Overview

Effectively managing risk is essential to ensuring the safety, performance, and compliance of medical devices. ISO 14971 outlines the international standard for medical device risk management, and understanding how to apply it is critical for organizations across the industry.

This live-online ISO 14971 training course is certified by Exemplar Global and offers a practical, hands-on approach to implementing risk management using ISO 14971:2019 and ISO/TR 24971:2020. Over two interactive days, participants will explore how to identify hazards, evaluate risk, implement controls, and maintain a comprehensive risk management process throughout the product lifecycle.

Whether you are new to risk management or looking to deepen your expertise, this course is designed to meet you at your current level and build your confidence through expert instruction and real-world case studies.

By the end of the course, participants will be able to:

• Understand the structure and requirements of ISO 14971 and ISO/TR 24971
• Apply risk analysis tools and techniques to medical device scenarios
• Develop and document effective risk management plans
• Integrate risk management into quality systems and design activities
• Monitor, review, and improve risk-related processes over time

Risk isn’t optional, and neither is compliance. This ISO 14971 training gives you more than a theoretical understanding of ISO 14971. It empowers you with practical skills that you can apply immediately in your role to reduce risk, improve product safety, and support regulatory readiness. Whether you’re preparing for audits, contributing to design decisions, or building risk files, this training will help you do it with confidence and credibility.

Prerequisites

There are no required prerequisites for this training.

This ISO 14971 training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students should bring their own printed copy of the ISO 14971:2019 and ISO/TR 24971:2020 standards.

The course provides an overview of these documents, but having your own copy to follow along with will be a powerful learning aid.

Who Should Attend

• Quality Managers
• Engineering Managers
• Audit Program Managers
• Internal and external auditors
• Design Teams
• Management Representatives
• Project Teams
• Anyone who needs to understand the difference between Risk Identification, Risk Assessment, and Risk Management and how to put these important tools to work for your organization

This ISO 14971 training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.

Overview

When a single failure can ground a fleet or compromise safety, aerospace manufacturers must get risk management right the first time. AS13004 offers a proven, structured approach to identifying and controlling process risks before they result in costly nonconformities, escapes, or customer dissatisfaction.

This focused, two-day AS13004 PFMEA Risk Management Training equips aerospace professionals with the tools and methods needed to identify, assess, and mitigate risk throughout the production process. This course directly supports compliance with AS9100, AS9120, and AS13004 by focusing on the practical application of PFMEA and Control Plan development as key elements of a proactive risk management strategy.

Led by instructors with deep industry experience, this course covers:

• The four-step risk management process outlined in ISO 31000.
• How ISO 9001 and AS9100 define and expect Risk-Based Thinking.
• Use of aerospace-specific tools: Process Flow Diagrams, PFMEAs, and Control Plans.
• How to quantify and prioritize risk for more effective decision-making.
• Applying AS13004 methodology to meet Operational Risk Management requirements.

Through case studies, interactive exercises, and detailed walkthroughs, participants will gain hands-on experience developing PFMEAs and Control Plans that reduce variability, improve product safety, and strengthen compliance across the aerospace supply chain.

What You Will Learn  

• How to address Risk-Based Thinking requirements of ISO 9001:2015 and AS9100 (per ISO 31000).
• How to address the Operational Risk Management requirements of AS9100 (per AS13004).
• Tools used for Risk Assessment such as DFMEA, Process Flow Diagrams, PFMEAs and Control Plans.
• How risk management can be applied to any organization, regardless of its products or customers.
• A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed.
• How to quantify risk as the first step in establishing priorities for your organization.
• Methods for controlling risks within your Supply Chain.

Who Should Attend

• Any organization that needs a formal, disciplined approach to the identification, assessment, and management of Risk.
• Organizations that must meet the requirements–AS9100 Operational Risk Management, and AS13004 PFMEA and Control Plans.
• Quality Managers
• Management Representatives
• Engineering Managers
• Internal and external auditors
• Design Teams
• Project Teams

Overview

Corrective and preventive action (CAPA) failures are among the most common—and most costly—issues cited by the FDA. For medical device and pharmaceutical companies, an ineffective CAPA system can trigger major compliance problems, regulatory scrutiny, and product risks. But when done right, CAPA in medical devices becomes a powerful driver of quality improvement and risk reduction.

