Under Regulation (EU) 2017/745 on Medical Devices manufacturers are required to ensure that their products consistently meet applicable safety and performance requirements. Process validation is a key component of this compliance, particularly when the output of a manufacturing process cannot be fully verified by subsequent inspection or testing.
This training session, “Fundamentals of Process Validation: From Concept to Continued Monitoring” offers a comprehensive and practical overview of the validation lifecycle, from initial process design through to ongoing monitoring and control. It aligns with EU MDR requirements (especially Annex I, Chapter I – General Requirements, and Annex IX/XI on conformity assessment procedures) and integrates best practices from related global standards, including ISO 13485:2016 and and FDA 21 CFR Part 820.
This course goes beyond theory by providing practical inputs and real-world insights into how process validation is applied across manufacturing operations. Participants will learn how to establish a validation master plan, define critical parameters, manage process changes and ensure continuous process control through effective monitoring and data-driven verification.
Training Objectives
By the end of the training, participants will:
- Understand the regulatory framework and global standards governing process validation (MDR, ISO 13485, FDA, GHTF, etc.).
- Learn the three stages of process validation: Process Design, Process Qualification, and Continued Process Verification.
- Gain practical skills in planning, executing, and documenting validation activities.
- Identify and control critical process parameters
- Develop an effective Process Validation Master Plan (PVMP) aligned with regulatory expectations.
- Learn to apply risk-based approaches and data-driven decision-making for process control and improvement.
- Understand how to maintain validation status through continued verification and lifecycle management.
Key Topics Covered
- Regulatory foundations for process validation under EU MDR and ISO 13485
- When and why process validation is required under EU MDR
- Three-stage lifecycle approach to validation:
- Stage 1: Process Design
- Stage 2: Process Qualification (including IQ, OQ, PQ)
- Stage 3: Continued Process Verification (CPV)
- Identifying and controlling Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
- Risk-based validation planning and documentation
- Integration with QMS, CAPA, and Change Control processes
- Managing re-validation triggers, non-conformities, and audit findings
- Common mistakes and how to avoid them: Case studies and practical examples
Benefits
After completing this training, participants will:
- Understand how process validation supports compliance with EU MDR
- Be able to design and execute a risk-based validation strategy
- Know how to prepare and maintain audit-ready validation documentation
- Gain tools and templates to support ongoing validation and monitoring
- Reduce risk of regulatory non-compliance, product failures and market access delays
Target Audience
Regulatory Affairs and Quality Assurance Managers, D&D Engineers, Clinical Affairs Managers, Manufacturers, Consultants
Certificate
Participants receive a Certificate of Attendance of DQS MED GmbH
Interested participants from other time zones are welcome to contact us regarding the training at [email protected].
