Introduction to CAPA - Aware
Course Description:
Struggling to understand the intricacies of CAPA management within a GMP environment? This introductory course provides a clear and concise overview of:
- What are CAPAs? Gain a basic understanding of the definition and purpose of Corrective and Preventive Actions (CAPAs) within the pharmaceutical industry.
- Why are CAPAs Critical? Learn why CAPAs are essential for maintaining Good Manufacturing Practices (GMP) compliance, ensuring product quality, and mitigating risks.
- The CAPA Lifecycle: Explore the key stages of the CAPA process, from identification to implementation, verification, and closure.
- Key Roles and Responsibilities: Understand the roles and responsibilities of various departments and individuals involved in the CAPA process, including Quality Assurance, Production, and R&D.
- Building a Robust System: Discover the importance of a well-defined and documented CAPA system for achieving and maintaining regulatory compliance.
Learning Outcome:
Benefits of Taking This Module:
- Build a Strong Foundation: Gain a solid understanding of CAPA principles and their application within a GMP environment.
- Enhance Compliance: Improve your understanding of regulatory expectations and minimise the risk of audit findings.
- Improve Quality: Contribute to the continuous improvement of product quality and patient safety.
Benefits of Taking This Module:
- Build a Strong Foundation: Gain a solid understanding of CAPA principles and their application within a GMP environment.
- Enhance Compliance: Improve your understanding of regulatory expectations and minimise the risk of audit findings.
- Improve Quality: Contribute to the continuous improvement of product quality and patient safety.
Course Features
| Modules | : | 3 |
| Duration | : | 3 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
Introduction to CAPA Management - Aware (CPCP0102)
This module provides an introductory understanding of Corrective and Preventive Actions (CAPAs). Explore their purpose, learn how to raise them correctly, and understand the step-by-step process of recording issues within a CAPA management system. Discover why proper CAPA management is crucial for maintaining quality standards, meeting regulatory requirements, and driving continuous improvement.
Introduction to CAPA Process - Aware (CPCP0401)
This module provides a foundational understanding of Corrective and Preventive Action (CAPA) management processes. Learn how and when to document incidents, conduct thorough investigations, and implement effective corrective and preventive actions. We'll cover key roles and responsibilities at each stage, emphasising the importance of adhering to timelines for successful CAPA execution.
Introduction to CAPA Recording System - Aware (CPCP0501)
This module provides a foundational understanding of Corrective and Preventive Action (CAPA) recording systems and their role in Good Manufacturing Practices (GMP) compliance. Learn key data integrity requirements, including secure archiving, audit trails, and trend analysis. Explore Quality Assurance and other departments’ responsibilities in ensuring the accuracy and security of the CAPA system.