Enjoy this awesome discussion with Rashmi R. Rao and Dori Gonzalez-Acevedo, as they unravel their journeys through entrepreneurship, innovation, and STEM advocacy in the dynamic world of healthcare technology.

Full of insights on leveraging technology to enhance lives, building impactful communities, and the vital role of diversity and leadership in shaping the future of healthcare and technology, they discuss:

-The transformative power of female empowerment in STEM.
-Crucial insights on integrating technology across diverse sectors.
-Strategies for scaling startups and navigating venture capital.
-The importance of community, health equity, and advocating for women's rights.
-Leadership philosophies and the art of building industry partnerships.
-The origin of the HLWF Alliance, and what they have in store for the future. 

This episode isn’t just a conversation; it’s a call to action for innovators, entrepreneurs, and advocates ready to make a mark.

*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

This episode was recorded live from the KENX Medical Device Validation University in Anaheim, CA! This time around, Jason Secola interviews your usual host, Dori Gonzalez-Acevedo to give a conference recap, as well as field some questions submitted by our LinkedIn audience.

Tune in as they dive into a variety of topics, not least of which is the world of AI and Software Quality in Medical Devices and the Life Sciences industry. Some key points discussed were the FDA's increasing approval of AI-powered devices, the importance of collaborative education, the criticality of developing a Quality by Design program, and the impact of diverse perspectives in the Life Sciences industry. 

Discover the keys to innovation, efficient processes, and nuanced risk management in this insightful conversation with Dori Gonzalez-Acevedo and Jason Secola. 

Share with a friend or colleague and subscribe wherever listen to podcasts!

*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

Dori Gonzalez-Acevedo Co-Founder & CEO of ProcellaRX welcomes Jacqueline Davidson, Owner of Davidson QA Consulting and Head of Regulatory Intelligence and Innovation at Sware, Inc to Software Quality Today.

Download now to listen to Jackie’s perspective on S.O.U.P, (Software of Unknown Providence) what is it and how can you leverage it within your organization.

Innovation is driven by scientists; they test the limits of their ideas as quick as possible to see what’s possible and vet out what’s not – one way to do that as efficiently as possible is with the use Open-Source technology/software rather than having to build their own.  As an industry we need to be able to shift to use S.O.U.P. where possible in order test our hypotheses and potentially save critical time to market as a competitive advantage. This often comes by using open-source technology but how can we if we don’t have ultimate control over that software?

S.O.U.P may not be a term you may not be familiar our guest today clarifies, puts it into perspective and how it could be utilized in a heavily regulated industry such as life sciences when it’s fit for purpose.
 
Sware LinkedIn

Sware Website 

*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

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.

This is a production of ProcellaRX

Recorded at the KENX GMP University in San Diego, Dori welcomes special guest and FDA Case For Quality Program Manager, Cisco Vicenty. They sit down together to to recap some important takeaways from the conference, as well as to discuss what is being done to enhance collaboration between the industry and regulators to help drive a shift in mindset and advance innovation in life sciences.

Please enjoy this special episode and don't forget to rate and subscribe!

Connect with Cisco on LinkedIn
Connect with Dori on LinkedIn

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

This is a production of ProcellaRX

Project management always has and always will be a crucial function in any organization. In life sciences, that function is changing. Project Managers need to adapt to ensure their teams continue to deliver successful projects in the face of a shifting technology and methodology landscape, while still ensuring compliance. Join us this episode for a fantastic interview with Project Manager extraordinaire, and Founder and CEO of MustardSeed, Steve Curry!

Steve Curry's LinkedIn
MustardSeed's LinkedIn
MustardSeed's Website

Steve Curry, PMP has a passion and calling to help lead projects, programs, teams, and businesses to tremendous success by increasing their maximum potential of operating efficiency through the utilization of program management best practices. He is equally passionate about communicating with clients when project risks and issues arise. It comes from Steve’s extensive experience and background in managing projects and programs of all sizes and his experience in finance, sales, business analysis, and management. Steve has had the benefit of working in PMOs in four different industries. Having spent nearly 20 years in the field, he has dedicated himself to collecting, organizing, compiling, and implementing today's best PM practices. Today Steve leads MustardSeed as Founder and CEO. MustardSeed provides project management services to life science companies.

*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

A risk-based approach to Computerized System Validation has been around for over 20 years, so what's the hype about CSA? Join us in this episode as we are joined by our amazing guest, Dr. Bob McDowall, to explore this question.

