Imacor GMP Quiz 2014

11 Questions | Total Attempts: 334

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Imacor GMP Quiz 2014

Questions and Answers
  • 1. 
    The Food and Drug Administration covers the following areas?
    • A. 

      US Regulatory Body

    • B. 

      CFR 820

    • C. 

      US Quality System Requirement

    • D. 

      All of the Above

  • 2. 
    The Management Representative responsibilty is documented in the Quality Manual?
    • A. 

      True

    • B. 

      False

  • 3. 
    What does GMP stand for? (Select All tha Apply)
    • A. 

      Good

    • B. 

      Medicinal

    • C. 

      Manufacturing

    • D. 

      Practices

    • E. 

      Procedures

  • 4. 
    All Medical Device Companies are required to be ISO 13485 Registered?
    • A. 

      True

    • B. 

      False

  • 5. 
    93/42/EEC is the European?
    • A. 

      Medical Device Mandate

    • B. 

      Medical Device Directive

    • C. 

      Medical Device Classification

    • D. 

      Medical Design Directive

  • 6. 
    CAPA stands for Corrective Action Presents Action?
    • A. 

      True

    • B. 

      False

  • 7. 
    The FDA has the authority to do all of the following EXCEPT:
    • A. 

      Fine ImaCor

    • B. 

      Not inspect ImaCor Facilities

    • C. 

      Recall an ImaCor Product

    • D. 

      Prosecute employees of Imacor

  • 8. 
    All of our QMS Work Instructions, SOP's, Forms, Databases, etc. are required to be "controlled".
    • A. 

      True

    • B. 

      False

  • 9. 
    What is the requirement for what must be done if you discover a nonconforming product, such as an instrument, out of date manual, or improper labeling. Please check the most appropriate answer:
    • A. 

      Call the FDA

    • B. 

      Prevent it from it's uninteded use

    • C. 

      Notify, Quality or the Program Manger who will do a root cause analysis

    • D. 

      Take appropriate actions to repair, destroy, set aside.

  • 10. 
    Where can the following documents be found:1. Quality Manual2. Quality Policy3. Quality SOP's
    • A. 

      G-drive

    • B. 

      S-drive

    • C. 

      C-Drive

    • D. 

      None of the Above

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