FDA Inspection (Audit) Readiness Procedure

Mark Meer

Trusted Information Resource
#11
All good tips. I will train everyone but was really trying to gauge if others formalized their "what to do when the FDA walks in the front door" into an SOP or WI.
Although not necessary for compliance purposes, we do have an SOP.

It is not particular to the FDA, but rather deals generally with the procedures to follow when any outside inspector/auditor shows up. It is a handy tool for training for the person(s) responsible for being the liaison/representative.

It's short and has some pretty simple things such as (among others):

  • What kind of agencies/organizations can be expected. And process for handling pre-scheduled audits vs. unannounced inspections.
  • Who is responsible for being company liaison/representative, and what the role entails.
  • Ask for ID
  • What can and cannot be discussed
  • Basic conduct (do not threaten, obfuscate, lie, make unsubstantiated claims, etc.)
  • Compile list of all documents, materials or samples given to the representative.

Pretty basic stuff....but worth training the person(s) that may be dealing with auditors on...

MM.
 
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Candi1024

Quite Involved in Discussions
#13
We do have a procedure. It covers everything from who to contact first, who clears out conference rooms, What we need in the front and back rooms (we keep logs and records, communicate through lync and a projector). Of course it includes not offering to buy them lunch or dinner. Who to call in as backups and runners. ect ect.
 
J

Jnks_Meddev

#14
How do you communicate documents from front room to back room during an audit? And how to SME's remember procedures and protocols to request?
 
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