Managing FDA After a Bad Inspection 2015

Topics

• The evidence against you
• FDA`s inspection strategy
• Discussions with the FDA (To promise not to promise, that is the question.)
• Inspectional List of Observations (Form FDA 483)
• Responding to a Warning Letter
• Responding to the 48
• FDA verification of corrective action

Who should Attend

• Manufacturing Director
• Regulatory Affairs Director
• Legal Counsel
• Sales and Marketing Manager
• FDA Consultants
• Product Liability Managers