Managing FDA Inspections from Readiness through Follow Up Responses 2016

Topics

• Details surrounding the management of inspections from announcement to close out meeting
• The steps necessary to prepare for an FDA inspection
• The methodology for responding to 483 and warning letters
• Responses to FAQs regarding typical inspector requests during inspections
• Common pitfalls to avoid during an inspection
• Templates for response letters

Who should Attend

Attendees from biopharmaceutical, pharmaceutical, medical device and biologics companies, including:

• Regulators
• Internal Auditors
• Compliance Officers
• Legal Departments
• QC Managers
• Validation Managers
• Facilities and Engineering Department Staff
• QA Managers
• Senior Management
• Compliance Consultants