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Free RAC-GS Exam Braindumps (page: 6)

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QUESTION: 21

Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

Systematic procedure to review published scientific journals
Systematic procedure to review experiences with the products in use
Vigilance procedure to ensure the full traceability of the products
Vigilance procedure to notify the regulatory authorities about serious incidents

Answer(s): C,D

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QUESTION: 22

According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

Risk estimation
Risk analysis
Risk control
Risk management

Answer(s): B

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QUESTION: 23

Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

Deleting an ingredient of the drug product
Deleting a drug substance
Introducing a new analytical method
Strengthening a precaution to the product labeling

Answer(s): D

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QUESTION: 24

According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?

25: C and 60% RH
30° C and 35% RH
30c C and 65% RH
30: C and 75% RH

Answer(s): D

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Raymond commented on May 02, 2022
Best way to cheat your exam. hahaha... all questions are in this dexam dump.
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