Overview: This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA`s concerns.
The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems should be risk-based. The presentation will give an example of how to develop a risk-based CAPA system.
Why should you attend: In reviewing FDA Form 483 inspection observation reports and Warning Letters which are published on FDA website, we find CAPA cited in most cases. CAPA has been part of FDA regulations on the medical device industry since the 1970`s and companies should have developed good CAPA systems some years ago. But FDA continues to find problems with Corrective Action and Preventive Action in quality systems. This is a foundation of the quality system and should be a well-controlled process. FDA feels CAPA is a very important process so it is always inspected as a part of routine inspections, and it usually one of the first quality management subsystems to be reviewed by investigators.
Areas Covered in the Session: - Review CAPA citations in FDA-483 and Warning Letters
- Identify common problems with CAPA
- Identify FDA CAPA regulatory requirements
- Identify ISO 13485 CAPA requirements
- Explore FDA`s risk expectations of CAPA systems
- Establishing a risk-based CAPA system
Who Will Benefit: - Regulatory Management
- Internal Auditors
- Quality System Managers
- Quality Engineers
- Regulatory Associates
