Managing AI Risk Across Global Quality Systems

How do you manage AI risk across global quality systems while the tools change every week? Julio Salwen, SVP and Chief Quality Officer at MiniMed, brings 35 years in pharma, devices, and diagnostics to a conversation about governance, risk tolerance, and what quality leaders need to learn right now.Julio and Nick get into why building for the auditor is the wrong instinct, how to introduce AI where the risk is genuinely low, why one overreaction makes an organization risk-averse, and what regulators will expect from AI governance.A few of Julio's key takeaways:Regulatory confidence means decisions you can explain, not just documentation you can produceStop asking what the auditor will think. Control the real risk and compliance follows as a byproductYou can't ChatGPT compliance. Turning people loose on AI without defined intended use is a serious unintentional riskStart AI where risk is low, research and drafting, and build confidence from there. Decisions stay with qualified professionalsDrop the control tower. Hybrid governance needs standards, decision rights, and escalation, not central control of everythingAutomating a broken process just gives you a faster broken processQuality leaders need risk management depth plus enough technical literacy to ask hard questionsInventory your AI use cases and classify them by risk. That's the practical starting pointAbout Julio SalwenJulio Salwen is SVP and Chief Quality Officer at MiniMed, the diabetes company recently spun off from Medtronic. An engineer by training with over 35 years in pharma, medical devices, and IVD, he previously served as VP of Quality for Medtronic's Diabetes Operating Unit, Divisional VP of Quality for Abbott Point of Care, and Global Head of Quality for Abbott Molecular, following more than two decades at Baxter Healthcare across Puerto Rico, Europe, and the US.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/