QPPV.COM KNOWLEDGE ASSESSMENT

Audit CAPAs in Pharmacovigilance: Professional Knowledge Assessment

Test your understanding of the concepts covered by Audit CAPAs in Pharmacovigilance.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which CAPA description is the most measurable?

Improve the quality of case processing Raise awareness of submission requirements Revise the submission workflow, implement a validated due-date control, and achieve zero missed submissions during a defined monitoring period Ensure that staff take the issue seriously

Question 2 of 10 What is the purpose of documenting residual risk and its acceptance in a CAPA record?

To show that risk was assessed after remediation and that any remaining risk was appropriately justified and accepted To avoid performing an effectiveness check To justify using the same timeline for every finding To replace evidence that actions were implemented

Question 3 of 10 Which proposed effectiveness check is most appropriate for a CAPA intended to reduce missed expedited reports?

Confirm that the revised SOP was approved Confirm that all affected staff received an email Review missed-report metrics and targeted compliance data during a defined post-implementation monitoring period Ask the CAPA owner whether the process appears improved

Question 4 of 10 What is the principal accountability of a CAPA owner?

To independently approve final closure in all cases To coordinate implementation, provide progress updates and assemble completion evidence To replace the audit team that identified the finding To determine the organisation’s regulatory reporting obligations without consultation

Question 5 of 10 What is the strongest interpretation of a repeat audit finding in the same process area?

It proves that the second auditor used an incorrect audit method It may indicate inadequate RCA, ineffective implementation, weak governance or an unsustainable CAPA It demonstrates that the original finding was minor It should be treated as a new issue without reference to prior CAPAs

Question 6 of 10 A vendor is responsible for a system used in safety case processing and receives an audit finding. Which oversight approach is most appropriate?

Rely solely on the vendor’s statement that the CAPA is complete Obtain the vendor’s RCA and CAPA evidence, reconcile it with sponsor responsibilities, and document sponsor oversight Transfer the finding to the vendor and remove it from the sponsor CAPA log Wait for the next vendor audit before reviewing implementation

Question 7 of 10 Which action best supports inspection readiness when storing CAPA records in an electronic quality system?

Retain only the final closure memo to simplify retrieval Maintain the template and linked evidence with versioning, an immutable audit trail and an index showing where evidence is located Allow owners to overwrite previous versions after approval Store supporting documents in personal email accounts

Question 8 of 10 What does a rising repeat finding rate most appropriately signal to governance bodies?

The audit programme is necessarily becoming more effective There may be systemic weaknesses in RCA, CAPA design, implementation or oversight requiring investigation All existing CAPAs should be closed immediately The QPPV should delegate all CAPA review to vendors

Question 9 of 10 Why should effectiveness rate and closure rate be reviewed together?

A high closure rate may conceal poor remediation if closure quality or effectiveness is weak They are alternative names for the same KPI Effectiveness rate determines which audit standard must be used Closure rate is meaningful only when effectiveness rate is zero

Question 10 of 10 What is the primary objective of managing an audit CAPA programme?

To reduce the number of audit findings reported To achieve administrative closure of all findings To reduce underlying risk and achieve sustainable improvement To transfer accountability for findings to the audited department

Audit CAPAs in Pharmacovigilance: Professional Knowledge Assessment

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