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Compliance Quiz: Questions on CAPA

1. Under "Subchapter H – Medical Devices in CFR Title 21, Subpart J Corrective and Preventive Action," all activities required under this section, and their results, shall be:
2. Under "Subchapter C – Drugs in Title 21, Subpart J Records and Reports," unexplained discrepancies, batch or specification failures must be investigated. "A___________ record of the investigation shall be made and shall include the_________ and _____________."
3. The ISO definition of a Corrective Action is:
4. The ISO definition of Preventive Action is:
5. In conjunction with an investigation, a ___________ ___________ ___________ should be conducted to determine the cause of the problem.
6. All CAPA projects must be validated to meet requirements for ___________, ____________, and _______________.
7. If the CAPA is effective, it is approved and closed as complete. If the CAPA is ineffective...
  • This question is required
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