TrueRegulatory auditsare conducted toensure adherenceto relevantregulations andguidelinesPMAWhat arethesubmissiontypes?ChangeRequestUsed toimplementchanges toa document.QualityManagementSystemQMSmeanFalseAn example ofa deliverable isto identifytrainingaudience for achange planGMP_____ ensuresthat a product isconsistentlyproducedaccording toquality standards:510kWhat arethesubmissiontypes?PDLIsAbbreviationfor Pre-defined LowImpactChanges.21 CFT820.30What is theCFR that iscommonlyfollowed?Replica of the1891 home offounder Dr.WallaceAbbott.Free!DMRChangeControlProcessConsists ofValidationProtocolWhat ensures aprocess,method, orsystem meetssetspecifications?RAAuditTerm used forreviewing andmaintainingregulatorycomplianceDeviationTemporarychange to aprocess and/ orprocedure.DocumentControlThis process isused to trackand managechanges indocumentation.FalseQualityAssurance (QA)is onlyconcerned withthe final product,not the process..SOPA documentthat describeshow toperform a taskcorrectly.QSRChangeControlProcessConsists ofAuditA routine checkto ensure that aprocess orsystem isworking asintendedPreventiveWhat doesthe letterP stand forin CAPA?DeNOVOWhat arethe USsubmissiontypes?7Number ofdays toinitiate a non-conformance.IVDRWhat arethesubmissiontypes?TrueRegulatory auditsare conducted toensure adherenceto relevantregulations andguidelinesPMAWhat arethesubmissiontypes?ChangeRequestUsed toimplementchanges toa document.QualityManagementSystemQMSmeanFalseAn example ofa deliverable isto identifytrainingaudience for achange planGMP_____ ensuresthat a product isconsistentlyproducedaccording toquality standards:510kWhat arethesubmissiontypes?PDLIsAbbreviationfor Pre-defined LowImpactChanges.21 CFT820.30What is theCFR that iscommonlyfollowed?Replica of the1891 home offounder Dr.WallaceAbbott.Free!DMRChangeControlProcessConsists ofValidationProtocolWhat ensures aprocess,method, orsystem meetssetspecifications?RAAuditTerm used forreviewing andmaintainingregulatorycomplianceDeviationTemporarychange to aprocess and/ orprocedure.DocumentControlThis process isused to trackand managechanges indocumentation.FalseQualityAssurance (QA)is onlyconcerned withthe final product,not the process..SOPA documentthat describeshow toperform a taskcorrectly.QSRChangeControlProcessConsists ofAuditA routine checkto ensure that aprocess orsystem isworking asintendedPreventiveWhat doesthe letterP stand forin CAPA?DeNOVOWhat arethe USsubmissiontypes?7Number ofdays toinitiate a non-conformance.IVDRWhat arethesubmissiontypes?

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