This webinar will include discussions on proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions, and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer-term projects and ensure they stay on track.
AREA COVERED
Definition of a CAPA:
- When a CAPA is needed
- Development of the essential pieces of a robust CAPA plan
Root Cause Analysis Methods:
- Discussion of different Root Cause Analysis methods and benefits of each
Establishment of the CAPA Plan:
- Project Summary development
- Responsibilities of individuals involved
- Establishing Completion Dates
- Creating meaningful effectiveness checks
Management of the CAPA System:
- Maintaining proper documentation of the CAPA plans
- Ensuring CAPA plans are progressing
- Proper close-out of CAPA plans
LEARNING OBJECTIVES
- Discuss what to do when problems occur
- Outline the requirements of the CAPA process and procedure including building a CAPA file
- Choose the most appropriate Root Cause Analysis methods for the situation
- Establishing a CAPA plan: project summary, individual responsibilities, and expected completion dates
- Management and Oversight of the CAPA system and its documentation
WHO WILL BENEFIT?
- Quality Control Personnel & Management
- Manufacturing Personnel & Management
- Senior Management
- Regulatory Affairs Personnel & Management
- Quality Assurance Personnel & Management
- Supplier Quality Personnel & Management
Definition of a CAPA:
- When a CAPA is needed
- Development of the essential pieces of a robust CAPA plan
Root Cause Analysis Methods:
- Discussion of different Root Cause Analysis methods and benefits of each
Establishment of the CAPA Plan:
- Project Summary development
- Responsibilities of individuals involved
- Establishing Completion Dates
- Creating meaningful effectiveness checks
Management of the CAPA System:
- Maintaining proper documentation of the CAPA plans
- Ensuring CAPA plans are progressing
- Proper close-out of CAPA plans
- Discuss what to do when problems occur
- Outline the requirements of the CAPA process and procedure including building a CAPA file
- Choose the most appropriate Root Cause Analysis methods for the situation
- Establishing a CAPA plan: project summary, individual responsibilities, and expected completion dates
- Management and Oversight of the CAPA system and its documentation
- Quality Control Personnel & Management
- Manufacturing Personnel & Management
- Senior Management
- Regulatory Affairs Personnel & Management
- Quality Assurance Personnel & Management
- Supplier Quality Personnel & Management
