ABSTRACT

Procedures ......................................................................................................87 6.4.1 Participants Invited/Interviewed ........................................................87 6.4.2 Training .............................................................................................. 89 6.4.3 Tools to Assist in Evaluations, Inspections, and Reviews ..................90 6.4.4 Facilities to Be Inspected .................................................................... 91 6.4.5 Scheduling ..........................................................................................93 6.4.6 Documentation and Follow-Up ...........................................................94 6.4.7 Postapproval Monitoring (PAM) ........................................................95