CAPA Study Guide 2026
Everything you need to pass the CAPA exam in one place: the exam format, every topic to study, real practice questions with explanations, flashcards, and full-length practice tests. Free, no sign-up needed.
📚 CAPA Topics to Study (21)
✍️ Sample CAPA Questions & Answers
1. In Risk Assessment & Prioritization, what is the FIRST step a CAPA professional should take when encountering a new case or situation?
In Risk Assessment & Prioritization, a thorough initial assessment ensures all relevant factors are identified before deciding on an appropriate course of action. This systematic approach is fundamental to Corrective and Preventive Action Certified practice.
2. What is 'design change control' in the context of a CAPA for a medical device?
Design change control per 21 CFR 820.30(i) ensures that any modification to device design is reviewed, verified, validated, and approved before implementation.
3. Which of the following best describes a preventive action that originates from analysis of supplier performance trend data?
A preventive action leverages trend data to address a potential future nonconformance before it escalates, distinguishing it from a corrective action which responds to an already-confirmed problem.
4. Which of the following tools is commonly used in root cause analysis?
The Fishbone Diagram helps visualize and categorize possible causes of a problem, supporting systematic analysis.
5. What is the PRIMARY purpose of continuing education requirements in Risk Assessment & Prioritization for CAPA professionals?
Continuing education in Risk Assessment & Prioritization ensures professionals maintain current knowledge and skills as standards, technologies, and best practices evolve in the Corrective and Preventive Action Certified field.
6. What is the PRIMARY purpose of continuing education requirements in Investigation Techniques for CAPA professionals?
Continuing education in Investigation Techniques ensures professionals maintain current knowledge and skills as standards, technologies, and best practices evolve in the Corrective and Preventive Action Certified field.