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Mastering Corrective and Preventive Action (CAPA); A Step-by-Step Guide to Ensuring Compliance and Managing Risk

Mastering Corrective and Preventive Action (CAPA); A Step-by-Step Guide to Ensuring Compliance and Managing Risk

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Mastering Corrective and Preventive Action (CAPA): A Step-by-Step Guide to Ensuring Compliance and Managing Risk



Course Overview

This comprehensive course provides a step-by-step guide to mastering Corrective and Preventive Action (CAPA), ensuring compliance, and managing risk. Participants will receive a certificate upon completion, issued by The Art of Service.



Course Features

  • Interactive and engaging learning experience
  • Comprehensive and personalized course content
  • Up-to-date and practical knowledge with real-world applications
  • High-quality content delivered by expert instructors
  • Certification upon completion
  • Flexible learning options with user-friendly and mobile-accessible platform
  • Community-driven learning environment
  • Actionable insights and hands-on projects
  • Bite-sized lessons for easy learning
  • Lifetime access to course materials
  • Gamification and progress tracking features


Course Outline

Module 1: Introduction to CAPA

  • Definition and purpose of CAPA
  • Regulatory requirements and industry standards
  • Benefits of implementing CAPA
  • Common challenges and pitfalls

Module 2: CAPA Process

  • Identifying and documenting CAPA activities
  • Assessing and prioritizing CAPA activities
  • Investigating and analyzing CAPA activities
  • Implementing and verifying CAPA activities
  • Reviewing and closing CAPA activities

Module 3: CAPA Tools and Techniques

  • Root cause analysis (RCA)
  • Fault tree analysis (FTA)
  • Hazard analysis and critical control points (HACCP)
  • Statistical process control (SPC)

Module 4: CAPA and Quality Management Systems

  • Integration with ISO 9001 and other quality management systems
  • Relationship with other quality processes (e.g., audit, complaint handling)
  • Role of CAPA in continuous improvement

Module 5: CAPA and Regulatory Compliance

  • Overview of regulatory requirements (e.g., FDA, EU, ISO)
  • Compliance with CAPA-related regulations
  • Preparing for regulatory audits and inspections

Module 6: CAPA and Risk Management

  • Risk assessment and mitigation
  • Risk-based approach to CAPA
  • Integrating CAPA with enterprise risk management (ERM)

Module 7: Implementing CAPA

  • Developing a CAPA plan and procedure
  • Establishing a CAPA team and roles
  • Training and awareness programs
  • Metrics and performance indicators

Module 8: Sustaining CAPA

  • Maintaining CAPA momentum and interest
  • Continuously improving CAPA processes
  • Ensuring CAPA is aligned with organizational goals

Module 9: CAPA Case Studies and Examples

  • Real-world examples of CAPA implementation
  • Lessons learned and best practices
  • Group discussions and activities

Module 10: CAPA Certification and Exam Preparation

  • Overview of CAPA certification options
  • Exam preparation and study tips
  • Practice exam questions and group review


Certificate of Completion

Upon completing this comprehensive course, participants will receive a Certificate of Completion, issued by The Art of Service.



Course Format

This course is delivered online, with interactive and engaging content, including video lessons, quizzes, group discussions, and hands-on projects.



Course Duration

This course is self-paced, allowing participants to complete the content on their own schedule. The estimated completion time is 40 hours.



Target Audience

This course is designed for quality professionals, regulatory affairs specialists, and anyone responsible for implementing and maintaining CAPA processes.



Prerequisites

There are no prerequisites for this course, although prior knowledge of quality management systems and regulatory requirements is recommended.

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