Bob McDowall is an analytical chemist with 50 years of experience including 15 years working in the pharmaceutical industry and 29 years as a consultant to the industry and suppliers to the industry. He has been involved with the validation of computerized systems for over 35 years and is the author of the second edition of a book on the validation of chromatography data systems published in 2017 and a book on data integrity for regulated laboratories in 2019.

Bob is the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns.  One such column in September 2021 was entitled Does CSA Mean Complete Stupidity Assured? It is available online at:
 https://www.spectroscopyonline.com/view/does-csa-mean-complete-stupidity-assured-

*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

Artificial Intelligence and Machine Learning are being used to great results in a variety of ways across numerous industries, but what does it mean for the Life Sciences industry? How can Life Sciences teams that want to stay on the cutting edge begin to practically incorporate AI/ML to drive better, more efficient results across their organizations?

If you're looking for answers, you've come to the right place. Give this podcast a listen to hear subject matter expert, Eric Staib, share his incredibly insightful and valuable thoughts on the topic.

*Disclaimer: Eric Staib participated in the podcast as an individual subject matter expert and contributor. The views and opinions he shares are not necessarily shared by his employer, Signant Health. Nor should any reference to specific products or services be interpreted as commercial endorsements by Signant Health.

*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

Dori welcomes long-time colleague and Sr. Manager of TCoE at Biogen, Ajay Pandey to the podcast. With extensive knowledge of application testing and software quality in Life Sciences, Ajay shares his insights on setting up a strategic Testing Center of Excellence framework, as well as the importance of incorporating risk-based testing.

Ajay is a Senior IT professional with over 19 years of progressive experience in management and governance of Application Lifecycle Management/SDLC toolsets in large Medical Device and Bio-Pharmaceutical space as well as a Certified Project Management Professional (PMP).

Give it a listen, and please don't forget to rate and subscribe wherever you get your podcasts.

*Disclaimer*: Ajay has agreed to participate in the Software Quality Today podcast as an individual subject matter expert. The views and opinions he shares are his own and are not necessarily shared by his employer, Biogen. Nor should any reference to specific tools or products be interpreted as commercial endorsements by Biogen.

*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

Dori is able to grab some time with Micro Focus SAP expert, Don Jackson.  From automating SAP, to process management, to streamlining maintenance of components and assets, Don has a variety of insights he shares based on his years of experience. In addition, he is able to share some extremely valuable tools that Micro Focus brings to the world of SAP testing/maintenance which help their clients in the realm of SAP and beyond.

General SAP testing questions? SolMan questions? S4HANA questions? Dori and Don cover it all, so tune it!

A bit more about Don: Don Jackson is an IT professional with 20+ years of experience delivering testing and quality initiatives.  Mr. Jackson is recognized in the IT Quality/Testing industry as a thought leader and has spoken at multiple conferences, webinars, seminars, and publications. Don is currently the Chief Technologist for ADM at Micro Focus.

Disclaimer: Don is appearing as an individual subject matter expert, and the views and opinions he shares are not necessarily shared by his employer, Micro Focus.

As always, please don't forget to rate and subscribe wherever you get your podcasts.

*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

In this episode, Dori sits down with fellow CSV and CSA guru Ken Shitamoto for some outdoor, morning coffee on the final day of the KENX Computer Systems Validation and Software assurance conference.

Together, they share their insights not only on CSV/CSA, but the overall state of software quality in Life Sciences and what we as industry professionals can do to collectively raise the bar as we move into 2022.

As mentioned in the episode outro, they discuss some recent comments from Cisco Vicenty where he discusses the current status of the CSA draft guidance. To further clarify, I wanted to direct you to the link below at about the 8:30 mark of the publicly available MDIC presentation recorded on December 8th in which Cisco elaborates on where the draft guidance currently is in the process.

View presentation here.

Thanks for tuning in and don't forget to subscribe wherever you get your podcasts to be notified whenever new episodes are released.

*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

Join us from a beach in San Diego, California, at the KENX Computer Systems Validation and Software Assurance conference. In this episode, Dori is joined by industry colleague and subject matter expert, Rohit Tyagi, President and CEO of Sagax Team.

They discuss some of the presentations and topics that have been covered at the KENX conference this year, as well as general thoughts, challenges, and successes that folks are currently experiencing related to CSV modernization and CSA adoption strategies.

