242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start

One of the hardest parts of auditing is not knowing what to look for.It is deciding where to start. Do you trace a deviation? Walk the process? Focus on one department? Audit CAPA across the organization? Or pull on a thread that does not quite make sense?In this video, Subhi walks through six audit strategies from the ASQ Certified Quality Auditor Body of Knowledge and explains how they apply in real-world pharma, biotech, and combination product audits.The six strategies covered are:1. Tracing2. Process Approach3. Process-Based Management4. Department Method5. Element Method6. Discovery MethodThese approaches are useful whether you are auditing a supplier, a manufacturing site, a testing laboratory, or a quality system that spans drug, device, and combination product responsibilities.Need support with combination product quality, auditing, supplier quality, or quality system strategy?Schedule a Let’s Combinate intro call:https://calendly.com/letscombinate/let-s-combinate-intro-sessionLearn more about Let’s Combinate:https://letscombinate.comPreparing for the CQA exam?Check out the CQA Master Class here:https://cqeacademy.teachable.com/p/the-cqa-master-class-courseChapters:00:00 Six Audit Strategies Overview01:12 Tracing Method Explained02:59 Process Approach Workflow04:27 Process-Based Management05:46 Department Method Deep Dive06:27 Element Method Across the QMS07:12 Discovery Method: Pull the Thread08:55 Summary: Pros and Cons11:31 Final Tips and Next StepsSubhi Saadeh is the Founder and Principal of 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 pharma, biotech, medical devices, and combination products.#Pharma #Biotech #Quality #Auditing #QualityAudits #CQA #GMP #CombinationProducts #QualitySystems #ISO13485