RAC-US Online Practice Questions and Answers

After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

A. Resubmit the entire package.

B. Inform upper management immediately.

C. Contact the legal department and ask them how to proceed.

D. Verify the procedure in the regulation for the corrections.

At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

A. Quality improvement

B. Quality assurance

C. Clinical affairs

D. Regulatory agency

At a recent scientific meeting,Company Y had two booths:

At one booth,Company Y provided brochures on a completed Phase II study.

In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products.

A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

A. Acknowledge receipt of the letter in a written response but do nothing further.

B. Inform the legal department of the letter and discuss how to respond.

C. Inform Company X that it has no right to send such a letter and do nothing further.

D. Inform the local regulatory authority of the letter and discuss how to respond.

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

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

The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

A. Transfer the notice of the upcoming international monograph change to QA for further processing.

B. Prepare the international monograph change submission first and then prepare the local change when required.

C. Confirm that the international monograph change is not related to local pharmacopeia.

D. Analyze the impact of the international monograph change on the local pharmacopeia.

According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

A. Class A

B. Class B

C. Class C

D. Class D

A company is currently marketing an implantable orthopedic medical device. The RandD department is planning to change the material used for the implant. The RandD department states that the change does not impact the safety and effectiveness of the product.

What action should the regulatory affairs professional take FIRST?

A. No action is needed in this situation.

B. Prepare regulatory submissions that detail the medical device's change in materials.

C. Review the content of change and supporting data for the equivalency with the current material.

D. Write a memo to file since the change does not impact product safety and effectiveness.

A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

A. In vitro studies show the product to be superior.

B. Government survey data indicate the product is superior.

C. Results of a three-year, post-market patient survey indicate the product is superior.

D. Results of adequate, well-controlled comparative clinical trial show the product is superior.

A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

A. Plasma fractionation

B. Product distribution

C. Individual plasma donation

D. Plasma pooling