June 30, 2023 • 28 mins
We're excited to welcome Director of Integrated C&Q and Kneat Services at VEQTOR, Phil Jarvis! Phil is extremely active in the life sciences community and is a staunch advocate for modernization and improvement in our industry backed by a wealth of experience and insights.
I have to apologize in advance for the audio. We had a bit of a technical issue when recording this live, but trust me, this conversation is well worth a listen as Dori and Phil dive deep on the importance of digitizing and integrating the entire validation ecosystem.
Please follow Phil on LinkedIn here and don't forget to
*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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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Dori Gonzalez-Acevedo (00:00):
Well, welcome to another episode of
software quality. Today, I'msuper excited to be able to
interview Phil Jarvis here liveat Connects validation
University. We're inPhiladelphia and Phil, you're in
from the, in from Ireland infrom Ireland from sunny, sunny
Limerick. Left, and it wasraining here yesterday. So that
(00:21):
wasn't really fun either.
Unknown (00:24):
It wasn't much of a climatic shock to me either,
which, which is good. But no,the travel was good. And he's
delighted to be here with youtoday.
Dori Gonzalez-Acevedo (00:32):
Yeah, great. Thanks. I know you were
in December you were withconnects live when we were over
in Ireland, in Dublin, Dublin.
And so you guys have beenjoining now as new sponsors for
connects
Unknown (00:46):
we have I've had a long standing affiliation with John,
ever since he left IVT andstarted connects. So I think
I've been faculty since itstarted. But no, I really enjoy
these events just because of theconnectivity and the knowledge
sharing and the actual real lifeexamples that are shared, I see
(01:06):
real value in it. And I think aspart of factor now, you know, we
see ourselves sponsoring andgrowing more with that
partnership, getting involved inpublications also, with
connects, and also maybe on thetraining side as well in the
future as well.
Dori Gonzalez-Acevedo (01:23):
That's awesome. Well, why don't we
start with telling us a littlebit about how you came to be in
validation? Because it's notsomething that we all aspire to
be?
Unknown (01:32):
No, no, I don't think you ever sort of go I'm going to
be a validation engineer. No. Istarted off being a chemist. So
I have two best people. And thenwent on to the lab from being a
chemist, and then obviously gotinto sort of HPLC, validation,
etc. Because no one else wantedto do it.
Dori Gonzalez-Acevedo (01:54):
With G factor is de facto role we had
to play. Yeah.
Unknown (01:59):
So from there got into more manufacturing, equipment
validation, process validation.
I worked in j&j for about 10years, and various validation
leads sorts of jobs. Until or, Iwould say that was about 1015
years ago now. And then I wenton to a big bio startup in in
(02:21):
Cork BioMarin. Oh, by marine,yeah, which was their validation
lead desk. That was my firststep of Greenfield sites. So
that was all exciting. And thenreally got into one of my
passions there, which was morearound risk based validation. So
how can we do things moreefficient? How can cause Bahrain
(02:42):
is rare diseases. So we werereally pushed with a mission of
this is the only medicine thatis out there for this disease.
And one of the great things thatIran did is they had a treatment
for battens disease, nothing outthere. And I don't know if you
know anything, no, I don't thinkso effects, usually children,
(03:04):
they don't usually live past,you know, 40, because the thing
is very debilitating disease,nothing out there to treat it at
the moment. So you know, verymuch like trying to get that
treatment out there as fast aspossible, embracing the most
lean methodologies available outthere. And through that, that
(03:26):
led me to, well, if we can onlygo so far with paper, what can
we do when we digitalize things?
And that has been my passionproperty for the last six to
seven years now? How can wedigitalize these processes? How
can we link systems together sowe can create this digital
(03:47):
ecosystem and share data andbecome much more data centric
than paper centric? Yeah,
Dori Gonzalez-Acevedo (03:53):
I know you and I share very much the
same sort of mindset aroundthat. And it's, and then you
were at Abbey, as well, I was
Unknown (04:00):
Yeah. So I went from Bahrain, and I went to AFI, I
was there as the EU, seeing Qlead for three years. And that
was really developing both theirrisk based CQ Strategy off the
ISP baseline guide version two.
So my boss, Laurie Kim, at thetime, he was a very, you know,
(04:23):
she was a great mentor to mevery. I would say inspirational
woman. Okay. She was one of yourco authors of the ISP guides,
and she said, look, let's getahead of the curve. I want to
push this into Byron and Aminheard that. But then at the same
time, we said let's digitizethis at the same time. We rolled
(04:45):
out in the last three or fouryears, we've rolled out to I
think, eight sites within theERP network.
Dori Gonzalez-Acevedo (04:54):
Yeah, that's awesome. And then you
bridge the gap and you've jumpedover to the dark side on the
consultant inside.
Unknown (05:00):
Yeah, so I don't know, have you ever met Martin rear
row Deki. From vector he's nowdirectors to his very
inspirational sorts of full ofenergy.
Dori Gonzalez-Acevedo (05:13):
I have to meet him, I love him.
Unknown (05:16):
But he's just a ball of energy. So vector was the
partner for HUD V, rolling outneat. And, you know, had really
good experience with them as aconsultant helping me at the
time. And I was beginning toevaluate, like, how can I
influence wider than than thenthat's just one organization,
(05:37):
and Vivian Fenton. So anotherwoman in pharma that I admire,
amazing, amazing woman, she's,you know, she's in the
automation space, very rare.
Yeah, someone in that space? Andshe was like, would you consider
coming over to, you know, theconsultancy side? And really,
it's been a revelation to me,because not only do you have
(05:59):
spare time to go to conferenceslike this. I'm very active in
the ISP, I'm active in Irishuniversities and upskilling
validation staff in in Ireland,but also is great work on like,
a very big variety of projects.
