RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 41:

  A process is ultimately validated to ensure which of the following?

  A. The process meets the regulatory requirements.
  B. The process meets the quality system requirements.
  C. The process consistently produces the desired results.
  D. The process consistently meets the desiredQuantity standards
  C. The process consistently produces the desired results.

• Question 42:

  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
  B. Failure modes, effects, and criticality analysis

• Question 43:

  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
  C. Vigilance procedure to ensure the full traceability of the products
  D. Vigilance procedure to notify the regulatory authorities about serious incidents

• Question 44:

  A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

  A. In vitro studies show the product to be superior.
  B. Government survey data indicate the product is superior.
  C. Results of a three-year, post-market patient survey indicate the product is superior.
  D. Results of adequate, well-controlled comparative clinical trial show the product is superior.
  D. Results of adequate, well-controlled comparative clinical trial show the product is superior.

• Question 45:

  After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

  A. Resubmit the entire package.
  B. Inform upper management immediately.
  C. Contact the legal department and ask them how to proceed.
  D. Verify the procedure in the regulation for the corrections.
  D. Verify the procedure in the regulation for the corrections.

• Question 46:

  Who has the PRIMARY responsibility for recall of products with quality defects?

  A. Consumer
  B. Distributor
  C. Manufacturer
  D. Regulatory authority
  C. Manufacturer

• Question 47:

  According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

  A. Class A
  B. Class B
  C. Class C
  D. Class D
  C. Class C

• Question 48:

  A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

  A. Negotiate with colleagues and the authority to find a better time.
  B. Insist that key personnel be available for the inspection.
  C. Inform the authority that the time is not suitable and request a new time
  D. Arrange for an inspection without all intended personnel.
  A. Negotiate with colleagues and the authority to find a better time.

• Question 49:

  In which section of the ICH Common Technical Document will the overview of clinical data appear?

  A. Module 1
  B. Module 2
  C. Module 3 D. Module 4
  B. Module 2
  C. Module 3 D. Module 4

• Question 50:

  A company is currently marketing an implantable orthopedic medical device. The RandD department is planning to change the material used for the implant. The RandD department states that the change does not impact the safety and effectiveness of the product.

  What action should the regulatory affairs professional take FIRST?

  A. No action is needed in this situation.
  B. Prepare regulatory submissions that detail the medical device's change in materials.
  C. Review the content of change and supporting data for the equivalency with the current material.
  D. Write a memo to file since the change does not impact product safety and effectiveness.
  C. Review the content of change and supporting data for the equivalency with the current material.