Root Cause Analysis (RCA) Tools and Corrective and Preventive Action (CAPA) for Non-Conformance in the GMP Environment Workshop by Tonex
The “Root Cause Analysis (RCA) Tools and Corrective and Preventive Action (CAPA) for Non-Conformance in the GMP Environment” workshop is specifically designed for professionals in the pharmaceutical and healthcare industries operating under Good Manufacturing Practices (GMP). This workshop provides participants with practical knowledge and skills to identify root causes of non-conformance, apply effective RCA tools, and develop robust CAPA strategies to ensure compliance and quality improvement. The workshop emphasizes the importance of maintaining GMP standards while addressing non-conformance issues.
Learning Objectives
By the end of the workshop, participants will be able to:
- Understand GMP Requirements: Gain a clear understanding of GMP requirements and their implications for RCA and CAPA.
- Apply RCA Tools: Learn and apply various RCA tools to identify root causes of non-conformance effectively.
- Develop Effective CAPA Plans: Create and implement CAPA plans that address root causes and prevent recurrence.
- Enhance Compliance and Quality: Improve compliance with GMP standards and enhance overall product quality.
- Facilitate RCA and CAPA Processes: Develop skills to facilitate RCA and CAPA processes within their organizations.
Audience
This workshop is ideal for:
- Quality assurance professionals
- Regulatory compliance personnel
- Production and manufacturing managers
- Quality control analysts
- Research and development scientists
- Anyone involved in maintaining GMP compliance and addressing non-conformance issues
Workshop Modules
Session 1: Introduction to GMP and Non-Conformance
- Overview of GMP requirements and standards
- Understanding non-conformance in the GMP environment
- Importance of RCA and CAPA in maintaining GMP compliance
Session 2: Root Cause Analysis Tools
- Introduction to RCA and its significance in the GMP environment
- Overview of RCA tools: Fishbone (Ishikawa) diagram, 5 Whys, Pareto analysis, and Fault Tree Analysis (FTA)
- Selection criteria for RCA tools based on different scenarios
Hands-on Practical Workshop
- Interactive session where participants practice using RCA tools on real-world non-conformance scenarios
- Group activities to analyze and identify root causes
Session 3: Developing Corrective and Preventive Actions (CAPA)
- Principles of effective CAPA in the GMP environment
- Steps to develop and implement CAPA plans
- Monitoring and evaluating the effectiveness of CAPA
Hands-on Practical Workshop
- Participants develop CAPA plans for identified root causes
- Group discussions on best practices for implementing and monitoring CAPA
Session 4: Case Studies and Best Practices
- Review of case studies highlighting successful RCA and CAPA implementations
- Lessons learned from real-world GMP non-conformance issues
- Best practices for continuous improvement in RCA and CAPA processes
Interactive Q&A and Discussion Sessions
- Open floor discussions with GMP compliance and quality experts
- Addressing specific participant questions and scenarios
- Collaborative problem-solving and idea exchange
Session 5: Facilitating RCA and CAPA Processes
- Techniques for facilitating effective RCA and CAPA sessions
- Ensuring team collaboration and participation
- Documenting and communicating RCA and CAPA findings
Hands-on Practical Workshop
- Role-playing exercises to practice facilitating RCA and CAPA sessions
- Group activities to document and present RCA and CAPA findings