Software Quality Today

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 indu...

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 ...

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...

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 w...

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 aft...

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 br...

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 ins...

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 partici...

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...

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 o...

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 ...

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 ...

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 Must...

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 ind...

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. ...

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 managem...

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.
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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 m...

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 ...