RAC-US 무료 덤프문제 온라인 액세스

Which term does NOT describe the same concept as the others?

• A.Follow-on protein products
• B.Biosimilars
• C.Monoclonal antibody
• D.Subsequent entry biologics

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

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.Fault tree analysis
• C.Failure mode and effect analysis
• D.ISO 14971 risk analysis

Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

• A.Train all new employees on regulatory compliance processes and assign a mentor to them.
• B.Develop documented procedures for regulatory compliance processes and train personnel.
• C.Train employees on all regulatory compliance processes using state-of-the-art systems.
• D.Document any failure to follow regulatory compliance processes in employee performance reviews.

According to ICH, which of the following components of study information is NOT required in a clinical study report?

• A.List of lECs or lRBs
• B.Detailed CV of all investigators
• C.Protocol and protocol amendments
• D.Randomization scheme and codes