right, so that we can help crafta better end solution, or what
is, you know, what is the nextbest thing for, for those
individuals, rather than acookie cutter sort of way of
repeating over and over andover. But it helps the teams to
be able to engage in differentways, whether it's some like the
(24:22):
whiteboard, right? So you know,and some, like listening to
things and some like otherthings. And so knowing knowing
who you're working with, andtrying to reach them in
different ways, I think, isgreat.
Sree K (24:34):
Yeah. And I would also sorry to interrupt to ask him
that I plus Peter, I know likebeing an industry leader, you
also lead big teams and get totalk. I also listened to you
talking about authenticleadership. You know, I let go
so what are some of yourthoughts around that? How do you
do you motivate your own team?
Like what are your experiencesin that friend? I would like to
(24:55):
hear that.
Dori Gonzalez-Acevedo (24:57):
Yeah, so I What I tried to do the best I
can each and every day is leadby example. Right? I think that
is the most important thing forme as a leader, as I've grown as
a leader is also to be moreconfident and comfortable in, in
showing up with my ideas, right.
And so creating the space for myteam to be able to share their
(25:22):
ideas, too. And I'm hoping torecord soon in a couple of
weeks, with some some folksabout this topic, specifically,
because I do think that there'ssome, you know, generational
gaps here, right, where, in ourindustry, there are a lot of
seasoned veterans that have beendoing this for a long time. And
(25:42):
I think we need to be curiousabout what else could be going
on? How is that possible? Whatis the potential there and
really acknowledging that we, Idon't know I seek to fail every
day, I was just talking to oneof my consultants this morning
about this, like, seeking tofail every day really helps me
(26:04):
evaluate myself around myimperfections, and I'm not
perfect. And so and what, whatneeds to be tweaked, or we saw
in my learning process, right?
So if I'm not thinking aboutwhat did I screw up today? I'm
(26:24):
not growing. Yeah. Right. Like,I don't feel like I'm growing as
a human. And so I tried to dothat with my team, giving my
team that also the tools to beable to make decisions within
the self conformed groups, likethe true agile sort of
methodology that best I can, youknow, agile is something from a
(26:44):
theoretical perspective Ireally, truly agree with. And
it's really hard to do. Youknow, in its purest form, right.
So what does that look like?
Right? Having all stakeholderscompletely and totally on the
same page with all the sameskill set and all the right to
be able to contribute all that?
Well, that's, that'sunrealistic, right? But that is
(27:07):
the ideal agile team, right? So.
So instead, it's getting to knoweach other as capacities, and
then what and how to utilizethem to the best of their
ability. And I know, for me,when I am doing what I do best,
I am in that constant flow.
Right. And that makes not onlymyself successful and feel
(27:32):
fulfilled, but it also motivatesthose around me. And it's a
ripple effect. Right? And that'swhat I kind of call that
authentic leadership. Right? iIt's an acronym, you know,
really, iced tea, I have calledand maybe I'll put this in the
show notes. Around, you know,for from a quality perspective,
(27:54):
we need to have trust, educationand accountability, right. From
a from a true qualityperspective. And then the ice
part is an interconnectedness,empowerment, and a dialectical
conversation. And I think thisis really important by having
the there is no right or wrong.
Right? These are all kinds ofstates of being and then you
(28:18):
choose, we're choice makers tofigure out what are we going to
do with all that? Yes. Right.
And I think that's what'sexciting around the CSA. So I
share in some of your enthusiasmaround it. I think it's a
insurgence to be able toquestion. It's an insurgence to
be able to, you know, break downsome historic baggage,
(28:43):
potentially that doesn't serveus in any way anymore. Right?
And how do we figure out a wayto really create something new?
Right and so another thing aboutPurcell is I was really very
intentional around rethink,reshape and remake? Because
it's, it's a learning process,right? It really is. It's what
(29:07):
works now might not work in amonth from now. Yeah. And as a
compliance and quality kind ofperson. I can see how that that
may make one nervous. But if youkind of embrace the fact that
we're doing this together,right, that we're we're making
these conscious choices to topivot together, then I think it
(29:32):
reduces our overall compliancerisk. Right. And the risk that
we have, not only to ourproduct, Safety and Quality,
right, but but for the overallprocess. Yeah, and I think it
makes sense but I think that'sone of the learnings out of
COVID. But I'm I'm not sure thatsome of that sticking. What do
you what do you think? What werewhat was your some of your
(29:55):
takeaways from COVID? And do youwhat do you think about them
today?
Sree K (29:58):
Yeah, and I loved The opportunity COVID has given us
to work remote, let me because Ihave two small children has
given me so much time to spendwith them and also pursue my
passions outside of life. So Ifeel blessed with COVID code a
couple of times, but then Ithink the you have to see the
(30:18):
past T radius, we have lost somany lives and a lot of near and
dear ones, but it's part of yourlife, right? I mean, we are all
here to go one day. So someonewho believes in the positive
aspect of things and you know,take every day as it comes. I
also like what you just saidabout, you know, doing something
(30:39):
new every day and alsoconnecting to the, you know, the
audience or in our audience, ifyou will. So, for example, you
and I have been hearing this CSAfor for at least two years
continuously, right. So we alsowant to get something new.
Right. So another thing I didlast week was, you know, and
everyone has been talking aboutthis tag GPT. And, you know,
(31:00):
things like, I was trying tothink, what is competencia CNDP
chat GPT, I actually wrote aLinkedIn article, a couple of
days, back, and a lot of peoplecame and say, this is
interesting, because there'snothing comes in between,
though, but I was just trying towhat I was trying to do is take
the interest in people, right,and then write something rated
(31:21):
so that people can at least readCSA stuff, right? So you don't
have to look at CSF from oneangle all the time, right. So
also, for you and me, we alsowant new things not just to
teach, but also to freeourselves new things, we also
don't want to get bored, doingthe same thing. So I think we
all have to look outside in wayswhere we can bring that new
(31:44):
ideas into what we do every day.
So you know, and also, some ofthe things which I also learned,
and then I tried to share withwhat I interact with, especially
the my team members is that, youknow, do something outside of
work. You don't have to spend somuch time at work, and then to
try to do your secondary, youknow, the other passions,
(32:04):
because when you do that, forexample, you play sports and
right, you bring the leadershipskills and some of the team
skills you bring to the table.
So, you know, all this helps.
Dori Gonzalez-Acevedo (32:16):
Yeah, you're right. And so I was asked
a couple days ago about so. So,you know, what is this with all
the women and validation and theDEI stuff you do? And I said,
Well, that is intimately tiedto, to what I do, as a business
as person because it's importantto me, it's part of my value
system, right? And so I'veworked to be able to align those
(32:40):
together, back to the authenticleadership, right? Like, I can't
not do that. Without the other,right, both have to be present
in order for me to fully show upas the leader that I want to be.
