MMD-107    Medical Devise Root Cause Analysis and CAPA

  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
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An effective RCA and CAPA system requires clear procedures, timely investigation, proper documentation, and cross-functional involvement. Organizations must also monitor the effectiveness of implemented actions and drive continual improvement. When properly executed, RCA and CAPA not only resolve quality issues but also strengthen the overall quality management system and enhance customer confidence.

Inadequate CAPA systems remain among the most frequently cited weaknesses during regulatory inspections and quality system audits. This 2-day programme provides a practical and regulatory-aligned understanding of how to establish, implement, and maintain an effective CAPA system for medical device operations, with reference to FDA Quality Management System Regulation (QMSR) requirements under 21 CFR Part 820, ISO 13485:2016, ISO/TR 24971, EU MDR, and related global expectations.
This course provides learners with:-
  • Understand the regulatory requirements and expectations for CAPA in the medical device industry
  • Explain the CAPA lifecycle, including identification, investigation, and closure of nonconformities
  • Apply basic root cause analysis tools to identify underlying causes of quality issues
  • Develop effective corrective and preventive action plans to address and prevent recurrence
  • Recognise the importance of CAPA effectiveness, documentation, and integration with the quality management system
  • Module 1: Regulatory Foundations & CAPA Overview 
  • Module 2: Problem Definition & Root Cause Analysis 
  • Module 3: CAPA Development & Implementation
  • Module 4: CAPA Effectiveness, Integration & Compliance 
Quality assurance and quality control personnel, regulatory affairs professionals, design assurance and R&D teams, manufacturing and operations managers, internal and supplier auditors, post-market surveillance personnel, and professionals responsible for CAPA, compliance, and risk management in medical device organisations.
This is a 2-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.