Overview:

ITS’ Understanding Corrective and Preventive Action Systems (CAPA) Training Course offers comprehensive training to ensure you run effective CAPA systems that not only benefit your business but also satisfy regulatory requirements.

This CAPA training course demystifies areas that often cause confusion, such as terms, definitions, deviations, non-conformances, and the use of corrections, corrective, and preventive actions.

By the end of this CAPA training, participants will have hands-on experience in applying the CAPA system and root cause analysis to a real-life scenario.

Content:

Investigate what a CAPA system is: Delve into the fundamentals of a CAPA system, understanding its purpose and how it fits into the larger quality management framework. Learn why CAPA is a critical component in regulated industries and how it ensures product safety and compliance.

Terms, acronyms, and their application: Get clarity on key terms and acronyms used in CAPA training courses. This section helps eliminate confusion and ensures a common understanding of the language used in CAPA processes.

What is CAPA and why is there so much emphasis on its use in the regulated industry? Explore the significance of CAPA in maintaining regulatory compliance and improving business processes. Understand the impact of CAPA on product quality and customer satisfaction.

Global Harmonisation Task Force’s structured approach to CAPA: Learn how to utilise the Global Harmonisation Task Force’s guidelines to standardise your CAPA processes, ensuring consistency and effectiveness across your organisation.

Overall approach of CAPA, including links to change control: Understand the comprehensive approach of CAPA systems, including their connection to change control processes. This integration helps in managing changes systematically and mitigating risks.

Common misconceptions and misinterpretations: Address and correct common misunderstandings about CAPA systems. Learn the differences between corrective actions and preventive actions, and when each should be implemented.

Corrections, corrective actions, and preventive actions: Distinguish between these three key components of CAPA and understand their specific roles and applications within the system.

Regulatory expectations: Reflect on the regulatory requirements and expectations for CAPA systems. This includes a review of FDA and EU regulator inspection findings and warning letters, helping you align your processes with global standards.

Root cause analysis techniques: Investigate various root cause analysis methods, such as Cause and Effect, Flow and Process Charts, and Mind Mapping, to determine the need for corrections, corrective actions, and preventive actions.

Risk management techniques: Learn to apply risk management techniques to prioritise CAPA activities and ensure resources are allocated effectively to mitigate potential risks.

Documenting CAPA activities: Master the documentation process for CAPA activities, ensuring comprehensive and accurate records that support regulatory compliance and continuous improvement.

Human error and CAPA: Explore the impact of human error on CAPA systems. Review human characteristics and factors contributing to errors, and identify strategies to address and mitigate these errors.

CAPA case studies and real-life applications: Apply CAPA principles to potential real-life scenarios through case studies, enhancing practical understanding and application of the concepts learned.

Effective CAPA systems: Summarise and reflect on the characteristics of effective CAPA systems. Engage in personal reflection and group discussions to consolidate learning and define best practices.

By enrolling in our CAPA training courses, you will gain the knowledge and skills needed to develop, implement, and maintain robust CAPA systems, ensuring regulatory compliance and continuous improvement within your organisation.