Quality Control and Process Validation Quiz
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Questions and Answers

Which of the following is NOT a requirement for labeling and packaging control?

  • Designing and constructing packaging to protect the device
  • Ensuring labels remain legible and affixed during processing
  • Establishing procedures for handling, storage, and distribution
  • Releasing labels without inspection (correct)

    • What should be done with nonconforming products?

  • Evaluate and segregate them (correct)
  • Use them after discovery of nonconformance
  • Maintain procedures for rework and retest
  • Dispose of them immediately

    • What is the purpose of Corrective and Preventive Action (CAPA)?

  • To maintain accessible records for review and copying
  • To investigate the causes of nonconformity
  • To analyze work operations and quality records
  • To fix problems and prevent their recurrence (correct)

    • Which of the following is NOT required for maintaining complaint files according to FDA regulations?

    <p>Investigating all complaints received</p> Signup and view all the answers

    Which of the following is NOT included in the Device Master Record (DMR) for each device?

    <p>Complaint files</p> Signup and view all the answers

    What is the purpose of establishing and maintaining procedures for statistical techniques in a quality system?

    <p>To ensure the acceptability of process capability and product characteristics</p> Signup and view all the answers

    What is the significance of the new regulations implemented in Europe for medical devices?

    <p>They have made medical device rules EU laws</p> Signup and view all the answers

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