December 11, 2022 • 23 mins
As we wrap up a very successful week at the highly attended KENX Computer Systems Validation and Software Assurance University conference in Philadelphia, PA, we are joined by James Northup from Tricentis. Dori Gonzalez-Acevedo sat down to discuss some key takeaways from the event for those unable to attend in person and recap some of the highlights from presentations promoting change in our industry, spanning CSV, gender equality and more.
Join us for this great conversation and don't forget to rate and subscribe wherever you listen to podcasts!
You can reach out to connect with James on LinkedIn here.
For more click on Don McPherson's work with Aspirational Masculinity and Alexander Prout and I Have the Right 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.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Dori Gonzalez-Acevedo (00:00):
Welcome to the stage, James Northrup
(00:04):
from tricentis. We are here onthe last day of day three of
connects CSV CSA University inPhiladelphia.
Unknown (00:13):
Thank you for having me. Appreciate it. Yeah, it's
been a it's been an awesome timehere learning a bunch, getting
some nice exposure to theupdates that are coming around
the industry and happy to besitting down with you.
Dori Gonzalez-Acevedo (00:21):
Awesome.
Thanks. I you know, I appreciateyou taking the moment to do
that. Because I find theserecaps helpful to folks, for
those that have been on thephone, it's still a hybrid
event, it's trying to captureeverything that's going on is
hard for those that a remote.
The people that are here inperson actually have really long
days too. So that's even moreexhausting. And trying to
(00:44):
summarize or kind of recap whatit is what we've been doing.
happens here
Unknown (00:49):
in Philadelphia, I can X what do we actually do here?
Yeah, um, so we've been doing abunch of events, or a bunch of
meetings and sitting down andlearning about, you know,
presentations and whatnot. But Iwanted to get your feedback on
what you thought some of the keyhighlights were and takeaways
from the CSA CSB connectspresentation in 2022.
Dori Gonzalez-Acevedo (01:08):
That's great, because I think what was
most exciting to me, what we sawwas, first attendance was huge
and person, right. So for thoseon the phone or listening in,
this was the largest in personevent that connects had this
year, very well attended alsovirtually in addition to that,
and part of that I see as thecourse of 2022 was more
(01:33):
participation, more wanting toreach out and understand what's
going on. At the conferenceitself, lots of questions about
the draft guidance that cameout. We had Cisco and members of
his team here. And part of thatconversation continues to be
what do we do with it?
Unknown (01:51):
How do we move forward?
And make sense of it?
Dori Gonzalez-Acevedo (01:55):
Make sense that what am I doing,
quote unquote, right or wrong?
And I think so part of thethat's kind of been the trend in
2022, asking a lot of questions.
And so what I think I'm we'releft leaving here, or at least
my hope, of what we're leavinghere with is a sense of question
(02:15):
asking is a good thing.
Unknown (02:17):
Yeah, absolutely. And I think just to kind of double
down on that, you know, where itconnects and the quality of
participant that's here isdifferent than other conferences
I've been to, it's veryspecific. If you're in the CSA,
CSP space, and you're not atclinics. You know, it's
something you should definitelycome out to and get a better
(02:37):
experience for. So I guess,speaking of asking the right
questions, how do you feel thatthat it's being received? How do
you feel that the transition toCSA and CSV is being adopted, I
guess, throughout the industry,or at least as of now,
Dori Gonzalez-Acevedo (02:53):
yeah. So interesting in the words that
you chose, because so one of thethings we did differently
connects this year was we alsobrought as our keynote speakers,
Don McPherson and Alex Prouthere to talk about gender
equality. Thank you. And now, Ithat also was extremely well
received. And the feedback wegot was great, as is a
(03:13):
conversation that needs to behad. And I draw parallels of
that conversation around how andwhat bringing more equality to
the rooms is around the conceptof change, right? Like, we in
the industry here, in some waysare broken. And we need to do
(03:34):
some reparations. Sure. So justaround, you know, women's rights
and equality, we reparationsand, and leveling the table
table needs to happen. You wantpeople to the conversation just
in general. Exactly. Bringingmore people to conversations. So
in because we want to move theindustry forward, we need to
have some of these hardconversations. So what works,
(03:55):
what doesn't work? What is risk?
What is not risky? You know,and, and how to cultivate that
in a way to hear everyone'sperspectives at the table.
