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.
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.
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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.
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.
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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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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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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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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
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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.
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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!
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