Achieving Compliance with Proper CAPA Systems
This webinar will include discussions, 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. Learning Objectives Discuss what to do when problems occurOutline the requirements of the CAPA process and procedure, including building a CAPA fileChoose the most appropriate Root Cause Analysis methods for the situationEstablishing a CAPA plan: project summary, individual responsibilities and expected completion datesManagement and Oversight of the CAPA system and its documentationAreas CoveredDefinition of a CAPA - When a CAPA is needed - Development of the essential pieces of a robust CAPA planRoot Cause Analysis Methods - Discussion of different Root Cause Analysis methods and benefits of eachEstablishment of the CAPA Plan - Project Summary development - Responsibilities of individuals involved - Establishing Completion Dates - Creating meaningful effectiveness checksManagement of the CAPA System - Maintaining proper documentation of the CAPA plans - Ensuring CAPA plans are progressing - Proper close out of CAPA plansWho Should AttendQuality control personnel and management Manufacturing personnel and management Senior managementRegulatory affairs personnel and management Quality assurance personnel and management Supplier quality personnel and management
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This webinar will include discussions, 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.
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
Areas 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
Who Should Attend
- Quality control personnel and management
- Manufacturing personnel and management
- Senior management
- Regulatory affairs personnel and management
- Quality assurance personnel and management
- Supplier quality personnel and management
