This course has been designed to learn CAPA (corrective and preventive action) system, its effective implementation and generate improved results (CAPA is a requirement from the FDA\'s Quality System Regulation), understand its essential current / future requirements, and assist in merging gaps to increase compliance and generate profitable bottom-line results.
Course Benefits
Participants will understand the elements of an effective CAPA program, latest FDA trends, origins of data (internal/external), cost-effectiveness, effective corrective action tools for routine problems/root cause analysis, and why regulatory agencies add preventive action in clause/requirements
Prerequisites:
Medical Device background
Topics Covered:
- Introduction / Background
- CAPA definition
- CAPA application for medical devices/pharmaceuticals
- CAPA implementation
- Quality data - sources
- Root Cause Analysis
- Effective implementation
- Reporting and Tracking
- Corrections
- Removals
- Communication
Who Should Attend?
The target audience for this course consists of executives, top management who work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations).