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

Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact is an event dedicated to the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do .

Topics

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

Who should Attend

• Quality Assurance Managers
• Regulatory Affairs Directors
• Manufacturing Directors and Managers
• Quality Control Managers
• Venture Capitalists
• Product Risk Managers