And so I think that's superimportant. And that leads me
into I know, You've beenmentoring, folks. And that is
(33:01):
also a passion of mine. So tellme, how is that going for you?
Sree K (33:05):
Yeah, it's been good. So one other thing I am doing is
the LinkedIn audio events. I dothat every Monday for one hour
free event. And sometimes peoplehave come and asked me, Hey, why
do you do it for free? Right?
We're going to create atraining, things like that. And
I thought to myself, I've beenwhatever I have learned in this
industry, I've learned on thejob, and I got paid for it. So
(33:25):
why Why should I, you know, asksomeone to pay for something
which I share my learnings with?
I got paid for it. So I thinkit's not about the money part of
it. But it is more aboutconnecting to other people.
Because, you know, yes, you dowork in an organization or let's
say, five organization, butthere are still more
(33:46):
organizational people who arelooking. And you can also learn,
right? So in some of my calls.
To bring into perspective,right? You have to do things to
fake right. And I didn't knowanything about when to now and
sometimes it is just one personall the time, sometimes it is
10, right. So you have to takethings in stride. But then I
just had this experience in my30 when I believe like someone
(34:08):
came only in the last 10minutes. And it was a very
fruitful conversation. I had somuch learning from that person
in the last 10 minutes. Becauseyou're here so much of
experience implement in this andin sharing lots of ideas, which
I took to the next event, right.
So I think yeah, so, you know, Iknow, like you may be doing the
same with your podcast and otherevents you do as well, where you
(34:31):
began to some of the learningsand then that helps you write
the names.
Dori Gonzalez-Acevedo (34:35):
Because it's a it's a process, right,
like and so every conversationinforms the next and so it's
very dynamic and you know, oneof you know, as my learning is
round and a lot of my I considermyself a systems person, right
(34:56):
and that and part of that isbecause of how I grew up in this
industry, right? Like, as aprocess engineer, chemical
process and cheering developingand pharmaceutical ingredients
with no, you know, processes inplace. Really, it was all on
paper, like we had to make itup. And that process of figuring
out the system, like as anorganization in an organization
(35:18):
that I was able to affect allpieces of that because we were
small. Yeah. Right. And solearning that system dynamic in
real time, full hands on now,that's the type of learner I am,
right, which may come to someoneelse by reading a book. Right,
right. But for me, it was allhands in for men, you know,
several years of reallyunderstanding how those systems
(35:42):
and dynamics worked. And I thinkthat was a huge life lesson, you
know, that has carried methrough throughout because all
those organizations areorganizations change, they
evolve and move. And we need tobe able to flow with that. It's
interesting, one of myscreensavers is one of those 3d
(36:04):
chips shifting things, right.
Like, it is like we'reconstantly kind of moving and
evolving. And I think thatthat's exciting. It's exciting
to me, I get that How am thatmight not be exciting to some
folks. And, you know, the folksthat I know in quality that a
lot of this makes them feeluncomfortable is because they
really like their boxes, rightthere. They like the the fixed
(36:25):
box, where I'm more of a personthan I like the the playdough
box where you can shape it andshift it and mold it and change
it. And one day it's a, youknow, a tree and the next day,
it's a boat or whatever.
Sree K (36:42):
Yeah, no, it's very true. Don't worry, what is it?
Because we all have been askedto think outside the box right?
Now, if you always stuck insidethe box, right? There is only so
much you can think outside thebox. And I realized by
experience, I was doing all thisdifferent stuff growing and all
this stuff. And then one day, Irealized I was spending like
(37:03):
1617 hours at work. Yes, I washelping a lot of people, but
then the health was not there.
They were not giving enough timeto family. And then that's one
of the things. That's why I saidCOVID has been a blessing,
right? And then it kind of givesyou that time to think, hey, is
this how you want to spend yourtime here? Right? You just got
one charter life? So yes, andthen only when they came out of
(37:26):
that box in really so much ofopportunities. And there's so
much, you know, areas you cangrow outside the box. And there
are, you know, our I think it'sby design. And I've wrote this
too, that, you know, they wantyou to be in the past so that
you don't you know that I wrotesomething about that
Unknown (37:48):
topical, potentially geopolitical conversation that
you and I can have maybe off,somebody needs to talk about it,
right? I do. I absolutely agreewith you. 100%. That is very,
very true.
Sree K (38:02):
And I also seen some examples, right, in my, in my
previous experiences, to theteam mentoring aspect of things.
While we were doing somevalidation process, I encourage
my team to do certification,other stuff, which are not
related. Now, what has happenedis they asked me, What is the
relevance, right? I mean, that'sagain, like thinking inside the
box. Now, that box, I said, itmay be helpful to you in the
(38:23):
future, Right. Steve Jobs,right, you can only connect the
dots backwards. So what hasreally happened like last couple
of hours. So you wrote aboutthis, like, I think four of my
previous teammates, they got tobetter jobs in the area this
week, or training that part ofthem that they came on time and
some nights you actuallywouldn't. But, you know, they're
seeing even happen. So it's thesame with with the mindset,
(38:45):
which we're seeing that people,you know, want to be there
because they feel safe, but onlywhen they get out and get
uncomfortable. I think then theywill see. They don't have to be
in there to get what they want.
Yeah.
Dori Gonzalez-Acevedo (38:58):
So you said that the magic words. So
the other key word for me isuncomfortable, right? We all
need to be more comfortable withthe uncomfortable. Exactly. And
if we if we're willing to in it,there's a willingness, like, it
doesn't mean that you have tosit in it all the time, right.
But there needs to be awillingness to at least
entertain the uncomfortable,whatever, right? Someone comes
(39:19):
to you and say, yep, you know,what we really wanted to do try
this different way. Or we wantto, you know, take this
different approach, and, andpart of that learning needs to
happen in order to figure outwhat is the next best thing,
right. So there's anexperimentation and part of that
(39:43):
is also again, a character traitof mine, right? Yes. I
anticipate being being in thatsilence. mindset of let's
experiment a little. Let's tweakit. Let's figure it out. Let's
try it on. It might not serveeveryone right now. And we
learned something We knew and wetweak it, and we will move on
right in that sort of agile sortof way. Right? And the, the
(40:07):
doubt that, my my pitfalls, whatI see are folks that are wanting
to not change anything, becauseit's always worked, right? Yeah,
I Oh, I know, you know, I'mgonna use this paperless system.
But you know what, I'm stillgonna push out PDF, and I'm
gonna put it in a documentrepository, or worse, I'm gonna
(40:30):
put it over and Iron Mountain.
And, and I know where it is. Andit's 20 years later, and we
still like, what? Like, for forwhat added purpose? Right? Where
is that adding compliance?
Right? It's not addingcompliance. It's, you know, it's
looking at things from aextremely risk based approach.
(40:52):
And that's hurting everyone.
Right? If we were to do that inCOVID, right, and that was our
stance, where would we havebeen?
Sree K (41:05):
Exactly. So sometimes you have to learn the hard way.
