Software Quality Today

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

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

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