CAPA - Corrective and Preventive Action Management Training

CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field.

TONEX RCA and CAPA Management Training Format

The course is fun and dynamic
The training is a blend of hypothesis and practice
The hypothetical area is conveyed as intuitive introduction
The reasonable area incorporates practicing with genuine precedents, singular/bunch exercises, and hands-on workshops

Learn About:

• CAPA application and implementation
• CAPA management
• FDA’s requirements for CAPA systems
• Importance of CAPA systems
• CAPA system main components
• The definition and differences of the terms corrections, corrective actions, and preventive actions
• CAPA data sources
• Methods of data analysis
• CAPA data flow charts
• CAPA tracking tools
• Medical device reporting and tracking
• FDA guidance for failure investigations and root cause analyses
• FDA’s trending principals / ECI
• Non-conformances or deviations
• RCA tools and methods
• Brainstorming methods
• Problem solving tools
• Process mapping / Regulatory resources
• Corrective action plan development steps
• Defining the problem statement properly
• Isolating and containing the problems
• Identifying the root cause
• Developing an effective corrective action
• Executing and validating the corrective action
• Preventing recurrence
• Preventive Action process
• Communication

Course Outline:

• Overview of CAPA
• RCA Definition
• Non-Conformances or Deviations
• Nonconformance Classification
• Problem Solving Process
• Creative Thinking Approaches
• FMEA Application in Clinical Devices
• Analysis and Prioritization Techniques
• Digging Down for the Root Causes
• Gathering Valuable Data for RCA and CAPA
• Analyzing Data
• Accidents Analysis and Role of Human Error
• Role of Management Behaviors in the Success of RCA/CAPA
• Implementing Corrective and Preventive Action Plans (CAPA)
• Elements of Effective CAPA
• Trending Requirements and CAPA
• CAPA Regulatory Requirements

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CAPA (Corrective and Preventive Action) Management Training