FDA Quality Management Quiz
5 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

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?

  • 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?

  • 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?

    <p>All of the above</p> Signup and view all the answers

    According to the text, what does it mean to be 'empowered' in the context of FDA regulations?

    <p>To have authority and independence</p> Signup and view all the answers

    More Like This

    Compass Health SOP Verification Procedures
    10 questions
    Compass Health SOP: Quality Systems Audit
    10 questions
    Use Quizgecko on...
    Browser
    Browser