Right. That's another thing. Iwant to connect this to your
experiences in the conferences,right to what you have not been
attending? I have listened toconference I have not been at in
person, which I was planning todo very soon. But I know like,
you have been to a lot ofconferences, you know, as a
speaker yourself. I mean, to thepersona, which you just explain,
(41:29):
have you seen such personascoming to these conferences and
also take actions after thatallow? What is your take?
Dori Gonzalez-Acevedo (41:35):
Yeah, so that so that's a great question.
So yes, yeah, we do see, folkswith with those personas coming
out. I think this gets back tomy quality tea aspect, right.
It's the accountability. And oneof the things that we've been
rolling out at Priscilla X, ourcompliance coaching engagements,
where we're helping keepcustomers accountable to their
(41:58):
desires, each and every month,right? Everyone is overburdened,
overworked, folks are asked todo things that are outside their
scope of their day to day. It'san epidemic, right, we have a
problem. And that's not going tochange. But what can be helpful
(42:19):
is to have outside coachingsupport, to vet through all of
what is the biggest priorityright now. Right? And from a
quality perspective, sometimesit's hard to figure that out,
because what's coming at you isall this all these asks, right,
this has to get done, this hasto get them this and no one's
(42:40):
there to say, okay, take a deepbreath. Right? And what is the
most critical thing of thislist? And what is the severity
and really be able to thenreprioritize and help coach
those folks in these leadershippositions, senior managers are
(43:01):
in that sort of level to be ableto say, I hear what you're
saying, and go, I don't, wedon't need to know about this,
but we need to know about thesethree things. Right. And that,
but having that accountabilityis not often in organizations on
a regular basis, and also havingsomeone as a consultant like
(43:22):
you, are i doing that? With themwith that outside perspective?
Right. And I think that's been ahuge change for some of my
customers to be able to knowthat they can reach out and get
a different take on things. Howdoes, it's not that they're
asking specifically, like, howdoes this company do this?
(43:43):
Again, this is, quality is notproprietary, we're talking about
philosophies and changes. It'snot that that that what I'm
going to say is going to beexactly what you do, but I'm
give I'm offering you something,to then impact you in some way
in which you are either moreemboldened by what you already
know, because most of us have ageneral sense gut instinct, and
(44:05):
that gut instinct, most of thetime is pretty good. But all the
other noise, or, you know, myboss is gonna do this, or we're
gonna lose this or, like, allthose things tend to muck up
that voice. And so so those aresome of the exciting things that
I'm doing, which I'm, I'm, Ithink needs to be embraced
(44:28):
because I think it gets to thisdeeper conversation. Right?
Yeah,
Sree K (44:31):
I think you know, it's also not just at the work,
right. So, you know, philosophy,really, people have to just stop
and think now if you're able toprioritize, because I have seen
this, somebody who's not able toprioritize at work. They cannot
also not practicing at home. Butif someone is able to do that at
(44:53):
home, then they can bring thesame experience with it doesn't
have to be two differentlifestyles. You have to live
with it. You're able toprioritize and make sure you
have time for to play with yourkids or have a family dinner.
Right? So those are yourpriorities. So you you take that
mindset to your work to you.
Yes, you have 100 emails toread, but you can still
prioritize and then work on thetop five top 10. Right, and make
(45:14):
those changes.
Dori Gonzalez-Acevedo (45:20):
So I'm really interested, I follow you
on LinkedIn. I love your yourchats, I love your cartoons. We
should do this more often. Andin the show notes, I'll leave
links to all your your yourspecifics
Sree K (45:37):
and your resume then.
Absolutely.
Dori Gonzalez-Acevedo (45:42):
Yeah, it's been a pleasure Sri. And I
hope you we, we continue thejourney, we can also continue
this journey new ways LinkedIn,like you're, you're, you're
playing with new stuff onLinkedIn all the time, which I
love.
Sree K (45:56):
That's great. Yeah.
Thank you. Thank you. I mean, Itried to explain and I also was
looking forward to spend somequality time with you in kind of
doing this kind of conversation.
I think you both have been busy.
So I'm glad that this thishappened. And I also thank you
to this for this opportunity.
And looking for futurecandidates who have not been in
person for the conference. I'lldefinitely would like to listen
(46:17):
to one of your talk in personwhen the next chances and also,
you know, be in touch.
Dori Gonzalez-Aceve (46:23):
Absolutely.
We'll see each other soon. Okay,
Thank you very excited to be here.
Dori Gonzalez-Acevedo (01:35):
It's been a while since we chatted, so we
it's always nice to be able tocatch up to while we're doing
some of these podcasts. Yeah,you've been active in in, in
posting and doing some new liveLinkedIn stuff. So how was
things going? And I would liketo know how things going and
where you are and how you cameto be in this industry.
Sree K (01:56):
Okay, great questions. I think it's really exciting times
to be in this industry, I thinkI would start from there. People
who are looking to join thisside of work in our industry,
this is the best time to arrive.
And that's the message I've beentrying to portray in my when I
talk to new people, or I try toshare something LinkedIn, things
like that. Because I mean, I'vebeen in the industry for 18
(02:19):
years. And a lot of the time Ifelt, as I heard you also in
other podcasts and people saywhat you actually do is kind of
boring, or doing the same stuffover and over again. I think the
reason CSA guidance coming outit's exciting time to be in this
industry and make really somechange, right? I mean, some of
us have that in us. We didn'thave something to refer to, but
(02:41):
now you have something to refer.
So go make that change.
Dori Gonzalez-Acevedo (02:49):
Yeah, so it's, I know, you and I both
have been in the mindset ofdoing risk based approach for
many, many years. Right. But itwas a lot of resistance we had
had for folks that say, Well, isthis really going to be
accepted? Or is this going to beokay, and so what are your some
of your thoughts around the CSAguidance? And and how does that
(03:11):
does this help thatconversation?
Sree K (03:14):
It does, right? So I think one of the key aspect is
to understand the key players inthe game, right? Especially when
you talk about validation,you're dealing with three
schools of thought, you have abusiness team, you have an IT
team, and then you have thequality team or CSV if it is
part of that, right. So my earlyconversations has been like, you
(03:34):
know, people want to see howothers are doing wait and watch
and then implement our, youknow, last farm, especially
this, like, hey, we have enoughresources to do what we were
doing in the past, right? Theydon't need to change anything,
we have enough time we haveenough resources, but what they
miss is they could allocatetheir resources to more mission
(03:56):
critical activities, if theyapproached you to their space.
Right. I think that's the partwhich is missing. And I've been
very vocal about it. And alsoyou in some, in some cases, it
is about doing and showing itright. So luckily for me, I had
the good fortune of doing a lotof automation testing projects
before. And once the customersees that kind of savings, yes,
(04:16):
you have to invest a little bitin upfront, like the first year
or so. But then you see thevalues in the second 30. And you
don't have to keep the same teamor in all right. So that's one
of the big, big savings I'veseen. And also these days as I
write and talk to more people Isee a lot of acceptance from all
(04:39):
different angles, someone orwait and watch, but already some
use cases coming from the spaceapproach and how each of the
customers have been benefited.
