Avoiding an FDA Warning Letter with a Strong CAPA Program 2012 is a webinar that covers topics such as:
- 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
Avoiding an FDA Warning Letter with a Strong CAPA Program 2012 brings together:
- Quality Managers
- Regulatory Affairs professionals
- Consultants
- Quality Engineers
- Quality System Auditors
- R&D Management
