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QA/RA Consulting, Auditing & Training

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

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.5

* 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

SkillsLab $3295

Course Code	Location	Class Begins	Class Ends	Daily Schedule	Course Delivery	Class Agenda	Registration
PVF	VIRTUAL DELIVERY (Eastern time - PM)	03 Feb 2025	07 Feb 2025	1:00PM - 5:00PM Eastern US Time	Virtual		REGISTER
PVF	VIRTUAL DELIVERY (Eastern time - PM)	11 Aug 2025	15 Aug 2025	1:00PM - 5:00PM Eastern US Time	Virtual		REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

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

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

SkillsLab

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

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.