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NEW QUESTION 35
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

• A. Causes of non-conformities
• B. Inadequate training
• C. Adverse environmental impacts
• D. Late and/or incorrect deliverables

Answer: A

NEW QUESTION 36
At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

• A. Inform the local regulatory authority of the letter and discuss how to respond.
• B. Acknowledge receipt of the letter in a written response but do nothing further.
• C. Inform Company X that it has no right to send such a letter and do nothing further.
• D. Inform the legal department of the letter and discuss how to respond.

Answer: D

NEW QUESTION 37
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

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

Answer: B

NEW QUESTION 38
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

• A. Expiration date
• B. Relevance to regulations
• C. Revision history
• D. Scope and level of detail

Answer: B

NEW QUESTION 39
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