Unknown (04:07):
Exactly. And I mean, at the end of the day, it's about
having the actual conversations,whether it's, it's business or
personal relationships, orhowever it is, you have to have
the conversation, you have toexplore it, and it can't be one
sided. It has to be an actualgiven taken. You're trying to
find a consensus at the end ofthe day, what works best for
everyone included in thatconversation. Yeah,
Dori Gonzalez-Acevedo (04:25):
you're 100% Right. And I think that's,
I know, part of your style, aswell as always to get to know
the other play, and I do that,as you know, as we've also co
sold and help folks out is it'sthere's no one size fits all for
anything. 100% right. And it'sreally trying to navigate those
(04:45):
conversations so that the trueunderstanding of intended use
and business use cases and andeven the team makeups that folks
have matter and terms of whatbusiness processes you're going
to put in place or not put inplace? Or what tools you're
going to purchase or notpurchase? Or what skill sets
(05:07):
does your people need now, andmoving forward versus what they
had before?
Unknown (05:13):
What do you say? It's what people process,
Dori Gonzalez-Aceve (05:15):
technology, and most importantly, culture?
Absolutely. And so a lot of theconversations are here around
the room this week is aroundchanging that culture. And so
there's some fundamental thingsthat we need to do to do that.
Unknown (05:32):
Absolutely. So as we kind of transition into 2023,
from 2022. And, you know, whatare some of the things that are
exciting you from, from anindustry standpoint, from an
operational standpoint, from aninterpersonal relationship
standpoint? What are kind ofwhat are you looking for on the
horizon?
Dori Gonzalez-Acevedo (05:49):
So inspiring, regular routine
conversations withaccountability. So one of the
workshops yesterday, and womenleading validation that we did
was really truly to try to findwhat it is for our, our personal
goals and objectives are, right,and how that translates to our
(06:10):
teams or their larger parts thatwe influence on a day to day
basis. And then the last ask iswhat is our organizations need
to do to help us get there? Andso for as if you're an
individual contributor, as partof a team, you might need to
figure out how to ask for whatyou want to do. And you've heard
these cool things that connectsand I want to try this, and I
want to try that, rather thanhaving this big, heaviness
(06:33):
around, oh, we have to do thisbig organizational change
management thing. We're talkingabout like small, let's try
something different. Short,
Unknown (06:41):
how do you think that's the best way to approach that
conversation with your seniorleadership? If you're trying to
just move the needle a tiny bit,right, you're not trying to
revolutionize how you're goingabout everything, but how do you
think is the best way to startthat conversation?
Dori Gonzalez-Acevedo (06:51):
That's great. I think the bottom line
is just coming back from thisconference and asking for a
meeting and saying, I'm reallyexcited about what I heard. Make
it short, simple, two or threethings and what is the ask that
you have of your boss orsupervisor, whoever to be able
to say, can I put you inconnection to so and so? Or can
we bring in someone so toeducate whatever that is? It's a
(07:15):
simple ask, most of us justdon't ask.
Unknown (07:18):
Yeah, I mean, I think it's funny. Um, you know, the
people here at Connects arenormally a little more leaning
into the industry leaning intochange, leaning into the sort of
things. The industry as a whole,though, I'd say, or not leaning
into these things and stuff likethat. So the champions that are
at Connects need to be championsin their internal business as
well, because 20 years has goneby and no one's ever come to
(07:40):
again, next, you know, doingcomputer systems validation,
right? It's right. It's juststarting that conversation.
Yeah. So what do you think arethe big changes from an
organizational standpoint, withmed device pharmaceutical
companies in the CSP? Space? Iguess?
Dori Gonzalez-Acevedo (07:53):
That's a That's a good question. Because
I think it when folks arestarting to now implement more
advanced technologies in termsof AI and machine learning, and
companies that had not beendeveloping software as a medical
device previously, that are thatare starting to because of the
necessity of the change of theindustry, in general, I think we
(08:15):
have a very good opportunity tospread our wings a little bit,
be a little bit more flexible,to get to the rapidness of the
the amount of release and changethat we're actually practically
seeing in the world. So, youknow, historically, I think we
were seeing, you know, oh, maybea major upgrade every other year
(08:39):
or something like that. Right.
But what we're actually seeingin the software as medical
device and medical device areais, is those type software
changes are happening weekly.
Absolutely. So it's a shift fromthis big, you know, kind of
corporate enterprise levelrelease management once a
quarter or once every half year,
Unknown (08:59):
once a quarter. That's aggressive. That's typical,
though.
Dori Gonzalez-Acevedo (09:03):
So once a quarter, that's sap that shows,
right so there is rapiddeployments in it, but we're
actually seeing shorter andshorter release cycles. And in
order to get to shorter, shorterrelease cycles, you have to
fundamentally change your CSPprocess into a more agile
methodology.
