Inside Out Quality

Inside Out Quality

Inside Out Quality explores product failures that effected lives and companies, which all could have been avoided. Aaron and Diane aim to both educate and share how a well-designed quality system can save your company and the lives of those you care about.

Episodes

December 6, 2022 30 min

Earlier this year, I began searching for a Quality Assurance motivational speaker. This search introduced me to many amazing people; Bart Bosch is one of them.  Bart is the founder of Vlitix and specializes in utilizing quality systems as a value driver for organizations. 

If you want to turn Quality Assurance into a value driver for your company, this is your episode! Listen in as Bart and I discuss how quality can make your compan...

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In the world of GMPs and quality, it's easy to overlook the importance of pest management until its too late. In this episode,  Frank Meek, Manager of Technical Services at Rollins/Orkin joins us to tell us how Orkin approaches all things pest control, from prevention, investigations, and control of pest along with other services they provide the industry. 

Frank Meek is a Technical Services Manager for Rollins. As a board-certi...

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Gabriel Licina is a leader in the world of independent science and was at the forefront of the biohacking culture. His work showed that exciting technology can be created from the home using networking, education, and freedom. 

I expected someone known as a Biohacker to be resistant to regulations and quality concepts, but I quickly learned the opposite. On this episode, Gabriel joins Leslie and I to talk about Biohacking, how he be...

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October 24, 2022 35 min

“Are you disturbed at night and broken of your rest by a sick child suffering…. It will relieve the poor sufferer…and is the prescription of one of the oldest and best female physicians and nurses in the United States.” --This is not an ad about our podcast :) This is an add from 1905 for Mrs. Winslow's Soothing Syrup (a morphine based product advertised to help sooth children)

FDA Historian Vanessa Burrows joins Leslie and I, a...

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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 Hi...

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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 Mar...

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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 ...

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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.

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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. 

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November 16, 2021 34 min

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...

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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!      

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November 2, 2021 53 min

"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 D...

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Chris Schilken is the Deputy Commissioner and the Director of Business Development in the South Dakota Governor’s Office of Economic Development. South Dakota has a growing Biotech community and Chris is key to helping businesses connect to state resources to help both startups and larger companies.

He joins us on this intermission as we learn more about him and how he can help.

Learn more or contact the Governor's Office of Eco...

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In this episode, we explore a vaccine contamination disaster in the early 1930's Germany. Dr. Gregory Fox, Professor and Pulmonary Physician at the University of Sydney,  joins us to discuss what went wrong, and how expecting the unexpected can alert us that something could be awry.
 
Read Dr. Fox's Paper on the Lubeck Disaster  Here

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South Dakota has a thriving biotech network, thanks largely to Joni Ekstrum, Executive Director for South Dakota Biotech. Joni also helped make this podcast happen.

In this episode we get to know Joni better and learn what Joni likes best about the biotech world and her work with SD Bio. Enjoy!

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Quality Assurance is all about controlling variation in the midst of science and human behavior.  We have outcomes we want, but sometimes take quirky paths to get there.

We explore this with help from  Dr. Lamont Lindstrom's and "Cargo Cults," a name attributed to social movements from  Melanesian Islanders, and scientists who embraced rituals to improve their research.

We are also joined by Defense Analyst, Dr. Tina Elie...

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On this intermission, I interview Megan McCray, who moved to South Dakota to study Human Factors Engineering.  Learn about human factors, a dog with excessive toe fur, and more about Megan and her studies in the USD graduate school.

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September 21, 2021 27 min

In 1909 food buying food came with a risk. Sadly, in a Rhode Island orphanage, 22 infants died from contaminated condensed milk. Today that's unheard of. Why? GMP manufacturing, FSMA, and other quality and regulatory controls. 

Kate Haiar, Quality Director for Regulatory and Audits and Sunbutter Divisions at Red River Commodities joins me to discuss all things food quality. Join us on this episode as we break away from our usual...

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September 14, 2021 12 min

In this intermission, we interview Jenifer Fjelstad. Jeni is an undergraduate at Augustana University in Sioux Falls and supports the podcast through her internship. Learn more about her on this intermission! 

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Primodos, a hormone-based pregnancy test, was given to women between 1959 and 1978. Its development occurred before GLP and before standardized testing for teratogenesis (causing birth defects).  There are data and suspicions that it caused birth defects, but more questions remain.

This episode of Inside Out Quality explores the story of this in vivo diagnostic with Dr. Neil Vargesson, from the University of Aberdeen, Scotland, UK. ...

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