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Inside Out Quality

Author: Aaron & Leslie

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Inside Out Quality explores product failures that effected lives and companies, which all could have been avoided. Aaron and Leslie aim to both educate and share how a well-designed quality system can save your company and the lives of those you care about.
40 Episodes
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“I will tell you something about stories. They aren't just entertainment. They are all we have to fight off illness and death. You don't have anything if you don't have stories.” ― Leslie Marmon SilkoThe story of Scott Jerome Parks captivated me and the filled headlines in 2010. His story led me to connect with people around the US and world and, ultimately, to Dr. Joel Carter, a palliative care physician. While treating patients, Joel discovered that stories alone provided relief from pain a...
Gordon Isaacs sat on a table at Stanford Medical School in 1955. A large linear accelerator shadowed behind him while he waited for treatment of the tumor growing in his retina. He made history as the first patient treated in the US with this radiation therapy approach. Linear Accelerators (LINACs) have come a long way since that time and have treated millions. How has there been so much success? The answer is a harmonization between quality and engineering. Dr. Todd Pawlicki, Professor and V...
Scott Jerome Parks died in 2007 from a radiation overdose. His slow, agonizing death captured headlines. Headlines were followed by a congressional hearing, where his dad shared of Scott's suffering and the need for reform in medical device and radiation safety. As I learned of his story, it brought me to many more stories. The first being the Therac 25. Natalia Silvis-Cividjian also found the story of the Therac 25. She too became captured and harnessed its lessons to teach students th...
In this episode, Dr. David Evans, Virologist at the University of Alberta joins Leslie and I, where we explore a question he once asked. Could he and his team synthetically recreate horsepox virus? Science is all about asking questions and creating experiments to answer them. These questions can make us uncomfortable. Quality Assurance also thrives on questions. Listen in while we discuss his experiment and ask him questions.Link to Dr. Evans' publication on horsepox virus:https://journa...
In 1920, the US began recording deaths from Opioids; between 1920 and 1921, 105 people died from accidental overdose.In 2021, 80,816 people died from overdose on opioids (CDC). We are losing a battle. The opioid crisis is a healthcare system problem; one component of this system is the sales rep. In this episode, we interview Alec Burlakoff. Alec was the VP for sales at Insys and a master of sales and building teams. His skills, contributed to explosive sales of Fentanyl and current crisis.&n...
Michelle Hutchison is an actress, voiceover coach, writer, and producer. She also teaches professionals in the medical product industries on how to present more effectively-- we knew we couldn't talk about motivational speaking with talking about the speaking part!In this episode, Michelle talks about performance in presentations with Leslie and I to discuss getting past slide decks and communicating with skilled expression and your emotional palette. To learn more about Michelle's class...
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 company more valuable and contribute to the bottom line.&n...
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-certified entomologist and 30-year industry veteran, he is an...
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 became an Independent Researcher, his research, and how the...
“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, as we dive into a notorious opioid product sold from the 1830's-193...
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 ...
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 t...
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 websi...
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!
"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 ...
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
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, and Neuroscientists Drs. Michael Long and Robert Froemke ...
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 discussions on drugs and devices to explore other areas the ...
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!
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. Learn another reason for the importance of Good Laborator...
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