Right. So people have startedreading those and then
especially my focus area rightnow is to work with small and
midsize farmers. So since youknow, in one way they're
disabled advantage is anadvantage because they don't
(05:01):
have the systems built in, theydon't have the linkage of, you
know, doing this in one way. Sothey're open, an open mindset,
they are ready to listen to whatis happening newness, try the
new stuff, because theirintelligence also get to the get
the product of the dog to themarket as fast as possible.
Right. So
Dori Gonzalez-Acevedo (05:21):
because they're smaller, they're more
nimble. Right. And they're giventhat they're smaller, they're, I
think, we can make the logicalassumption that they're closer
to understanding the why theproduct is what it is, or when
why the urgency to get thingsdone. Right. Yeah. Whereas when
you get to the big enterprise,you know, organizations, that
(05:42):
journey to the end goal isfurther away and less tangible.
Sree K (05:47):
Yeah, I think there's good and bad to eat as well,
right. So you know, enough, thereality check I had in my career
was, I worked for Big Pharma for15 years. And then I wanted, I
did a lot of different roles inour major change, I thought, I
can make these kinds of changesin a smaller pharma faster, and
I can learn faster. But some ofthe challenges remaining small
(06:07):
farmers already you you feelwhen you go to small farmer,
you, you may be working with AI,ml, and all this new stuff. But
then I had this reality checkingoff my experience where they
were still paper based, right?
So there was not even a singletool for doing electronic
validation, for example, like,so. Yeah. I mean, they have
their own challenges. But Ithink from a philosophy
standpoint, right, it is easy tohave these kinds of
(06:30):
conversations about risk basedapproach, why we are seeing this
what kind of benefit you wouldsee there is a guidance to refer
to an FDA themselves have beenmore vocal thing I have seen in
the last couple of years aboutthis approach. They're working
very closely with our industry.
So it's not that the customer ishearing this story from one side
(06:50):
right now, just as consult, andyou bring that here, these are
the best practices for industry,they're also seeing that FDA is
agreeing to their approach, andthey themself are partnering a
little more. So I think it's awin win situation. That's why
I'm really excited about what'shappening right now.
Dori Gonzalez-Acevedo (07:06):
Yeah, so the, at the end of the day, one
of the things you mentioned isaround the the automation,
right, and that has thecapacity, we have the capacity
to be able to change that theefficiency with a CSA model,
right, if we truly apply that inthe way that it's intended.
(07:27):
Right. And, and I think there'sa hesitancy to to do that on a
grand scheme, because like,organizations can't have that
impact of that change from abusiness process perspective,
right? Because one thing is tosay, we're going to change the
(07:50):
methodology, right? Or, or orrefocus that. But then the other
part of that is how muchtraining that needs to happen in
order for that to to be done,right? What are the third
parties that interact with usthat already know our business
processes, and then that has tochange the tools and electronic
tools, right, or that need to bemodified according to like, it's
(08:13):
like a ripple effect, that whilethe upside and benefits could be
there, that you had said it wasa little push for, like
automation change, like,typically, a major automation
practice is a huge push. Right,that then diminishes over time?
I think the similar sort ofconundrum I think we're
(08:36):
struggling with is how much toinvest in doing a better
business process from the verybeginning. Right, or altering
that or changing that. So do youlike what are some of the things
we can communicate to folksabout the benefits of moving to
a newer approach?
Sree K (08:55):
Yeah, you're absolutely right. Right. But what I think
is, it's all in the thinkinginitially, without seeing,
right, that's where they havethe fear. Yes, consultants can
come and talk about, hey, wehave implemented this in this
area, or this customer. Andthese are the benefits, we can
show those in a super goodslides to show but the customer
(09:15):
believes would only come whenthey actually see. So I think
the best approach in myexperience is, you know, pick a
small project, maybe a GXP, orsmall, non GSP project, right?
So they're the amount ofvalidation you do is
comparatively little lesserthan, let's say, critical three
parter. So your turnaround timeis less. So you could
(09:37):
immediately show the benefits,right? In terms of percentages
when you show that, hey, you'reusing a, let's say, example of
cloud software. And softwareproduct vendor has three
releases per year, right. So youhave a set of regression test
cases, let's say you're notplanning to do any
announcements, right? are alittle bit of announcement like
10%. So in those cases, if youhave a regression suit, to
(09:59):
Today, you may be using fivetesters, I mean, those
regressions sold for four for amonth every month. So you're
basically spending three monthsof your year five testers
engaged, right? The actual workis nothing but just re running
the existing scripts. But if youautomate, you can reduce the
number of testers to in thisexample, write one tester. And
(10:20):
then the execution itself isreduced from, you know, one
month to a few weeks or a fewdays right. Now, the, the
hindrance I have seen in thiskind of exercise is more from to
be harnessed, right, fromquality essential because they,
in some cases, they are not upto date on the technological
advancements, to be fair tothem, right, because not so much
(10:44):
of education and training hasbeen focused in that part of the
group or they're busy in auditand other stuff. But what I have
seen is, in my experience, whenI worked with the quality team,
it's also because they don'thave an automation procedure,
right how to do automation. Sohumans typically always have a
CSV, or a testing procedure, butnot automate so. So what I did
(11:05):
was we brought experts fromoutside and helped write
something and then they coulduse it for a small pilot
project. So if you did a small,and then build a bridge that
showed recourse, the otherorganization showed them the
benefit and smaller GXP projectscame into picture, and then the
big gap. So now, I because Istill have contacts in those
(11:28):
organizations today. And then Istill hear from that, you know,
a lot of benefits they arereaping from that exercise,
which was done like five yearsback. So I think the initial
assistance will be there. But Ithink you need to pick a small
project as a case study. And,you know, when that confidence
that the your experience fromoutside may not, you know, may
(11:48):
not give get give the game, givethem the full confidence to go
out with that. But if you dothat the smaller one, I think
you can still win.
Dori Gonzalez-Acevedo (11:57):
Yeah.
Makes some interesting points.
But tree, let's circle backaround. So how did you even come
into this industry? Like, thisis not something you go to
school for? So what's yourjourney here?
Sree K (12:08):
Yeah, so I did not know anything about validation. So I
graduated as a computer scienceand engineering. So I did a
little bit of programminginitially for back in Sector
back in India. So I graduatedIndia. And then I traveled to
Germany for an assignment to do.
But it was a pharma company whowas doing sample oriented
pipetting, the blood tests, so Iwas writing software for them.
(12:29):
And since I was only one intheir office in Germany, you
know, I had to do some testingaround it. And they asked me to
do system testing, that's when Iget into the testing part of
things. And then an opportunitycame in the US with a big farm.
