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!
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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
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.
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:
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.
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.
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.
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.
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
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!
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!
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.
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!
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!
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.
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/
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: