Fundamentals of Process Validation: From Concept to Continued Verification/Monitoring

Interested participants from other time zones are welcome to contact us regarding the training at [email protected].

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

Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under EU MDR.