Deviations, CAPA and Change Control
Description
This course tackles one of the most critical inspection triggers: weak investigations. It teaches how to move beyond superficial root causes and build defensible deviation reports supported by evidence. Participants learn structured root cause analysis, sustainable CAPA development, and effective change control aligned to 21 CFR 820.100 principles. The focus is on long-term system strength — trending, metrics, and risk-based thinking that prevent repeat issues. By strengthening deviation handling and CAPA effectiveness, organizations significantly reduce repeat findings and demonstrate mature quality oversight.
Agenda:
- Deviation and nonconformance management
- Root cause analysis methods
- Writing defensible investigations
- CAPA effectiveness and sustainability
- Risk assessment tools
- Change control requirements
- Trending, metrics, and continuous improvement
- Maintaining long-term inspection readiness
This is Module 4 of Practitioner Course "GMP Master Class for Life Sciences".You can either sign up only for this Module here.Or the entire course → Here
Who This Training Is Designed For
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Operations Departments
- Production Departments
- Regulatory Affairs Departments
- Validation Professionals
- Engineering Departments
- Compliance Specialists
- Training Managers
- Document Control Personnel
