{"podcast":{"title":"Let's Combinate - Drugs + Devices","slug":"let-s-combinate-drugs-devices-4474248","podcast_index_feed_id":4474248,"rss_url":"https://anchor.fm/s/6770b9a0/podcast/rss","website_url":"https://letscombinate.com","image_url":"https://d3t3ozftmdmh3i.cloudfront.net/staging/podcast_uploaded_nologo/17254408/17254408-1735275370987-64c671ec88d89.jpg","author":"Subhi Saadeh","episode_count":261,"summary":"Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!","last_synced_at":"2026-09-07T22:17:41.545168+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248"},"episode":{"title":"249 - The Best Audit Advice Nobody Told Me","slug":"249-the-best-audit-advice-nobody-told-me","published_at":"2026-08-05T10:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/249-the-best-audit-advice-nobody-told-me","show_page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248","url":"https://podcasters.spotify.com/pod/show/letscombinate/episodes/249---The-Best-Audit-Advice-Nobody-Told-Me-e3mvrbf","audio_url":"https://anchor.fm/s/6770b9a0/podcast/play/123775791/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-7-4%2F429230947-44100-2-71ded49cdbd7f.mp3","summary":"Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve. In this video, I share the lessons I learned as I moved from being audited and supporting audit rooms to conducting audits as a certified lead auditor: 1) Audit the system, not the person: The goal is to understand how the system operates, not to catch an individual making a mistake. 2) Look for patterns, not isolated errors: One typo is different from a recurring or systemic problem, unless the individual event is critical. 3) Scope the audit before you start: The objective, criteria, time, resources, and agenda need to align before the audit begins. 4) Technical expertise is not the same as audit skill: Auditing requires its own tools, tactics, strategies, interviewing skills, and qualification. 5) Lower the temperature to get better evidence: People communicate more clearly when the auditor reduces unnecessary anxiety, although assertiveness is sometimes necessary when information is being withheld. Chapters 00:00 Audits Aren’t Gotchas 00:38 Audit the System, Not the Person 03:16 Look for Patterns, Not Isolated Mistakes 05:27 Set a Clear Audit Scope 08:21 Auditing Is Its Own Skill and Being Technical Helps 11:11 Lower the Temperature and Be a Human About Subhi Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical-device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution. Learn more…","meta_description":"Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitab…","key_points":[],"chapters":[],"topics":[],"duration_seconds":869,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248/episodes/249-the-best-audit-advice-nobody-told-me/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/249-the-best-audit-advice-nobody-told-me.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}