This course is designed to provide participants with a solid understanding of the fundamentals of action planning and management as part of a CAPA. Throughout the course, participants will explore the complete project planning and management cycle, from initiation to closure. Through a combination of theory and practice, participants will learn how to develop effective action plans, monitor and control project progress, and close projects efficiently.

At The End Of The Course You Will Be Able To

• Provide engineers and other professionals in the medical device industry, with project planning knowledge and tools to support the CAPA Actions process.
• Define the role and expectations of an action planning owner.
• Learn the importance stablishing a project structure and the characteristics of a typical Action Planning phase of a CAPA.
• Learn and use the tools provided during this course to develop the different stages of the Action Planning phase of a CAPA.
• Learn how to report the project status and performance to stakeholders.

Course Content

• Management and Planning Basics
• Action Planning & Management Cycle
  • Initiation
  • Planning
  • Monitoring & Controlling
  • Closure

The Investigation Report Assessment course is designed to provide medical device industry professionals with the skills necessary to effectively and accurately complete CAPA investigation reports. From introduction to the key elements of an investigation report to analysis and action planning, this course provides a guide to developing reports that are critical to continuous improvement and product safety in the medical device industry.

At The End Of The Course You Will Be Able To

• Understand the fundamentals of an investigation report and its importance in the medical device industry.
• Follow an established process flow for research reporting.
• Identify and describe the key elements of a research report, including impact assessment, research analysis and conclusions.
• Conduct an initial impact assessment and apply techniques such as bracketing, risk assessment, and containment actions.
• Conduct a historical review to contextualize the problem and improve understanding of its origin.
• Analyze data collected during the investigation to identify significant trends and patterns.
• Clearly and concisely present research findings in a report.
• Conduct a final evaluation of the impact of actions taken and propose corrective and preventive action plans.
• Develop an effectiveness plan to monitor the implementation of corrective and preventive actions.
• Use an investigation checklist to ensure completeness and consistency in the report writing process.

Course Content

1. Introduction to Investigation Reporting
2. Process Flow
3. Key Report Elements and Purpose
4. Description
5. Impact Assessment
   • Bracketing
   • Risk Assessment
   • Containment Actions
6. Historical Review
7. Investigation Analysis
8. Investigation Findings
9. Final Impact Assessment
10. Actions Planning
    • Corrective Action
    • Preventive Action
11. Effectiveness Plan
12. Investigation Checklist

• Define general inspection preparation activities.

• Define the Dos and Don’ts of an FDA inspection.

• Identify the team members of your audit team.

• Identify different types of questions during an FDA inspection.

• Understand the consequences of failing the FDA Inspection.

• Recognize the best practices of the industry for an FDA inspection.

Course Content

1. Inspections and Audits.
2. What is FDA?
3. FDA inspection purpose and scope.
4. What to expect from and FDA Inspection?
5. QSIT Inspection.
6. Audit Team: roles and responsibilities.
7. FDA Inspection Do's and Don'ts.
8. Consequences of failing the FDA Inspection.
9. Best practices of the Industry.

• Understand what risk is and its importance in the context of medical devices.
• Become familiar with regulatory requirements related to risk management in medical devices, including ISO 13485:2016, Medical Device Directive (MDR), and FDA - 21 CFR 820.
• Apply the principles of ISO 14971:2019 in medical device risk management.
• Perform a risk analysis and assessment, taking into account intended use and potential misuses.
• Maintain and update the risk management system throughout the lifecycle of the medical device.
• Create and maintain risk management documents.
• Understand risk management in the context of medical device software, including cybersecurity considerations.

Course Content

1. What is Risk and the importance for medical devices
   • Welcome to Course, Presentations and Outline Review
   • Real world RM Case Example
   • Risk Concept Definition
2. Regulatory Requirements for Risk Management
   • ISO 13485:2016
   • Medical Device Directive (MDR)
   • FDA - 21 CFR 820
3. Key Terms and Definitions
4. Overview of ISO 14971:2019
5. General Requirements for Risk Management System
   • Risk Management Process
   • Management responsibilities
   • Personnel
   • Risk Management Plan
6. Risk Analysis and Evaluation
   • Intended Use/Foreseeable misuse
   • Safety Characteristics
   • Hazard and Hazardous Situations
   • Risk Estimation
7. Product and Production Risk Controls
   • Risk Management in Product Design
     • Preliminary Hazard Analysis
     • Hazards Analysis
     • Use FMEA
     • Design FMEA
   • Risk Management in Production
     • Process FMEA
8. Sustaining The Risk Management System
   • Management reporting
   • Production and postproduction activities
     • Production Feedback
     • Post Market feedback (Complaint handling, Service reports, Field studies, Scientific Literature)
     • Risk Documents Sustaining and Update
9. Overall Residual Risk
   • Individual and Overall residual risk
10. Benefit-risk analysis
11. Medical device software risk management
    • Software as a medical device
    • Software as a component
    • Software as an accessory
12. Application of ISO 14971 and Software specific standards
    • Basics for software
    • FDA Level of Concern
    • Cybersecurity
    • Risk Reduction

At The End Of The Course You Will Be Able To

• Understand FDA’s and other regulatory officials’ expectations for “what CAPA is” and the steps required to get you there.
• Know how to improve your CAPA process, from CAPA sources and preventive actions through root cause analysis, action plans and effectiveness check.
• Understand the main elements and sequence of activities for conducting a CAPA.
• Understand how to define a problem statement, the conducting of root cause investigations, tools that can aid you in effectively investigating problems.
• Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.
•  Understand how to establish a compliant Corrective Action and Preventive Action (CAPA).

Course Content

1.  Module 1. Initiate – Investigation Plan – Correction/Containment
   • Introduction to CAPA
   • Initiation
   • Investigation
   • Plan
   • Containment / Correction
2. Module 2. Investigation, Root Cause Analysis – Solution V&V
   • Root Cause Analysis
   • Solution V&&
3. Module 3. Implementation-VoE-Closure
   • Implementation
   • VoE
   • Closure