{"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":"238 - 6 Audit Strategies Every Auditor Should Know","slug":"238-6-audit-strategies-every-auditor-should-know","published_at":"2026-05-13T10:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/238-6-audit-strategies-every-auditor-should-know","show_page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248","url":"https://podcasters.spotify.com/pod/show/letscombinate/episodes/238---6-Audit-Strategies-Every-Auditor-Should-Know-e3j9ttg","audio_url":"https://anchor.fm/s/6770b9a0/podcast/play/119911792/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-4-13%2F424047885-44100-2-cc0c35bf70004.mp3","summary":"Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and Discovery Course Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-course In this episode, Subhi explains why selecting the right auditing strategy matters when auditors have limited time, limited access, and a specific audit objective. He walks through six major strategies: tracing, process approach, process-based management, department method, element method, and discovery method. The episode covers how each strategy works, where it is useful, and where it can fall short. Subhi also explains why real audits rarely rely on only one method. Strong auditors know how to combine strategies based on the audit objective, the evidence being reviewed, and what the audit trail reveals. Timestamps 00:00 Six Audit Strategies Overview 00:22 Why Strategy Matters 01:13 Course Context and Setup 02:28 Tracing Method Explained 03:26 Process Approach Walkthrough 04:21 Department Method Deep Dive 05:26 Element Method Against Standards 06:12 Discovery Method String Pull 06:36 Pros, Cons, and Final Summary 09:53 Wrap Up and Next Session Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.","meta_description":"Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and Discovery Course Link: https://cqeacademy.teachable.co…","key_points":[],"chapters":[],"topics":[],"duration_seconds":604,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248/episodes/238-6-audit-strategies-every-auditor-should-know/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-4474248/238-6-audit-strategies-every-auditor-should-know.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}