Latest Quality assurance Podcast Episodes
Intermission: Sue Lancaster --Entrepreneur and Business Developer :)
Inside Out Quality - November 09, 2021 11:00 - 7 minutes ★★★★★ - 6 ratingsAfter 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 ...
Intermission: Sue Lancaster --Entrepreneur and Business Developer :)
Inside Out Quality - November 09, 2021 11:00 - 7 minutes ★★★★★ - 6 ratingsAfter 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 ...
BSE: One Protein, Three Perspectives.
Inside Out Quality - November 02, 2021 10:00 - 53 minutes ★★★★★ - 6 ratings"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 explore...
BSE: One Protein, Three Perspectives.
Inside Out Quality - November 02, 2021 10:00 - 53 minutes ★★★★★ - 6 ratings"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 explore...
Case Study: Quality Complaint Investigations
RCA Radio - October 26, 2021 14:00 - 10 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, go over a case study where we tried to teach a client that received a warning letter life lessons for Quality Complaint investi...
Intermissions: Chris Schilken --Deputy Commissioner of GOED
Inside Out Quality - October 26, 2021 10:00 - 9 minutes ★★★★★ - 6 ratingsChris 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 compan...
The Lubeck Disaster: Expecting the Unexpected
Inside Out Quality - October 20, 2021 11:00 - 23 minutes ★★★★★ - 6 ratingsIn 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. F...
Case Study: Warning Letter Remediation
RCA Radio - October 12, 2021 14:00 - 11 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Executive VP of Pharmaceuticals, Steven Lynn go over how RCA helped an international company perform a gap analysis based on multiple FDA investigations. Listen in as we break down the client's Warnin...
Intermissions: Joni Ekstrum --Executive Director and Connector for SD Biotech
Inside Out Quality - October 12, 2021 10:00 - 6 minutes ★★★★★ - 6 ratingsSouth 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!
Cargo Cult Quality: Better Science Through Rituals
Inside Out Quality - October 05, 2021 10:00 - 40 minutes ★★★★★ - 6 ratingsQuality 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 Melanes...
Cargo Cult Quality: Better Science Through Rituals
Inside Out Quality - October 05, 2021 10:00 - 40 minutes ★★★★★ - 6 ratingsQuality 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 Melanes...
Intermissions: Megan McCray --Human Factors Student, Pizza Critic
Inside Out Quality - September 28, 2021 10:00 - 7 minutes ★★★★★ - 6 ratingsOn 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.
What Makes a Great Quality Management System
RCA Radio - September 22, 2021 14:00 - 14 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, guest host Dean Coston and Susan Schniepp, Regulatory Compliance Associates Inc.'s (RCA) Distinguished fellow go over how the people, processes, and documentation all come together to make a Quality Management System. About RCA Regulatory Compliance Associates® ...
When Milk Goes Bad: With Kate Haiar
Inside Out Quality - September 21, 2021 10:00 - 27 minutes ★★★★★ - 6 ratingsIn 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 Sunbutte...
Intermission: Jeni = 4 Letters for Laughter
Inside Out Quality - September 14, 2021 10:00 - 12 minutes ★★★★★ - 6 ratingsIn 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: Zebrafish, GLP, and Unanswered Questions
Inside Out Quality - September 07, 2021 10:00 - 34 minutes ★★★★★ - 6 ratingsPrimodos, 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...
Design of Protocols for Biologics
RCA Radio - August 31, 2021 19:00 - 43 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Walter Mason, (Regulatory Compliance Associates Inc.'s (RCA) Executive VP of Pharmaceuticals, RCA's Sr. Director of Quality Control and Consulting Services) go over the design of biologic protocols, the importance of keeping data...
Design of Protocols for Biologics
RCA Radio - August 31, 2021 19:00 - 43 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Walter Mason, (Regulatory Compliance Associates Inc.'s (RCA) Executive VP of Pharmaceuticals, RCA's Sr. Director of Quality Control and Consulting Services) go over the design of biologic protocols, the importance of keeping data...
Intermission: Hailey Nold our first intern and future therapist
Inside Out Quality - August 31, 2021 10:00 - 9 minutes ★★★★★ - 6 ratingsHailey Nold joined Inside Out Quality for season two to help with planning, research, and locating guests. Learn more about Hailey and how she made our work so much fun on this intermission!
Intermission: Hailey Nold our first intern and future therapist
Inside Out Quality - August 31, 2021 10:00 - 9 minutes ★★★★★ - 6 ratingsHailey Nold joined Inside Out Quality for season two to help with planning, research, and locating guests. Learn more about Hailey and how she made our work so much fun on this intermission!
Elixir Sulfanilamide and the FD&C Act
Inside Out Quality - August 24, 2021 10:00 - 45 minutes ★★★★★ - 6 ratingsHow 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 sto...
Intermission: Diane and Nate Vegans in Midwest
Inside Out Quality - August 17, 2021 10:00 - 12 minutes ★★★★★ - 6 ratingsIn season 2 we are bringing you intermissions: short interviews with local professionals and those that help make this podcast happen. We hope you enjoy! In this intermission, I interview Diane Cox and Nate Poeppel about one of things they have in common: a vegan diet. Join us as we discuss how...
Boeing 737 MAX: Human Factors with Dr. Mica Endsley
Inside Out Quality - August 10, 2021 10:00 - 41 minutes ★★★★★ - 6 ratingsIn 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, ...
Boeing 737 MAX: Human Factors with Dr. Mica Endsley
Inside Out Quality - August 10, 2021 10:00 - 41 minutes ★★★★★ - 6 ratingsIn 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, ...
Managing Compliance in Highly Regulated Industries
Quality Watch by TIP Technologies - April 12, 2021 05:00 - 12 minutesAt TIP Technologies, we focus on serving the needs of companies in regulated discrete manufacturing industries and serve companies up and down the supply chain. In today's episode, we learn from Ron Dolan, President of TIP Technologies, about some examples of the regulatory standards TIPQA is de...
A Horse Named Jim: The Biologics Control Act of 1902
Inside Out Quality - April 06, 2021 10:00 - 1 hour ★★★★★ - 6 ratingsIn 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 (https://www.historyofvaccines.org/). He helps exp...
A Horse Named Jim: The Biologics Control Act of 1902
Inside Out Quality - April 06, 2021 10:00 - 1 hour ★★★★★ - 6 ratingsIn 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 (https://www.historyofvaccines.org/). He helps exp...
Quality Watch Teaser
Quality Watch by TIP Technologies - March 24, 2021 21:45 - 2 minutesThis is an introduction to the Quality Watch podcast series by TIP Technologies.
TGN1412 and PMOA –Story of a monoclonal antibody that did the unexpected
Inside Out Quality - March 23, 2021 10:00 - 50 minutes ★★★★★ - 6 ratingsIn this episode, Diane and I are joined by Husain Attarwala, Head of Pharmacometrics and Clinical Pharmacology at Moderna and author of a paper diving into the 2006 failed clinical trial of TGN1412. We discuss how things went wrong, and what to consider when planning clinical trials to help kee...
A Case of Counterfeit Rabies Vaccines and Supply Chain Risk
Inside Out Quality - March 09, 2021 11:00 - 1 hour ★★★★★ - 6 ratingsWe are all familiar with counterfeit money, but what happens when your vaccine supply is counterfeit? In this episode, Diane and I interview Dr. Karl Henson from The Medical City hospital in Pasig City of the Philippines. He shares their story of both identifying the counterfeit rabies vaccines ...
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