QPPV.COM KNOWLEDGE ASSESSMENT

Common Pharmacovigilance Inspection Failures: Knowledge Assessment

Test your understanding of the concepts covered by Common Pharmacovigilance Inspection Failures.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Why is a re-audit or equivalent verification important before closing a significant CAPA?

It replaces the need for root-cause analysis It demonstrates whether the corrective action produced sustained improvement in practice It ensures that the original audit report is no longer available It allows the CAPA owner to avoid documenting implementation evidence

Question 2 of 10 An employee is asked a question during an inspection but does not know the answer. What behaviour best aligns with the playbook?

Speculate so that the organisation appears well prepared Give a short, factual answer within their knowledge and identify the appropriate evidence owner if follow-up is needed Refuse to answer all questions until legal counsel is present Provide an unofficial explanation based on how the process should work

Question 3 of 10 A major PV system change has been implemented, but the PSMF still describes the former vendor and workflow. What should have occurred?

The PSMF should have been updated through change control and reconciled with operational evidence Only the vendor should have retained the change documentation The PSMF should remain unchanged until the next inspection The change should be documented only in employee training records

Question 4 of 10 What underlying issue are inspectors most likely to investigate when they identify a recurring pharmacovigilance error?

Whether the individual employee should receive disciplinary action Why the quality system allowed the error to occur or recur Whether the error can be removed from the inspection sample Whether the relevant SOP contains enough technical terminology

Question 5 of 10 Which evidence package would most convincingly demonstrate effective remediation of delayed individual case closure?

A new SOP with no training or performance data An audit finding, root-cause-based CAPA, implementation records, before-and-after metrics, and a confirming re-audit A management email stating that delays are no longer expected A list of overdue cases without an assessment of their causes

Question 6 of 10 Which statement best reflects the MAH’s position when pharmacovigilance activities are outsourced?

The vendor assumes all regulatory responsibility once the contract is signed The MAH retains ultimate responsibility and must demonstrate active vendor oversight The QPPV has no need to review vendor performance if an SDEA exists Vendor performance only needs to be assessed after an inspection finding

Question 7 of 10 Which post-inspection action most directly supports a credible response to an observation?

Close the issue immediately to demonstrate responsiveness Define the root cause, interim and long-term actions, owners, timelines, and effectiveness verification Respond only with a revised SOP and no implementation evidence Wait until the next inspection to assess whether the response worked

Question 8 of 10 Why is continuous inspection readiness preferable to preparation that begins only after an inspection notice?

It eliminates the need for inspectors to request evidence It keeps records, responsibilities, and evidence current and reduces rushed responses and inconsistencies It guarantees that no observations will be issued It permits the organisation to avoid maintaining a QMS

Question 9 of 10 What does a coherent PSMF, current KPI dashboard, documented QPPV review, and verified CAPA system collectively demonstrate?

Only that the organisation has produced a large volume of documents Visibility, accountability, control, and improvement within the pharmacovigilance system That inspection findings are impossible That operational staff no longer require training

Question 10 of 10 A critical vendor has repeatedly missed reporting timelines. Which response is most consistent with the article’s approach?

Record the misses but wait for the next routine contract renewal Track the issue through KPIs, escalation, corrective actions, and effectiveness verification Delete the affected cases from the vendor’s performance dashboard Treat the issue as solely a vendor training matter without investigating the system

Common Pharmacovigilance Inspection Failures: Knowledge Assessment

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