Free!DocumentControlThis process isused to trackand managechanges indocumentation.ValidationProtocolWhat ensures aprocess,method, orsystem meetssetspecifications?IVDRWhat arethesubmissiontypes?TrueRegulatory auditsare conducted toensure adherenceto relevantregulations andguidelines7Number ofdays toinitiate a non-conformance.QualityManagementSystemQMSmeanPreventiveWhat doesthe letterP stand forin CAPA?RAAuditTerm used forreviewing andmaintainingregulatorycomplianceFalseAn example ofa deliverable isto identifytrainingaudience for achange planReplica of the1891 home offounder Dr.WallaceAbbott.DMRChangeControlProcessConsists ofAuditA routine checkto ensure that aprocess orsystem isworking asintendedPMAWhat arethesubmissiontypes?510kWhat arethesubmissiontypes?DeNOVOWhat arethe USsubmissiontypes?SOPA documentthat describeshow toperform a taskcorrectly.DeviationTemporarychange to aprocess and/ orprocedure.PDLIsAbbreviationfor Pre-defined LowImpactChanges.QSRChangeControlProcessConsists of21 CFT820.30What is theCFR that iscommonlyfollowed?GMP_____ ensuresthat a product isconsistentlyproducedaccording toquality standards:FalseQualityAssurance (QA)is onlyconcerned withthe final product,not the process..ChangeRequestUsed toimplementchanges toa document.Free!DocumentControlThis process isused to trackand managechanges indocumentation.ValidationProtocolWhat ensures aprocess,method, orsystem meetssetspecifications?IVDRWhat arethesubmissiontypes?TrueRegulatory auditsare conducted toensure adherenceto relevantregulations andguidelines7Number ofdays toinitiate a non-conformance.QualityManagementSystemQMSmeanPreventiveWhat doesthe letterP stand forin CAPA?RAAuditTerm used forreviewing andmaintainingregulatorycomplianceFalseAn example ofa deliverable isto identifytrainingaudience for achange planReplica of the1891 home offounder Dr.WallaceAbbott.DMRChangeControlProcessConsists ofAuditA routine checkto ensure that aprocess orsystem isworking asintendedPMAWhat arethesubmissiontypes?510kWhat arethesubmissiontypes?DeNOVOWhat arethe USsubmissiontypes?SOPA documentthat describeshow toperform a taskcorrectly.DeviationTemporarychange to aprocess and/ orprocedure.PDLIsAbbreviationfor Pre-defined LowImpactChanges.QSRChangeControlProcessConsists of21 CFT820.30What is theCFR that iscommonlyfollowed?GMP_____ ensuresthat a product isconsistentlyproducedaccording toquality standards:FalseQualityAssurance (QA)is onlyconcerned withthe final product,not the process..ChangeRequestUsed toimplementchanges toa document.

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