FalseAn example ofa deliverable isto identifytrainingaudience for achange planRAAuditTerm used forreviewing andmaintainingregulatorycomplianceQSRChangeControlProcessConsists ofTrueRegulatory auditsare conducted toensure adherenceto relevantregulations andguidelinesGMP_____ ensuresthat a product isconsistentlyproducedaccording toquality standards:DocumentControlThis process isused to trackand managechanges indocumentation.ValidationProtocolWhat ensures aprocess,method, orsystem meetssetspecifications?DeNOVOWhat arethe USsubmissiontypes?QualityManagementSystemQMSmeanDeviationTemporarychange to aprocess and/ orprocedure.PreventiveWhat doesthe letterP stand forin CAPA?SOPA documentthat describeshow toperform a taskcorrectly.PDLIsAbbreviationfor Pre-defined LowImpactChanges.Free!PMAWhat arethesubmissiontypes?AuditA routine checkto ensure that aprocess orsystem isworking asintended510kWhat arethesubmissiontypes?21 CFT820.30What is theCFR that iscommonlyfollowed?FalseQualityAssurance (QA)is onlyconcerned withthe final product,not the process..DMRChangeControlProcessConsists of7Number ofdays toinitiate a non-conformance.ChangeRequestUsed toimplementchanges toa document.IVDRWhat arethesubmissiontypes?Replica of the1891 home offounder Dr.WallaceAbbott.FalseAn example ofa deliverable isto identifytrainingaudience for achange planRAAuditTerm used forreviewing andmaintainingregulatorycomplianceQSRChangeControlProcessConsists ofTrueRegulatory auditsare conducted toensure adherenceto relevantregulations andguidelinesGMP_____ ensuresthat a product isconsistentlyproducedaccording toquality standards:DocumentControlThis process isused to trackand managechanges indocumentation.ValidationProtocolWhat ensures aprocess,method, orsystem meetssetspecifications?DeNOVOWhat arethe USsubmissiontypes?QualityManagementSystemQMSmeanDeviationTemporarychange to aprocess and/ orprocedure.PreventiveWhat doesthe letterP stand forin CAPA?SOPA documentthat describeshow toperform a taskcorrectly.PDLIsAbbreviationfor Pre-defined LowImpactChanges.Free!PMAWhat arethesubmissiontypes?AuditA routine checkto ensure that aprocess orsystem isworking asintended510kWhat arethesubmissiontypes?21 CFT820.30What is theCFR that iscommonlyfollowed?FalseQualityAssurance (QA)is onlyconcerned withthe final product,not the process..DMRChangeControlProcessConsists of7Number ofdays toinitiate a non-conformance.ChangeRequestUsed toimplementchanges toa document.IVDRWhat arethesubmissiontypes?Replica of the1891 home offounder Dr.WallaceAbbott.

QA & RA Week - Call List

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