VIP Exclusive
CAPA Certified Professional VIP Exam
CAPA — No single universally accredited 'CAPA Certified' credential exists from one governing body; CAPA competency is assessed within ASQ certifications (CQE, CQPA), RAPS RAC, and private training providers (ComplianceOnline, MasterControl Academy). This exam mirrors the knowledge domains tested across those programs: FDA 21 CFR Part 820.100, ISO 9001:2015 Clause 10.2, ISO 13485, and ICH Q10 pharmaceutical quality systems.
29
Questions
90m
Time Limit
75.00%
To Pass
Question 1 of 29👑 VIP
During an internal audit of a medical device manufacturer, an auditor finds that the same assembly-line torque error has been documented in three separate nonconformance reports over six months. Each report was closed after rework, but no CAPA was initiated. Under FDA 21 CFR Part 820.100, what is the MOST critical regulatory deficiency?
Questions 2–29 and full explanations are VIP-exclusive.