About the Course
Introduction to this course:
This course focuses on eliminating the causes of nonconformities and deviations in quality processes. Building on deviation management and root-cause analysis, it delves into the corrective actions and preventive actions (CAPA) phase. You’ll learn to identify, document, and implement CAPAs to prevent recurrence and ensure continuous improvement in your quality management system.
Who should attend:
This course is designed for professionals seeking to enhance their skills in deviation handling, root-cause analysis, and CAPA management: QA/QC, regulatory affairs, manufacturing and production, compliance, and auditors.
Learning Outcomes:
By the end of this lesson, you will be able to:
Identify the symptoms of an ineffective CAPA system.
Explain how to manage an effective CAPA process by implementing a systematic, proactive, and continuous approach, using root-cause analysis, and ensuring balanced use of CAPA to prevent and address nonconformities effectively.
Describe how to apply CAPAs in real-world scenarios by analyzing case studies, identifying root causes, and determining appropriate actions to address and prevent nonconformities in the manufacturing process.
What will I gain:
Participants will gain a comprehensive understanding of the CAPA process and how it ensures Quality Management System (QMS) integrity and effectiveness. In this course, you will learn how to identify, analyze, and address nonconformities and deviations using proven CAPA methodologies. You will develop the skills necessary to implement robust CAPA strategies, fostering continuous improvement and preventing the recurrence of quality issues within your organization.
Prerequisites:
Prerequisites for this course include a basic understanding of quality management systems and processes within regulated industries. Familiarity with concepts related to deviation management, root-cause analysis, and quality assurance principles would be beneficial.
Additional information:
Course duration: 00:31:00
Course code/version (effective date): L-42/v1.0 (26/04/2023)
Course Categories
-
Introduction to CAPA
- Lesson 1: Key concepts
- Lesson 2: Ineffective vs effective CAPA system
- Lesson 3: The path to the CAPA process
- Lesson 4: CAPA Case Studies
- Reading: How to create an effective CAPA form using the 8D approach
-
Additional resources
- Mind map: Deviations and CAPA management
- Reading: Is human error a root cause? A guide to human error in root cause analysis.
About the Course
Introduction to this course:
This course focuses on eliminating the causes of nonconformities and deviations in quality processes. Building on deviation management and root-cause analysis, it delves into the corrective actions and preventive actions (CAPA) phase. You’ll learn to identify, document, and implement CAPAs to prevent recurrence and ensure continuous improvement in your quality management system.
Who should attend:
This course is designed for professionals seeking to enhance their skills in deviation handling, root-cause analysis, and CAPA management: QA/QC, regulatory affairs, manufacturing and production, compliance, and auditors.
Learning Outcomes:
By the end of this lesson, you will be able to:
Identify the symptoms of an ineffective CAPA system.
Explain how to manage an effective CAPA process by implementing a systematic, proactive, and continuous approach, using root-cause analysis, and ensuring balanced use of CAPA to prevent and address nonconformities effectively.
Describe how to apply CAPAs in real-world scenarios by analyzing case studies, identifying root causes, and determining appropriate actions to address and prevent nonconformities in the manufacturing process.
What will I gain:
Participants will gain a comprehensive understanding of the CAPA process and how it ensures Quality Management System (QMS) integrity and effectiveness. In this course, you will learn how to identify, analyze, and address nonconformities and deviations using proven CAPA methodologies. You will develop the skills necessary to implement robust CAPA strategies, fostering continuous improvement and preventing the recurrence of quality issues within your organization.
Prerequisites:
Prerequisites for this course include a basic understanding of quality management systems and processes within regulated industries. Familiarity with concepts related to deviation management, root-cause analysis, and quality assurance principles would be beneficial.
Additional information:
Course duration: 00:31:00
Course code/version (effective date): L-42/v1.0 (26/04/2023)
-
Introduction to CAPA
- Lesson 1: Key concepts
- Lesson 2: Ineffective vs effective CAPA system
- Lesson 3: The path to the CAPA process
- Lesson 4: CAPA Case Studies
- Reading: How to create an effective CAPA form using the 8D approach
-
Additional resources
- Mind map: Deviations and CAPA management
- Reading: Is human error a root cause? A guide to human error in root cause analysis.
