Deviations, Root Cause Analysis and CAPA Resolution

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.

Audience

Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel

Topics Include

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

Learning Objectives

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