(06:23):
So no, it's been, it's been verygood so far, but very different.
Dori Gonzalez-Acevedo (06:27):
Yeah, different. And I like, for me,
too, is the variety and be ableto spread that wealth of
knowledge across a much, muchmore broader spectrum and really
helps inspire more, right? Andthen how do we tap into that
next generation, just likeyou're saying, You're doing the
Irish universities, right? Like,how can we teach this stuff?
(06:49):
Because we were never taughtthis? You would
Unknown (06:51):
never talk? Yes, exactly. And that's one of my
great passion. So about what Ithink is about six or seven
years ago, like islands justexploding by attack wise moment,
and there was just a completeshortage of validations. That
staff. So we got together a lotof companies with IBEC, which is
(07:13):
one of the Irish government allsorts of authorities there and
said, How do we increase thevisibility of validation? Being
a great career? Yeah, becausepeople were just not aware,
though, is out there. And said,right, well, we'll start small.
And we will do some upskillingcourses, some Springboard
courses, they call them. Andthey pulled experts from the
(07:37):
Irish validation community, andcreated very interactive sorts
of classes with case studieslike that. So we got really good
feedback from there, but and nowthey're doing masters courses,
modules for BSC honors coursesin biotech. So it's great
because we get people now thathave a solid understanding of
(07:59):
validation coming out ofuniversity. The other thing is,
and this is a bit of a spoileralert, actually, me and neat
were Vectra an official partnerwith NEET. We are working on
Irish universities validationinstance of meat, so that they
will use need as part of digitalvalidation modules going
(08:23):
forward. Yeah. So
Dori Gonzalez-Acevedo (08:24):
that's a great, yeah. So how to
incorporate these things fromthe very beginning, rather than
waiting to folks getting into acareer or into a full time
position at a big organizationto have that experience, but
actually get it in. That's,that's great. That's awesome.
Unknown (08:40):
I mean, he, you know, I think it really gives benefit to
all sorts of parties, because weget staff rates, right, you can
hire Yep. But now the skill, theskill sets, but also, we also
have an awareness right fromthem that this is a career and
(09:02):
what skill sets that
Dori Gonzalez-Acevedo (09:03):
what's needed. And so actually going to
be launched tomorrow on thepodcast is my episode with Sue
black from the UK. She is doingsimilar in her work on tech up
women were really partneringwith companies to be very
specific about what the skillsare, that are needed, and then
(09:26):
teach those skills because theyknow what they are. We just
haven't educated across theboard for what they need to be.
Unknown (09:33):
And I think those skill sets are constantly evolving,
especially your way technologyis evolving so fast. Yeah. Like
critical thinking, decisionmaking. You know, creating good
knowledge management process,etc. Yeah. So it's yeah, it's
great to be involved, somethingthat I'm highly passionate
(09:54):
about, like trying to teach youknow, you know, give give young
people a great start talking bis an amazing career.
Dori Gonzalez-Acevedo (10:01):
Yeah, that sounds so the one of the
things that I'm interested inand I was wondering, pick your
brain about see what you thinkyou know about because you're
often in the commissioning sideand equipment commissioning
side, there's so much newtechnology coming out there with
how to do literally validationon the floor, right, which is
(10:23):
amazing and awesome. And yet Ican hear in the back of my head,
some quality folk may be perhapshesitant on wanting to adopt
some of that new technology. Sodo you have any thoughts about
that?
Unknown (10:35):
Yeah, so it's something you know, we definitely have had
to contend with with withmultiple clients at the moment
because a lot of especiallygoing to digital validation
practices or very newtechnologies there there is that
hesitancy there? Because I thinkwe're we're a very conservative
industry at the end of the day.
But I, I think there's there'smore of a drive by companies now
(10:57):
of the speed to market. I thinkthat's really helping pull the
quality folks into the fold, andbecome involved in so sort of
solving that problem. And a lotof these things are big cultural
changes as well. They're noteasy to
Dori Gonzalez-Acevedo (11:13):
do.
Right? Yeah, cultural changes,which include process change,
which includes people change,right. And I think you and I
have talked about this, it's notthe tools we can do the tool
part is the easy part, right?
It's the people part that wehave to help along the way how
to enable how to utilize thesystems that were putting into
place the most effectively asthat they're designed for,
(11:37):
right? Like, a lot of thesetools do a lot of things, but
not everyone uses all of thosethings.
Unknown (11:44):
How would you provide people with really top class
training? A lot of our clientsat the moment, especially in the
need space, you look at themwanting to make their training
more efficient. So looking atmore CBT types of courses. But a
lot of the time, there's so manyscenarios in validation that you
(12:06):
can't be an instructor led sortof classroom based session as
well. But I think you raise areally, really good point.
There's the new technologies andnew tools that are coming out.
But especially in the digitalspace, there are huge challenges
of how we're going to validatethings. So if we look at AI,
(12:29):
deep learning, machine learning,how do we actually validate
something those determinatingits own decisions? Yeah, yeah.
Yeah. And these are reallyexciting challenges, right, that
we need to solve quite quickly.
Yeah.
Dori Gonzalez-Acevedo (12:43):
And have to think about differently.
Right. So getting back to yourearlier point about critical
thinking, right? Like, we can'ttake the same methodologies that
we've been doing for the last1520 years, right and apply it
to the same way, it doesn't workthat way. It's not possible.
Which leads me to more of theagile mindset conversations,
right? And how to helporganizations make that
(13:07):
transition, just even thinkingabout that in a different way.
Right.
Unknown (13:12):
And I have a case study, I have a session tomorrow
at Connects around farmer 4.0.
