5 Questions
According to 21 CFR Part 820, what is the purpose of the requirements in this regulation?
To ensure that finished devices will be safe and effective
Who is responsible for conducting quality audits according to 21 CFR Part 820?
Those who have no direct responsibility for the areas being audited
According to 21 CFR Part 820, what is the role of management in the quality system?
All of the above
What is the requirement for personnel according to 21 CFR Part 820?
All of the above
According to the text, what does it mean to be 'empowered' in the context of FDA regulations?
To have authority and independence
Test your knowledge on the FDA's requirements for quality management in this quiz. Learn about management commitment, personal accountability, good documentation practices, and more. Find out if you have what it takes to recognize and fix problems in the field of quality control.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
