CAPA / RCA / Investigations Workshop by Tonex
The CAPA / RCA / Investigations Workshop is designed to provide pharmaceutical professionals with an in-depth understanding of Corrective and Preventive Action (CAPA), Root Cause Analysis (RCA), and the role of Investigations within the framework of the Pharmaceutical Quality System (PQS). This workshop emphasizes CAPA and Continuous Improvement through Process Performance & Product Quality Monitoring Systems (PPPQMS), supported by ICH Q10. Through a combination of lectures and hands-on team exercises, participants will learn how to achieve Quality Management Maturity by effectively integrating CAPA and PPPQMS into their PQS.
Learning Objectives
By the end of the workshop, participants will be able to:
- Understand Regulatory Frameworks: Gain knowledge of ICH Q10, ICH Q7, and 21 CFR 211, and their linkage to the Pharmaceutical Quality System.
- Integrate CAPA and Continuous Improvement: Understand the importance of CAPA and Continuous Improvement in PQS and how to integrate these processes effectively.
- Achieve Quality System Management Maturity: Learn about Quality System Management Maturity, the role of Management Responsibility, and the enablers of a Pharmaceutical Quality System.
- Perform Effective Correction and CAPA: Develop skills for effective deviation authoring, investigating true root causes, and implementing holistic CAPA.
- Utilize PPPQMS: Understand and apply Product Performance and Product Quality Monitoring Systems for ongoing product and process improvement.
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 CAPA, RCA, and investigations in the pharmaceutical industry
Workshop Modules
Module 1: Introduction to Regulatory Frameworks
- Overview of ICH Q10, ICH Q7, and 21 CFR 211
- Linkage to the Pharmaceutical Quality System (PQS)
- Importance of these frameworks in maintaining product quality and compliance
Module 2: Integrating CAPA and Continuous Improvement in PQS
- The role of CAPA and Continuous Improvement in PQS
- Understanding Quality System Management Maturity
- The role of Management Responsibility in PQS
Hands-on Practical Workshop
- Interactive session on integrating CAPA and Continuous Improvement into PQS
- Group activities to analyze and discuss Management Responsibility and enablers of PQS
Module 3: Performing Effective Correction and CAPA
- Effective deviation authoring techniques
- Investigating for true root causes
- Steps to develop and implement holistic CAPA
Hands-on Practical Workshop
- Participants practice deviation authoring and root cause analysis
- Group activities to develop and implement CAPA plans
Module 4: Product Performance and Product Quality Monitoring System (PPPQMS)
- Understanding Product and Process Monitoring Systems
- Tools for product and process understanding
- Techniques for monitoring and continual improvement
Hands-on Practical Workshop
- Interactive session on applying PPPQMS tools and techniques
- Group activities to develop monitoring and improvement plans
Module 5: Case Studies and Best Practices
- Review of case studies highlighting successful CAPA and PPPQMS implementations
- Lessons learned from real-world applications
- Best practices for sustaining improvements and achieving Quality Management Maturity
Interactive Q&A and Discussion Sessions
- Open floor discussions with industry experts on CAPA, RCA, and investigations
- Addressing specific participant questions and scenarios
- Collaborative problem-solving and idea exchange