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RAC-US Exam Questions & Answers

Exam Code: RAC-US

Exam Name: Regulatory Affairs Certification (RAC) US

Updated:

Q&As: 100

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Practice These Free Questions and Answers to Pass the RAPS Certifications Exam

Questions 1

Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

A. Systematic procedure to review published scientific journals

B. Systematic procedure to review experiences with the products in use

C. Vigilance procedure to ensure the full traceability of the products

D. Vigilance procedure to notify the regulatory authorities about serious incidents

Show Answer
Questions 2

The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

A. Production

B. Analytical

C. Quality

D. Regulatory

Show Answer
Questions 3

What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

A. Ask the vendor to take responsibility.

B. Document and perform audits.

C. Request an inspection from a regulatory authority.

D. Request documentation from the sub-contractor.

Show Answer
Questions 4

In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

A. Local reimbursement requirements

B. Service operation procedures

C. Training program for sales people

D. Written procedure for product traceability

Show Answer
Questions 5

According to ICH, which of the following components of study information is NOT required in a clinical study report?

A. Randomization scheme and codes

B. Protocol and protocol amendments

C. ListoflECsorlRBs

D. Detailed CVofall investigators

Show Answer

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