2021 - Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact

FDA legal authority to inspect
Over products
Over firm’s
Scientific/clinical studies
Premarket requirements
Postmarket requirements
FDA’s annual inspection work plan
Inspection Procedures
FDA inspection Manuals
FDA Training
Documenting violations
Refusals
Human factors
Recall procedures (What FDA expects from you.)
FDA Field Office Management
FDA Center(s) Management
The firm’s job
Inspectional observations (Form FDA-483)
Responding to a 483
Responding to a Warning Letter
FDA enforcement actions
Follow up inspections
Foreign Inspections