And there's an example of thatin machine learning. So how do
you get people comfortable,especially, especially the
quality organization? So I usean example in there a vision
system? Okay. So let's sayyou're inspecting a medical
device, let's say it's a contactlens. Okay. A lot of the time,
(13:34):
you are teaching that visionsystem, what is good and what's
bad, if you go into somethingthat is using machine learning,
is going to begin determiningwhat's good and what's bad. And
that's quite scary for quality.
So what can you put in place thesort of the pieces that that can
get the quality mindset around?
Okay, is it doing a good job? Isit making good decision? Well,
(13:57):
you can put parallel activitiesin place, so maybe, okay, you
allow it to make that decision.
But then that's vetted by ahuman being, yes, that is bad, a
new talent, talent is bad. Ormaybe for a certain amount of
time, you will have maybe a QCcheck that's ongoing with. So I
(14:17):
think there's ways of beginningto make people
Dori Gonzalez-Aceve (14:22):
comfortable the approach. Yeah, I think it's
similar. We saw this in softwarequality testing and test
automation, right, folks reallynot understood or not
understanding the technologyabout test automation, right,
and having to do that parallelsort of approach for a while,
right, running a manual test andthen running an automated test
and showing that it's the samething. Now where we're at with
(14:44):
the automation tools from a testsoftware quality test. You don't
need to do that anymore. Right.
But we didn't need to do that inthe beginning maybe. Granted,
some folks are still doing that.
But the technology has wellsurpass the the need to do that
pair Allow approval, if youwill, from test automation
perspective and software qualitytesting, be the same for machine
(15:06):
learning and other types ofwhere you physically can do that
visual inspection versus maybesomething else to do that
comparison for us, right.
Unknown (15:15):
Yeah, exactly. And it's just, it's helping that process
and along its way, just gettingpeople comfortable with that
route challenge that.
Dori Gonzalez-Acevedo (15:22):
Yeah. The other thing I was wondering, you
know, this. So, again, I oftencome from a software development
kind of perspective, but theconstant change that's needed in
order to get out there today,right? It's, we're ideating as
we go. But that's the same onthe production floor. Yep. Yeah.
(15:45):
Right. So I mean, in that, sowhen I, back in the day when I
was on pilot and doing chemicalprocess engineering, right, we
did hundreds of of experimentsin tort until we got to the
final one, right. So what do youthink about it? Has anything
really fundamentally changed? Oris it Are we are we able to
(16:06):
adopt a, that iterative processon so we were talking about
validation? 4.0 and pharmaperformed pretty well, right? So
really continuous manufacturingchain, right, which is different
than 15 years ago, where it wasa discrete set tasks? Does that
make sense?
Unknown (16:27):
Indeed, and I think a lot of that comes down to a lot
of what's been discussed heretoday, by some good speakers,
like, what is our decisionmaking process? What is the
risk? So you know, we have tosay, well, if I'm making
something those a treatment fora year person, especially in the
(16:47):
ATMP, sort of space, where it isliterally the only treatment
with someone that's dying, orwhat is the risk of
Dori Gonzalez-Acevedo (16:54):
greater they're gonna die or not.
Anyway, right. Yeah, exactly.
Yeah.
Unknown (16:59):
So that some of that is around the risk and the decision
making, right when talking totalking about, and then some of
it needs to be, you know, so Sowhat's so bad about failing?
Great question about
Dori Gonzalez-Acevedo (17:12):
learning.
Yeah. So that's giving up thebeing perfectionist, which I'll
talk about tomorrow, and myauthentic leadership, that sort
of thing, right is giving upthat we always have to get it
right all the time, right. Andas part of the quality mindset
that perhaps needs to be setaside and failing first failing
fast is was is regular for likesoftware development, but we
(17:33):
need to actually embed that intoeverything. Right.
Unknown (17:38):
But as you say, is fundamental to the whole
production process. When we dopharmaceutical design. Yeah, as
per ich, QQ Q eight, you know,we're there right up again,
during the world do we usefinding our edge? Yeah, no, you
shouldn't just stop there, rightnow. informs the process process
(17:59):
going forward. But I think wejust need to be more cognizant
of risk. Yeah, more things.
Actually.
Dori Gonzalez-Acevedo (18:06):
I thought it was interesting this morning.
What James Mason was talkingabout the hand sanitizers, did
you did you hear that? Oh, youdidn't see that part. So the FDA
saw that the the in the warningletters and things around the
hand sanitizers went up becauseeveryone was trying to get hand
sanitizers out during thevaccines, right. But there was a
lot of knockoffs that was beingdone and not being tested
(18:29):
properly. And it just highlightsthe fact that risk constantly
has to be reevaluated. Right?
Because it's something like thatwe couldn't have anticipated
before. But then it's just avery good way to say, yeah, it's
a constant looking at risk,right? So not just doing a risk
assessment from the very onetime it's done. It's not that
(18:50):
it's this constant living sortof breathing thing. One of my
pet peeves around requirements,specifications, right, is that,
you know, folks want to takethis requirements specification
and put it in a dock managementsystem and think that it's done.
Requirements are living, right.
(19:10):
We all you know, designers andengineers understand that, like
that's constantly evolving. Andpart of that is looking at the
risk each and every time thatwe're doing something.
