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.
1. CAPA Definitions and Approaches
2. Example CAPA forms
3. CAPA Regulatory expectations (drugs, biologics and medical products)
4. Pharmaceutical Quality System Guidelines (ICH Q10) and product lifecycle approach
5. 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)
6. Failure Modes, Effects, and Criticality Analysis (FMECA)
7. Sources of CAPA
8. FDA Inspection Observations (FDA Form 483)
9. Technical Writing tips for clarity and completeness
10. Investigations/ Problem/Event Statements and summaries
11. Records/Sources of information/Identification
12. Root Cause Analysis (RCA) definitions, tools, and approach
13. CAPA implementation and resolution
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Provided by the college
Classroom or virtual meeting technology
80% attendance
N/A
Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel, Training Personnel, Bioprocess Technicians, Community College Faculty
Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel, Bioprocess Technicians
N/A
Manufacture/Production Operators
Team Leaders and Supervisors
Quality Control Personnel
Quality Assurance Personnel
Maintenance/Engineering Personnel
Bioprocess Technicians
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Requisites: None
To view information on this course and additional non-degree course offerings, visit the Workforce Continuing Education Catalog