Inside Out Quality

Jason Vuic, author and historian, joins Leslie and I to discuss one of the best examples of quality reputation and public perception: the Yugo.
Zastava manufactured the low cost car in the 1980's, but low cost could not overcome the quality issues that turned the name Yugo, into a punchline for jokes. Car and Driver named it "Worst Car in History."
Jason wrote the book: The Yugo -The Rise and Fall of the Worst Car in History and joins us to discuss the impact of quality on reputation and how the Yugo fits into history.
To learn more about Jason Vuic and his work, see his website: https://www.jasonvuic.com/home

Quality Assurance professionals are tasked with bringing continuous improvement to organizations. This means change. Change can evoke emotions. Do we prepare our quality professionals to navigate emotional conflict?
This episode discusses tactics to minimize and de-escalate conflict in the workplace with help from Joel Reinesch, Assistant Professor of Criminal Justice at Dakota Wesleyan University, former Police Officer, and Marine.
Special Agent Wade Krieger inspired the idea for this podcast and had planned to record this with me. He passed away in 2021. The episode is a tribute to him.

Warning Letters are more than a slap on the wrist. They are the first step in what can be a costly remediation and legal battle.
How do we prevent them? What is within the power of the FDA and government when they spot quality issues? To help us with these questions and more, we are joined by Amanda Johnston of Gardner Law. Amanda has over a decade of experience in FDA Regulatory Law and experience with all sizes of companies.
To learn more about Gardener Law, check out their website: https://gardner.law/

On this intermission, we meet Shannon Van Buskirk. She recently joined SD Bio to provide extra support for members and is jumping into our community. She brings a background in pharmaceutical sales, talent on the piano, and a passion for meeting new people. If you haven't met her yet, you definitely should!
p.s. we recorded this the week before Thanksgiving, and I showed up wearing a turkey hat for the interview.

In this intermission Aaron Harmon, podcaster and General Manager for Inanovate Inc. joins us, as Joni Ekstrum interviews Aaron and takes her turn at hosting an episode.
Aaron started this podcast with the hopes of sharing stories and exploring the world of quality assurance through interviews with amazing people. On this episode you'll get to know him more as he sits on the other side of the questions.

The FDA stands for The Food and Drug Administration, but they are also key in regulating the cosmetic industry. In 1938, The Federal Food, Drug, and Cosmetic Act gave the FDA the responsibility for regulating cosmetics and protecting customers.
To explore how cosmetics are regulated, Charmain Rodriques, Regulatory Affairs Manager at LVMH joins us to explore how the FDA, FTC, and even customers shape the cosmetic industry. Hope you enjoy!

After graduating from the University of South Dakota, Sue Lancaster jumped into the local biotech community to help bring a variety of products to market, which has included technologies from two faculty at South Dakota State University. Learn more about her career journey and other fun details on this intermission!

"Mad Cow Disease" emerged in the United Kingdom in 1986. Named from the symptoms seen in cattle, it was eventually renamed more appropriately to Bovine Spongiform Encephalopathy (BSE). When humans are infected, the disease seen is variant creutzfeldt-jakob disease (vCJD).
This episode explores the story of how a prion shaped the beef and biotech industries and revealed a failure in questions and ethics. We are joined by Dr. Fiona Houston (senior researcher and veterinarian), Anne McVey (ethics advocate and mother of a victim), and Kelly Creighton (biologics manufacturing regulatory expert).
Join us to learn how scientists tackle emerging infections, why we need to ask the hard questions, and how this prion has shaped the industry.