RAC-US Dumps PDF | RAPS RAC-US Free Sample Questions

Sample Questions:

Question: 1

A superiority advertising claim for a product versus its competitor's product can only be made under
which of the following circumstances?

A. In vitro studies show the product to be superior.
B. Government survey data indicate the product is superior.
C. Results of a three-year, post-market patient survey indicate the product is superior.
D. Results of adequate, well-controlled comparative clinical trial show the product is superior.

Answer: D

Question: 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. Relevance to regulations
C. Revision history
D. Scope and level of detail

Answer: B

Question: 3

Which term does NOT describe the same concept as the others?

A. Biosimilars
B. Follow-on protein products
C. Monoclonal antibody
D. Subsequent entry biologics

Answer: C

Question: 4

SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

A. Inadequate training
B. Late and/or incorrect deliverables
C. Causes of non-conformities
D. Adverse environmental impacts

Answer: C

Question: 5

During the review of a design dossier, the reviewer asks why the company has only carried out a topdown risk approach. The reviewer is referring to which of the following?

A. ISO 14971 risk analysis
B. Failure mode and effect analysis
C. Fault tree analysis
D. Hazard and operability study

Answer: A

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