SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?
A. Inadequate training
B. Late and/or incorrect deliverables
C. Causes of non-conformities
D. Adverse environmental impacts
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?
A. The ISO national member body
B. The ISO technical committee in charge of the area
C. The ISO Secretariat
D. The country's regulatory authority
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?
A. Initiate testing immediately to ensure compliance.
B. Consult with colleagues about the request.
C. Contact the regulatory authority that issued this request and discuss the requirement.
D. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
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. Ask that the regulatory authority provide the actual product subject to the complaint.
C. Respond to the regulatory authority that the product subject to the complaint is most likely acounterfeit product.
D. Respond to the regulatory authority that the company will provide copies of the relevant QCrecords for batch release.
According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?
A. 3
B. 5
C. 7
D. 9
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?
A. Obtain a copy of the proposed regulation and analyze the impact.
B. Inform the company's senior management and arrange an emergency meeting
C. Consult with the company's legal department regarding options.
D. Arrange for additional testing of the product at the testing facility.
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?
A. Increase the frequency of monitoring visits.
B. Inform the institution that granted a medical license to the Pi.
C. Send a letter of complaint to the Ethics Committee that approved the site.
D. Terminate the PI and inform the regulatory authorities.
Which of the following statements regarding export regulations for an approved product is CORRECT?
A. The product must not be in accord with the specifications of the foreign purchaser.
B. The product must not be in conflict with the laws of the country to which it is intended forexport.
C. The product must not be labeled on the outside of the shipping package that it is intendedfor export.
D. The product must not be sold or offered for sale in domestic commerce.
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
A. Adverse event reports
B. Clinical experience
C. Clinical investigations
D. Literature search
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?
A. Inform the regulatory authorities.
B. Delay the start of product production.
C. Correct the label text.
D. Abort the product launch.
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