Part 4 – Closeout
• You asked for it… Wanted more review of the
steps involved

• This series is designed in parts
•
•
•
•
•

Part 1 – Prepa...
When you see that the end of the audit is
nearing:
• Inform senior management – I always
recommend that senior management ...
If all goes well – great!
If you get a 483 – trust me, it’s not the end of the world but you will
need to address the situ...
Once the inspectors have left the building, you have
to clean up the documentation
Verify everything is reconciled – if it...
Your team has worked hard – give thanks where it is
needed
You may even consider a day off if the audit was
long or intens...
Call us at 513-860-3512
See our website at
www.Compliance-Insight.com
Send us an email at
info@Compliance-Insight.com

Tha...
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FDA audit series part 4, the closeout

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Making the most out of the closing meeting with the FDA

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FDA audit series part 4, the closeout

  1. 1. Part 4 – Closeout
  2. 2. • You asked for it… Wanted more review of the steps involved • This series is designed in parts • • • • • Part 1 – Preparing for the FDA Part 2 – What to do when the FDA arrives Part 3 – What to do while the FDA is there Part 4 – What to do during closeout Part 5 – What to do with the 483 This is Part 4 – What to do during closeout
  3. 3. When you see that the end of the audit is nearing: • Inform senior management – I always recommend that senior management be present at the closeout • Decide who will attend – DO NOT have everyone there! Only the key players. Typically, management staff level in QA, OPS, RA – maybe Validation, QC • Have an appropriately sized area ready – if an area other than the audit room where you’ve been working
  4. 4. If all goes well – great! If you get a 483 – trust me, it’s not the end of the world but you will need to address the situation quickly and skillfully Determine how you will respond in the closeout • Remember, if you make commitments during the closeout, you will be held to those items • Highly recommend that you state you will review the observations, make decisive changes and respond within the allotted time frame Take notes – you will get the FDA 483 but you want to note anything discussed during the closeout, especially from the inspector Correct any errors
  5. 5. Once the inspectors have left the building, you have to clean up the documentation Verify everything is reconciled – if it was brought in, you still have it or have returned it Gather all notes and copies – don’t throw anything away until you are positive everything is accounted for and the situation is resolved.
  6. 6. Your team has worked hard – give thanks where it is needed You may even consider a day off if the audit was long or intense Pass along the observations to management and corporate – be prepared to have conference calls or meetings to discuss the situation Remember…you have 15 days to respond to the observations
  7. 7. Call us at 513-860-3512 See our website at www.Compliance-Insight.com Send us an email at info@Compliance-Insight.com Thanks for watching!

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