Laboratory Controls – Anticipate the Systems Based FDA Inspection 2018

Topics

• Preparing for a Laboratory Audit
  • Review of materials, equipment, tests and assays
  • Training of analysts in proper inspection behavior
• Defining the Systems Based Inspection
  • FDA inspection techniques
  • What are Lab Controls?
  • Why FDA switched to Systems based Inspections
• Inspection Expectations and Results / Real Life citations
  • Addressing observations or findings
  • Responsibilities of QC / QA personnel during the audit
  • Real life citations

Who should Attend

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Senior Management
• Operations Departments