Module 17 2024

05/12/2024

Agency Initiated

Agency initiated contact  DON’T PANIC

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Assess the request or inquiry in context  If you do not fully understand something, ask for clarification  Do not just answer.(never “fire” from the hip even if it is a

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simple obvious answer) Take time to formulate a response

If documents are requested -review them BEFORE they are sent.  Its harder to get toothpaste back in the tube

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Follow your internal procedures

Recalls and Defects

Failure analysis Trending Reporting documents CAPA

Documents will become key

Give facts - Don't ad lib Document all interactions (phone, email, etc)

Be honest when queried

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