The 7 Mistakes That Trigger FDA Warning Letters
60 minutes. 7 critical gaps. A clear action plan you can start today, without rebuilding your validation system from scratch.
60 minutes. 7 critical gaps. A clear action plan you can start today, without rebuilding your validation system from scratch.
The same 7 mistakes keep showing up, year after year, across companies of every size.
Internal reviews often miss them – not because teams aren't diligent, but because these gaps hide in plain sight.
But auditors? They know exactly where to look.
This webinar shows you exactly which 7 mistakes to look for, why they keep happening, and how to fix them – with clear, practical steps you can act on immediately.
Know exactly which 7 TMV gaps auditors target first – so you can check your own system before they do.
Stop guessing what auditors want. Get the validation principles that FDA and Notified Bodies actually accept – based on real inspection outcomes, not textbook theory.
Walk away with a clear "fix this first" list you can start acting today – without needing to overhaul your entire QMS.
Replace the anxiety of "will we pass?" with the clarity of knowing exactly where you stand and what to do next.
Simon has spent over a decade inside the quality systems of medical device companies – from startups to global manufacturers across Europe, America, and Asia.
As a TUV SUD Academy trainer, he's trained hundreds of professionals on TMV compliance.
As a consultant, he's helped companies resolve FDA Warning Letters and pass audits they weren't prepared for.
In this webinar, he shares the patterns he sees repeated across the industry – the 7 mistakes that keep showing up, and the practical fixes that actually work.
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