Unknown (09:20):
So do you think now in my time working with you and me,
I've heard CSA, I've heard theconversations about shifting and
testing first and more often. Doyou think we're at the precipice
yet where we're actually goingto get some change? Or do you
think people are D fearing thisconcept a little bit or so?
Dori Gonzalez-Acevedo (09:37):
It's interesting. That was another
topic down and I've shared somethoughts around around this
concept of fear. And it's not Idon't think we have to get rid
of the fear. Yeah, I think weneed to have a healthy respect
of what that fear is, andunderstand the obstacles and
mindsets that have left us stuckin that Fear, rather than giving
(10:01):
us an opportunity to try a newtechnique or try a new tool, and
I think I've spoken this in thepast on podcast, but you know,
being a scientist is is part ofconstantly questioning things
for me, and that's who I am. ButI think also for us as humans,
we've forgotten to be curioushere.
Unknown (10:21):
Yeah, that was the one thing curious, cautious, you
know, methodical about yourapproach. And test it? You know,
like you said, you're ascientist, right? That's the
whole entire foundation istesting does it work?
Dori Gonzalez-Acevedo (10:32):
So there's a fundamental part. And
I think Donna was even talkingabout, like, you know, from
young men to adult men, we'vemissed out the opportunity for
the fun piece. We've lost thefun, we've lost the curiosity,
we've lost the playfulness.
Sure. And we you know, so if wecan do that, and translate that
to all these new techniques thatwe heard about for the last
(10:55):
three days, try one pick one outdoesn't have to be all of them,
just one to try something new.
Unknown (11:01):
And it doesn't have to be something that is potentially
could have these massiveramifications, you don't that
you know, you can implementsomething on a small scale, and
then grow it from there and seethat it actually works. So as
far as to go back to Dan'spresentation, and then Alex, you
know, so what happens fromthere? Right. So I know that
when the conversation ended, itwas definitely got some awesome
(11:24):
feedback. But what are the nextsteps for people that want to
hear more about it? And, youknow, continue to expand this
conversation?
Dori Gonzalez-Acevedo (11:29):
Yeah. So anyone that is wanting to bring
in Don and Alex into theirorganization to have these
conversations around genderequality, we can set up meetings
and schedules for that's theeasy ask. I think the the big
ask is also within our connectscommunity to start advancing
(11:49):
other alliances in 2023. So toexpand, that is one of the top
agenda items for us. I believe
Unknown (11:58):
there's a pledge you can take online, there's a
pledge for I have a right
Dori Gonzalez-Acevedo (12:01):
to you can take online. And so you can
reach out to that I have I havea right to.org And reach across
the aisle get to know someone,these three days have been such
rich conversations. Yeah. Haveyou been having those?
Unknown (12:19):
Absolutely. I mean, just across the board, whether
it's, you know, companies thatare, you know, full blown, you
know, either using oursolutions, or automated from
their companies that are onpaper, or, you know, just been,
you've been able to just talk,you know, without having the
stigma of, hey, this guy's insales, and he's going to try and
sell you something, it's like,just talk, you know, at the end
(12:40):
of the day, this is such acomplex thing that we're working
through. So you actually have tolay options on the table, you
have to discuss and kind of findout the best way of what might
make sense for you. And it mightbe a bimodal approach. It might
be implementing differentmethodologies or whatever it
might be, but until you kind ofkick the tires, how you're just
(13:01):
going to do what you know best.
Right? Yeah. So. So as we kindof wrap up kennix. And what's on
the docket for you leading intothe new year? Obviously, we have
holidays coming in, butPriscilla Rex is off and running
right now. So
Dori Gonzalez-Acevedo (13:16):
yeah, so we're planning our schedules are
talking schedules or road tripshows, for 2023. As Prasad
works, we are offering supply ofwide variety things to support
our partners, like yourself aswell, because having these
conversations often you needthat facilitator to do that,
(13:36):
right. And so bridging the gapof terminology across the QA
department versus the ITdepartment versus the business
unit. And so I'm really excitedabout that, and bringing those
conversations to the table in2020.
Unknown (13:49):
So let's say that I'm somebody that is, you know,
listening to the podcast, I'minterested in hearing more and
understanding how I couldpotentially, you know, implement
some new things in my businessprocesses. But I don't
necessarily come mechanics. Idon't necessarily dive in what
are some ways that I can kind ofexpose myself to the new
thinking and new processes andmethodologies? Or what would you
say would be a good way to kindof dip my toe in? I guess?
