Course Offerings

This course introduces technicians and other professionals to current CAPA (Corrective Action and Preventive Action) systems for drug, biologic, and medical products. It covers CAPA definitions, principles, regulatory requirements, and Root Cause Analysis (RCA) techniques. The course also covers technical writing for investigations, including CAPA statement writing, with hands-on exercises, examples, feedback, and tips.

Course 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.

Outline of Instruction

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

Contact Hours

6

CEUs

No

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

None

Learning Supplies Needed

Provided by the college

Clinical Site/Special Facilities

Classroom or virtual meeting technology

Requirements for Successful Completion

80% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel, Training Personnel, Bioprocess Technicians, Community College Faculty

Specific Industry or Business Support Needs

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

Wake County Need for Industry Positions

N/A

Industry or Job Titles Related to Training Outcomes for Employment

Manufacture/Production Operators

Team Leaders and Supervisors

Quality Control Personnel

Quality Assurance Personnel

Maintenance/Engineering Personnel

Bioprocess Technicians

Related Courses

CTP-GY01

Course Contact Information

Cynthia Lawrence
919-335-1037
[email protected]