Course Outline

Course Information

• The course begins at the time stated below
• The course is broken up into modules outlined below
• There will be breaks between modules

17 & 18 June 2026

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

Session 1 | Day 1

210 mins | 1:00 PM UK

Introduction to Process Validation

• Purpose and definitions in the context of medical devices
• Regulatory framework: EU MDR, FDA 21 CFR Part 820 (QSR), ISO 13485
• Key regulatory expectations and guidance (GHTF, FDA, ISO standards)

Planning and Preparing for Process Validation

• Validation master plans (VMPs): scope and structure
• Identifying critical process parameters (CPPs) and critical quality attributes (CQAs)
• Risk-based approaches to validation (ISO 14971 links)
• Supplier and subcontractor considerations

Validation Stages & Documentation

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Documentation requirements and traceability

Session 2 | Day 2

210 mins | 1:00 PM UK

Executing and Documenting Validation Studies

• Protocol development and execution
• Establishing acceptance criteria
• Data collection, analysis, and reporting
• Managing deviations and non-conformances

Maintaining the Validated State

• Ongoing monitoring and process control
• Revalidation triggers (changes, scale-up, new equipment)
• Integration with QMS and regulatory audits

Case Studies and Best Practices

• Examples of successful process validation in device manufacturing
• Common pitfalls and lessons learned from inspections
• Preparing for Notified Body and FDA audits

Wrap-Up & Q&A

• Key take-home messages
• Final interactive Q&A session

Richard Young has over 25 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.