Overview:
This trainer-led CAPA & Root Cause Analysis Training course provides an in-depth overview of the regulations and guidance related to Corrective And Preventive Actions (CAPA) and Root Cause Investigations in medical device manufacturing.
The course delves into CAPA system requirements, event investigation flow within the CAPA process, and CAPA effectiveness, incorporating process monitoring and Acceptance Quality Level (AQL) and c=0 sampling approaches.
The training also introduces a risk-based approach to the root cause analysis process in line with ICH Q9 guidelines.
Participants will explore techniques and tools for analysing situations and events that necessitate root cause analysis, ensuring a structured and comprehensive methodology.
The course includes practical applications through case studies based on real-world scenarios.
Content:
Day 1
Regulatory Requirements and Key Concepts of CAPA: Gain a thorough understanding of the regulatory landscape surrounding CAPA. Learn the key concepts, including CAPA system requirements, event investigation flow, and root cause investigation.
CAPA System Requirements and Event Investigation Flow: Discover the essential components of an effective CAPA system. Understand how to conduct thorough event investigations within the CAPA framework to identify and address root causes.
Tools and Techniques for Root Cause Analysis: Explore various tools and techniques for root cause analysis, such as:
Cause and Effect Diagrams: Learn to use these diagrams to identify potential causes of problems.
5 Whys Technique: Master the 5 Whys technique to drill down to the root cause of an issue.
Walkthroughs and Variance Analysis: Understand how to perform walkthroughs and variance analysis to uncover underlying issues.
CAPA Effectiveness: Delve into the methods for ensuring the effectiveness of CAPA initiatives. Learn about performance monitoring and the application of AQL and c=0 sampling methodologies to verify CAPA outcomes.
Real-World Scenarios: Engage in detailed exploration of real-world scenarios from event occurrence to resolution. Apply learned concepts to practical case studies, enhancing your ability to manage actual CAPA situations.
By enrolling in our CAPA & Root Cause Analysis training programs, you will gain the essential knowledge and skills to implement robust CAPA systems and perform thorough root cause analyses, ensuring quality and compliance in your manufacturing processes.