Please listen to get all their insights, but please don't forget to rate and subscribe wherever you get your podcasts. Also, please reach out to Rohit and Sagax team via the LinkedIn profiles and URLs below:

Sagax Team Website: https://www.sagaxteam.com/
Rohit's LinkedIn: https://www.linkedin.com/in/247results/?miniProfileUrn=urn%3Ali%3Afs_miniProfile%3AACoAAACDuxYBeNHQ7o6FuO-IhNvldXFdFjGNUig 

*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

Welcome to another episode of Software Quality Today! On today’s show, Dori welcomes Natalie Kaminski.
 
Amongst other things, they chat about Natalie’s path from QA Tester to CEO of a technology company, and how her background in QA shaped her approach to launching and running a software development company.

With more than 20 years of experience in the technology industry, Natalie is a dynamic and resourceful web and mobile technology entrepreneur. She is the CEO and founder of JetRockets, a custom software, web and mobile application development company.
 
She is also the co-founder of OneTribe, an HR management platform for hybrid and remote teams. She lives in Brooklyn with her husband and two daughters.

Follow Natalie on LinkedIn here and reach out to let her know you listened! 

*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

In this quick episode following our attendance at the ISPE Annual Meeting and Expo, I sat down with our host, Dori Gonzalez-Acevedo, to do a bit of a post-conference wrap-up episode. We discuss some of the highlights of the conference relating to software quality, common themes we heard, issues that our industry needs to address, and the overall takeaways from the event.

Tune in to hear Dori's thoughts and don't forget to rate and subscribe where you get your podcasts!

*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

Join Dori as she interviews Lydia Castiallas, the Southeast Sales Leader for Enterprise Accounts at Micro Focus - but fear not, dear listeners! This is not a sales conversation or a sales pitch. Lydia brings a wealth of experience to the table and some valuable insights on the current state of IT, as well as important considerations for staying ahead in an ever-changing landscape.

Later in the conversation, they spend some time discussing the diversity and inclusion groups that Lydia is involved with at Micro Focus and elsewhere - a subject and pursuit that Dori shares a passion for.

This was a great episode, so give it a listen and don't forget to subscribe!

*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

Eric Toburen, Co-Founder of Tx3 Services, joins Dori in this episode to discuss what it took to build Tx3, the mentality that we bring to our clients, and the excitement of being considered a leading provider in the Life Sciences industry. That's not all, though! Give it a listen to hear the full conversation.

*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

In this episode, Dori is joined by longtime friend and colleague, Mike Fannon, the CEO of BioIT Solutions. With Mike's extensive career in the Biotech space, ranging from manufacturing through SQA, they discuss the evolution of the Biotech industry, the trends of today, the impacts of COVID, and how Mike and the BioIT Solutions team are enabling "a new better" for the Biotech world. Jump in and give it a listen!

*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

Before we get too deep into the run of this show, we thought it would be good to do an episode where you fine folks at home can get to know the host of Software Quality Today, Dori Gonzalez-Acevedo. 

I know why you can and should trust Dori as a true subject matter expert in our world of regulated software, and after this episode I'm sure you will too!

*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

In this episode, Dori interviews Ed Hein, Manager of Digital Validation and Verification at Lifescan. With years of experience in the medical device field, Ed shares his thoughts on the challenges and best practices for testing software as a medical device, as well as some insights on the current state and future of the industry.

Take a listen to get the scoop!

*Ed has agreed to participate in this podcast as an individual subject matter expert, and his views and opinions do not necessarily reflect those of his employer, Lifescan. Nor should any mention of products or services be interpreted as endorsements by Lifescan.

*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

In today’s episode, Dori interviews longtime friend, colleague, and Tx3 Co-Founder/CEO, Jason Tepfenhardt. From his start back in the labs all the way through forming Tx3, they’ll discuss everything in between. 

Through providing an honest view of himself, Tx3, and lessons he’s learned along the way, Jason shares his ideas on what he wants for not just the Tx3 team, but also for our clients, and the Life Sciences industry as a whole.

We were even graced by a brief, but special guest appearance by Jason’s dog, Newman. Did Newman have any valuable insights on the state of the industry to share? Well, probably not, but tune in to the episode to find out for yourself!

Visit us at https://www.tx3services.com/ 

*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

It’s never been more apparent that change is happening all around us. How we and our organizations choose to act and adapt to those changes will set us apart from those around us. Join us for an exploratory conversation as we dive into this theme with thought leaders in IT and QA at some of the top Life Sciences organizations in the industry. 

