QualityManagementSystemQMSmeanValidationProtocolWhat ensures aprocess,method, orsystem meetssetspecifications?TrueRegulatory auditsare conducted toensure adherenceto relevantregulations andguidelinesPreventiveWhat doesthe letterP stand forin CAPA?DMRChangeControlProcessConsists ofSOPA documentthat describeshow toperform a taskcorrectly.DeviationTemporarychange to aprocess and/ orprocedure.510kWhat arethesubmissiontypes?QSRChangeControlProcessConsists ofFree!PMAWhat arethesubmissiontypes?ChangeRequestUsed toimplementchanges toa document.AuditA routine checkto ensure that aprocess orsystem isworking asintendedDocumentControlThis process isused to trackand managechanges indocumentation.RAAuditTerm used forreviewing andmaintainingregulatorycomplianceDeNOVOWhat arethe USsubmissiontypes?FalseAn example ofa deliverable isto identifytrainingaudience for achange planReplica of the1891 home offounder Dr.WallaceAbbott.GMP_____ ensuresthat a product isconsistentlyproducedaccording toquality standards:21 CFT820.30What is theCFR that iscommonlyfollowed?7Number ofdays toinitiate a non-conformance.PDLIsAbbreviationfor Pre-defined LowImpactChanges.FalseQualityAssurance (QA)is onlyconcerned withthe final product,not the process..IVDRWhat arethesubmissiontypes?QualityManagementSystemQMSmeanValidationProtocolWhat ensures aprocess,method, orsystem meetssetspecifications?TrueRegulatory auditsare conducted toensure adherenceto relevantregulations andguidelinesPreventiveWhat doesthe letterP stand forin CAPA?DMRChangeControlProcessConsists ofSOPA documentthat describeshow toperform a taskcorrectly.DeviationTemporarychange to aprocess and/ orprocedure.510kWhat arethesubmissiontypes?QSRChangeControlProcessConsists ofFree!PMAWhat arethesubmissiontypes?ChangeRequestUsed toimplementchanges toa document.AuditA routine checkto ensure that aprocess orsystem isworking asintendedDocumentControlThis process isused to trackand managechanges indocumentation.RAAuditTerm used forreviewing andmaintainingregulatorycomplianceDeNOVOWhat arethe USsubmissiontypes?FalseAn example ofa deliverable isto identifytrainingaudience for achange planReplica of the1891 home offounder Dr.WallaceAbbott.GMP_____ ensuresthat a product isconsistentlyproducedaccording toquality standards:21 CFT820.30What is theCFR that iscommonlyfollowed?7Number ofdays toinitiate a non-conformance.PDLIsAbbreviationfor Pre-defined LowImpactChanges.FalseQualityAssurance (QA)is onlyconcerned withthe final product,not the process..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. QMS mean
    Quality Management System
  2. What ensures a process, method, or system meets set specifications?
    Validation Protocol
  3. Regulatory audits are conducted to ensure adherence to relevant regulations and guidelines
    True
  4. What does the letter P stand for in CAPA?
    Preventive
  5. Change Control Process Consists of
    DMR
  6. A document that describes how to perform a task correctly.
    SOP
  7. Temporary change to a process and / or procedure.
    Deviation
  8. What are the submission types?
    510k
  9. Change Control Process Consists of
    QSR
  10. Free!
  11. What are the submission types?
    PMA
  12. Used to implement changes to a document.
    Change Request
  13. A routine check to ensure that a process or system is working as intended
    Audit
  14. This process is used to track and manage changes in documentation.
    Document Control
  15. Term used for reviewing and maintaining regulatory compliance
    RA Audit
  16. What are the US submission types?
    De NOVO
  17. An example of a deliverable is to identify training audience for a change plan
    False
  18. Replica of the 1891 home of founder Dr. Wallace Abbott.
  19. _____ ensures that a product is consistently produced according to quality standards:
    GMP
  20. What is the CFR that is commonly followed?
    21 CFT 820.30
  21. Number of days to initiate a non-conformance.
    7
  22. Abbreviation for Pre-defined Low Impact Changes.
    PDLIs
  23. Quality Assurance (QA) is only concerned with the final product, not the process..
    False
  24. What are the submission types?
    IVDR