Process Validation - Validation of Processes and Software Used in Production and Quality Systems
This course provides a practical structured and regulatory aligned introduction to process validation and the validation of software used in production and quality management systems. Participants learn how to meet the regulatory expectations defined in EN ISO 13485, IEC/TR 80002-2:2017, and the FDA’s 21 CFR 820 Quality System Regulation. The training explains how to plan, execute, and document validation activities, how to generate objective evidence, and how to apply risk based approaches to software validation. Through real world examples, the training demonstrates how to establish robust, risk based validation strategies that withstand scrutiny from Notified Bodies and regulatory authorities.
Course Outline
- Regulatory foundations for process and software validation
- Process validation fundamentals and terminology
- Planning and executing IQ/OQ/PQ
- Software validation requirements and IEC/TR 80002-2 guidance
- Documentation, objective evidence, and common pitfalls
- Validation lifecycle, revalidation, and change control
- Integration into QMS structures
- Practical examples and implementation strategies
Learning Outcomes
- Regulatory foundations: MDR/IVDR, EN ISO 13485, IEC/TR 80002-2, 21 CFR 820
- When process validation is required — and when not
- Practical application of the process model
- Planning & executing IQ, OQ, PQ
- Creating validation plans, protocols, reports & objective evidence
- Software validation for production & QMS applications
- Risk based validation approaches
- Avoiding common validation pitfalls
- Maintaining validated states, change control & revalidation triggers
- Real industry examples and best practice workflows
Who Should Attend
- Developers and manufacturers of medical devices
- Process validation specialists and production managers
- Quality management representatives
- Software developers
- IT professionals
- Auditors
Why You Should Attend
This course is ideal for professionals who need a clear and actionable understanding of process and software validation. It equips participants with the tools needed to evaluate processes, define validation activities, and prepare compliant validation plans and evidence. The training delivers practical insights into regulatory expectations, risk based approaches, and lifecycle management, enabling organizations to build robust, sustainable and audit ready validation strategies.
510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market
AI Act, MDR/IVDR, QMSR: Practical AI compliance trainings for medical devices
AI in Medical Devices - Expectations in a Maturing Field
Biological Evaluation of Medical Devices - How to Succeed in Your Notified Body Assessment
CAPA Considerations: A Comprehensive Overview
Need help choosing?
Our training advisors can help you find the perfect match.