Learning from FDA Warning Letters 2014

Key Topics

• Understanding the warning letter process – from inspection to enforcement
• Current FDA warning letter trends
• How to analyze a warning letter – code phrases, prioritization points, and more
• Other enforcement tactics used by the agency instead of a warning letter – and why you’ll never see them
• How to share warning letters in a way that’s immediately relevant and actionable
• How to "read between the lines" of a warning letter
• How to use warning letters to anticipate inspectional priorities at your firm
• Review current FDA inspectional emphases in warning letters
• Other ways to use public warning letters, from supplier qualification, training tool, and more

Who should Attend

• Regulatory affairs managers and professionals
• Quality managers and professionals
• Directors of quality and compliance