Dori Gonzalez-Acevedo (14:11):
That's good. There's lots of ways to do
that. So there's, not only isthere connects, there's ISP II
is a great organization to dothat. And there's software
quality assurance as QA that isthere. There's several of those
sorts of networking things. TheFDA also puts out a lot of
position papers on theirwebsite. And they are doing
(14:35):
running more webinars themselvesas they are educating and
training their investigators. SoI think that's really awesome. I
know Cisco and his team arewilling to come into
organizations and give thingtalks. So it's kind of using a
multi prong approach to getthose things there is. In
(14:55):
addition, there's onlinecommunities too, that LinkedIn
is a great one. way to do thatwe have women in CSV, which is a
private LinkedIn group thatwe've grown over, I think it's
we're now over at a women withinlike six or seven years, and
which is outstanding, the womenleading validation group within
(15:16):
connects is the other butthere's others out there to
engaging in dialogue. Andonline, you'll see a lot of
questions in some of the biggroups. There's like GAMP
groups, and there's othergroups, which are like, 1000s of
people belong to these groupsand posing questions or, or
pondering things
Unknown (15:36):
this community is open.
Like, I don't know, if peopleunderstand that, you know, you
can ask a question. The wholeprocess is very opinion based in
a certain way. But you can askquestions, and people will give
you their honest feedback abouthow they're going about this,
how they're accomplishing thesesorts of things. And even to
that point, I mean, I have a tonof experience talking with
Cisco, and specifically the FDA,but to see them sitting front
(15:58):
row, answering questions,speaking with Louis and, and so
on, and so forth. And reallyinterjecting based on how they
intended this to be written andtaken. So yeah, my takeaway was,
the FDA is ready to have theconversation they want
Dori Gonzalez-Acevedo (16:15):
to they have been and so it's, they're
always the position is to becollaborative. And so I get back
to what we were talking about alittle bit ago, it's the ask,
you just need to ask. And often,that asked seems more
terrifying, because you don'twant to know what the what the
what the response is, or maybeyou already know what the
(16:36):
response is, but you haven't yetgotten your organization to get
there. And so it seems like areally hard thing to overcome.
But incremental, small changes,right? Like, really do have that
ripple effect, right? You canalways do the big, dropping the
big stone in the pool and go atfull full force. But that also
(17:00):
has a different ripple effect.
And then how to support that.
But when it comes down to timeis our finite thing. And with
that time is is also the limitof our resources, and our people
capital. And we need to investmore in our people.
Unknown (17:18):
Absolutely. I mean, in the companies that are sending
their people here, to thisconference and conferences, I
like to sit in on these 45minute sessions that we're, you
know, we're talking with some ofthe biggest companies in the
world that are exposing how theyhave transformed their
processes, how they approach thedocumentation and how they
approach their theirmethodologies. And then chiming
(17:40):
in and dispelling myths orwhatever it might be, it's been
really eye opening for me ingeneral, it's good to get a feel
for that. But kudos to companiesthat have people out here,
Dori Gonzalez-Acevedo (17:49):
could you would you mind reflecting a
little bit on Don and Alex'stalk and how that impacted you?
Yeah, man.
Unknown (17:56):
Yeah, I mean, so, you know, when I look around, and
I'm in rooms with people, andthroughout my whole entire life,
it's been a lot of man's workfor the majority. Right. And,
you know, I don't necessarilyhave the experience with, you
know, potentially, you know,excluding people just based on
(18:17):
their gender in a certain way,but I can feel it, you know, I
can look around and see it, andwhen you've, it's one of those
things, when you noticesomething, it's hard to not
notice something. So, yeah, Ithought it was I thought it was
genuine. I thought Alex spokeabout his daughter and the
experiences that she faced, Donbeing, you know, a former
college star and professionalathlete, you know, talking about
(18:40):
masculinity and how to who youare as a person. It was, yeah,
it was, it was definitelypowerful. It was an awesome
conversation. And, you know, Ithink it needs to happen more,
you know, make this moreinclusive in general. There's a
lot of there's a lot of brightladies here. I mean, I'm turning
around having conversations, andthese people have been in the
(19:00):
industry for 2030 years, andthey have a lot to say, and it's
valuable. So just need toconsistently have that
conversation and ask the rightquestions and whatever scenario
you're in. Yeah.
Dori Gonzalez-Acevedo (19:12):
Okay, well, I know we're have to break
down. start wrapping up. Iappreciate your time, James,
Unknown (19:17):
thank you for having me. Appreciate it. Yeah.
