QUESTION: 49

What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

Ask the vendor to take responsibility.
Document and perform audits.
Request an inspection from a regulatory authority.
Request documentation from the sub-contractor.

Answer(s): B

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QUESTION: 50

A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

Documented agreement
Frequent communication
Early collaboration
Follow-up meeting after submission

Answer(s): B

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QUESTION: 51

Which of the following claims would classify an apple as a drug?

"It will make you look younger."
"It will satisfy hunger."
"It will whiten teeth."
"It will prevent colds."

Answer(s): D

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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?

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

Answer(s): B,D

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Free RAC-GS Exam Braindumps (page: 13)

QUESTION: 49

QUESTION: 50

QUESTION: 51

QUESTION: 52