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NEW QUESTION 38
A process is ultimately validated to ensure which of the following?

A. The process meets the regulatory requirements.B. The process meets the quality system requirements.C. The process consistently meets the desired Quantity standardsD. The process consistently produces the desired results.

Answer: D

 

NEW QUESTION 39
In which section of the ICH Common Technical Document will the overview of clinical data appear?

A. Module 2B. Module 3C. Module 1D. Module 4

Answer: A

 

NEW QUESTION 40
A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

A. Obtain regulatory documents and history and provide the information to R&D.B. Summarize regulatory documents and history and provide the information to the management team.C. Ask the trade association representative to provide an overview of the new product area to the marketing team.D. Obtain competitor research and provide the information to the management team.

Answer: B

 

NEW QUESTION 41
......

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