Fda audit series part 3, while the fda is there
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This document provides guidance on what to do while an FDA audit is occurring. It advises being prepared to address any issues or observations from the inspectors as they arise, and if possible, to remediate problems before the audit ends. It also recommends moving meetings, having someone handle daily tasks, keeping senior management informed, and discussing major issues with the inspectors. The document stresses being prepared to provide options for resolving issues, controlling all documentation in a "war room," and addressing inspector concerns and needs at the end of each day.
Fda audit series part 3, while the fda is there
- 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 dont 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, dont 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 youve 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 dont let them snap or loose control. Tired people make mistakes you cant 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!