This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements. Many regulated companies still do not have a robust Failure Investigation and/or CAPA programs. Failure investigations and Corrective and Preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters. Companies have procedures but either they are not adequate or are not followed. This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements.
Areas Covered in the seminar:
- Determining when a CAPA is necessary.
- Integration of Root Cause Analysis.
- Writing CAPA’s that are both appropriate and measurable.
- Avoiding common pitfalls.
- What is the Best Solution?
- Recommending and Implementing Corrective Actions.
- Tracking progress and re-evaluating corrective action effectiveness.
- Documenting close-out and validating appropriateness of corrective action.
- Challenges and solutions for improving the review and approval process.
Who Will Benefit:
This webinar will provide direction to all regulated companies that need to comply with CAPA requirements; including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields include:- Managers
- Supervisors and Associates in the Pharamceutical and Device Industry that have daily responsibilities in Quality Assurance
- Quality Control
- Compliance and Manufacturing
Course Provider
Michelle Sceppa,
