During FDA audits, Investigators are continuing to review failure investigation reports and evaluate the effectiveness of the FDA regulated firm’s CAPA System. FDA audits the firm’s procedures and failure investigation documentation and pays close attention to the firm’s ability to identify, investigate, and correct unexpected issues in a timely manner. The firm must also demonstrate that their corrective actives were effective so the issue does not reoccur and product was not impacted. Still firms are continually faced with FDA 483s, since FDA Investigators still observe the use non compliant Failure Investigation and CAPA procedures, firms not following their procedure, as well as firms are unable to defend their investigations, conclusions, and corrective actions. The purpose of this teleseminar is to review the following areas:
1) Overview of FDA Requirements
2) Define and Document the Problem
3) Performing Effective Investigations
4) Identifying Root Cause and Conclusion
5) Corrective and Preventive Action (CAPA)
6) Link to Product Release and Product Impact
7) Properly documenting Failure Investigation reports
8) Avoiding Common Pitfalls
Note: Power point Slides and free 14 day audio podium playback provided for those who register.
WHEN: Wednesday, February 3rd, 2010 from 12pm to 1pm, EST
WHERE: Teleseminar session on Bridge line
Admission: All levels of Management for all departments QA/QC/Compliance/
Registration:
