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
Call us today at +1-972-665-9786. Learn more about this course audience, objectives, outlines, seminars, pricing , any other information. Visit our website link below.
CAPA (Corrective and Preventive Action) Management Training
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