Every organization needs to investigate problems well, find root causes and put workable corrective action in place on time. This 60-minute CAPA and root cause analysis training shows how to build a system that does that.
An effective CAPA process depends on trained internal investigators who think critically and can coach others, and on a common model and language so investigators learn the process quickly. You'll cover what a CAPA is, when one is required, and the root cause analysis methods available and their benefits.
The session then covers building a CAPA plan, effectiveness checks, documentation, tracking progress and proper closure, including keeping longer-term CAPA projects on track.
WHY SHOULD YOU ATTEND?
A weak CAPA system lets problems recur and leaves gaps in documentation. This webinar covers proper CAPA system maintenance, root cause analysis, CAPA documentation and building a robust CAPA plan, with tips for keeping long-term CAPAs on schedule.
It suits quality control, quality assurance, manufacturing, regulatory affairs and supplier quality staff and managers, and senior management.
AREA COVERED
- What a CAPA is and when it is required
- What to do when problems occur
- Key pieces of a strong CAPA plan and building a CAPA file
- Root cause analysis methods and their benefits
- Establishing a CAPA plan: project summary, individual responsibilities and completion dates
- Creating meaningful effectiveness checks
- Managing the CAPA system
- Maintaining CAPA documentation
- Making sure CAPA plans progress
- Properly closing out CAPA plans
LEARNING OBJECTIVES
- Explain what a CAPA is and when one is required
- Outline the CAPA process and procedure, including building a CAPA file
- Choose the most appropriate root cause analysis method for the situation
- Establish a CAPA plan with a project summary, responsibilities and completion dates
- Create meaningful effectiveness checks
- Manage and oversee the CAPA system and its documentation through closure
WHO WILL BENEFIT?
- Quality Control Personnel & Management
- Manufacturing Personnel & Management
- Senior Management
- Regulatory Affairs Personnel & Management
- Quality Assurance Personnel & Management
- Supplier Quality Personnel & Management
A weak CAPA system lets problems recur and leaves gaps in documentation. This webinar covers proper CAPA system maintenance, root cause analysis, CAPA documentation and building a robust CAPA plan, with tips for keeping long-term CAPAs on schedule.
It suits quality control, quality assurance, manufacturing, regulatory affairs and supplier quality staff and managers, and senior management.
- What a CAPA is and when it is required
- What to do when problems occur
- Key pieces of a strong CAPA plan and building a CAPA file
- Root cause analysis methods and their benefits
- Establishing a CAPA plan: project summary, individual responsibilities and completion dates
- Creating meaningful effectiveness checks
- Managing the CAPA system
- Maintaining CAPA documentation
- Making sure CAPA plans progress
- Properly closing out CAPA plans
- Explain what a CAPA is and when one is required
- Outline the CAPA process and procedure, including building a CAPA file
- Choose the most appropriate root cause analysis method for the situation
- Establish a CAPA plan with a project summary, responsibilities and completion dates
- Create meaningful effectiveness checks
- Manage and oversee the CAPA system and its documentation through closure
- Quality Control Personnel & Management
- Manufacturing Personnel & Management
- Senior Management
- Regulatory Affairs Personnel & Management
- Quality Assurance Personnel & Management
- Supplier Quality Personnel & Management