CAPA CAPA Change Control & Management 2

Question 1

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

Accepted Answer

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

Answer

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

Question 2

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

Accepted Answer

21 CFR 820.70(b)

Answer

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

Question 3

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

Accepted Answer

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

Answer

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

Question 4

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

Accepted Answer

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

Answer

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

Question 5

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

Accepted Answer

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

Answer

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

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA CAPA Change Control & Management 2