JETT-Charter_home

《JETT-Charter_home》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、JETTConsortiumRevision3.0JETTCharter22JAN2006JETTCharterRevision3.0EffectiveDate:01/19/06REVISIONHISTORYRev.DateDevelopedBy:RevisionSummary1.02003JETTInitialRelease2.021OCT2004JETTChangeintheattendancerequirementsbasedontheimplementationofwebbasedmeetings.3.022

2、JAN2006JETTChangereferencesto“pharmaceutical”to“healthcare”.AddSubteamTaskLeadertocoverresponsibilitiesforsubteamssuchasRiskandTesting–AlsorevisedformatofnumberinglayouttoreflecttypicalJETTstructure.Page4of4JETTConsortiumRevision3.0JETTCharter22JAN20061.JETTMis

3、sion1.1.ImprovecommunicationsamongUsers,Suppliers,&Consultantstomoreeffectivelymeetthe“validation”requirementsofthehealthcareindustries..2.Goals2.1.ThegoalsoftheJETTSpecialInterestGroup(SIG)areasfollows:2.2.StreamlinetheprocurementandqualificationprocessofAutom

4、atedProductionSystemsbyapplyingtheGAMPBusinessModel.2.3.ImprovecommunicationsamongUsers,Suppliers,andConsultantsinthehealthcareindustriesthroughtheuseofcommonindustrybusinessprocesses.2.4.Toprovideacommontechnicallanguagebaseandsampledocumentsthatwillbewidelyac

5、ceptedbythehealthcareindustries..3.SIGStructure3.1.TheJETTSIGisoverseenbytheGAMPAmericaSteeringCommittee.TheJETTChairisamemberofthiscommittee3.2.Chair:NominatedbytheJETTCoreMembershipandapprovedbyGAMPAmericasSteeringCommittee.3.3.ChairTermLimit:NoTermLimit.3.4.

6、TaskLeadersarevolunteersfromwithintheActiveMembers.3.5.TaskLeaderTermLimit:CompletionofTaskorRequestforReplacement.4.MembershipRequirements4.1.Membershipopentoanysubjectmatterexpertfromindustry,suppliers,consultantsorassociatedindustries(pharmaceutical,biotech,

7、medicaldevices,etc.)thataresubjecttoGoodPractice(GxP)regulations4.2.Membershipwillconsistof2classifications:4.2.1.ActiveMembers4.2.2.AssociateMembers4.3.ActiveMembershipcriteria4.3.1.Mustattend50%ofthemeetingsoverthelast24monthsorparticipateinmajorteamactivitie

8、ssuchasreviewsandpresentations.Web-basedmeetingattendanceisalsoacceptableiftravelconstraintsprohibitregularattendanceinperson.4.3.2.Mustparticipateinatleastoneworking/taskgr