최신RAPS Regulatory Affairs Certification (RAC) Global Scope - RAC-GS무료샘플문제

A. Allow the auditor accompanied access to the room to retrieve the records.

B. Deny the auditor access to the room and retrieve only the requested records.

C. Deny the auditor access to the room and records due to confidentiality concerns.

D. Allow the auditor access to the room and records due to the current audit.

A. Hazard and operability study

B. ISO 14971 risk analysis

C. Failure mode and effect analysis

D. Fault tree analysis

A. Until the product has been discontinued from marketing in all ICH regions

B. Fora minimum of 10 years after completion of the clinical study

C. Three years after the last clinical study site was supplied with investigational drugs

D. For at least two years after the last approval of an application in an ICH region

A. Subject is hospitalized due to complications of the product administration.

B. Subject is hospitalized for the purpose of product administration.

C. Subject's hospitalization is prolonged during the clinical trial.

D. Subject's hospitalization is due to an unscheduled hip operation.

A. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

B. Perform either an identification study or a non-clinical qualification study.

C. Perform both identification and non-clinical qualification studies concurrently.

D. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

A. Ask the trade association representative to provide an overview of the new product area to the marketing team.

B. Summarize regulatory documents and history and provide the information to the management team.

C. Obtain competitor research and provide the information to the management team.

D. Obtain regulatory documents and history and provide the information to R&D.

A. Deleting a drug substance

B. Strengthening a precaution to the product labeling

C. Introducing a new analytical method

D. Deleting an ingredient of the drug product

A. Previous actions taken by regulatory authorities on similar products

B. Regulatory requirements for labeling and packaging

C. Capacity of the manufacturing facilities to fully produce the new product

D. Potential clinical sites for the Phase III clinical trial

A. Quality and effectiveness

B. Safety and failure risk

C. Quality and failure risk

D. Safety and effectiveness

A. Train all new employees on regulatory compliance processes and assign a mentor to them.

B. Train employees on all regulatory compliance processes using state-of-the-art systems.

C. Document any failure to follow regulatory compliance processes in employee performancereviews.

D. Develop documented procedures for regulatory compliance processes and train personnel.