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NEW QUESTION 35
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. Train employees on all regulatory compliance processes using state-of-the-art systems.C. Document any failure to follow regulatory compliance processes in employee performance reviews.D. Develop documented procedures for regulatory compliance processes and train personnel.

Answer: D

 

NEW QUESTION 36
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 assuranceB. Quality improvementC. Clinical affairsD. Regulatory agency

Answer: A

 

NEW QUESTION 37
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

A. Import licenseB. Export licenseC. Product licenseD. Site license

Answer: D

 

NEW QUESTION 38
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