And then I came here becausethey show they wanted both
development and the testingexperience. And then the
testing. Organization was partof the quality group that time
(12:54):
and the statics and bandleaderredeposit, they said, Hey, you
have testing, we have thisprocess, learn this process,
everybody attesting to that,and, you know, we call it
validation, understand theseregulations, you know, study
these, right and follow theseapproaches. So I did that. And,
you know, I came to actuallystart a testing center of
excellence to that customer.
That was the first one and thenwe grew to more than 100 people
(13:17):
over over 10 years. So it doesmean that, but I think I'm an
accidental revelation person.
But eventually what happened wasthat I started loving the team I
was working with, and then italso gave me a lot of
opportunity to as I mentionedbefore, right? There are three
organizations you always workwith, you can work with ITT, we
can work with the business team,we can also work with the
(13:37):
quality and so these are threepillars of any farmer
organization, right. So theexposure you get, and the
learning you can, if you'rewilling and open minded, is
tremendous. What has happened tome was as part of quality of
research for a while, then movedto IT side, and then also the
business lead for a bit byimplementation. So I was able to
(14:00):
step into those shoes and seehow they think. So that's when
I, you know, when I became aconsultant, myself, and I was
able to think, you know, now myconversations are more
accommodating, I would callbecause I kind of understand
where they come from, right? Whythis ask for something, you
know, they ask for things likethat. But so yeah, so there was
(14:22):
also the creative side ofMidori, which always thought
okay, yes, you do the validationfor two years right and you keep
repeating like the you justwidened. Basically you started
with one point and you're doingtemperance but we're not doing
going deep enough you're only Irealized this when I came out,
started reading this actual FDAvalidation documents ESA
(14:45):
guidance doc Gam documents, notmany people read they just
picked something from thisslide. No, no, I myself question
was how did I survive in thisindustry? By not really reading
the actual Bible? Right. So Now,that's something which I tried
to embed into the team askingthem to read. You don't have to
read these documents in entiretyevery day. But as a daily
(15:07):
practice, what I do is I readthis guidance every day, at
least one page one page everyday is because every time I
reread it, there is some somenew person in new, which is
having a better understanding ofwhat they are trying to see.
Right? Because FDA always saysit is their current
understanding, they are not thatprescriptive. So you can make
things out of it. And you know,yeah, that's right. And so the
(15:29):
prescriptive part, which is whypart of why Priscilla X is
originally is prescription forsoftware quality? Because it is,
is an interpretation, right?
Even doctors, right? Do you donot, there's not one set answer,
you can ask, you know, variousdoctors all skilled within their
there, but they have differentapproaches to how to solve a
(15:52):
patient's ailments, it's thesame thing. Obviously, yes,
there are some go to things inlife critical situations where
you're going to prescribesomething, something specific,
but other things, you know,daily kind of maintenance and
health and well being can beachieved in many, many different
ways. And it doesn't work foreverybody. Right? So, you know,
(16:15):
I like what you're saying, andalso taking part of education,
even in a in a trusted advisorlike yourself, right, that
knows, kind of the basicprinciples is doing a daily
practice of reaching, reachingout and educating yourself, and
then seeing how that applies.
You know, that is also part ofan enriching culture of
(16:37):
learning. And in so when I hearyou say something to the effect
of, you know, so it's not oftenI hear this often, right, that
the quality team often is theones that perhaps need some
guidance, or education or somekind of dialogue, right? It's,
(16:57):
it's how to how to have thatdialogue in a learning sort of
mindset, right? It's not thatall it are right, or not all
business people are right, orquality people. Right, right.
But how do we have thisdialogue? Right, where we have
different perspectives? Yeah,everyone comes to it from from
(17:18):
different parts of theorganization or different, you
know, histories, right? So youwere in a pharma, and now you're
out, you're like, some do theopposite. Some are only ever
been, you know, in one place orthe other. And having, not being
forced to try on differentperspectives, really limit our
(17:39):
way of thinking. And I think oneof the, you know, the critical
thinking piece that, that thethe new camp guidance has come
out with, is is important,right? Because I think that that
was missing from the originalkind of risk based approach. We
said, We want a risk basedapproach. But what did we see?
(18:00):
We saw a bunch of checklistscome out and not getting down to
some details, right. And so whatdo you think the future of, of
this is given? We're in anindustry that is typically, you
know, again, generalization, buttypically slow to do change in
(18:22):
these sorts of operationalchanges that we're talking
about?
Yeah. What do you see is future?
Yeah, I mean, as I mentionedbefore, at least now I see the
future is really bright foranyone who is trying to enter
into this industry, right? AndI'm also not generalizing right.
When I say quality needs somekind of exposure, I will given a
class example, in my personallife. So I went to MIT meet
(18:45):
this. So initially, when Istarted my career, right, in
validation, I used to get thisFedEx packages from India, like
test is excellent in the bigpacket. So I was the evaluation
lead. So my role was to takethese packets, take a shuttle go
around the buildings in thecampus and get into a quality
person. So I go to this site,carry one laptop, right? So I
(19:08):
don't have an external monitorat that point of time. So I go
to this quality person, he hasgot two big monitors, and well
qualified persons. And I askedhim what I do. And he said, you
know, comparing these documentswith just send us a soft copy,
like basically looking from mydocument, the other admin
matting, and I said, Okay, fine.
(19:28):
So, when he left the company,after 1015 years, I went back to
this person to say goodbye. Hewas doing the same. Instead of
two, he just had four monitors.
He said, Yes, my right. So Ifelt bad. But I think that's one
of the user persona, right? Imean, when you talk about the
future, right, I think the it inthat aspect, I believe, again,
I'm talking from my experience,you know, not to generalize
(19:50):
right has been lucky in where toget exposed to these new
technologies, right? Same withbusiness, right. So so they have
a legacy. A system, they maymove into clouds. So the other
festivals to start engaging inthe quality typically comes at
the last, I think there's basedapproaches one very, very good
way of getting this quality upin the discussion. And I'll tell
(20:13):
you an in class example,recently, when I'm doing this
risk based approach, right, thefirst thing I do is do a
brainstorming session wherequality is also involved. And we
talked about them, right, hey,this is a stimulus. These are
the requirements. These are theimpact of product quality, and
patient safety. And now wecategory. So this exercise we do
as a team, including quality,they always have this feeling,
(20:35):
at least in my experience thatHey, you come to me at the last
moment, saying that somebody hasclassified this is high, medium
low, and you're giving me thisevidence, I'm not happy about
it, right? Or you're giving meonly five days to do my review.
I think, at least in my recent,my recent experience has been
positive that the organizationrealize that quality has to be
upfront in those discussions. Sothat's a welcome change. Because
(20:59):
when we do that, they also getto know the technology, right?
