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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: 
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. Alec joins Leslie and I, so we begin to understand how we each parts of healthcare contributed to the crisis. We discuss sales and Alec shares about his life and work. To learn more about Alec's current work, see his sites:Limitless! Sales Coaching FREE 20 minute Consult
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 classes visit:
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. To reach out to Bart, his email is bart@vlitix.com
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 acknowledged leader in the field of pest management.  He loves insects, spiders, and crawl spaces. Listen in as Frank shares his passion for pest control and teaches Leslie and I how to be better insect detectives.To reach out to Orkin's industry team, visit here: You can also visit:
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 regulations are still important in this space for safety and progress.You can learn more about Gabriel here:
“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-1930's resulting in countless deaths and misled consumers. This episode underscores the importance of product labeling, advertising, and muckrakers in the history of drug development and regulations.To learn more about the work of the FDA's History Office, check out their site: 
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:
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: 
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 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.  
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 on this journey to understand and perhaps embrace rituals!To learn more about Cargo Cults check out Dr. Lindstrom's book:Amazon Scholar Space Dr. Michael Long's LabDr. Robert Froemke's Lab
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 FDA regulates.      
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 Laboratory Practices and why pre-clinical studies are key to keeping people safe.To learn more about Dr. Vargesson's research, visit his site here: Link    Dr. Vargesson's research  publication discussed on this show: Link   
How did a formulation change, turn a life saving drug into a poison? How did tragedy push US lawmakers into passing a new act to regulate Food, Drugs, and Cosmetics? Historian Vanessa Burrows with the FDA joins us to share the story of Elixir Sulfanilamide and the FD&C Act of 1938. This is a story of what can go wrong when morality, science, and businesses are done wrong. To learn more about the FDA's history check out these sites: Kelsey’s oral history Elixir sulfanilamide sample bottleOral Histories Video blogsA synopsis of the Elixir Sulfanilamide tragedy
In this episode we explore the tragic failure in human factors engineering on the Boeing 737 MAX and why early incorporation of the user’s needs and limitations is key to developing better, safer products. Dr. Mica Endsley, former Chief Scientist of the Air Force and founder of SA Technologies, joins us to discuss Human Factors Engineering and what we can learn from the 737 MAX tragedies.  Human Factors & Ergonomics Society:
In our last episode for season 1, Diane and I dive into the story behind the first US law passed for protecting people from a medical product failure: The Biologics Control Act of 1902. Joining us is René Najera editor of the History of Vaccines ( He helps explain the development of diphtheria antitoxin and discusses early product development and public perception.    Also joining us is Kelly Creighton of Clinipace to discuss how regulations shape product development and help protect patients.Stay tuned for season 2! 
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