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RAC-US Dumps - Regulatory Affairs Certification (RAC) US Practice Exam Questions

RAPS RAC-US - RAC Regulatory Affairs Certification Practice Exam

  • Certification Provider:RAPS
  • Exam Code:RAC-US
  • Exam Name:Regulatory Affairs Certification (RAC) US Exam
  • Total Questions:100 Questions and Answers
  • Updated on:May 21, 2024
  • Product Format: PDF & Test Engine Software Version
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RAPS RAC-US This Week Result

RAC-US Question and Answers

Question # 1

According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability study?

Options:

A.  

25: C and 60% RH

B.  

30° C and 35% RH

C.  

30c C and 65% RH

D.  

30: C and 75% RH

Discussion 0
Question # 2

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

Options:

A.  

To carry out a complete review of product applications

B.  

To define how to prepare new product submissions

C.  

To document compliance history

D.  

To train sales representatives

Discussion 0
Question # 3

Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

Options:

A.  

Utilize the STED template to complete global requirements.

B.  

Initiate a global submission process after all submission data are finalized.

C.  

Identify countries where special requirements exist during the product development phase.

D.  

Plan regulatory approval update meetings with senior management and stakeholders.

Discussion 0

PDF vs Software Version

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