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Fundamentals of IQOQPQ Process Validation of Medical Devices
Rating: 4.3 out of 5(989 ratings)
2,560 students

Fundamentals of IQOQPQ Process Validation of Medical Devices

Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) || Medical Devices
Created byPhaniendra Somraj
Last updated 1/2026
English

What you'll learn

  • Process Validation of Medical Devices using IQOQPQ Phases to meet ISO 13485 standard requirements and FDA regulations.
  • In less than 2 hours you can be an Expert on how to perform Process Validation in your Manufacturing facility
  • Create a Process Validation Procedure
  • Perform Installation Qualifications
  • Perform Operational Qualifications
  • Perform Performance Qualifications and launch your New product Introductions regime
  • Medical Device Development NPI
  • Teach IQ OQ PQ to your teams and collaborate better
  • Molding Qualification
  • Injection Molding Process Validation

Course content

3 sections • 9 lectures • 59m total length

  • Introduction to the Course4:29

    This Introduction Chapter gives you a basic understanding of WHY we do Process Validation. Process Validation not just mitigates the Compliance risk, it also helps you build quality at the source, prevent nonconformities long term and help produce premium quality products for the safety of your final users/customers.

    Process Validation is a very hot topic in Med device companies and there is a lot to it due to the stages from bringing an idea to manufacturing to your final customer. The instructor did do his best to provide everything that is needed for you to be successful to perform Process Validations.

    Good luck on this journey of learning.

  • 483s - FDA Data Analysis7:15

    You can skip this lecture, if you want. But as a professional in Med Devices industry, it is always very helpful to know what the FDA auditors look for in various audits that they perform year wide. This is an open source data, and very people in the industry are aware of it.

    This will help you better prepare from day1, when you start to write your procedures and train your staff to perform the validations.

    The instructor has varied experience from working for contract manufacturers to OEMs, and surely see a lot of value  in this data analysis, to better prepare for successfully launching new products that will have no findings in any future audits - at least in the area of Process Validations.

  • Manufacturing Scenario3:29

    There are so many different varieties of Med device products out there. The reach of this course is broad and it is hard to cover one type of product family in the course. So the instructor has decided to provide ONE type of scenario - Injection Molded parts, to help you understand the overall steps at the lowest level at operators/ inspectors etc and how it feeds into the broader Process  validation process.

    Again there is so much to cover, but the format of the course is written to help understand the support system as well as the core IQ OQ PQ process.

    This can be benchmarked to your product and your process - to the closest possible. After all you, if you are here taking this course, you are all manufacturing some sort of a product - from a test kit, a ventilator, a tablet to a dentist tool.

Requirements

  • Basic knowledge of Quality inspection will help

Description

Process Validation of Class 1/2/3 Medical Devices shall meet ISO 13485 standard and FDA 21CFR 820.75 requirements.

The objective of the course is to provide the course audience with the tools and knowledge to use the Process development, Quality principles and Program management to perform their Process Validation activities to meet regulatory, compliance and customer requirements.

It is a vast subject completely based on YOUR products, medical device class, team size, manufacturing method etc.

The course is explained with various phases and links to make a New Product Launch Validation successful.

A Designer doesn't get a manufacturing perspective, a Process Engineer doesn't understand a QE and QC lab perspective, the Instructor covered all those important bases to make this course holistic to manage and be successful.

This course will teach you cross collaboration activities involved in Process Validations from Engineering responsibility to Quality to Operations.

This is a high collaboration work with various hand offs between various functions in your organization, but once trained on the overall process, you will be ready to start. The first 2 product launches will help you identify the processes and the bottlenecks within, and when you are ready to launch your third product, your team's maturity on the process will help a lot to successfully & smoothly do your Process Validation.

The standards and FDA requirements have a lot of room for interpretation, the Instructor has taken his best diligence to provide guidance through this  course. At the end of this course, you will have been provided with an overview of the Process Validation regulatory requirements and what you need to perform them without any bottlenecks in your organization.

A very good luck on this journey. 

Who this course is for:

  • Contract Manufacturers, Director of Quality, Quality Managers, Quality Engineers, Supplier Quality Managers, Supplier Quality Engineers, Internal Auditors, Process Engineers, Process Technicians
  • Medical Device Industry Quality professionals, Risk Management, FDA 483 responses for Process Validation warning letters
  • Mechanical Engineering Students; Sterilization, Passivation, Calibration etc. service providers
  • Medical Devices Start Up
  • Manufacturing Engineers, Quality Engineers
  • Supply Chain Management
  • Indian Medical Device Manufacturers and contractors

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