Avoiding an FDA Warning Letter with a Strong CAPA Program 2012

Topics

• Differences in FDA`s QSR and ISO 13485 CAPA terminology
• FDA`s most common findings related to CAPA Review samples of warning letters published by FDA for deficiencies in the CAPA system
• How to define and document CAPA in the Quality System, including what needs to be included in the various stages of CAPA response, review and approval
• How to address nonconformities in the CAPA system
• Address Ownership, Timelines and Escalation of CAPAs

Who should Attend

• Quality Managers
• Regulatory Affairs professionals
• Consultants
• Quality Engineers
• Quality System Auditors
• R&D Management