This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product Corrective Action and Preventive Action (CAPA) systems. A brief overview of regulatory requirements, CAPA definitions, Root Cause Analysis (RCA) techniques, and investigation writing will be covered. Hands-on activities are used to provide examples and feedback on adequate CAPA and statement writing. Technical writing tips will be incorporated throughout the course.
Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel
- CAPA Definitions and Approaches
- Example CAPA forms
- CAPA Regulatory expectations (drugs, biologics and medical products)
- Pharmaceutical Quality System Guidelines (ICH Q10) and product lifecycle approach
- Quality Risk Management (ICH Q9) and risk assessment (RA) approaches to CAPA, including Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), Hazard and Operability Analysis (HAZOP), Failure Modes Effects Analysis (FMEA)
- Failure Modes, Effects, and Criticality Analysis (FMECA)
- Sources of CAPA
- FDA Inspection Observations (FDA Form 483)
- Technical Writing tips for clarity and completeness
- Investigations/ Problem/Event Statements and summaries
- Records/Sources of information/Identification
- Root Cause Analysis (RCA) definitions, tools, and approach
- CAPA implementation and resolution
- Apply technical writing tips to writing investigation problem statements, RCA, and CAPA; to more clearly document and better resolve nonconformities
- Explain CAPA system elements and FDA expectations
- Explain how Risk Assessment tools can be used to determine priority and significance of CAPA
- List different Root Cause Analysis tools and resources
Delivered in-person in a classroom or lab setting.
Delivered online with a live instructor at a scheduled date and time.