Category: Competent Authority Inspection Preparation Advice
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The Key to a Successful Inspection
Stock up on tea and coffee, it’s that time again. The inspectors are coming. Minimise the chance of follow-up and repeat visits. The key to a successful inspection is preparation. 👉 Correct & up to date documents Have inspections in mind the moment you receive the green light for a project. Start those required documents,…
hoffmanhealthcareconsultancy
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Don’t Pester the Inspector
Waiting for an FDA, EMA or MHRA competent authority inspection? Don’t pester the inspector. We know it’s tempting to ask lots of questions to gain as much information as possible, however: Before contacting the inspector, first, check the authority blogs and pages. Some of the generic information you require may already be available so worth checking…
hoffmanhealthcareconsultancy
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Are You Inspection Ready?
8 bite-sized tips to help you prepare for competent authority inspections: 1 – Accurate dossiers Make that first impression a good one. Your dossiers are the first thing the lead inspector sees, it won’t bode well if your paperwork isn’t up to date and contains inaccuracies. 2 – Mock Inspections. Stop the guesswork and instil…
hoffmanhealthcareconsultancy
