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Process Validation Training for Medical Devices: Principles and Protocols

This class is now offered as a virtual online seminar. 

The FDA and ISO 13485:2016 require process validation, but don’t offer much guidance. Through interactive discussions and workshops, you’ll take a simple process through the entire validation cycle – writing protocols, determining key operating parameters, and identifying data analysis strategies. You will learn how to interpret the regulations, standards, and guidance documents; correctly apply the principles of risk management; create qualification protocols (IQ, OQ, PQ); and identify statistical methods and tools when implementing and maintaining process validation activities.

You’ll also evaluate real-world process validation examples and warning letters, as well as learn best practices for the practical application of process validation in medical device manufacturing.

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (Eastern Time) 11/14/2022 5 $3295.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 12/05/2022 5 $3295.00 Add to Cart CONTACT US
San Jose, Costa Rica 12/12/2022 3 $3295.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 02/13/2023 5 $3295.00 Add to Cart CONTACT US

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Explain the purpose of process validation, understand its life cycle, and describe key concepts needed to successfully conduct process validations.
  • Identify the available guidelines and sources of requirements.
  • Create a validation master plan (VMP).
  • Explain the intent of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
  • Describe the requirements for IQ, OQ, and PQ and create associated protocols.
  • Identify and manage sources of variation in measurement systems.
  • Articulate the role of quality management systems, metrology and measurements systems, risk management, and quality tools and analysis in 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. 

Virtual Class Days

 5 days, daily 1:00  - 5:00 PM Eastern time

Virtual Half-Days: 5
In-Person Full-Days: 3
CEUs: 2.5

Virtual Session Details

The same great training, from the comfort of your home or office

Oriel STAT A MATRIX is known for our in-person workshops and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. Our instructor and students interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment.

This is an ideal alternative to the typical classroom setting for quality and regulatory professionals who are unable to travel, work across various regions or loactions, or who just prefer the convenience of attending a class without having to leave their own personal environment.

This class can be delivered as a private virtual learning exclusively for your company. 

Online Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time (EST).
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

Tablets and mobile devices may lack some essential functionalities and are not recommended.  


Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

Get answers right now. Call 1.800.472.6477