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NEW QUESTION 46
What is the LAST stage in the development of a quality risk management process for a medical device?

A. Risk evaluationB. Risk reductionC. Risk acceptanceD. Risk analysis

Answer: C

 

NEW QUESTION 47
Which of the following criteria is MOST appropriate to define the animal species needed for the
pre-clinical toxicity testing of a biotechnology product?

A. Proposed dose and volume of administrationB. Immunochemical and functional testsC. Biological activity with species and/or tissue specificityD. Proposed product route and frequency of administration

Answer: C

 

NEW QUESTION 48
An inspection of a manufacturing site determines that a number of manufacturing changes have been
implemented without obtaining the necessary regulatory clearance. Which of the following actions should
the regulatory affairs professional complete FIRST?

A. Establish validation procedures.B. Review the stability data for the changes.C. Assess the impact of the changes.D. Stop product manufacturing.

Answer: D

 

NEW QUESTION 49
Which of the following situations does NOT require rapid communication to regulatory authorities?

A. A lack of efficacy with a medicinal product used in treating a life-threatening diseaseB. A statistically significant increase in the number of deaths in an animal dose finding studyC. A clinically important increase in the rate of occurrence of an "expected." but serious ADRD. A major safety finding from a newly completed animal carcinogenicity study

Answer: C

 

NEW QUESTION 50
A company is developing a line of products for which no ISO standard of performance is available. As a
result, the company wishes to propose developing such a standard. Whom should the company contact in
order to start the development of the new standard?

A. The ISO technical committee in charge of the areaB. The country's regulatory authorityC. The ISO SecretariatD. The ISO national member body

Answer: D

 

NEW QUESTION 51
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