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Medical Device Process Validation Training Course: FDA and ISO 13485 Requirements

This course introduces process validation in the medical device sector. You will learn how to interpret the US FDA and ISO 13485:2016 process validation requirements; plan the process validation; create qualification protocols (IQ, OQ, and PQ); execute the protocols; monitor the validation; and identify measurement and statistical tools that support process validation activities. Learn about the interrelationships of process validation, risk management, and management of change.

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Brief Overview of This FDA and ISO 13485 Process Validation Requirements Training Course

SkillsLab Class ?

Class Content


Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion


Continuing Education Units (CEUs)


* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Classes Focused on Medical Device Process Validation Requirements

SkillsLab $3295

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
PVF VIRTUAL DELIVERY (Eastern time - PM) 23 Sep 2024 27 Sep 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER


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Register 3 people, 4th attends free!


*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Medical Device Validation Class

Become your company's expert on process validation! Obtain hands-on practical application experience involving planning, execution, and reporting of process validation activities as part of the integrated requirements of a quality management system that meets FDA and ISO 13485 requirements.  

Course Overview
SkillsLab Class

Introduction to Process Validation

  • Purpose of process validation and when it is needed
  • The process validation life cycle
  • Requirements from US FDA and ISO 13485:2016
  • Role of guidance for process validation
  • Case Study! Identify Critical-to-Quality (CTQ) Steps

Planning Process Validation

  • The validation master plan (VMP): purpose, contents
  • Scoping the validation
  • Process validation team
  • Risk management and risk-based thinking
  • Change control
  • Purpose of protocols
  • Protocol input, general contents
  • Interface between design qualification and process validation
  • Case Study! Assess Validation Master Plan Information Needs

Installation Qualification

  • IQ purpose, inputs
  • IQ protocol contents
  • IQ execution and output
  • Common issues in IG
  • Case Study! Assess IQ Needs
  • Overview of measurement topics: metrology prism, variation, uncertainty, gage R&R
  • Case Study! Practice Gage R&R

Operational Qualification

  • OQ purpose, inputs
  • OQ protocol contents
  • OQ execution and output
  • Common issues in OQ
  • Case Study! Assess OQ Needs
  • Overview of statistical tools: frequency plots, Pareto charts, trends analysis
  • Case Study! Practice Using Statistical Information

Performance Qualification and Final Report

  • PQ purpose and inputs
  • PQ protocol contents
  • PQ execution and output
  • Common issues in PQ
  • Case Study! Assess PQ Needs
  • Verifying process stability and capability
  • Case Study! Evaluate Process Stability and Capability
  • Final report: purpose, audience, contents, and life cycle

Monitoring the Process

  • Monitoring the process after validation: purpose, sources of variation, internal audits, mistake-proofing, statistical process control, handling deviations
  • Revalidation: purpose and when it is needed
  • Activity! Next Steps
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to

Plan a process validation and document a validation master plan (VMP).

Explain the purpose of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

Create IQ, OQ, and PQ protocols.

Execute IQ, OQ, and PQ protocols.

Identify measurement tools that support process validation.

Identify statistical tools that support process validation.

Monitor the process after process validation.

Who Should Attend

Who Should Attend

Recommended for quality, regulatory, engineering, manufacturing, and other technical professionals who plan, execute, report, maintain, review, or manage process validation activities, and who have basic knowledge of statistics or statistical tools. This course is tailored to medical device companies but will also provide value to students from pharmaceutical organizations. 

  • Device RA/QA Professionals
  • Engineering Teams
  • Manufacturing Personnel
  • Process Validation Professionals
  • Pharmaceutical RA Professionals

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