Post on 07-Jan-2016
description
transcript
Audit Announcements
Ellen Buchanan
ORA/OO/IO/Audit Staff Director
IntroductionsIvy
MartyActors
HistoryBevToni
ActorsEllen
Preparing for a visitRoom
PaperworkPaperworkPaperwork
What to expectNot pass/fail
This is not cramming for a final exam
Verification
18 monthProgram Assessment
Validation AuditHave - Use
36 month Program Assessment
Validation AuditHave - Use
60 monthProgram Audit
Have – Use - Improve
ReportsClose-out
Draft reportsComments
Final with ACRA signature
Questions?Pat
Steve
Updates to the Standards
MeasurableMetrics
Meaningful
Animal Feed StandardsAFRPS
Lessons Learned
Contact Information
ellen
ORA/OO/IO/Audit Staff Director
Ellen.buchanan@fda.hhs.gov