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NEW QUESTION # 24
Which of the following is the PRIMARY purpose of an audit report?
- A. To train sales representatives
- B. To document compliance history
- C. To carry out a complete review of product applications
- D. To define how to prepare new product submissions
NEW QUESTION # 25
During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?
- A. All senior management from the main office
- B. As many as government attendees
- C. The minimum number of attendees necessary to address the issues
- D. As many as required by international standards
NEW QUESTION # 26
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?
- A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
- B. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release.
- C. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.
- D. Ask that the regulatory authority provide the actual product subject to the complaint.
NEW QUESTION # 27
A process is ultimately validated to ensure which of the following?
- A. The process meets the quality system requirements.
- B. The process consistently produces the desired results.
- C. The process consistently meets the desired Quantity standards
- D. The process meets the regulatory requirements.
NEW QUESTION # 28