Regulatory Affairs Study Guide
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Regulatory Affairs Certification Study Guide
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RAC-US PDF DEMO: QUESTION NO: 1 Who has the PRIMARY responsibility for recall of products with quality defects? Distributor B. Manufacturer C. Regulatory authority Answer: B QUESTION NO: 2 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?
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 Answer: C QUESTION NO: 3 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?
Failure mode and effect analysis B. Fault tree analysis C. ISO 14971 risk analysis D. Hazard and operability study Answer: C QUESTION NO: 4 In which section of the ICH Common Technical Document will the overview of clinical data appear? Module 4 Answer: A QUESTION NO: 5 A regulatory affairs professional has submitted a package for regulatory review.
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According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach? Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
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