2. • You asked for it… Wanted more review of the
steps involved
• This series is designed in parts
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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 3 –
What to do while the FDA is there
3. Try to understand any issues (observations) as they
happen.
• If possible, remediate prior to the end of the audit
but…
• Use caution when implementing quick changes without
the opportunity to fully evaluate
Be prepared to work late or over the weekend
Move your routine meetings around – don’t leave the
audit for something else
Have someone handle day-to-day activities for you while
you are at the audit
Keep management and corporate in the loop.
4. If the audit goes badly and you are seeing a major issue being
evaluated, don’t just accept it:
• Pass the information along to senior management
• Discuss the issues with the inspector
• Be concerned – show that you are willing to resolve the issue
At some point, you may want to bring in some options for resolving
the issues:
• Corporate help – not directly with the audit but to fix the issues
• Third Party
Be prepared – the inspectors may dig deeper into the issue or expand
into other areas
5. If you’ve ever been in an audit – especially a long or complex
audit – you know that there will be a ton of documentation
pulled for review
Have your war room practices well defined.
Keep control of all your documents
People may start to get burned out – tired – after a few days of
intense audit. Watch for this issue – don’t let them snap or
loose control. Tired people make mistakes – you can’t afford
mistakes.
6. At the end of each day:
• Review the concerns of the inspector
• What will they need for the morning
• Schedule still as previously discussed
• Management should be aware of the situation
• Inform folks in the facility as to what is happening
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!