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

RAPS RAC-US - Regulatory Affairs Certification (RAC) US Braindumps

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:Nov 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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RAC-US FAQs

The Regulatory Affairs Certification (RAC) is a credential for regulatory professionals in the healthcare sector. It verifies proficiency in the regulatory field for pharmaceuticals or medical devices.

There are two RAC designations: RAC-Drugs, for professionals working with pharmaceuticals, and RAC-Devices, for those focused on medical devices.

The RAC exams are intended for individuals with at least three years of regulatory experience in industries like healthcare, regulatory agencies, or consultancy firms.

RAC certification illustrates regulatory proficiency, highlights accomplishments, promotes ongoing development, and can secure higher earning potential, with RAC holders earning 7.5% more than non-RAC holders.

For employers, RAC certification validates employees’ competence, encourages continuous professional development, enhances workforce productivity, and serves as a tool for employee retention.

Each RAC exam consists of 100 multiple-choice questions, and candidates have two hours to complete the exam.

The exam includes three types of questions: recall, application, and analysis. These formats test specific knowledge, practical application, and critical analysis skills.

The RAC-Devices exam covers full product development and lifecycle requirements for medical devices, as well as FDA requirements, European regulations, and globally applicable regulatory practices.

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