Deviations, CAPA and Change Control

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

Course Director: Charles H. Paul

Charles H. Paul is the President of CHP Consulting LLC – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 25 years and has published numerous white papers on varies subject from project management and technical writing to regulatory compliance in the life sciences.  The firm works with both domestic and international clients designing solutions for complex training and documentation issues within the life sciences.