CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals Training

Days: 2 • CEU Hours: 1.6

7:30 AM – 4:30 PM MST

Learn Root Cause Investigation & CAPA in Medical Devices & Pharmaceuticals.

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

CAPA in Medical Device - Woman opening a machine with vials

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

Training Objectives For CAPA in Medical Devices

Practice within a compliant corrective action & preventive action (CAPA) process.
Perform effective root cause investigations.
Understand when and how to apply the appropriate root cause investigation tool/method.
Understand which records are required to demonstrate compliance to the FDA’s CFR Part 4 and CFR Part 820 regulations and ISO 13485 requirements.
Establish effective corrective action plans.
Plan & perform a Verification of Effectiveness (VoE) to assess if the corrective actions resolved the root of the problem.
Understand how to keep the CAPA process SIMPLE, effective, and adding value while reducing costs.
Understand how CAPA and Kaizen Events (Proactive) work together to demonstrate compliance.
Understand the interrelationships between: Nonconformities, Complaints, Post Market Surveillance and QMS monitoring and statistical techniques.

Agenda

Day 1

Part 1: Overview – Why CAPA in Medical Devices are Required

Part 2: Typical Problems with Root Cause Investigations

Part 3: Responsibilities for Root Cause and Corrective/Preventive Action

Part 4: Step 1: Assigning a Corrective Action Team Leader: Cross-Functional Team

Part 5: Step 2: Describing the Problem – COPQ

Part 6: Step 3: Containing the Problem

Part 7: Step 4: Identifying the Root Cause or Causes

Part 8: Data Collection and Analysis

Day 2

Part 1: Step 5: Verifying the Root Cause or Causes

Part 2: Step 6: Implementing Corrective Actions

Part 3: Step 6a: Risk Assessment: Verify CAPA Does Not Impact Regulatory or Safety Requirements

Part 4: Step 7: Verifying Corrective Action Effectiveness

Part 5: Step 8: Closing the Corrective Action

Part 6: Course Insights and Final Exam

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Date/Registration

CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals Training — $1295