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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