This practical, two-day live-online training equips you with the skills and tools to build and maintain a compliant, effective CAPA system in line with FDA 21 CFR and ISO 13485 requirements. Designed specifically for professionals in medical device and pharmaceutical industries, the course teaches you how to perform efficient root cause investigations and develop corrective actions that truly solve problems and prevent recurrence.

Led by experts in medical device and pharma compliance, this course covers:

• Key CAPA requirements from 21 CFR Parts 4, 820, 210/211, 201/801, and ISO 13485.

   

• EU MDR expectations, including Article 83 (PMS), Article 89 (Serious Incidents), and Article 10 (Manufacturing).

   

• Fast-paced, fact-based investigation tools including 5 Whys, Fault Tree Analysis, and Fishbone Diagrams.

   

• Real-world case studies that walk through containment, root cause analysis, corrective action planning, and verification of effectiveness.

   

• Practical tips for documenting CAPA activities to meet global regulatory expectations.

   

• Risk management tools like FMEA and incident risk analysis to enhance the impact of your CAPA system.

Whether you’re responding to complaints, audit findings, or internal quality events, you’ll leave this course with the confidence to manage CAPA in medical devices and pharmaceuticals with clarity, consistency, and compliance.

Topics

• The regulatory requirements for CAPA in medical devices and pharmaceuticals.
• How to perform effective fast-paced root cause analysis and complaint investigations.
• How to document complaint investigations and maintain records to demonstrate compliance.
• Root cause investigation methods, such as:
  • The 5 Whys: Including 5-Whys Tree and 3×5 Whys (or 3-legged 5-Whys)
  • Fault Tree Analysis
  • Cause and Effect
  • Flow Charting
  • Pareto Charting
  • Fish-bone/6 M approach (Man, Method, Machine, Material, Milieu (Measurement & Mother Earth)
• Other helpful pharma & medical device CAPA Tools including:
  • 5-W 2-H and 5-W 2-H Proof
  • FMEA
  • Containment approaches
  • Incident Risk Analysis
  • Paynter Charts
  • Layered Process Auditing
  • Corrective Action Plans
  • COPQ approach to CAPA profit enhancement

Who Should Attend

• Quality Engineers (QE)
• Manufacturing Engineering (ME)
• Process Engineers & Technicians
• Electrical Engineers (EE) and Technicians
• Top Management – They are ultimately responsible for ensuring the CAPA system is working effectively.
• Operations Directors & Management
• Engineering Directors & Management
• Manufacturing Directors & Management
• Regulatory Directors & Management
• Quality Assurance Directors & Management
• Purchasing Managers
• Supply Chain Managers who deal with SCAR and CAR processes

Overview

Mistakes happen and processes fail, but unresolved issues and recurring problems can lead to wasted resources, compliance risks, and operational inefficiencies. It’s important for organizations to have effective root cause analysis procedures in order to ensure that these issues are corrected and prevented in the future.

To help organizations tackle these challenges, Axeon’s Root Cause Analysis & CAPA training provides a structured, 8-step approach to Root Cause Analysis (RCA), Corrective Action, and Preventive Action (CAPA). This course applies to any industry or organization looking to improve problem-solving effectiveness. It emphasizes proven methodologies for identifying root causes, implementing corrective actions, and preventing recurrence, all while ensuring compliance with quality management system requirements.

Using industry-recognized tools such as Five Whys, Ishikawa diagrams, and Failure Modes and Effects Analysis (FMEA), this Root Cause Analysis & CAPA training course provides a practical framework for improving process reliability and sustaining long-term improvements.

Available both online and in-person, this interactive course combines expert instruction with hands-on exercises and real-world case studies. Whether you’re new to corrective actions or looking to refine your approach, this training will equip you with the skills needed to drive meaningful improvements in your organization.

Root Cause Analysis & CAPA Training Key Topics  

• Root Cause Analysis fundamentals and common challenges
• Systematic problem description and containment strategies
• Data-driven tools for identifying and verifying root causes
• Developing and implementing effective corrective actions
• Layered Process Audits and verification methods
• Preventing recurrence and closing corrective action reports

Who Should Attend

• Employees responsible for conducting or managing corrective actions
• Quality managers, engineers, and auditors involved in CAPA processes
• Supervisors and frontline managers overseeing process improvements
• Production and operations personnel responsible for identifying and resolving issues
• Regulatory and compliance professionals ensuring adherence to quality standards
• Team members involved in problem-solving initiatives or process improvement projects
• Anyone seeking a structured approach to root cause analysis and corrective action