Imacor GMP Quiz 2014
11 Questions
| Total Attempts: 379
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- 9.What is the requirement for what must be done if you discover a nonconforming product, such as an instrument, out of date manual, or improper labeling.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
Back to top