Unknown (19:21):
Yeah. And I think digitization is going to help us
out as well, because we're goingto have much more advanced
process controls in place,especially if where companies
are, you know, definitely, youknow, we saw in one of the ISP
polls at that moment, that therewas done recently there was a
survey by the CQ cop, and moreand more companies are looking
(19:43):
towards digitalization and Ithink that helps with the
constant assessment risk,because you're able to use pap
technologies to say, or thisattribute isn't quite right at
this step, even if it is acontinuous process. What can we
do maybe then to have just thatprocess. And maybe that's where
machine learning comes in. If wecan build up all these
(20:06):
technologies on top of eachother, we get a much more
dynamic and a much strongercontrol strategy that then
allows us to make
Dori Gonzalez-Acevedo (20:14):
good decisions. Yeah. And along those
lines, I didn't know I couldimagine. And when you're you're
implementing NEET for acustomer. Similar is you're,
you're looking at their businessprocess to kind of align some of
those data points, right, sothat they're not totally
whatever they think, right?
You're trying to help them guidethem towards standardizing their
data to not just implementing asystem, right? Because it's more
(20:39):
than just implementing a system,it's actually standardizing
their data so that they can makemeaning of that data as they go
along. Because if we don't dothat process, right, if we don't
go through and have thatstandardization, we can't make
any further predictions oranalysis. Right. Yeah.
Unknown (20:57):
And I think that's, that's a great challenge for the
future as well. How do you getall of these systems talking to
each other in a standardlanguage without this need for
middleware to convert?
Dori Gonzalez-Acevedo (21:08):
Yeah, I know, we were talking about this
on the the ISP subcommittee thatwe're on, right, like that is
like the ideal, right, like howto do that. And part of my, you
know, lessons learned over thelast 15 years is is, you know,
companies ask for lots ofthings. But as a consultant,
they might not be asking for theright thing. And there's a way
(21:31):
that we can to given that we seea lot and a lot of different
varieties out there. Beingconsultants, we can actually
help standardize the industrybetter if we do that
collectively. And so that's oneof the things I love about the
ISP subcommittees as well as inyou know, connects like this,
right, we work collaborate onwhat are the best industry
practices? What do we want tomove forward? One of the things
(21:54):
I was thinking about when youwere sharing also with the next
generation coming in? is datascience in general. Any thoughts
about that?
Unknown (22:03):
Yeah, I think data analytics and data sciences,
this is going to become more andmore of a growth need within the
industry. Which is why, youknow, it's great to get the
things like meat in Irishuniversities level. So they know
that these the systems arecapable of doing these things.
We have a very good partnership,actually, with a data analytics
(22:25):
company as part of vector. So wesee that strategically being
like definitely a growth sort ofthing within vector as well. But
yeah, making sense of datacontent, contextualizing the
data, and making decisions ofthat data, and improving, you
know, is this the right theright data? Because statistics
(22:46):
can lie.
Dori Gonzalez-Acevedo (22:47):
Bridge rates? Exactly. Yeah, you can
pick and choose poorly.
Unknown (22:53):
I've had very blended career, I've been very blessed
that, I guess that way, I spendhalf of my life in medical
devices, which is verystatistically based, yeah. And
then a lot of time in biotech,and then steroids, etc. So, you
know, having that statisticalbase, as you say, you get to
challenge the data, you know,so, you know, if I have data,
(23:18):
which looks great, but it's notnormal, you know, yeah. What's
that really telling? Yeah,that's right. You've got to have
some, you know, generalpresumptions about that data.
Yeah, or assessment of the data.
So I think data's gonna become ahuge thing in the future,
especially when we're looking atthings like real time release,
especially with things liketechnologies like ATMP is when
(23:40):
you're going to want that realtime release to give it to a
patient.
Dori Gonzalez-Acevedo (23:46):
Yeah.
Yeah. Awesome. Are there otherthings that you want to touch on
while we have time today? Plansfor the future things that
things that you
Unknown (23:58):
plans for the future? I think, you know, I'm learning a
lot. I think the great thingabout the consultancy is that
you're learning something newevery single day at the moment.
I'm really excited about thefuture, the partnership with
neat, especially as their newversion 9.0 goes on. And there's
(24:19):
much more powerful, powerfulfunctionality to connect to
other systems and create thatdigital weak eco structure that
we're talking about. But reallyexcited to be at the event
today. And actually, you know,talking to people
Dori Gonzalez-Acevedo (24:36):
I know.
Yeah, it was. I was at s QA acouple of weeks ago, and it was,
like 800 people, and it was alot of people came out because
it was the first time was fullin person and really enjoying in
community. Right. And one of thethings I think you said earlier
around the connects communitywas we're trying to build more
support structure for everyone.
(25:00):
For us, you know, whereveryou're at within your career,
right, so folks like yourself,and I can come in and help guide
folks from the very beginning,give them some questions space
to ask questions. And, and thenwith the FDA here as well, we've
gotten great representation fromfrom the FDA. So
Unknown (25:18):
the thing that I would say is I'm not I'm very positive
about the future as well,because, you know, we're hiring
a lot of new engineers tosupport our growth in Ireland.
And what we're finding is we'rerecruiting especially at a
junior level, definitely peopleyounger generation or myself,
(25:39):
yes. Yeah. And, you know, butthey're so bright, especially
when it comes to digitalsystems. Yeah. They're teaching
me things. Yeah.
Dori Gonzalez-Acevedo (25:50):
They're digital natives. Right. And so
that's where they really grewup. And I am I'm, the ideas that
they have are amazing, right.
And so my hope is to be able toremind folks of our generation
to listen to them.
Unknown (26:08):
You can learn amazing things off. Yes. Yeah,
absolutely. Well, thanks, Phil,I
Dori Gonzalez-Aceved (26:12):
appreciate your time today.
Unknown (26:14):
I really appreciate you for having me. And it's great to
see you in person, rather thanjust Oh, yeah,
Dori Gonzalez-Acevedo (26:19):
it's absolutely. Alright. Well, I
have to come over to Irelandsoon.
