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

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

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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.

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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

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.

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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.  

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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.  

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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.

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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 

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