QPPV.COM KNOWLEDGE ASSESSMENT

Inspection Findings in Pharmacovigilance: Knowledge Assessment

Test your understanding of the concepts covered by Inspection Findings in Pharmacovigilance.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What should normally occur first after receipt of a significant inspection finding?

Close the finding pending completion of a future audit Perform and document a prompt risk assessment and consider interim controls Rewrite every pharmacovigilance procedure immediately Wait for the next inspection before assessing the issue

Question 2 of 10 Which evidence would best demonstrate effectiveness of a CAPA addressing delayed serious adverse-reaction reporting?

A signed statement that the team considers the issue resolved A revised procedure alone Sustained reporting-timeliness metrics supported by data review, audit or sampling and defined acceptance criteria A list of planned training sessions without completion records

Question 3 of 10 Which root cause would most directly explain recurring failures caused by unclear decision rights and inadequate escalation?

Governance weakness Technology limitation Resource constraint only Isolated record-management error

Question 4 of 10 Why should CAPA timelines include realistic milestones rather than only a final completion date?

Milestones eliminate the need for effectiveness verification Milestones allow progress, dependencies and delays to be governed before the final deadline Milestones ensure all actions are completed simultaneously Milestones are used primarily to reduce the apparent severity of the finding

Question 5 of 10 Which traceability practice would most facilitate regulatory follow-up?

Store all CAPA files in one folder without cross-references Map the inspection finding to each CAPA action, evidence item and relevant PSMF section Provide only a narrative summary without source documents Replace original records with retrospective summaries

Question 6 of 10 Which CAPA proposal most clearly addresses a root cause rather than only treating a symptom?

Manually correct the backlog once and take no further action Remind one employee to be more careful Revise unclear triage responsibilities, correct the workflow defect, strengthen vendor alerts and verify performance Archive the inspection correspondence after the backlog is cleared

Question 7 of 10 Why may inspectors regard a localized documentation error as potentially significant beyond the individual record?

Because every documentation error is automatically classified as critical Because it may indicate weaknesses in broader processes, controls or governance Because documentation issues are assessed independently of patient-safety risk Because localized errors require immediate suspension of all pharmacovigilance activities

Question 8 of 10 A vendor repeatedly misses agreed safety-data transmission timelines despite a previous CAPA. What is the most appropriate interpretation?

The issue is solely the vendor's responsibility and is outside the MAH's inspection risk The repeat issue may indicate ineffective CAPA, inadequate root cause analysis or weak vendor governance The issue should automatically be closed because a CAPA already exists The issue is minor because the activity is outsourced

Question 9 of 10 Which scenario best illustrates a major rather than a minor finding?

One isolated record-management error with no identified wider impact Systemic reporting delays affecting multiple products and creating a compliance risk A typographical error corrected before the inspection A single incomplete meeting agenda with no effect on oversight

Question 10 of 10 What is the purpose of a post-closure monitoring period?

To delay closure indefinitely To detect recurrence and confirm that improvement is sustainable after implementation To replace the initial risk assessment To reduce the need for retained evidence

Inspection Findings in Pharmacovigilance: Knowledge Assessment

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