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Fda audit series part 3, while the fda is there


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What to do when the FDA is at your facility.

What to do when the FDA is at your facility.

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  • 1. Part 3 – While the FDA is there
  • 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 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 Send us an email at Thanks for watching!