So in my example, I told before,that person may get to know what
the team is trying to do fromday one and start putting his or
her perspectives. And that couldactually give them a better
compliance after the end of theday. Right. So it's a welcome
change. And that's one of thereason I also encourage my
(21:20):
friends or whoever reaches outto me earlier, as I told you,
right, and somebody asked forvalidation. You know, it's kind
of a boring, not people.
Because, as you mentioned, it'sa slow. In our industry, it's
considered slow perceived toother industries. Because, yes,
typically, our drug would takeanywhere between 10 to 15 years.
Yes. Why? And then they canCOVID has changed things a
(21:42):
little bit, which is good. Andthat's where we are going ahead,
right. But there are still inolder ways of doing it. So I
think, yeah, the perceptionchanging is one of the thing we
all as consultant, Kenyan,especially, that's something
which I tried to portray in theLinkedIn or try to draw some
cartoon just to show that youcan also have fun.
Dori Gonzalez-Acevedo (22:01):
Yeah, so tell us about our cartoon, the
cartoons. You're an artist. Sotell us a little bit.
Sree K (22:07):
Yeah, I mean, I don't call myself an artist. So it's
something which I used to doearlier drawing. And then I
started this doing intentionallywhen I started training my team,
because after a while, as youknow, it's also part of a
leadership style, right? So yousee a team doing the same
mundane routine stuff, and theyget bored easily, right. And
(22:29):
they also have a question inthemselves, Hey, I see all those
technological automation AMLhappened there, I want to be
there. But I'm stuck here,right? A lot of my team members
used to feel that I used to drawcartoons to show them the
evolution of the foundation,right and show them, hey, the
future is bright, things havechanged, at least Yes, the pace
of the changes, and it will slowcompared to what you see
(22:51):
outside. But the other way tolook at is this industry is
really strong, right? Itactually doesn't fluctuate that
much, if you look at therecession, or the other things
happening across our industry.
So you know, if you're lookingfor a stable, secure carrier,
this is a really good industryto be in, you just need to keep
an open mind also tight adaptfrom outside what you can bring
(23:11):
in. But it's a very stableindustry.
Dori Gonzalez-Acevedo (23:16):
It is it's very exciting. And I know
that ways in which people learnalso matter, right? And so I
love what you're saying aboutyour team and trying to engage
them in different ways. I'vebeen trying to do similar stuff,
right? Because over my years ofunderstanding folks, we all have
(23:38):
different strengths, right? Andso in ways of comprehending
information, and being able tohandle that, and our judgments,
or unconscious biases that wehave, right, and so how to
engage our teams in a way that,especially as consultants,
right, to elicit moreinformation from our customers,
(24:01):
right, so that we can help crafta better end solution, or what
is, you know, what is the nextbest thing for, for those
individuals, rather than acookie cutter sort of way of
repeating over and over andover. But it helps the teams to
be able to engage in differentways, whether it's some like the
(24:22):
whiteboard, right? So you know,and some, like listening to
things and some like otherthings. And so knowing knowing
who you're working with, andtrying to reach them in
different ways, I think, isgreat.
Sree K (24:34):
Yeah. And I would also sorry to interrupt to ask him
that I plus Peter, I know likebeing an industry leader, you
also lead big teams and get totalk. I also listened to you
talking about authenticleadership. You know, I let go
so what are some of yourthoughts around that? How do you
do you motivate your own team?
Like what are your experiencesin that friend? I would like to
(24:55):
hear that.
Dori Gonzalez-Acevedo (24:57):
Yeah, so I What I tried to do the best I
can each and every day is leadby example. Right? I think that
is the most important thing forme as a leader, as I've grown as
a leader is also to be moreconfident and comfortable in, in
showing up with my ideas, right.
And so creating the space for myteam to be able to share their
(25:22):
ideas, too. And I'm hoping torecord soon in a couple of
weeks, with some some folksabout this topic, specifically,
because I do think that there'ssome, you know, generational
gaps here, right, where, in ourindustry, there are a lot of
seasoned veterans that have beendoing this for a long time. And
(25:42):
I think we need to be curiousabout what else could be going
on? How is that possible? Whatis the potential there and
really acknowledging that we, Idon't know I seek to fail every
day, I was just talking to oneof my consultants this morning
about this, like, seeking tofail every day really helps me
(26:04):
evaluate myself around myimperfections, and I'm not
perfect. And so and what, whatneeds to be tweaked, or we saw
in my learning process, right?
So if I'm not thinking aboutwhat did I screw up today? I'm
(26:24):
not growing. Yeah. Right. Like,I don't feel like I'm growing as
a human. And so I tried to dothat with my team, giving my
team that also the tools to beable to make decisions within
the self conformed groups, likethe true agile sort of
methodology that best I can, youknow, agile is something from a
(26:44):
theoretical perspective Ireally, truly agree with. And
it's really hard to do. Youknow, in its purest form, right.
So what does that look like?
Right? Having all stakeholderscompletely and totally on the
same page with all the sameskill set and all the right to
be able to contribute all that?
Well, that's, that'sunrealistic, right? But that is
(27:07):
the ideal agile team, right? So.
So instead, it's getting to knoweach other as capacities, and
then what and how to utilizethem to the best of their
ability. And I know, for me,when I am doing what I do best,
I am in that constant flow.
Right. And that makes not onlymyself successful and feel
(27:32):
fulfilled, but it also motivatesthose around me. And it's a
ripple effect. Right? And that'swhat I kind of call that
authentic leadership. Right? iIt's an acronym, you know,
really, iced tea, I have calledand maybe I'll put this in the
show notes. Around, you know,for from a quality perspective,
(27:54):
we need to have trust, educationand accountability, right. From
a from a true qualityperspective. And then the ice
part is an interconnectedness,empowerment, and a dialectical
conversation. And I think thisis really important by having
the there is no right or wrong.
Right? These are all kinds ofstates of being and then you
(28:18):
choose, we're choice makers tofigure out what are we going to
do with all that? Yes. Right.
And I think that's what'sexciting around the CSA. So I
share in some of your enthusiasmaround it. I think it's a
insurgence to be able toquestion. It's an insurgence to
be able to, you know, break downsome historic baggage,
(28:43):
potentially that doesn't serveus in any way anymore. Right?
And how do we figure out a wayto really create something new?
Right and so another thing aboutPurcell is I was really very
intentional around rethink,reshape and remake? Because
it's, it's a learning process,right? It really is. It's what
(29:07):
works now might not work in amonth from now. Yeah. And as a
compliance and quality kind ofperson. I can see how that that
may make one nervous. But if youkind of embrace the fact that
we're doing this together,right, that we're we're making
these conscious choices to topivot together, then I think it
(29:32):
reduces our overall compliancerisk. Right. And the risk that
we have, not only to ourproduct, Safety and Quality,
right, but but for the overallprocess. Yeah, and I think it
makes sense but I think that'sone of the learnings out of
COVID. But I'm I'm not sure thatsome of that sticking. What do
you what do you think? What werewhat was your some of your
(29:55):
takeaways from COVID? And do youwhat do you think about them
today?