Dori Gonzalez-Acevedo (19:19):
Always good to see you in person.
Definitely. Uh, hopefully in2023. We'll get to see a lot
more people in person. Oh,
Unknown (19:25):
yeah. I'm all for the events. Let's get out. Let's
talk. Let's ask questions andkeep moving forward. Awesome.
Thanks for having me. Thanks.
Welcome to the stage, James Northrup
(00:04):
from tricentis. We are here onthe last day of day three of
connects CSV CSA University inPhiladelphia.
Unknown (00:13):
Thank you for having me. Appreciate it. Yeah, it's
been a it's been an awesome timehere learning a bunch, getting
some nice exposure to theupdates that are coming around
the industry and happy to besitting down with you.
Dori Gonzalez-Acevedo (00:21):
Awesome.
Thanks. I you know, I appreciateyou taking the moment to do
that. Because I find theserecaps helpful to folks, for
those that have been on thephone, it's still a hybrid
event, it's trying to captureeverything that's going on is
hard for those that a remote.
The people that are here inperson actually have really long
days too. So that's even moreexhausting. And trying to
(00:44):
summarize or kind of recap whatit is what we've been doing.
happens here
Unknown (00:49):
in Philadelphia, I can X what do we actually do here?
Yeah, um, so we've been doing abunch of events, or a bunch of
meetings and sitting down andlearning about, you know,
presentations and whatnot. But Iwanted to get your feedback on
what you thought some of the keyhighlights were and takeaways
from the CSA CSB connectspresentation in 2022.
Dori Gonzalez-Acevedo (01:08):
That's great, because I think what was
most exciting to me, what we sawwas, first attendance was huge
and person, right. So for thoseon the phone or listening in,
this was the largest in personevent that connects had this
year, very well attended alsovirtually in addition to that,
and part of that I see as thecourse of 2022 was more
(01:33):
participation, more wanting toreach out and understand what's
going on. At the conferenceitself, lots of questions about
the draft guidance that cameout. We had Cisco and members of
his team here. And part of thatconversation continues to be
what do we do with it?
Unknown (01:51):
How do we move forward?
And make sense of it?
Dori Gonzalez-Acevedo (01:55):
Make sense that what am I doing,
quote unquote, right or wrong?
And I think so part of thethat's kind of been the trend in
2022, asking a lot of questions.
And so what I think I'm we'releft leaving here, or at least
my hope, of what we're leavinghere with is a sense of question
(02:15):
asking is a good thing.
Unknown (02:17):
Yeah, absolutely. And I think just to kind of double
down on that, you know, where itconnects and the quality of
participant that's here isdifferent than other conferences
I've been to, it's veryspecific. If you're in the CSA,
CSP space, and you're not atclinics. You know, it's
something you should definitelycome out to and get a better
(02:37):
experience for. So I guess,speaking of asking the right
questions, how do you feel thatthat it's being received? How do
you feel that the transition toCSA and CSV is being adopted, I
guess, throughout the industry,or at least as of now,
Dori Gonzalez-Acevedo (02:53):
yeah. So interesting in the words that
you chose, because so one of thethings we did differently
connects this year was we alsobrought as our keynote speakers,
Don McPherson and Alex Prouthere to talk about gender
equality. Thank you. And now, Ithat also was extremely well
received. And the feedback wegot was great, as is a
(03:13):
conversation that needs to behad. And I draw parallels of
that conversation around how andwhat bringing more equality to
the rooms is around the conceptof change, right? Like, we in
the industry here, in some waysare broken. And we need to do
(03:34):
some reparations. Sure. So justaround, you know, women's rights
and equality, we reparationsand, and leveling the table
table needs to happen. You wantpeople to the conversation just
in general. Exactly. Bringingmore people to conversations. So
in because we want to move theindustry forward, we need to
have some of these hardconversations. So what works,
(03:55):
what doesn't work? What is risk?
What is not risky? You know,and, and how to cultivate that
in a way to hear everyone'sperspectives at the table.
Unknown (04:07):
Exactly. And I mean, at the end of the day, it's about
having the actual conversations,whether it's, it's business or
personal relationships, orhowever it is, you have to have
the conversation, you have toexplore it, and it can't be one
sided. It has to be an actualgiven taken. You're trying to
find a consensus at the end ofthe day, what works best for
everyone included in thatconversation. Yeah,
Dori Gonzalez-Acevedo (04:25):
you're 100% Right. And I think that's,
I know, part of your style, aswell as always to get to know
the other play, and I do that,as you know, as we've also co
sold and help folks out is it'sthere's no one size fits all for
anything. 100% right. And it'sreally trying to navigate those
(04:45):
conversations so that the trueunderstanding of intended use
and business use cases and andeven the team makeups that folks
have matter and terms of whatbusiness processes you're going
to put in place or not put inplace? Or what tools you're
going to purchase or notpurchase? Or what skill sets
(05:07):
does your people need now, andmoving forward versus what they
had before?
