Inside Out Quality Podcast

Check out our new podcast.  Inside Out Quality podcast explores product failures that affected lives and companies—all of which could have been avoided through basic quality practices. Our goal is to educate and share how a well-designed quality system can save your company and the lives of those you care about.

  • FDA and other regulatory requirements are easily viewed as a burden or hurdle to cross in product development and manufacturing, instead of a tool to keep consumers and companies protected from potential problems.
  • Our podcast will explore real-life problems (both big and small) and how a well-suited quality system would have prevented lost revenue and saved lives.
  • Interviews will include guests who have expertise in either the events of the story featured or the technical/behavioral challenges that were faced.
  • We also provide practical solutions for how to solve the issues in a quality system while ensuring compliance to regulatory requirements.
Inside Out Quality Podcasts

Aaron Harmon

Host

After getting a Ph.D., Aaron joined an animal health company and spent 10 years in product development while leading quality initiatives in the lab. From there, he went to the University of South Dakota (USD) and worked with their GMP Facility and dove further into quality systems working with start-up companies, and the co-founded of QUIBIT, a local quality assurance professionals network.

Now, he works as a General Manager and Director of Quality for a start-up medical device company and continues teaching courses on quality and product development at USD. Aaron enjoys exploring quality systems and regulations and how they shape product development and ultimately our world. He has been blessed to work with great people and hopes to contribute back to others through his work.

CONTACT AARON

Diane Cox

Season One Co-Host

Diane Cox is a Quality Management System (QMS) Consultant who brings over 16 years of experience in the life sciences industry, primarily in Medical Device design and manufacturing. She has a proven background of achieving quality excellence through scoping, chartering, planning, and leading cross-functional team projects, meeting business deadlines, and anticipating and mitigating project risks.

Diane has led and participated in QMS development, remediation, and integration/ harmonization efforts for medical device companies ranging in size from small to large with domestic and global presence. She has extensive experience with remediation of QMS processes and records resulting from FDA 483’s and Warning Letters. She specializes in post-market quality processes, and she served as a subject matter expert for CAPA and Field Actions throughout her Corporate career. She also has participated in the validation of software systems to streamline quality processes for electronic management.

With an ASQ Certified Quality Auditor designation, Diane has conducted a number of supplier qualification audits and internal audits. She has completed formal training to the US FDA’s Quality System Regulation (21 CFR 820), ISO 13485:2016, and the European Union’s Medical Device Regulation (EU MDR), and has working knowledge of Health Canada Brazil ANVISA, Australia TGA, and Japan MHLW medical device requirements. She has actively participated in Risk Management Activities in accordance with ISO 14971:2019.

Diane is skilled in finding an effective balance between meeting the needs of the business and meeting regulatory requirements, and she upholds continuous improvement concepts to ensure processes evolve with changing regulations, standards, and company growth.

CONTACT DIANE

QUIBIT

POWERED BY QUIBIT
QUality, Integration, Best practices,Innovation, and Technology.

LEARN MORE

Season Two: Episode 1

Human Factors and the 737 Max with Dr. Mica Endsley

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: www.hfes.org


LISTEN HERE



 

Season Two: Episode 2

Elixir Sulfanilamide and the FD&C Act

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.

LISTEN HERE

To learn more about the FDA's history check out these sites:

www.fda.gov/history

Frances Kelsey’s oral history

Elixir sulfanilamide sample bottle

Oral Histories

Video blogs

A synopsis of the Elixir Sulfanilamide tragedy


 

Intermission: Intern Hailey Nold

Hailey 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!


LISTEN NOW




 

Season Two: Episode 3

Primodos: Zebrafish, GLP, and Unanswered Questions


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

View Dr. Vargesson's research publication discussed on this show here.

LISTEN HERE
 

Intermission: Jeni = 4 Letters for Laughter

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!

LISTEN NOW




 

Season Two: Episode 4

When Milk Goes Bad: With Kate Haiar

In 1909, buying food came with 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.      

LISTEN NOW

 

Intermission: Megan McCray - Human Factors Student, Pizza Critic


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.

LISTEN HERE


 

Season Two: Episode 5

Cargo Cult Quality: Better Science Through Rituals


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!

LISTEN HERE

To learn more about Cargo Cults check out Dr. Lindstrom's book:
Amazon
Scholar Space

Also, learn more about our guests here:
Dr. Michael Long's Lab
Dr. Robert Froemke's Lab
 

Intermissions: Joni Ekstrum - Executive Director and Connector for SD Biotech


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!

LISTEN HERE
 

Season Two: Episode 6

The Lubeck Disaster: Expecting the Unexpected

In episode 6 of Inside Out Quality podcast, 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 Aaron to discuss what went wrong, and how expecting the unexpected can alert us that something could be awry.

LISTEN HERE

Intermission: Sue Lancaster - Entrepreneur and Business Developer


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!     

LISTEN HERE



 

Season Two: Episode 7



BSE: One Protein, Three Perspectives.


"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 Encephalitis (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.  


Listen Here


 

Intermission: Chris Schilken - Deputy Commissioner of GOED

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 Economic Development here:
https://sdgoed.com 
goedinfo@state.sd.us

LISTEN HERE
 

Season Two: Episode 8

The Beauty of Regulations

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!
 
LISTEN HERE


 

Season Two: Episode 9

Intermission: Aaron Harmon -– Reversing Roles with Joni

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. 

LISTEN HERE
 

Intermission: Shannon Van Buskirk

Meet Shannon Van Buskirk, South Dakota Biotech's member relations specialist

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!

