RAPS RAC-GS Exam Questions & Answers

A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?

A. Review the company's existing Quality ManagementSystem

B. Reformulate the products with a replacement material.

C. Qualify another supplier and execute a supplier agreement.

D. Complete a gap analysis to identify options.

A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

A. Documented agreement

B. Frequent communication

C. Early collaboration

D. Follow-up meeting after submission

An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?

A. Stop product manufacturing.

B. Establish validation procedures.

C. Assess the impact of the changes.

D. Review the stability data for the changes.