QPPV.COM KNOWLEDGE ASSESSMENT

What is CAPA in Pharmacovigilance?

Test your understanding of the concepts covered by What Is CAPA in Pharmacovigilance?.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which item is least sufficient as the sole evidence that a CAPA is effective?

A targeted re-audit using a predefined sample and acceptance criterion A trend analysis over a predefined period showing error reduction A process metric or automated check compared with a baseline A statement from the action owner that the procedure now appears to work

Question 2 of 10 Which sequence best represents an inspection-ready CAPA lifecycle?

Closure, implementation, issue identification, RCA, management review Issue identification, risk assessment, investigation and RCA, CAPA planning, implementation, effectiveness verification and closure Training, audit, closure, risk assessment and preventive action RCA, closure, containment, implementation and initial issue identification

Question 3 of 10 Which KPI combination best supports monitoring of CAPA timeliness and outcome quality?

Number of meetings held and number of emails sent Time to initiation, milestone completion on time, effectiveness success rate and reopen rate Number of staff in QA and number of SOPs in the QMS Total number of CAPAs opened without considering risk or age

Question 4 of 10 What is the primary purpose of initial CAPA risk categorisation?

To determine the appropriate priority, escalation, resources and timelines based on potential impact To decide which CAPAs can be omitted from the tracking system To assign legal liability before investigating the issue To ensure that every issue receives the same investigation method

Question 5 of 10 Which responsibility best reflects the QPPV's role in CAPA governance?

Personally executing every CAPA action Maintaining awareness and oversight of significant CAPAs and signing off those with safety or regulatory impact when required Approving all vendor invoices associated with CAPAs Replacing QA as the process owner for the CAPA system

Question 6 of 10 A CRO performs case processing and has a significant finding. Which approach best reflects effective vendor CAPA oversight?

Accept the CRO's verbal assurance that the issue is resolved Require the vendor to investigate and provide evidence, while retaining oversight and conducting independent verification where appropriate Transfer all MAH responsibility for the PV system to the CRO Close the CAPA once the vendor submits a revised invoice

Question 7 of 10 Which statement best explains why interim containment should be documented separately from the long-term CAPA solution?

Containment limits immediate impact, while CAPA remediation addresses the underlying cause and recurrence risk Containment automatically proves that the root cause has been removed Containment is used only for low-risk documentation issues Documenting containment makes investigation and effectiveness verification unnecessary

Question 8 of 10 Which description best captures the purpose of a CAPA process in pharmacovigilance?

To document deviations without necessarily changing the underlying process To identify, investigate, correct and prevent recurrence of compliance or quality issues To replace routine pharmacovigilance audits with a single annual review To assign responsibility for all PV activities exclusively to the QPPV

Question 9 of 10 Which governance body is primarily described as the operational forum for reviewing new CAPAs, assigning owners and monitoring due dates?

The CAPA Review Committee The pharmacovigilance inspection team The clinical trial data monitoring committee The local ethics committee

Question 10 of 10 Which feature most clearly distinguishes an effectiveness check from an implementation record?

An implementation record proves that an action was completed; an effectiveness check assesses whether the action achieved its intended outcome An implementation record is prepared by management; an effectiveness check is prepared only by a vendor An implementation record addresses root causes; an effectiveness check assigns the CAPA owner An implementation record is optional; an effectiveness check is required only for low-risk CAPAs

What is CAPA in Pharmacovigilance?

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