Unknown (26:22):
Oh, definitely.
Invited. Yeah, it's locked in.
As long as you like Guinness andyou like the rain.
Dori Gonzalez-Acevedo (26:27):
It's good. It's very good. All right.
Well, back to the show here.
Thanks.
Well, welcome to another episode of
software quality. Today, I'msuper excited to be able to
interview Phil Jarvis here liveat Connects validation
University. We're inPhiladelphia and Phil, you're in
from the, in from Ireland infrom Ireland from sunny, sunny
Limerick. Left, and it wasraining here yesterday. So that
(00:21):
wasn't really fun either.
Unknown (00:24):
It wasn't much of a climatic shock to me either,
which, which is good. But no,the travel was good. And he's
delighted to be here with youtoday.
Dori Gonzalez-Acevedo (00:32):
Yeah, great. Thanks. I know you were
in December you were withconnects live when we were over
in Ireland, in Dublin, Dublin.
And so you guys have beenjoining now as new sponsors for
connects
Unknown (00:46):
we have I've had a long standing affiliation with John,
ever since he left IVT andstarted connects. So I think
I've been faculty since itstarted. But no, I really enjoy
these events just because of theconnectivity and the knowledge
sharing and the actual real lifeexamples that are shared, I see
(01:06):
real value in it. And I think aspart of factor now, you know, we
see ourselves sponsoring andgrowing more with that
partnership, getting involved inpublications also, with
connects, and also maybe on thetraining side as well in the
future as well.
Dori Gonzalez-Acevedo (01:23):
That's awesome. Well, why don't we
start with telling us a littlebit about how you came to be in
validation? Because it's notsomething that we all aspire to
be?
Unknown (01:32):
No, no, I don't think you ever sort of go I'm going to
be a validation engineer. No. Istarted off being a chemist. So
I have two best people. And thenwent on to the lab from being a
chemist, and then obviously gotinto sort of HPLC, validation,
etc. Because no one else wantedto do it.
Dori Gonzalez-Acevedo (01:54):
With G factor is de facto role we had
to play. Yeah.
Unknown (01:59):
So from there got into more manufacturing, equipment
validation, process validation.
I worked in j&j for about 10years, and various validation
leads sorts of jobs. Until or, Iwould say that was about 1015
years ago now. And then I wenton to a big bio startup in in
(02:21):
Cork BioMarin. Oh, by marine,yeah, which was their validation
lead desk. That was my firststep of Greenfield sites. So
that was all exciting. And thenreally got into one of my
passions there, which was morearound risk based validation. So
how can we do things moreefficient? How can cause Bahrain
(02:42):
is rare diseases. So we werereally pushed with a mission of
this is the only medicine thatis out there for this disease.
And one of the great things thatIran did is they had a treatment
for battens disease, nothing outthere. And I don't know if you
know anything, no, I don't thinkso effects, usually children,
(03:04):
they don't usually live past,you know, 40, because the thing
is very debilitating disease,nothing out there to treat it at
the moment. So you know, verymuch like trying to get that
treatment out there as fast aspossible, embracing the most
lean methodologies available outthere. And through that, that
(03:26):
led me to, well, if we can onlygo so far with paper, what can
we do when we digitalize things?
And that has been my passionproperty for the last six to
seven years now? How can wedigitalize these processes? How
can we link systems together sowe can create this digital
(03:47):
ecosystem and share data andbecome much more data centric
than paper centric? Yeah,
Dori Gonzalez-Acevedo (03:53):
I know you and I share very much the
same sort of mindset aroundthat. And it's, and then you
were at Abbey, as well, I was
Unknown (04:00):
Yeah. So I went from Bahrain, and I went to AFI, I
was there as the EU, seeing Qlead for three years. And that
was really developing both theirrisk based CQ Strategy off the
ISP baseline guide version two.
So my boss, Laurie Kim, at thetime, he was a very, you know,
(04:23):
she was a great mentor to mevery. I would say inspirational
woman. Okay. She was one of yourco authors of the ISP guides,
and she said, look, let's getahead of the curve. I want to
push this into Byron and Aminheard that. But then at the same
time, we said let's digitizethis at the same time. We rolled
(04:45):
out in the last three or fouryears, we've rolled out to I
think, eight sites within theERP network.
Dori Gonzalez-Acevedo (04:54):
Yeah, that's awesome. And then you
bridge the gap and you've jumpedover to the dark side on the
consultant inside.
Unknown (05:00):
Yeah, so I don't know, have you ever met Martin rear
row Deki. From vector he's nowdirectors to his very
inspirational sorts of full ofenergy.
Dori Gonzalez-Acevedo (05:13):
I have to meet him, I love him.
Unknown (05:16):
But he's just a ball of energy. So vector was the
partner for HUD V, rolling outneat. And, you know, had really
good experience with them as aconsultant helping me at the
time. And I was beginning toevaluate, like, how can I
influence wider than than thenthat's just one organization,
(05:37):
and Vivian Fenton. So anotherwoman in pharma that I admire,
amazing, amazing woman, she's,you know, she's in the
automation space, very rare.
Yeah, someone in that space? Andshe was like, would you consider
coming over to, you know, theconsultancy side? And really,
it's been a revelation to me,because not only do you have
(05:59):
spare time to go to conferenceslike this. I'm very active in
the ISP, I'm active in Irishuniversities and upskilling
validation staff in in Ireland,but also is great work on like,
a very big variety of projects.
(06:23):
So no, it's been, it's been verygood so far, but very different.
