Avoiding an FDA Warning Letter with a Strong CAPA Program
Overview:
The development and implementation of an effective CAPA system is not well understood by many device companies. This webinar is designed to clarify what the FDA is looking for in the CAPA system. Examples of warning letters will be reviewed to understand common themes found by FDA.
Part of the problem is differences in terminology between the QSR and ISO 13485. This leads to confusion at times with the various team members involved in CAPA resolution. The differences in terminology will be clarified and an approach towards how to reconcile these within your system will be covered during this webinar.
The webinar will also address what to include within the CAPA system, how to appropriately document CAPA responses, reviews and approvals. Also timelines and escalation process will be covered as well.
Why should you attend: CAPA is a major subsystem of the FDA’s Quality System Regulation (QSR) and is always included in any QSIT inspection. Deficiencies in the CAPA system are consistently the top area of FDA 483 observations.
A study of the FDA's EIR Turbo Database conducted for all 2010 data identified 1058 observations related to CAPA, making it number one on the list of overall observations.
Too often medical device companies fail to implement an effective CAPA program and find themselves in the unfortunate position of responding to FDA warning letters, along with subsequent additional FDA oversight which are a matter of public record.
Beyond FDA, ISO 13485 Registrars also place a high degree of focus on the CAPA system during their certification and surveillance audits.
Areas Covered in the Session:
- Understand FDA's most common findings related to CAPA Review samples of warning letters published by FDA for deficiencies in the CAPA system
- Review and reconcile differences in FDA’s QSR and ISO 13485 CAPA terminology
- Review examples of nonconformities and how they should be addressed in the CAPA system (Correction, Corrective Action, Preventive Action determination)
- Overview of 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
- Address Ownership, Timelines and Escalation of CAPAs
Who Will Benefit:
- Regulatory Affairs professionals
- Quality Managers
- Quality Engineers
- Consultants
- Quality System Auditors
- Manufacturing Managers
- Manufacturing Engineers
- Design Managers
- Design Engineers
- Purchasing Managers
- Buyers