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RAC Regulatory Affairs Certification RAC-GS (PDF, APP, software).
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RAC-GS PDF DEMO:
QUESTION NO: 1
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control
activities for a medical device?
A. Fishbone analysis
B. Failure modes, effects, and criticality analysis
C. Fault tree analysis
D. Quality by design analysis
Answer: B
QUESTION NO: 2
Who has the PRIMARY responsibility for recall of products with quality defects?
A. Consumer
B. Distributor
C. Manufacturer
D. Regulatory authority
Answer: C
QUESTION NO: 3
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which
of the following approvals should be received FIRST?
A. Site license
B. Product license
C. Import license
D. Export license
Answer: A
QUESTION NO: 4
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
A. Ask the trade association representative to provide an overview of the new product area to the marketing team.
B. Obtain competitor research and provide the information to the management team.
C. Obtain regulatory documents and history and provide the information to R&D.
D. Summarize regulatory documents and history and provide the information to the management team.
Answer: D
QUESTION NO: 5
Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study
with a new product intended to treat an acute life-threatening disease with less than optimal available
therapy?
A. Active-controlled
B. Cross-over
C. Dose-ranging
D. Placebo-controlled
Answer: B
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Updated: May 28, 2022