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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
NEW QUESTION 48
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Manufacturer
- B. Distributor
- C. Consumer
- D. Regulatory authority
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
NEW QUESTION 50
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