CAPA Management Training: Corrective and Preventive Actions (CAPA) in Medical Devices: Investigation, Planning, Technical Writing, and Reporting by Tonex
CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action management in the FDA field.
This intensive 2-day course is designed to provide participants with a comprehensive understanding of the Corrective and Preventive Actions (CAPA) process specifically tailored to the medical device industry.
The course will cover the key aspects of CAPA, including investigation, planning, technical writing, and reporting, ensuring compliance with regulatory requirements and enhancing product quality and safety.
Learning Objectives:
- Understand the regulatory requirements for CAPA in the medical device industry.
- Learn the step-by-step CAPA process, from problem identification to implementation of corrective and preventive actions.
- Develop skills in conducting thorough investigations to determine root causes.
- Master planning and executing effective CAPA activities.
- Enhance technical writing skills for CAPA documentation and reporting.
- Ensure compliance with FDA and ISO standards through effective CAPA management.
Target Audience:
- Quality Assurance and Quality Control Professionals
- Regulatory Affairs Specialists
- Medical Device Engineers and Designers
- Compliance Officers
- Technical Writers in the Medical Device Industry
Course Agenda:
Session 1: Introduction to CAPA in Medical Devices
- Overview of CAPA
- Regulatory Requirements (FDA, ISO 13485)
- Importance of CAPA in Medical Device Industry
Session 2: CAPA Process Overview
- CAPA Lifecycle: Identification, Evaluation, Investigation, Action, Verification
- Key Elements of a Successful CAPA System
- Common Pitfalls and How to Avoid Them
Session 3: Investigation Techniques
- Problem Identification and Definition
- Root Cause Analysis Methods (5 Whys, Fishbone Diagram, etc.)
- Gathering and Analyzing Data
Session 4: Planning and Implementing CAPA
- Developing a CAPA Plan
- Risk Assessment and Prioritization
- Implementing Corrective and Preventive Actions
- Monitoring and Measuring Effectiveness
Session 5: Technical Writing for CAPA
- Documentation Requirements
- Writing Clear and Concise CAPA Reports
- Best Practices for Technical Writing in CAPA
Session 6: CAPA Reporting and Compliance
- Internal and External Reporting Requirements
- Ensuring CAPA Compliance with FDA and ISO Standards
- Preparing for Regulatory Inspections and Audits
Session 7: Case Studies and Practical Exercises
- Real-world Examples of CAPA in Medical Devices
- Group Exercises on CAPA Investigation and Planning
- Writing and Reviewing CAPA Reports
Session 8: Q&A and Course Review
- Open Forum for Questions and Discussions
- Recap of Key Points
- Final Assessment and Feedback
Training Materials:
- Course Handbook with Slides and Notes
- CAPA Process Templates and Checklists
- Case Study Materials
- Access to Online Resources and Regulatory Guidelines
Assessment:
- Participation in Practical Exercises
- Written CAPA Report Exercise
- Final Quiz on Course Content
Certification:
Participants will receive a Certificate of Completion for “Corrective and Preventive Actions (CAPA) in Medical Devices” upon successful completion of the course.