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Process Validation for Medical Device Manufacturing
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Process Validation for Medical Device Manufacturing

17 & 18 June 2026 | 2-Day Live Online Course

Original price was: £595.Current price is: £476.

2-day Live Online Training 

Learn how to plan, execute, and maintain process validation to ensure regulatory compliance and product quality.

 

Register Early to Save

 

Enrol before 22 May to save 20% (June Course)

Discount has been applied to the price above. VAT, if applicable, will be added.

Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Process validation is a critical requirement in medical device manufacturing, ensuring that processes consistently produce products that meet predetermined quality, safety, and performance standards. Both the EU MDR and FDA QSR place significant emphasis on process validation as part of regulatory compliance.

 

This course provides a comprehensive yet practical introduction to process validation for medical devices, covering regulatory requirements, validation planning, protocols, and reporting. Participants will explore best practices, common pitfalls, and real-world case examples to support successful implementation.

 

Learn more about how we deliver live online training.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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Key Learning Objectives

 

  • Understand the regulatory basis for process validation under EU MDR and FDA QSR
  • Differentiate between installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
  • Develop and implement process validation plans, protocols, and reports
  • Recognise critical process parameters and acceptance criteria
  • Apply risk-based approaches to validation
  • Manage ongoing process monitoring and revalidation requirements

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer through interactive and engaging sessions
  • Unlimited access to session recordings for 2 weeks after the course (live format)
  • One month of unlimited access to recordings and slides (on-demand format only)
  • Validated certificate of attendance, available to download or share on LinkedIn

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

17 & 18 June 2026

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

 

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.

This course is designed for professionals working in:

  • Quality Assurance and Regulatory Affairs
  • Manufacturing, Operations, and Engineering
  • R&D and Process Development teams
  • Supplier Quality and Technical Teams
  • Anyone involved in process design, validation, and compliance activities

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Process Validation for Medical Device Manufacturing

17 & 18 June 2026 | 2-Day Live Online Course

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