Dori Gonzalez-Acevedo (06:27):
Yeah, different. And I like, for me,
too, is the variety and be ableto spread that wealth of
knowledge across a much, muchmore broader spectrum and really
helps inspire more, right? Andthen how do we tap into that
next generation, just likeyou're saying, You're doing the
Irish universities, right? Like,how can we teach this stuff?
(06:49):
Because we were never taughtthis? You would
Unknown (06:51):
never talk? Yes, exactly. And that's one of my
great passion. So about what Ithink is about six or seven
years ago, like islands justexploding by attack wise moment,
and there was just a completeshortage of validations. That
staff. So we got together a lotof companies with IBEC, which is
(07:13):
one of the Irish government allsorts of authorities there and
said, How do we increase thevisibility of validation? Being
a great career? Yeah, becausepeople were just not aware,
though, is out there. And said,right, well, we'll start small.
And we will do some upskillingcourses, some Springboard
courses, they call them. Andthey pulled experts from the
(07:37):
Irish validation community, andcreated very interactive sorts
of classes with case studieslike that. So we got really good
feedback from there, but and nowthey're doing masters courses,
modules for BSC honors coursesin biotech. So it's great
because we get people now thathave a solid understanding of
(07:59):
validation coming out ofuniversity. The other thing is,
and this is a bit of a spoileralert, actually, me and neat
were Vectra an official partnerwith NEET. We are working on
Irish universities validationinstance of meat, so that they
will use need as part of digitalvalidation modules going
(08:23):
forward. Yeah. So
Dori Gonzalez-Acevedo (08:24):
that's a great, yeah. So how to
incorporate these things fromthe very beginning, rather than
waiting to folks getting into acareer or into a full time
position at a big organizationto have that experience, but
actually get it in. That's,that's great. That's awesome.
Unknown (08:40):
I mean, he, you know, I think it really gives benefit to
all sorts of parties, because weget staff rates, right, you can
hire Yep. But now the skill, theskill sets, but also, we also
have an awareness right fromthem that this is a career and
(09:02):
what skill sets that
Dori Gonzalez-Acevedo (09:03):
what's needed. And so actually going to
be launched tomorrow on thepodcast is my episode with Sue
black from the UK. She is doingsimilar in her work on tech up
women were really partneringwith companies to be very
specific about what the skillsare, that are needed, and then
(09:26):
teach those skills because theyknow what they are. We just
haven't educated across theboard for what they need to be.
Unknown (09:33):
And I think those skill sets are constantly evolving,
especially your way technologyis evolving so fast. Yeah. Like
critical thinking, decisionmaking. You know, creating good
knowledge management process,etc. Yeah. So it's yeah, it's
great to be involved, somethingthat I'm highly passionate
(09:54):
about, like trying to teach youknow, you know, give give young
people a great start talking bis an amazing career.
Dori Gonzalez-Acevedo (10:01):
Yeah, that sounds so the one of the
things that I'm interested inand I was wondering, pick your
brain about see what you thinkyou know about because you're
often in the commissioning sideand equipment commissioning
side, there's so much newtechnology coming out there with
how to do literally validationon the floor, right, which is
(10:23):
amazing and awesome. And yet Ican hear in the back of my head,
some quality folk may be perhapshesitant on wanting to adopt
some of that new technology. Sodo you have any thoughts about
that?
Unknown (10:35):
Yeah, so it's something you know, we definitely have had
to contend with with withmultiple clients at the moment
because a lot of especiallygoing to digital validation
practices or very newtechnologies there there is that
hesitancy there? Because I thinkwe're we're a very conservative
industry at the end of the day.
But I, I think there's there'smore of a drive by companies now
(10:57):
of the speed to market. I thinkthat's really helping pull the
quality folks into the fold, andbecome involved in so sort of
solving that problem. And a lotof these things are big cultural
changes as well. They're noteasy to
Dori Gonzalez-Acevedo (11:13):
do.
Right? Yeah, cultural changes,which include process change,
which includes people change,right. And I think you and I
have talked about this, it's notthe tools we can do the tool
part is the easy part, right?
It's the people part that wehave to help along the way how
to enable how to utilize thesystems that were putting into
place the most effectively asthat they're designed for,
(11:37):
right? Like, a lot of thesetools do a lot of things, but
not everyone uses all of thosethings.
Unknown (11:44):
How would you provide people with really top class
training? A lot of our clientsat the moment, especially in the
need space, you look at themwanting to make their training
more efficient. So looking atmore CBT types of courses. But a
lot of the time, there's so manyscenarios in validation that you
(12:06):
can't be an instructor led sortof classroom based session as
well. But I think you raise areally, really good point.
There's the new technologies andnew tools that are coming out.
But especially in the digitalspace, there are huge challenges
of how we're going to validatethings. So if we look at AI,
(12:29):
deep learning, machine learning,how do we actually validate
something those determinatingits own decisions? Yeah, yeah.
Yeah. And these are reallyexciting challenges, right, that
we need to solve quite quickly.
Yeah.
Dori Gonzalez-Acevedo (12:43):
And have to think about differently.
Right. So getting back to yourearlier point about critical
thinking, right? Like, we can'ttake the same methodologies that
we've been doing for the last1520 years, right and apply it
to the same way, it doesn't workthat way. It's not possible.
Which leads me to more of theagile mindset conversations,
right? And how to helporganizations make that
(13:07):
transition, just even thinkingabout that in a different way.
Right.
Unknown (13:12):
And I have a case study, I have a session tomorrow
at Connects around farmer 4.0.
And there's an example of thatin machine learning. So how do
you get people comfortable,especially, especially the
quality organization? So I usean example in there a vision
system? Okay. So let's sayyou're inspecting a medical
device, let's say it's a contactlens. Okay. A lot of the time,
(13:34):
you are teaching that visionsystem, what is good and what's
bad, if you go into somethingthat is using machine learning,
is going to begin determiningwhat's good and what's bad. And
that's quite scary for quality.
