RAPS RAC-US Exam Questions & Answers

A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?

A. Approved indications of the drug

B. Determination of primary mode of action

C. Determination of product design deliverables

D. Guidance documents for the device

Which of the following is the PRIMARY purpose of an audit report?

A. To carry out a complete review of product applications

B. To define how to prepare new product submissions

C. Todocument compliance history

D. To train sales representatives

Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

A. Document any failure to follow regulatory compliance processes in employee performancereviews.

B. Develop documented procedures for regulatory compliance processes and train personnel.

C. Train all new employees on regulatory compliance processes and assign a mentor to them.

D. Train employees on all regulatory compliance processes using state-of-the-art systems.