(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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What does the letter P stand for in CAPA?
Preventive
An example of a deliverable is to identify training audience for a change plan
False
Change Control Process Consists of
DMR
Number of days to initiate a non-conformance.
7
Regulatory audits are conducted to ensure adherence to relevant regulations and guidelines
True
_____ ensures that a product is consistently produced according to quality standards:
GMP
QMS mean
Quality Management System
Term used for reviewing and maintaining regulatory compliance
RA Audit
What are the submission types?
510k
Used to implement changes to a document.
Change Request
Free!
What are the submission types?
IVDR
What is the CFR that is commonly followed?
21 CFT 820.30
Replica of the 1891 home of founder Dr. Wallace Abbott.
What ensures a process, method, or system meets set specifications?
Validation Protocol
Temporary change to a process and / or procedure.
Deviation
This process is used to track and manage changes in documentation.
Document Control
A document that describes how to perform a task correctly.
SOP
A routine check to ensure that a process or system is working as intended
Audit
What are the US submission types?
De NOVO
Change Control Process Consists of
QSR
What are the submission types?
PMA
Quality Assurance (QA) is only concerned with the final product, not the process..
False
Abbreviation for Pre-defined Low Impact Changes.
PDLIs
