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NEW QUESTION 47
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

  • A. Adverse environmental impacts
  • B. Inadequate training
  • C. Late and/or incorrect deliverables
  • D. Causes of non-conformities

Answer: D

 

NEW QUESTION 48
Who has the PRIMARY responsibility for recall of products with quality defects?

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

Answer: A

 

NEW QUESTION 49
A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

  • A. Labeling
  • B. Risk management process
  • C. Regulatory application summary
  • D. Safety-related reporting

Answer: A

 

NEW QUESTION 50
……

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