Key Steps to Avoid 483 Warning Letters & Remediation if you get one 2012

Topics

• Causes of Form 483 / Warning Letter
• FDA Inspections - background
• Best Practices for Responding to 483
• Some recent results of companies failing to respond appropriately
• What to do if the responses fai
• Best Practices for Responding to Warning Letter

Who should Attend

IT Management, Project Managers, Quality Managers, Business Process Owners, GxP, Quality Engineers and Consultants.