Practice Test Geeks(CAPA) Corrective and Preventive Action Certified Practice Test
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CAPA Change Control & Management Flashcards

6 cards from real CAPA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 CAPA Change Control & Management flashcards as text

  1. What role does a Configuration Management Board (CMB) or Change Control Board (CCB) typically play in CAPA-driven changes?

    Answer: It reviews, approves, or rejects proposed changes based on technical and regulatory criteria

    A CCB provides cross-functional oversight to ensure proposed changes are thoroughly evaluated before authorization.

  2. Which FDA regulation specifically requires medical device manufacturers to establish and maintain change control procedures?

    Answer: 21 CFR 820.70(b)

    21 CFR 820.70(b) mandates that device manufacturers establish change control procedures to ensure process changes are reviewed and approved.

  3. What is 'design change control' in the context of a CAPA for a medical device?

    Answer: A formal process to manage changes to device design and ensure they meet design input requirements

    Design change control per 21 CFR 820.30(i) ensures that any modification to device design is reviewed, verified, validated, and approved before implementation.

  4. Why is it critical to re-validate a process after a CAPA-driven change in a pharmaceutical manufacturing environment?

    Answer: Because changes can alter process parameters that were previously validated, potentially affecting product quality

    Changes to validated processes can invalidate previous qualification data, making re-validation necessary to confirm the process still consistently produces acceptable results.

  5. In CAPA change management, what is the significance of a 'change effectiveness check'?

    Answer: It confirms that the implemented change achieved its intended purpose without introducing new issues

    A change effectiveness check verifies that the change resolved the original problem and did not create unintended negative effects on quality or compliance.

  6. What should be done if a CAPA-driven change is found to have introduced a new quality issue during the change effectiveness check?

    Answer: Open a new CAPA or deviation to address the newly identified issue

    A newly discovered quality issue must be formally documented and addressed through the quality system, which may require initiating a new CAPA.

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