So what can you put in place thesort of the pieces that that can
get the quality mindset around?
Okay, is it doing a good job? Isit making good decision? Well,
(13:57):
you can put parallel activitiesin place, so maybe, okay, you
allow it to make that decision.
But then that's vetted by ahuman being, yes, that is bad, a
new talent, talent is bad. Ormaybe for a certain amount of
time, you will have maybe a QCcheck that's ongoing with. So I
(14:17):
think there's ways of beginningto make people
Dori Gonzalez-Aceve (14:22):
comfortable the approach. Yeah, I think it's
similar. We saw this in softwarequality testing and test
automation, right, folks reallynot understood or not
understanding the technologyabout test automation, right,
and having to do that parallelsort of approach for a while,
right, running a manual test andthen running an automated test
and showing that it's the samething. Now where we're at with
(14:44):
the automation tools from a testsoftware quality test. You don't
need to do that anymore. Right.
But we didn't need to do that inthe beginning maybe. Granted,
some folks are still doing that.
But the technology has wellsurpass the the need to do that
pair Allow approval, if youwill, from test automation
perspective and software qualitytesting, be the same for machine
(15:06):
learning and other types ofwhere you physically can do that
visual inspection versus maybesomething else to do that
comparison for us, right.
Unknown (15:15):
Yeah, exactly. And it's just, it's helping that process
and along its way, just gettingpeople comfortable with that
route challenge that.
Dori Gonzalez-Acevedo (15:22):
Yeah. The other thing I was wondering, you
know, this. So, again, I oftencome from a software development
kind of perspective, but theconstant change that's needed in
order to get out there today,right? It's, we're ideating as
we go. But that's the same onthe production floor. Yep. Yeah.
(15:45):
Right. So I mean, in that, sowhen I, back in the day when I
was on pilot and doing chemicalprocess engineering, right, we
did hundreds of of experimentsin tort until we got to the
final one, right. So what do youthink about it? Has anything
really fundamentally changed? Oris it Are we are we able to
(16:06):
adopt a, that iterative processon so we were talking about
validation? 4.0 and pharmaperformed pretty well, right? So
really continuous manufacturingchain, right, which is different
than 15 years ago, where it wasa discrete set tasks? Does that
make sense?
Unknown (16:27):
Indeed, and I think a lot of that comes down to a lot
of what's been discussed heretoday, by some good speakers,
like, what is our decisionmaking process? What is the
risk? So you know, we have tosay, well, if I'm making
something those a treatment fora year person, especially in the
(16:47):
ATMP, sort of space, where it isliterally the only treatment
with someone that's dying, orwhat is the risk of
Dori Gonzalez-Acevedo (16:54):
greater they're gonna die or not.
Anyway, right. Yeah, exactly.
Yeah.
Unknown (16:59):
So that some of that is around the risk and the decision
making, right when talking totalking about, and then some of
it needs to be, you know, so Sowhat's so bad about failing?
Great question about
Dori Gonzalez-Acevedo (17:12):
learning.
Yeah. So that's giving up thebeing perfectionist, which I'll
talk about tomorrow, and myauthentic leadership, that sort
of thing, right is giving upthat we always have to get it
right all the time, right. Andas part of the quality mindset
that perhaps needs to be setaside and failing first failing
fast is was is regular for likesoftware development, but we
(17:33):
need to actually embed that intoeverything. Right.
Unknown (17:38):
But as you say, is fundamental to the whole
production process. When we dopharmaceutical design. Yeah, as
per ich, QQ Q eight, you know,we're there right up again,
during the world do we usefinding our edge? Yeah, no, you
shouldn't just stop there, rightnow. informs the process process
(17:59):
going forward. But I think wejust need to be more cognizant
of risk. Yeah, more things.
Actually.
Dori Gonzalez-Acevedo (18:06):
I thought it was interesting this morning.
What James Mason was talkingabout the hand sanitizers, did
you did you hear that? Oh, youdidn't see that part. So the FDA
saw that the the in the warningletters and things around the
hand sanitizers went up becauseeveryone was trying to get hand
sanitizers out during thevaccines, right. But there was a
lot of knockoffs that was beingdone and not being tested
(18:29):
properly. And it just highlightsthe fact that risk constantly
has to be reevaluated. Right?
Because it's something like thatwe couldn't have anticipated
before. But then it's just avery good way to say, yeah, it's
a constant looking at risk,right? So not just doing a risk
assessment from the very onetime it's done. It's not that
(18:50):
it's this constant living sortof breathing thing. One of my
pet peeves around requirements,specifications, right, is that,
you know, folks want to takethis requirements specification
and put it in a dock managementsystem and think that it's done.
Requirements are living, right.
(19:10):
We all you know, designers andengineers understand that, like
that's constantly evolving. Andpart of that is looking at the
risk each and every time thatwe're doing something.
Unknown (19:21):
Yeah. And I think digitization is going to help us
out as well, because we're goingto have much more advanced
process controls in place,especially if where companies
are, you know, definitely, youknow, we saw in one of the ISP
polls at that moment, that therewas done recently there was a
survey by the CQ cop, and moreand more companies are looking
(19:43):
towards digitalization and Ithink that helps with the
constant assessment risk,because you're able to use pap
technologies to say, or thisattribute isn't quite right at
this step, even if it is acontinuous process. What can we
do maybe then to have just thatprocess. And maybe that's where
machine learning comes in. If wecan build up all these
(20:06):
technologies on top of eachother, we get a much more
dynamic and a much strongercontrol strategy that then
allows us to make
Dori Gonzalez-Acevedo (20:14):
good decisions. Yeah. And along those
lines, I didn't know I couldimagine. And when you're you're
implementing NEET for acustomer. Similar is you're,
you're looking at their businessprocess to kind of align some of
those data points, right, sothat they're not totally
whatever they think, right?
