MMD-123    Computer Software Validation (CSV) & Data Integrity for Medical
                      Devices - GAMP 5 & Regulatory Compliance
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• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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This comprehensive 2-day training on Computer Software Validation (CSV) & Data Integrity for Medical Devices is designed to provide participants with a solid understanding of regulatory requirements and practical implementation within GxP environments. The programme covers key frameworks such as ISO 13485, expectations from the U.S. Food and Drug Administration, and EU Medical Device Regulation (MDR), along with detailed guidance on 21 CFR Part 11 and GAMP 5.

Participants will gain practical knowledge on the software validation lifecycle, risk-based validation approaches, and validation requirements for different system categories, including spreadsheet validation. The course also emphasises current regulatory focus on Data Integrity, incorporating guidance from the Medicines and Healthcare products Regulatory Agency and International Society for Pharmaceutical Engineering. Key topics include data lifecycle management, data governance frameworks, regulatory expectations, and challenges associated with modern technologies such as cloud computing and mobile devices.

Through practical exercises and case studies, participants will be equipped to implement compliant computer system validation processes and maintain robust data integrity practices, ensuring inspection readiness and regulatory compliance within the medical device industry.
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By the end of this training, participants will be able to:

• Understand the principles of Computer Software Validation (CSV) and its application within GxP-regulated environments for medical devices.
• Interpret key regulatory requirements including ISO 13485, U.S. Food and Drug Administration expectations, EU MDR, and 21 CFR Part 11.
• Apply the software validation lifecycle and risk-based approach, including the V-Model and GAMP 5 framework.
• Understand and implement Data Integrity principles across the data lifecycle, including regulatory expectations from Medicines and Healthcare products Regulatory Agency and industry guidance.
• Enhance compliance and inspection readiness by applying best practices in data governance, GxP systems, and regulatory requirements.

• ​Module 1: Fundamentals of Computer Systems Validation
• Module 2: Regulatory Framework for Computer Systems
• Module 3: Electronic Records & Signatures (System-Level Controls)
• Module 4: Validation Lifecycle, Risk-Based Approach & GAMP 5
• Module 5: Data Integrity Principles & Regulatory Expectations
• Module 6: Data Lifecycle & Risk Points
  
• Module 7: Data Governance & Integrity in GxP Systems
  
• Module 8: Data Integrity Maturity, Regulatory Findings & Best Practices
  

This course is designed for Quality managers, quality engineers and quality technicians involved in the development and manufacturing of medical devices. Professionals directly involved in meeting the FDA’s quality system

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.