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Questions and Answers
According to 21 CFR Part 820, what is the purpose of the requirements in this regulation?
According to 21 CFR Part 820, what is the purpose of the requirements in this regulation?
- To establish guidelines for conducting quality audits
- To empower individuals to do their job correctly
- To ensure that finished devices will be safe and effective (correct)
- To define personnel accountability
Who is responsible for conducting quality audits according to 21 CFR Part 820?
Who is responsible for conducting quality audits according to 21 CFR Part 820?
- Those who have direct responsibility for the areas being audited
- Those who have no direct responsibility for the areas being audited (correct)
- Those who have experience in quality system management
- Those who have received the necessary education and training
According to 21 CFR Part 820, what is the role of management in the quality system?
According to 21 CFR Part 820, what is the role of management in the quality system?
- To take corrective action when necessary
- To identify training needs for personnel
- To review the results of quality audits
- All of the above (correct)
What is the requirement for personnel according to 21 CFR Part 820?
What is the requirement for personnel according to 21 CFR Part 820?
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According to the text, what does it mean to be 'empowered' in the context of FDA regulations?
According to the text, what does it mean to be 'empowered' in the context of FDA regulations?
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