You're trying to help them guidethem towards standardizing their
data to not just implementing asystem, right? Because it's more
(20:39):
than just implementing a system,it's actually standardizing
their data so that they can makemeaning of that data as they go
along. Because if we don't dothat process, right, if we don't
go through and have thatstandardization, we can't make
any further predictions oranalysis. Right. Yeah.
Unknown (20:57):
And I think that's, that's a great challenge for the
future as well. How do you getall of these systems talking to
each other in a standardlanguage without this need for
middleware to convert?
Dori Gonzalez-Acevedo (21:08):
Yeah, I know, we were talking about this
on the the ISP subcommittee thatwe're on, right, like that is
like the ideal, right, like howto do that. And part of my, you
know, lessons learned over thelast 15 years is is, you know,
companies ask for lots ofthings. But as a consultant,
they might not be asking for theright thing. And there's a way
(21:31):
that we can to given that we seea lot and a lot of different
varieties out there. Beingconsultants, we can actually
help standardize the industrybetter if we do that
collectively. And so that's oneof the things I love about the
ISP subcommittees as well as inyou know, connects like this,
right, we work collaborate onwhat are the best industry
practices? What do we want tomove forward? One of the things
(21:54):
I was thinking about when youwere sharing also with the next
generation coming in? is datascience in general. Any thoughts
about that?
Unknown (22:03):
Yeah, I think data analytics and data sciences,
this is going to become more andmore of a growth need within the
industry. Which is why, youknow, it's great to get the
things like meat in Irishuniversities level. So they know
that these the systems arecapable of doing these things.
We have a very good partnership,actually, with a data analytics
(22:25):
company as part of vector. So wesee that strategically being
like definitely a growth sort ofthing within vector as well. But
yeah, making sense of datacontent, contextualizing the
data, and making decisions ofthat data, and improving, you
know, is this the right theright data? Because statistics
(22:46):
can lie.
Dori Gonzalez-Acevedo (22:47):
Bridge rates? Exactly. Yeah, you can
pick and choose poorly.
Unknown (22:53):
I've had very blended career, I've been very blessed
that, I guess that way, I spendhalf of my life in medical
devices, which is verystatistically based, yeah. And
then a lot of time in biotech,and then steroids, etc. So, you
know, having that statisticalbase, as you say, you get to
challenge the data, you know,so, you know, if I have data,
(23:18):
which looks great, but it's notnormal, you know, yeah. What's
that really telling? Yeah,that's right. You've got to have
some, you know, generalpresumptions about that data.
Yeah, or assessment of the data.
So I think data's gonna become ahuge thing in the future,
especially when we're looking atthings like real time release,
especially with things liketechnologies like ATMP is when
(23:40):
you're going to want that realtime release to give it to a
patient.
Dori Gonzalez-Acevedo (23:46):
Yeah.
Yeah. Awesome. Are there otherthings that you want to touch on
while we have time today? Plansfor the future things that
things that you
Unknown (23:58):
plans for the future? I think, you know, I'm learning a
lot. I think the great thingabout the consultancy is that
you're learning something newevery single day at the moment.
I'm really excited about thefuture, the partnership with
neat, especially as their newversion 9.0 goes on. And there's
(24:19):
much more powerful, powerfulfunctionality to connect to
other systems and create thatdigital weak eco structure that
we're talking about. But reallyexcited to be at the event
today. And actually, you know,talking to people
Dori Gonzalez-Acevedo (24:36):
I know.
Yeah, it was. I was at s QA acouple of weeks ago, and it was,
like 800 people, and it was alot of people came out because
it was the first time was fullin person and really enjoying in
community. Right. And one of thethings I think you said earlier
around the connects communitywas we're trying to build more
support structure for everyone.
(25:00):
For us, you know, whereveryou're at within your career,
right, so folks like yourself,and I can come in and help guide
folks from the very beginning,give them some questions space
to ask questions. And, and thenwith the FDA here as well, we've
gotten great representation fromfrom the FDA. So
Unknown (25:18):
the thing that I would say is I'm not I'm very positive
about the future as well,because, you know, we're hiring
a lot of new engineers tosupport our growth in Ireland.
And what we're finding is we'rerecruiting especially at a
junior level, definitely peopleyounger generation or myself,
(25:39):
yes. Yeah. And, you know, butthey're so bright, especially
when it comes to digitalsystems. Yeah. They're teaching
me things. Yeah.
Dori Gonzalez-Acevedo (25:50):
They're digital natives. Right. And so
that's where they really grewup. And I am I'm, the ideas that
they have are amazing, right.
And so my hope is to be able toremind folks of our generation
to listen to them.
Unknown (26:08):
You can learn amazing things off. Yes. Yeah,
absolutely. Well, thanks, Phil,I
Dori Gonzalez-Aceved (26:12):
appreciate your time today.
Unknown (26:14):
I really appreciate you for having me. And it's great to
see you in person, rather thanjust Oh, yeah,
Dori Gonzalez-Acevedo (26:19):
it's absolutely. Alright. Well, I
have to come over to Irelandsoon.
Unknown (26:22):
Oh, definitely.
Invited. Yeah, it's locked in.
As long as you like Guinness andyou like the rain.
Dori Gonzalez-Acevedo (26:27):
It's good. It's very good. All right.
Well, back to the show here.
Thanks.
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