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 non-conformities

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

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 approaches to CAPA, including Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), Hazard and Operability Analysis (HAZOP) and 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

Investigation/Problem/Event Statements and Summaries

Records/Sources of Information/Identification

Root Cause Analysis (RCA) Definitions, Tools and Approach

CAPA Implementation and Resolution

Contact Hours

8

CEUs

1

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

N/A

Learning Supplies Needed

BioNetwork will provide

Clinical Site/Special Facilities

N/A

Requirements for Successful Completion

90% 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

Specific Industry or Business Support Needs

N/A

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 Assurance personnel

Quality Control personnel

Maintenance/engineering personnel

Related Courses

Course Contact Information

Gina Driver

[email protected]