(Print) Use this randomly generated list as your call list when playing the game. There is no need to say the BINGO column name. Place some kind of mark (like an X, a checkmark, a dot, tally mark, etc) on each cell as you announce it, to keep track. You can also cut out each item, place them in a bag and pull words from the bag.
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An example of a deliverable is to identify training audience for a change plan
False
What are the submission types?
PMA
A routine check to ensure that a process or system is working as intended
Audit
This process is used to track and manage changes in documentation.
Document Control
Regulatory audits are conducted to ensure adherence to relevant regulations and guidelines
True
Number of days to initiate a non-conformance.
7
What is the CFR that is commonly followed?
21 CFT 820.30
What are the submission types?
IVDR
What are the US submission types?
De NOVO
Quality Assurance (QA) is only concerned with the final product, not the process..
False
Change Control Process Consists of
QSR
What are the submission types?
510k
Free!
Temporary change to a process and / or procedure.
Deviation
_____ ensures that a product is consistently produced according to quality standards:
GMP
Abbreviation for Pre-defined Low Impact Changes.
PDLIs
Term used for reviewing and maintaining regulatory compliance
RA Audit
A document that describes how to perform a task correctly.
SOP
QMS mean
Quality Management System
Replica of the 1891 home of founder Dr. Wallace Abbott.
What ensures a process, method, or system meets set specifications?
Validation Protocol
What does the letter P stand for in CAPA?
Preventive
Change Control Process Consists of
DMR
Used to implement changes to a document.
Change Request