Sree K (29:58):
Yeah, and I loved The opportunity COVID has given us
to work remote, let me because Ihave two small children has
given me so much time to spendwith them and also pursue my
passions outside of life. So Ifeel blessed with COVID code a
couple of times, but then Ithink the you have to see the
(30:18):
past T radius, we have lost somany lives and a lot of near and
dear ones, but it's part of yourlife, right? I mean, we are all
here to go one day. So someonewho believes in the positive
aspect of things and you know,take every day as it comes. I
also like what you just saidabout, you know, doing something
(30:39):
new every day and alsoconnecting to the, you know, the
audience or in our audience, ifyou will. So, for example, you
and I have been hearing this CSAfor for at least two years
continuously, right. So we alsowant to get something new.
Right. So another thing I didlast week was, you know, and
everyone has been talking aboutthis tag GPT. And, you know,
(31:00):
things like, I was trying tothink, what is competencia CNDP
chat GPT, I actually wrote aLinkedIn article, a couple of
days, back, and a lot of peoplecame and say, this is
interesting, because there'snothing comes in between,
though, but I was just trying towhat I was trying to do is take
the interest in people, right,and then write something rated
(31:21):
so that people can at least readCSA stuff, right? So you don't
have to look at CSF from oneangle all the time, right. So
also, for you and me, we alsowant new things not just to
teach, but also to freeourselves new things, we also
don't want to get bored, doingthe same thing. So I think we
all have to look outside in wayswhere we can bring that new
(31:44):
ideas into what we do every day.
So you know, and also, some ofthe things which I also learned,
and then I tried to share withwhat I interact with, especially
the my team members is that, youknow, do something outside of
work. You don't have to spend somuch time at work, and then to
try to do your secondary, youknow, the other passions,
(32:04):
because when you do that, forexample, you play sports and
right, you bring the leadershipskills and some of the team
skills you bring to the table.
So, you know, all this helps.
Dori Gonzalez-Acevedo (32:16):
Yeah, you're right. And so I was asked
a couple days ago about so. So,you know, what is this with all
the women and validation and theDEI stuff you do? And I said,
Well, that is intimately tiedto, to what I do, as a business
as person because it's importantto me, it's part of my value
system, right? And so I'veworked to be able to align those
(32:40):
together, back to the authenticleadership, right? Like, I can't
not do that. Without the other,right, both have to be present
in order for me to fully show upas the leader that I want to be.
And so I think that's superimportant. And that leads me
into I know, You've beenmentoring, folks. And that is
(33:01):
also a passion of mine. So tellme, how is that going for you?
Sree K (33:05):
Yeah, it's been good. So one other thing I am doing is
the LinkedIn audio events. I dothat every Monday for one hour
free event. And sometimes peoplehave come and asked me, Hey, why
do you do it for free? Right?
We're going to create atraining, things like that. And
I thought to myself, I've beenwhatever I have learned in this
industry, I've learned on thejob, and I got paid for it. So
(33:25):
why Why should I, you know, asksomeone to pay for something
which I share my learnings with?
I got paid for it. So I thinkit's not about the money part of
it. But it is more aboutconnecting to other people.
Because, you know, yes, you dowork in an organization or let's
say, five organization, butthere are still more
(33:46):
organizational people who arelooking. And you can also learn,
right? So in some of my calls.
To bring into perspective,right? You have to do things to
fake right. And I didn't knowanything about when to now and
sometimes it is just one personall the time, sometimes it is
10, right. So you have to takethings in stride. But then I
just had this experience in my30 when I believe like someone
(34:08):
came only in the last 10minutes. And it was a very
fruitful conversation. I had somuch learning from that person
in the last 10 minutes. Becauseyou're here so much of
experience implement in this andin sharing lots of ideas, which
I took to the next event, right.
So I think yeah, so, you know, Iknow, like you may be doing the
same with your podcast and otherevents you do as well, where you
(34:31):
began to some of the learningsand then that helps you write
the names.
Dori Gonzalez-Acevedo (34:35):
Because it's a it's a process, right,
like and so every conversationinforms the next and so it's
very dynamic and you know, oneof you know, as my learning is
round and a lot of my I considermyself a systems person, right
(34:56):
and that and part of that isbecause of how I grew up in this
industry, right? Like, as aprocess engineer, chemical
process and cheering developingand pharmaceutical ingredients
with no, you know, processes inplace. Really, it was all on
paper, like we had to make itup. And that process of figuring
out the system, like as anorganization in an organization
(35:18):
that I was able to affect allpieces of that because we were
small. Yeah. Right. And solearning that system dynamic in
real time, full hands on now,that's the type of learner I am,
right, which may come to someoneelse by reading a book. Right,
right. But for me, it was allhands in for men, you know,
several years of reallyunderstanding how those systems
(35:42):
and dynamics worked. And I thinkthat was a huge life lesson, you
know, that has carried methrough throughout because all
those organizations areorganizations change, they
evolve and move. And we need tobe able to flow with that. It's
interesting, one of myscreensavers is one of those 3d
(36:04):
chips shifting things, right.
Like, it is like we'reconstantly kind of moving and
evolving. And I think thatthat's exciting. It's exciting
to me, I get that How am thatmight not be exciting to some
folks. And, you know, the folksthat I know in quality that a
lot of this makes them feeluncomfortable is because they
really like their boxes, rightthere. They like the the fixed
(36:25):
box, where I'm more of a personthan I like the the playdough
box where you can shape it andshift it and mold it and change
it. And one day it's a, youknow, a tree and the next day,
it's a boat or whatever.
Sree K (36:42):
Yeah, no, it's very true. Don't worry, what is it?
Because we all have been askedto think outside the box right?
Now, if you always stuck insidethe box, right? There is only so
much you can think outside thebox. And I realized by
experience, I was doing all thisdifferent stuff growing and all
this stuff. And then one day, Irealized I was spending like
(37:03):
1617 hours at work. Yes, I washelping a lot of people, but
then the health was not there.
They were not giving enough timeto family. And then that's one
of the things. That's why I saidCOVID has been a blessing,
right? And then it kind of givesyou that time to think, hey, is
this how you want to spend yourtime here? Right? You just got
one charter life? So yes, andthen only when they came out of
(37:26):
that box in really so much ofopportunities. And there's so
much, you know, areas you cangrow outside the box. And there
are, you know, our I think it'sby design. And I've wrote this
too, that, you know, they wantyou to be in the past so that
you don't you know that I wrotesomething about that
Unknown (37:48):
topical, potentially geopolitical conversation that
you and I can have maybe off,somebody needs to talk about it,
right? I do. I absolutely agreewith you. 100%. That is very,
very true.
Sree K (38:02):
And I also seen some examples, right, in my, in my
previous experiences, to theteam mentoring aspect of things.
