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