cGMP 101 Knowledge Check (Module 1) Rev 1_13SEP2022

Who is the Quality Systems Manager?
Cari Prosi
Nichole Navarro
Andrea Beutler
Laura Garland
Roya Bazl
Where do I look to identify QA Representatives?
Walk around the office
Ask Siri
On the Org Chart
Your Supervisor should know
Where is the Org Chart located/housed?
S:\Document Library - Approved\6000_HR and Training
S:\Employee Resources
The breakroom
Committed to memory
What does cGMP stand for?
common Great Manufacturing Policies
current Good Manufacturing Practice
customary Grand Manufacturing Parameters
critical Glorious Manufacturing Procedures
If you identify an error on a record - prior to using it for a manufacturing process - you are permitted to ignore the error and use the record performing the process in correct way?
Go ahead and use it, just so long as YOU are aware of the error
No, bring the error to the attention of QA prior to carrying out the intended process
Who enforces the 21CFR820 Medical Device regulation?
EUMDR - European Union Medical Device Regulation
JoiCo - Joint Commission
CMS - Centers for Medicare & Medicaid Services
FDA - Food and Drug Administration
Where do you find/obtain approved documents for use in manufacturing?
Stored on my desktop
S:\Manufacturing
S:\Document Library - Approved
Google it
The document I printed from the S drive says that it's at revision 1, effective in 2017; however, I know that it revised in 2022. QA never makes mistakes, so I should just go ahead and use it.
Since QA never makes a mistake, YOU must have been mistaken thinking it revised
Check with QA prior to using the document, QA is comprised of people who can make mistakes, ensure the document is most current before using it
 
cGMPs are considered
Solid recommendations, but not necessary to follow
Not necessary when no one is looking
The 'gold standard' for manufacturing, the expectation is that they are followed precisely.
Undecided
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