Course Objectives:
By the end of this course, participants will:
- Understand the principles of a Risk-Based Training System and its alignment with ISO 13485:2016.
- Learn how to assess training needs based on risk levels of job roles.
- Develop an effective training matrix and competency assessment system.
- Implement and monitor training effectiveness using regulatory best practices.
Course Duration:
- Standard Course: 1 Full Day (7 Hours)
- Customizable: Based on company needs
Target Audience:
- Quality Assurance (QA) & Regulatory Affairs (RA) Teams
- Manufacturing & Production Personnel
- Human Resources (HR) & Training Coordinators
- Process Engineers & Validation Teams
- Auditors & Compliance Officers
Course Outline and Training Methodology:
- Introduction to Risk-Based Training System (1 Hour)
- Why is training critical in medical device manufacturing?
- Overview of ISO 13485:2016 Clause 6.2 (Competence, Training & Awareness)
- Regulatory requirements (FDA, MDR, MDSAP, GMP)
- Common audit findings related to training
- Understanding the Risk-Based Approach to Training (1 Hour)
- What is a Risk-Based Training System?
- How risk impacts training needs
- Risk levels of job functions (High/Medium/Low)
- ISO 14971:2019 Risk Management principles in training
- Identifying critical job roles affecting patient safety
- Creating a Risk-Based Training Matrix (1.5 Hours)
- Steps to develop a training matrix
- Defining mandatory vs. role-specific training
- Competency gap analysis (How to assess current vs. required skills)
- Example: Training matrix for QA, Production, and Supply Chain teams
- Implementing Risk-Based Training in Your Organization (1.5 Hours)
- Methods of training: Classroom, E-learning, On-the-Job Training (OJT)
- Competency assessment methods: Exams, practical tests, supervisor evaluations
- Documenting training records for compliance
- Using a Training Management System (TMS) for automation
- Evaluating Training Effectiveness & Continuous Improvement (1.5 Hour)
- Measuring training effectiveness (KPIs & audit metrics)
- Linking training outcomes to CAPA & audit findings
- Retraining triggers: SOP changes, nonconformities, and new regulations
- Case Study: Best practices in training compliance
- Course Assessment & Certification (1 Hour)
- Quiz / Knowledge Assessment (MCQs, Open-ended Questions)
- Practical exercise: Evaluate a sample training matrix for effectiveness
- Certificates issued for successful participants
Course Deliverables:
- Training Material (Slides & Handouts)
- Risk-Based Training Matrix Template (Excel)
- Competency Assessment Forms
- Checklist for Auditing Training Compliance
- Certificate of Completion
Interested with this course? Send us enquiries below!