 NOTE: This Intermission was recorded the week before Thanksgiving, and Aaron showed up wearing a turkey hat for the interview. :-)

LISTEN HERE

 

Season One: Episode 1

Starting Out In Quality – Management Matters

How to start up a quality system and why management support is so critical. Leadership is critical in quality – along with being a legal requirement! We’ll hear from Doug Mofle, a scientist who worked with me at Novartis Animal Health for many years, and his wife, Robin, who is a consultant in quality systems. We also will be joined by Stephanie Armstead, Director of Quality at Prairie Aquatech.

LISTEN NOW

Season One: Episode 2

NASA and the SAPA Investigation – Supplier Management


In this episode, Diane and I interview Special Agent Wade Krieger from NASA's Office of Inspector General. He shares insight and lessons learned from the investigation into supplier fraud from SAPA Materials.

We also discuss best practices in investigations and supplier management with Lindsey Marshall from OmegaQuant, a Sioux Falls company ranked in the Inc. 5,000 list.    

LISTEN HERE

Season One: Episode 3

“Conversation with Adam Litwin M.D. – Personnel Qualification”

This episode explores the story of two individuals charged with impersonating a physician. One, Gerald Barnes, had motivations of money and caused the death of John Mckenzie. The other, Adam Litwin, had a passion for medicine, caused no harm, and later completed medical school and is now a physician. The difference was engagement and passion for medicine. 

Quality systems require that employees are qualified. Diane and I discuss this with Adam Litwin M.D. and Bill McGuckin of Oxenham Group.

LISTEN HERE

Season One: Episode 4

The 2013 Baxter Mold Incident — Lessons in HEPA Filtration

In 2011, Chris Wall, an HVAC technician at a Baxter Healthcare manufacturing site in North Carolina inspected the HEPA filters in a room where sterile Saline IV Bags were filled. He found them to be contaminated with mold. Management stopped him from changing them for 2 years, until he finally reached for help to the FDA. The result was a warning letter and 18 million dollar fine. 

In this episode, Diane and Aaron meet with Tony Lee of AT Analytical to discuss the 2013 incident of mold contamination, and how to prevent mold contamination and ensure customer safety.  

LISTEN HERE

 

Season One: Episode 5

Rotateq and Rotarix — A story of vaccine contamination and prevention

In 2010, two companies learned their vaccines for a childhood infection (rotavirus) had another virus present: porcine circovirus. Both companies couldn't detect the virus lurking in a key material used for vaccine manufacture, and it went undetected until an academic lab discovered with new technology. 

Virologist and Vaccine Developer Dick Hesse from Kansas State University joins me and Diane to discuss vaccine contamination. We are also joined by Julia Schaar with Medgene Labs a local livestock vaccine developer to share best practices for preventing product contamination.  

LISTEN HERE

 

Season One: Episode 6

Thalidomide —The Drug and Woman That Changed the FDA Forever

In the late 1950's a new drug was launched in Europe. Clinical trials weren't like they are today; as a result, thousands of children suffered from extreme birth defects or died before birth due to Thalidomide. Frances Kelsey, a new FDA reviewer, pushed for safety data before allowing it to be approved US,  and spared the US from tragedy. 
 
We are joined by Neil Vargesson, Chair in Developmental Biology and expert in Thalidomide, as we discuss the drug's history and how it caused birth defects. Justine Peterson, P.A., joins us also to give a clinical perspective on drugs, trials, and how they shape her world.

LISTEN HERE 

 

Season One: Episode 7

The 1983 Air Canada Incident and Design Controls

This episode of Inside Out Quality explore an Air Canada incident where a flight ran out of fuel at 40,000 feet in the air. Retired United Airlines Captain Sam Biondo joins Diane and Aaron to talk about aviation safety and this incident. Joe Ostendorf, a medical device regulatory consultant also joins Episode 7 to discuss design controls and how they can prevent your product develop from running out of fuel.

If you are interested in reaching out to Joe, he can be reached at joseph@ostendorfconsultingllc.com 

LISTEN HERE

Season One: Episode 8

A Case of Counterfeit Rabies Vaccines and Supply Chain Risk

We are all familiar with counterfeit money, but what happens when your vaccine supply is counterfeit? In this episode, Diane and Aaron 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 that were injected into patients and the steps they took to prevent it from happening again.

To read their report: Counterfeit Rabies Vaccines: The Philippine Experience

Aaron and Diane are also joined by Daniel Stanton, President and Co-Founder of SecureMarking and author of Supply Chain Management for Dummies, and Mark Manning, Founder and CEO of iTrace Technologies. They discuss the impact of counterfeit goods on company revenue, and in the case of counterfeit pharmaceuticals and medical devices, the potentially dire consequences to patient health. Daniel and Mark educate on how counterfeit products enter the supply chain and what technologies are available to help manufacturers, including biotech companies, prevent it.

To reach out to Mark or Daniel:
Itracetech.com
securemarking.com


LISTEN NOW
 

Season One: Episode 9

TGN1412 and PMOA – Story of a monoclonal antibody that did the unexpected.

In this episode, Diane and Aaron 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. They discuss how things went wrong, and what to consider when planning clinical trials to help keep study participants safe.
 
Kelly Creighton, VP for Regulatory and Strategic Development at Clinipace also joins the Inside Out Quality podcast to discuss the importance of understanding the Primary Mechanism of Action (PMOA) of biologics and FDA expectations. 

LISTEN NOW


 

Season One: Episode 10

A Horse Named Jim: The Biologics Control Act of 1902

In our last episode for season 1, Diane and Aaron 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 them 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! 

LISTEN HERE