Module 5 Presentations

Post-Inspection Activities

Inspection report • Produced within approximately 25 working days from the last day of inspection. Responses • Confirm if accepted. • Impact and risk assessment. • Root cause – to analyse the reason for the error and its extent. • CAPA plans. • Timelines. Closure – inspection statement

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Hints and Tips for the Inspection

• Inspectors work transparently and will discuss issues with the organisation throughout the inspection. • Inspectors want to get a true understanding of an organisation; if things have been misunderstood by inspectors, arrange a time to clarify. • Answer the question being asked. It is your chance to demonstrate compliance so be forthcoming in answering fully. • Do not guess the answer if you don’t know! • If you are unclear on what is being asked or requested, ask for clarification (it may save you time and effort).

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