The ImaCor GMP Quiz 2014 assesses knowledge on regulatory compliance and quality management in the medical device sector, covering FDA areas, ISO standards, and European directives. It is essential for professionals in the medical device industry.
True
False
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US Regulatory Body
CFR 820
US Quality System Requirement
All of the Above
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Good
Medicinal
Manufacturing
Practices
Procedures
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True
False
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Call the FDA
Prevent it from it's uninteded use
Notify, Quality or the Program Manger who will do a root cause analysis
Take appropriate actions to repair, destroy, set aside.
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Medical Device Mandate
Medical Device Directive
Medical Device Classification
Medical Design Directive
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True
False
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Fine ImaCor
Not inspect ImaCor Facilities
Recall an ImaCor Product
Prosecute employees of Imacor
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G-drive
S-drive
C-Drive
None of the Above
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Quiz Review Timeline (Updated): Mar 22, 2023 +
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