Managing Your FDA Inspection: Before, During and After 2019

Topics

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