Unknown (05:13):
What do you say? It's what people process,
Dori Gonzalez-Aceve (05:15):
technology, and most importantly, culture?
Absolutely. And so a lot of theconversations are here around
the room this week is aroundchanging that culture. And so
there's some fundamental thingsthat we need to do to do that.
Unknown (05:32):
Absolutely. So as we kind of transition into 2023,
from 2022. And, you know, whatare some of the things that are
exciting you from, from anindustry standpoint, from an
operational standpoint, from aninterpersonal relationship
standpoint? What are kind ofwhat are you looking for on the
horizon?
Dori Gonzalez-Acevedo (05:49):
So inspiring, regular routine
conversations withaccountability. So one of the
workshops yesterday, and womenleading validation that we did
was really truly to try to findwhat it is for our, our personal
goals and objectives are, right,and how that translates to our
(06:10):
teams or their larger parts thatwe influence on a day to day
basis. And then the last ask iswhat is our organizations need
to do to help us get there? Andso for as if you're an
individual contributor, as partof a team, you might need to
figure out how to ask for whatyou want to do. And you've heard
these cool things that connectsand I want to try this, and I
want to try that, rather thanhaving this big, heaviness
(06:33):
around, oh, we have to do thisbig organizational change
management thing. We're talkingabout like small, let's try
something different. Short,
Unknown (06:41):
how do you think that's the best way to approach that
conversation with your seniorleadership? If you're trying to
just move the needle a tiny bit,right, you're not trying to
revolutionize how you're goingabout everything, but how do you
think is the best way to startthat conversation?
Dori Gonzalez-Acevedo (06:51):
That's great. I think the bottom line
is just coming back from thisconference and asking for a
meeting and saying, I'm reallyexcited about what I heard. Make
it short, simple, two or threethings and what is the ask that
you have of your boss orsupervisor, whoever to be able
to say, can I put you inconnection to so and so? Or can
we bring in someone so toeducate whatever that is? It's a
(07:15):
simple ask, most of us justdon't ask.
Unknown (07:18):
Yeah, I mean, I think it's funny. Um, you know, the
people here at Connects arenormally a little more leaning
into the industry leaning intochange, leaning into the sort of
things. The industry as a whole,though, I'd say, or not leaning
into these things and stuff likethat. So the champions that are
at Connects need to be championsin their internal business as
well, because 20 years has goneby and no one's ever come to
(07:40):
again, next, you know, doingcomputer systems validation,
right? It's right. It's juststarting that conversation.
Yeah. So what do you think arethe big changes from an
organizational standpoint, withmed device pharmaceutical
companies in the CSP? Space? Iguess?
Dori Gonzalez-Acevedo (07:53):
That's a That's a good question. Because
I think it when folks arestarting to now implement more
advanced technologies in termsof AI and machine learning, and
companies that had not beendeveloping software as a medical
device previously, that are thatare starting to because of the
necessity of the change of theindustry, in general, I think we
(08:15):
have a very good opportunity tospread our wings a little bit,
be a little bit more flexible,to get to the rapidness of the
the amount of release and changethat we're actually practically
seeing in the world. So, youknow, historically, I think we
were seeing, you know, oh, maybea major upgrade every other year
(08:39):
or something like that. Right.
But what we're actually seeingin the software as medical
device and medical device areais, is those type software
changes are happening weekly.
Absolutely. So it's a shift fromthis big, you know, kind of
corporate enterprise levelrelease management once a
quarter or once every half year,
Unknown (08:59):
once a quarter. That's aggressive. That's typical,
though.
Dori Gonzalez-Acevedo (09:03):
So once a quarter, that's sap that shows,
right so there is rapiddeployments in it, but we're
actually seeing shorter andshorter release cycles. And in
order to get to shorter, shorterrelease cycles, you have to
fundamentally change your CSPprocess into a more agile
methodology.
Unknown (09:20):
So do you think now in my time working with you and me,
I've heard CSA, I've heard theconversations about shifting and
testing first and more often. Doyou think we're at the precipice
yet where we're actually goingto get some change? Or do you
think people are D fearing thisconcept a little bit or so?