In this great thought leadership panel discussion, our host,  Dori Gonzalez-Acevedo, VP of Strategic Solutions at Tx3 Services, will Interview: 

• Alyce Deegan – (former) Director of Computer System Validation, Seattle Genetics 
• Pritam Khade – Director of Quality Assurance, AbbVie (formerly Allergan) 
• Raechelle Raimondo – Executive Director – Global Systems Assurance, AbbVie (formerly Allergan)
• Wendy Zambrana – Director of IT Quality, Biogen 

*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

Join us in welcoming Richard Lightfoot for his first appearance on the show! Rich leads the sales and business strategy development of OpenText Global Product Authentication Service, or GPAS, in the Americas and is responsible for channel partner and new market opportunities.

Dori and Rich have a great discussion around the applicability and importance of GPAS within the life sciences industry. GPAS is based on unit level serialization of finished goods and helps brands protect their products and secure their supply chains through the delivery of innovative analytics and business intelligence - all while creating a new marketing channel in which to engage their customers.

Connect with Richard on LinkedIn here and learn more about GPAS here.

*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

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

Join us as we welcome Steve Thompson in a special swap-cast episode that will be published here to Software Quality Today, as well as to the soon to be revamped and relaunched podcast from ValGenesis that Steve will be hosting.  Steve is a highly respected, extremely involved figure in the life sciences community and is currently the Sr. Product Marketing Manager at ValGenesis.

In this episode, Dori and Steve sat down after several days of the KENX  “Lean Validation – Implementing CSA and Modernizing 21 CFR Part 11” conference to spend some time dissecting the event and some of the content presented. Some themes included where and how 21 CFR part 11 fits into the current landscape relative to its inception in 1997, the state of CSV at many organizations, as well as other relevant industry regulatory codes and guidances that come into play both from an FDA perspective, as well as global equivalents.

What two better people to have a conversation to share insights and summarize a content rich event?

Follow Steve on LinkedIn here and be sure to check out the ValGenesis podcast upon its triumphant return.

In the meantime, please enjoy this episode and don't forget to subscribe, rate, and share.

*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

In this episode, we welcome VP of of IT Training, Growth & Development at United Wholesale Mortgage, Jillian Mantua.

Jillian is passionate about developing and guiding teams through the uncharted territories that come with organizational transitions and rapid growth by leveraging best practices across all industries. She focuses on identifying what and how to do things differently than current day practices, how to bring out the best in employees, and true alignment with organizational values.

Tune into hear Dori and Jillian discuss a variety of topics around the importance of fostering and developing growth within an organization to achieve operational efficiencies, and the recipe that United Wholesale Mortgage has developed to do just that.

Follow Jillian on LinkedIn here and don't forget to rate, subscribe, and share this podcast with friends and colleagues!

*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

Welcome back to another episode! Today, Dori sits down with Sree K, a life sciences industry professional with over 18 years experience that spans roles in testing, validation, IT, Business, and Quality. As an expert in test automation, Sree is a huge advocate for automation in validation and modernizing our approaches to software compliance.

Sree is also very active on LinkedIn, providing his followers with unique and insightful life sciences related content, and illustrating what an exciting time it is to be a part of this industry.

You can follow Sree on LinkedIn here, but in the meantime, put in your earbuds and enjoy another great episode of Software Quality Today!

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

This is a production of ProcellaRX

In this fantastic episode, Dori Gonzalez-Acevedo and Professor Sue Black OBE get into a highly engaging discussion around Sue's personal journey in tech and beyond, the programs she's established to support women in tech, and her role in preserving Bletchley Park.

Please don't forget to subscribe, rate and share!

Connect with Sue on LinkedIn: Professor Sue Black OBE

*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

This episode we are excited to welcome to the podcast Danielle Duran, Director of GxP Compliance and Training at Aimmune Therapeutics! As fellow advocates for education and continuous enablement in life sciences, Dori and Danielle share their insights on the current state of learning in our industry, and where we can do better to support more effective outcomes in IT and Quality organizations.

Listen in now to learn more a bout leveraging effective learning to support quality culture, shifting towards effectiveness measures of training, and, perhaps most importantly, moving towards a people-centric learning model as part core business operations.

Enjoy the episode and please don't forget to rate, subscribe and share! 

*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