최신 RAC Regulatory Affairs Certification RAC-US 무료샘플문제:

1. What is the LAST stage in the development of a quality risk management process for a medical device?

A) Risk reduction
B) Risk analysis
C) Risk evaluation
D) Risk acceptance

2. A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

A) Expiration date
B) Scope and level of detail
C) Revision history
D) Relevance to regulations

3. A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

A) Risk management process
B) Labeling
C) Safety-related reporting
D) Regulatory application summary

4. The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?

A) Prepare the legal team in Country Y for possible litigations.
B) Initiate a mandatory recall of the product in Country Y.
C) Review alt distribution records and complaints reported in Country Y.
D) Draft a formal letter to customers in Country Y about this recall.

5. A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

A) Individual plasma donation
B) Plasma fractionation
C) Product distribution
D) Plasma pooling

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