Dori Gonzalez-Acevedo (09:37):
It's interesting. That was another
topic down and I've shared somethoughts around around this
concept of fear. And it's not Idon't think we have to get rid
of the fear. Yeah, I think weneed to have a healthy respect
of what that fear is, andunderstand the obstacles and
mindsets that have left us stuckin that Fear, rather than giving
(10:01):
us an opportunity to try a newtechnique or try a new tool, and
I think I've spoken this in thepast on podcast, but you know,
being a scientist is is part ofconstantly questioning things
for me, and that's who I am. ButI think also for us as humans,
we've forgotten to be curioushere.
Unknown (10:21):
Yeah, that was the one thing curious, cautious, you
know, methodical about yourapproach. And test it? You know,
like you said, you're ascientist, right? That's the
whole entire foundation istesting does it work?
Dori Gonzalez-Acevedo (10:32):
So there's a fundamental part. And
I think Donna was even talkingabout, like, you know, from
young men to adult men, we'vemissed out the opportunity for
the fun piece. We've lost thefun, we've lost the curiosity,
we've lost the playfulness.
Sure. And we you know, so if wecan do that, and translate that
to all these new techniques thatwe heard about for the last
(10:55):
three days, try one pick one outdoesn't have to be all of them,
just one to try something new.
Unknown (11:01):
And it doesn't have to be something that is potentially
could have these massiveramifications, you don't that
you know, you can implementsomething on a small scale, and
then grow it from there and seethat it actually works. So as
far as to go back to Dan'spresentation, and then Alex, you
know, so what happens fromthere? Right. So I know that
when the conversation ended, itwas definitely got some awesome
(11:24):
feedback. But what are the nextsteps for people that want to
hear more about it? And, youknow, continue to expand this
conversation?
Dori Gonzalez-Acevedo (11:29):
Yeah. So anyone that is wanting to bring
in Don and Alex into theirorganization to have these
conversations around genderequality, we can set up meetings
and schedules for that's theeasy ask. I think the the big
ask is also within our connectscommunity to start advancing
(11:49):
other alliances in 2023. So toexpand, that is one of the top
agenda items for us. I believe
Unknown (11:58):
there's a pledge you can take online, there's a
pledge for I have a right
Dori Gonzalez-Acevedo (12:01):
to you can take online. And so you can
reach out to that I have I havea right to.org And reach across
the aisle get to know someone,these three days have been such
rich conversations. Yeah. Haveyou been having those?
Unknown (12:19):
Absolutely. I mean, just across the board, whether
it's, you know, companies thatare, you know, full blown, you
know, either using oursolutions, or automated from
their companies that are onpaper, or, you know, just been,
you've been able to just talk,you know, without having the
stigma of, hey, this guy's insales, and he's going to try and
sell you something, it's like,just talk, you know, at the end
(12:40):
of the day, this is such acomplex thing that we're working
through. So you actually have tolay options on the table, you
have to discuss and kind of findout the best way of what might
make sense for you. And it mightbe a bimodal approach. It might
be implementing differentmethodologies or whatever it
might be, but until you kind ofkick the tires, how you're just
(13:01):
going to do what you know best.
Right? Yeah. So. So as we kindof wrap up kennix. And what's on
the docket for you leading intothe new year? Obviously, we have
holidays coming in, butPriscilla Rex is off and running
right now. So
Dori Gonzalez-Acevedo (13:16):
yeah, so we're planning our schedules are
talking schedules or road tripshows, for 2023. As Prasad
works, we are offering supply ofwide variety things to support
our partners, like yourself aswell, because having these
conversations often you needthat facilitator to do that,
(13:36):
right. And so bridging the gapof terminology across the QA
department versus the ITdepartment versus the business
unit. And so I'm really excitedabout that, and bringing those
conversations to the table in2020.
Unknown (13:49):
So let's say that I'm somebody that is, you know,
listening to the podcast, I'minterested in hearing more and
understanding how I couldpotentially, you know, implement
some new things in my businessprocesses. But I don't
necessarily come mechanics. Idon't necessarily dive in what
are some ways that I can kind ofexpose myself to the new
thinking and new processes andmethodologies? Or what would you
say would be a good way to kindof dip my toe in? I guess?
