Understanding How To Write A Compliant CAPAs
Duration: 240 Minutes
To provide a comprehensive understanding of the CAPA process and risk management within the CAPA process and including its importance, implementation, and best practices for continuous improvement. The webinar will discuss Step by Step the CAPA process, we will discuss appropriate Tools, Investigation, and Implementation methods. We will look at Best Practices and Common Pitfalls.
- The CAPA Process: Steps and Methodology
- Risk assessment and management
- Preventive Actions
- Verification and Validation
- CAPA Best Practices and Common Pitfalls
- Case studies and real-world examples
- Tools and Resources for CAPA Management
- Templates and checklists
1. Welcome and Introduction (15 minutes)
• 1.2. Overview of the webinar objectives and agenda
• 1.3. Brief participant introduction (optional)
• 1.4. Technical tips for interacting with the webinar platform
2. Understanding CAPA (30 minutes)
• 2.1. Definition of Corrective and Preventive Actions
• 2.2. The importance of CAPA in quality management systems
• 2.3. Key differences between corrective and preventive actions
• 2.4. Overview of regulatory requirements and standards (e.g., ISO 9001, FDA)
Break (5 minutes)
3. The CAPA Process: Steps and Methodology (60 minutes)
• 3.1. Identifying the Problem
o Root cause analysis
o Tools for problem identification (e.g., Fishbone Diagram, 5 Whys)
• 3.2. Implementing Corrective Actions
o Developing action plans
o Assigning responsibilities and timelines
• 3.3. Preventive Actions
o Proactive measures to prevent recurrence
o Risk assessment and management
• 3.4. Verification and Validation
o Ensuring effectiveness of actions
o Monitoring and follow-up
Break (10 minutes)
4. CAPA Best Practices and Common Pitfalls (45 minutes)
• 4.1. Best practices for effective CAPA implementation
o Documentation and tracking
o Communication and training
• 4.2. Common challenges and pitfalls
o Avoiding overcomplication
o Ensuring consistency and accountability
• 4.3. Case studies and real-world examples
Interactive Q&A Session (30 minutes)
• Open floor for participant questions
• Addressing specific concerns or scenarios raised by participants
5. Tools and Resources for CAPA Management (30 minutes)
• 5.1. Overview of software tools for CAPA management
• 5.2. Templates and checklists
• 5.3. Further reading and resources
• 5.4. Recommendations for additional training
6. Wrap-Up and Closing Remarks (15 minutes)
• 6.1. Recap of key points and takeaways
• 6.2. Feedback survey and next steps
• 6.3. Contact information for follow-up questions
• 1.2. Overview of the webinar objectives and agenda
• 1.3. Brief participant introduction (optional)
• 1.4. Technical tips for interacting with the webinar platform
2. Understanding CAPA (30 minutes)
• 2.1. Definition of Corrective and Preventive Actions
• 2.2. The importance of CAPA in quality management systems
• 2.3. Key differences between corrective and preventive actions
• 2.4. Overview of regulatory requirements and standards (e.g., ISO 9001, FDA)
Break (5 minutes)
3. The CAPA Process: Steps and Methodology (60 minutes)
• 3.1. Identifying the Problem
o Root cause analysis
o Tools for problem identification (e.g., Fishbone Diagram, 5 Whys)
• 3.2. Implementing Corrective Actions
o Developing action plans
o Assigning responsibilities and timelines
• 3.3. Preventive Actions
o Proactive measures to prevent recurrence
o Risk assessment and management
• 3.4. Verification and Validation
o Ensuring effectiveness of actions
o Monitoring and follow-up
Break (10 minutes)
4. CAPA Best Practices and Common Pitfalls (45 minutes)
• 4.1. Best practices for effective CAPA implementation
o Documentation and tracking
o Communication and training
• 4.2. Common challenges and pitfalls
o Avoiding overcomplication
o Ensuring consistency and accountability
• 4.3. Case studies and real-world examples
Interactive Q&A Session (30 minutes)
• Open floor for participant questions
• Addressing specific concerns or scenarios raised by participants
5. Tools and Resources for CAPA Management (30 minutes)
• 5.1. Overview of software tools for CAPA management
• 5.2. Templates and checklists
• 5.3. Further reading and resources
• 5.4. Recommendations for additional training
6. Wrap-Up and Closing Remarks (15 minutes)
• 6.1. Recap of key points and takeaways
• 6.2. Feedback survey and next steps
• 6.3. Contact information for follow-up questions
This webinar will be beneficial for anyone who may be involved in CAPA investigations. In particular, this course will be beneficial for Quality Teams, Quality Managers, Quality Specialists, Quality Associates - Manufacturing teams,
- Quality Managers.
- Quality Specialists.
- Quality Associates.
- Quality Engineer.
Ms. Marie Dorat, is a hands on Regulatory/Quality Professional with 23 years experience in the Medical Device, Biopharmaceutical/Pharmaceutical industries in various senior positions. She has a high level of expertise in the regulatory/quality arenas, with an astute knowledge of GCP, cGMP QMS Development, validation, CAPA, NCMR, Change Control, and Training. Ms. Dorat is also a certified Lead Auditor for ISO/IVDR/MDSAP and has published articles for compliance magazines related to Clinical Site Inspections FDA vs. EU; Developing a compliant Quality System to name two.
She has facilitated e-QMS enterprise development, software validations, worked in a Consent Decree environment and supported remediation projects.
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