Handling OOS Test Results and Completing Robust Investigations 2019

Topics

• What the FDA looks for in terms of human errors
• The responsibilities of analysts and supervisors
• The frequency for re-testing and re-sampling
• When a full investigation should be triggered
• How to implement the corrective and preventive action plans (CAPA)

Who should Attend

• Supervisors and Managers in Pharmaceutical or Biological Laboratories
• Lab Analysts
• GMP Auditors
• Regulatory Affairs
• Consultants
• Quality control and Quality Assurance Personnel responsible for Generating or Evaluating test results in a regulated Environment
• Training Departments