최신 RAC-US 무료덤프 - RAPS Regulatory Affairs Certification (RAC) US

문제1

During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?

A. Withdraw the affected product from the markets.

B. Notify the global regulatory authorities.

C. Send a "Dear Dr." letter to customers.

D. Assess the potential safety risk.

정답: B

문제2

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. Abort the product launch.

B. Correct the label text.

C. Delay the start of product production.

D. Inform the regulatory authorities.

정답: D

문제3

Which of the following claims would classify an apple as a drug?

A. "It will prevent colds."

B. "It will make you look younger."

C. "It will whiten teeth."

D. "It will satisfy hunger."

정답: A

문제4

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 Secretariat

B. The ISO national member body

C. The ISO technical committee in charge of the area

D. The country's regulatory authority

정답: B

문제5

Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

A. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.

B. The manufacturer's experience level with the type of IVD medical device is limited.

C. The device incorporates well-established technology that is already present in the market.

D. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.

정답: B

문제6

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 for export.

C. The product must not be sold or offered for sale in domestic commerce.

D. The product must not be labeled on the outside of the shipping package that it is intended for export.

정답: B

문제7

In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

A. Service operation procedures

B. Local reimbursement requirements

C. Training program for sales people

D. Written procedure for product traceability

정답: C

문제8

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

A. Distributor

B. Manufacturer

C. Regulatory authority

D. Consumer

정답: B

문제9

During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

A. Hazard and operability study

B. ISO 14971 risk analysis

C. Fault tree analysis

D. Failure mode and effect analysis

정답: B

문제10

What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A. Quality and failure risk

B. Safety and effectiveness

C. Safety and failure risk

D. Quality and effectiveness

정답: B

최신 RAC-US 무료덤프 - RAPS Regulatory Affairs Certification (RAC) US

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