FDA Warning Letter Closeout Program 2013

Topics

• FDA inspection process
• Outline of FDA enforcement and compliance scheme
• Warning letter issuance
• Lead up to a warning letter - warning signs
• What to avoid when dealing with FDA warning letters
• Company response to FDA warning letters
• Correcting FDA warning letter closeout mistakes

Who should Attend

• Director of Quality
• VP of Quality
• Board of Directors
• CEO, COO, President and other operating executives
• Internal auditors
• Quality managers and personnel
• Consultants