While we were doing somevalidation process, I encourage
my team to do certification,other stuff, which are not
related. Now, what has happenedis they asked me, What is the
relevance, right? I mean, that'sagain, like thinking inside the
box. Now, that box, I said, itmay be helpful to you in the
(38:23):
future, Right. Steve Jobs,right, you can only connect the
dots backwards. So what hasreally happened like last couple
of hours. So you wrote aboutthis, like, I think four of my
previous teammates, they got tobetter jobs in the area this
week, or training that part ofthem that they came on time and
some nights you actuallywouldn't. But, you know, they're
seeing even happen. So it's thesame with with the mindset,
(38:45):
which we're seeing that people,you know, want to be there
because they feel safe, but onlywhen they get out and get
uncomfortable. I think then theywill see. They don't have to be
in there to get what they want.
Yeah.
Dori Gonzalez-Acevedo (38:58):
So you said that the magic words. So
the other key word for me isuncomfortable, right? We all
need to be more comfortable withthe uncomfortable. Exactly. And
if we if we're willing to in it,there's a willingness, like, it
doesn't mean that you have tosit in it all the time, right.
But there needs to be awillingness to at least
entertain the uncomfortable,whatever, right? Someone comes
(39:19):
to you and say, yep, you know,what we really wanted to do try
this different way. Or we wantto, you know, take this
different approach, and, andpart of that learning needs to
happen in order to figure outwhat is the next best thing,
right. So there's anexperimentation and part of that
(39:43):
is also again, a character traitof mine, right? Yes. I
anticipate being being in thatsilence. mindset of let's
experiment a little. Let's tweakit. Let's figure it out. Let's
try it on. It might not serveeveryone right now. And we
learned something We knew and wetweak it, and we will move on
right in that sort of agile sortof way. Right? And the, the
(40:07):
doubt that, my my pitfalls, whatI see are folks that are wanting
to not change anything, becauseit's always worked, right? Yeah,
I Oh, I know, you know, I'mgonna use this paperless system.
But you know what, I'm stillgonna push out PDF, and I'm
gonna put it in a documentrepository, or worse, I'm gonna
(40:30):
put it over and Iron Mountain.
And, and I know where it is. Andit's 20 years later, and we
still like, what? Like, for forwhat added purpose? Right? Where
is that adding compliance?
Right? It's not addingcompliance. It's, you know, it's
looking at things from aextremely risk based approach.
(40:52):
And that's hurting everyone.
Right? If we were to do that inCOVID, right, and that was our
stance, where would we havebeen?
Sree K (41:05):
Exactly. So sometimes you have to learn the hard way.
Right. That's another thing. Iwant to connect this to your
experiences in the conferences,right to what you have not been
attending? I have listened toconference I have not been at in
person, which I was planning todo very soon. But I know like,
you have been to a lot ofconferences, you know, as a
speaker yourself. I mean, to thepersona, which you just explain,
(41:29):
have you seen such personascoming to these conferences and
also take actions after thatallow? What is your take?
Dori Gonzalez-Acevedo (41:35):
Yeah, so that so that's a great question.
So yes, yeah, we do see, folkswith with those personas coming
out. I think this gets back tomy quality tea aspect, right.
It's the accountability. And oneof the things that we've been
rolling out at Priscilla X, ourcompliance coaching engagements,
where we're helping keepcustomers accountable to their
(41:58):
desires, each and every month,right? Everyone is overburdened,
overworked, folks are asked todo things that are outside their
scope of their day to day. It'san epidemic, right, we have a
problem. And that's not going tochange. But what can be helpful
(42:19):
is to have outside coachingsupport, to vet through all of
what is the biggest priorityright now. Right? And from a
quality perspective, sometimesit's hard to figure that out,
because what's coming at you isall this all these asks, right,
this has to get done, this hasto get them this and no one's
(42:40):
there to say, okay, take a deepbreath. Right? And what is the
most critical thing of thislist? And what is the severity
and really be able to thenreprioritize and help coach
those folks in these leadershippositions, senior managers are
(43:01):
in that sort of level to be ableto say, I hear what you're
saying, and go, I don't, wedon't need to know about this,
but we need to know about thesethree things. Right. And that,
but having that accountabilityis not often in organizations on
a regular basis, and also havingsomeone as a consultant like
(43:22):
you, are i doing that? With themwith that outside perspective?
Right. And I think that's been ahuge change for some of my
customers to be able to knowthat they can reach out and get
a different take on things. Howdoes, it's not that they're
asking specifically, like, howdoes this company do this?
(43:43):
Again, this is, quality is notproprietary, we're talking about
philosophies and changes. It'snot that that that what I'm
going to say is going to beexactly what you do, but I'm
give I'm offering you something,to then impact you in some way
in which you are either moreemboldened by what you already
know, because most of us have ageneral sense gut instinct, and
(44:05):
that gut instinct, most of thetime is pretty good. But all the
other noise, or, you know, myboss is gonna do this, or we're
gonna lose this or, like, allthose things tend to muck up
that voice. And so so those aresome of the exciting things that
I'm doing, which I'm, I'm, Ithink needs to be embraced
(44:28):
because I think it gets to thisdeeper conversation. Right?
Yeah,
Sree K (44:31):
I think you know, it's also not just at the work,
right. So, you know, philosophy,really, people have to just stop
and think now if you're able toprioritize, because I have seen
this, somebody who's not able toprioritize at work. They cannot
also not practicing at home. Butif someone is able to do that at
(44:53):
home, then they can bring thesame experience with it doesn't
have to be two differentlifestyles. You have to live
with it. You're able toprioritize and make sure you
have time for to play with yourkids or have a family dinner.
Right? So those are yourpriorities. So you you take that
mindset to your work to you.
Yes, you have 100 emails toread, but you can still
prioritize and then work on thetop five top 10. Right, and make
(45:14):
those changes.
Dori Gonzalez-Acevedo (45:20):
So I'm really interested, I follow you
on LinkedIn. I love your yourchats, I love your cartoons. We
should do this more often. Andin the show notes, I'll leave
links to all your your yourspecifics
Sree K (45:37):
and your resume then.
Absolutely.
Dori Gonzalez-Acevedo (45:42):
Yeah, it's been a pleasure Sri. And I
hope you we, we continue thejourney, we can also continue
this journey new ways LinkedIn,like you're, you're, you're
playing with new stuff onLinkedIn all the time, which I
love.
Sree K (45:56):
That's great. Yeah.
Thank you. Thank you. I mean, Itried to explain and I also was
looking forward to spend somequality time with you in kind of
doing this kind of conversation.
I think you both have been busy.
So I'm glad that this thishappened. And I also thank you
to this for this opportunity.
And looking for futurecandidates who have not been in
person for the conference. I'lldefinitely would like to listen
(46:17):
to one of your talk in personwhen the next chances and also,
you know, be in touch.
Dori Gonzalez-Aceve (46:23):
Absolutely.
We'll see each other soon. Okay,
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