Dori Gonzalez-Acevedo (14:11):
That's good. There's lots of ways to do
that. So there's, not only isthere connects, there's ISP II
is a great organization to dothat. And there's software
quality assurance as QA that isthere. There's several of those
sorts of networking things. TheFDA also puts out a lot of
position papers on theirwebsite. And they are doing
(14:35):
running more webinars themselvesas they are educating and
training their investigators. SoI think that's really awesome. I
know Cisco and his team arewilling to come into
organizations and give thingtalks. So it's kind of using a
multi prong approach to getthose things there is. In
(14:55):
addition, there's onlinecommunities too, that LinkedIn
is a great one. way to do thatwe have women in CSV, which is a
private LinkedIn group thatwe've grown over, I think it's
we're now over at a women withinlike six or seven years, and
which is outstanding, the womenleading validation group within
(15:16):
connects is the other butthere's others out there to
engaging in dialogue. Andonline, you'll see a lot of
questions in some of the biggroups. There's like GAMP
groups, and there's othergroups, which are like, 1000s of
people belong to these groupsand posing questions or, or
pondering things
Unknown (15:36):
this community is open.
Like, I don't know, if peopleunderstand that, you know, you
can ask a question. The wholeprocess is very opinion based in
a certain way. But you can askquestions, and people will give
you their honest feedback abouthow they're going about this,
how they're accomplishing thesesorts of things. And even to
that point, I mean, I have a tonof experience talking with
Cisco, and specifically the FDA,but to see them sitting front
(15:58):
row, answering questions,speaking with Louis and, and so
on, and so forth. And reallyinterjecting based on how they
intended this to be written andtaken. So yeah, my takeaway was,
the FDA is ready to have theconversation they want
Dori Gonzalez-Acevedo (16:15):
to they have been and so it's, they're
always the position is to becollaborative. And so I get back
to what we were talking about alittle bit ago, it's the ask,
you just need to ask. And often,that asked seems more
terrifying, because you don'twant to know what the what the
what the response is, or maybeyou already know what the
(16:36):
response is, but you haven't yetgotten your organization to get
there. And so it seems like areally hard thing to overcome.
But incremental, small changes,right? Like, really do have that
ripple effect, right? You canalways do the big, dropping the
big stone in the pool and go atfull full force. But that also
(17:00):
has a different ripple effect.
And then how to support that.
But when it comes down to timeis our finite thing. And with
that time is is also the limitof our resources, and our people
capital. And we need to investmore in our people.
Unknown (17:18):
Absolutely. I mean, in the companies that are sending
their people here, to thisconference and conferences, I
like to sit in on these 45minute sessions that we're, you
know, we're talking with some ofthe biggest companies in the
world that are exposing how theyhave transformed their
processes, how they approach thedocumentation and how they
approach their theirmethodologies. And then chiming
(17:40):
in and dispelling myths orwhatever it might be, it's been
really eye opening for me ingeneral, it's good to get a feel
for that. But kudos to companiesthat have people out here,
Dori Gonzalez-Acevedo (17:49):
could you would you mind reflecting a
little bit on Don and Alex'stalk and how that impacted you?
Yeah, man.
Unknown (17:56):
Yeah, I mean, so, you know, when I look around, and
I'm in rooms with people, andthroughout my whole entire life,
it's been a lot of man's workfor the majority. Right. And,
you know, I don't necessarilyhave the experience with, you
know, potentially, you know,excluding people just based on
(18:17):
their gender in a certain way,but I can feel it, you know, I
can look around and see it, andwhen you've, it's one of those
things, when you noticesomething, it's hard to not
notice something. So, yeah, Ithought it was I thought it was
genuine. I thought Alex spokeabout his daughter and the
experiences that she faced, Donbeing, you know, a former
college star and professionalathlete, you know, talking about
(18:40):
masculinity and how to who youare as a person. It was, yeah,
it was, it was definitelypowerful. It was an awesome
conversation. And, you know, Ithink it needs to happen more,
you know, make this moreinclusive in general. There's a
lot of there's a lot of brightladies here. I mean, I'm turning
around having conversations, andthese people have been in the
(19:00):
industry for 2030 years, andthey have a lot to say, and it's
valuable. So just need toconsistently have that
conversation and ask the rightquestions and whatever scenario
you're in. Yeah.
Dori Gonzalez-Acevedo (19:12):
Okay, well, I know we're have to break
down. start wrapping up. Iappreciate your time, James,
Unknown (19:17):
thank you for having me. Appreciate it. Yeah.
Dori Gonzalez-Acevedo (19:19):
Always good to see you in person.
Definitely. Uh, hopefully in2023. We'll get to see a lot
more people in person. Oh,
Unknown (19:25):
yeah. I'm all for the events. Let's get out. Let's
talk. Let's ask questions andkeep moving forward. Awesome.
Thanks for having me. Thanks.
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