ISO 14971 vs ICH Q9 Explained: Risk Management for Devices and Drugs

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com 🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this episode of Let's Combinate, host Subhi Saadeh explores the essential frameworks of risk management in medical devices and pharmaceuticals: ISO 14971 and ICH Q9. We discuss the origins, key elements, similarities, and differences of these standards and guidelines, explaining their application in the development and manufacturing of combination products. Also discussed are the definitions of risk, historical developments, and updates in these frameworks, particularly ICH Q9's recent refinements on managing subjectivity and the formality of risk assessments. The episode compares the structured approach of ISO 14971, focused on patient safety through the entire lifecycle of medical devices, with the broader risk management scope of ICH Q9, which encompasses various elements within the pharmaceutical process. This episode also provides insights into specialized tools, the concept of state-of-the-art, and the importance of verification of implementation and effectiveness in risk management plans. Listeners from regulatory, quality, product development, and risk management fields will gain a comprehensive understanding of balancing these crucial frameworks for combination products. 00:00 Introduction to Risk Management 00:21 Understanding ISO 14971 and ICH Q9 01:02 Key Elements and Differences 01:35 Deep Dive into ISO 14971 05:08 Deep Dive into ICH Q9 08:53 Comparing Risk Management Tools 14:21 Combination Products and Risk Management 18:34 State-of-the-Art and Residual Risks 21:35 Verification and Effectiveness 22:50 Conclusion and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. Descript,Risk Management for Devices and Drugs,risk management for devices and drugs,ISO 14971 vs ICH Q9 Explained,iso 14971 vs ich q9 explained,medical device,14971 vs ICH Q9 Explained Risk Management for Devices and Drugs,medical devices,medical device development,podcast recording,   • ISO 14971 vs ICH Q9 Explained: Risk Manage...  ,descript app,   / inx5nymmlfm,explained   Risk Management for Devices and Drugs,what is descript,Risk Management for Devices,iso 14971