Software Quality Today – Details, episodes & analysis

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