Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems – For Starter Validation, CQV and C&Q Roles

Take this course and join a Validation Team in a Pharma Company or Engineering Consultancy or Contractor in 10-Weeks. Learn to read P&IDs and piping isometrics. Populate an IQ OQ PQ validation protocol. Validate equipment and systems. Developed in consultation with the pharma industry including Pfizer and MSD.

Develop an IQ OQ PQ validation protocol
Validate equipment and systems
Build on your industry experience and start a higher-paying career in validation
Application Deadline: Wednesday 27th November

Study Online part-time
15hrs/week for 10 Weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress every week and follow up with you to help you finish the course
Join 1654 Learners

Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems Course

Apply NOW and Learn to Populate an IQ OQ PQ Validation Protocol

Developed in consultation with the pharma industry including Pfizer and MSD.

Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems – For Starter Validation, CQV and C&Q Roles

Develop an IQ OQ PQ validation protocol
Validate equipment and systems
Build on your industry experience and start a higher-paying career in validation
Application Deadline: Wednesday 27th November

Study Online part-time
15hrs/week for 10 Weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress every week and follow up with you to help you finish the course
Join 1654 Learners

Our learners work for the world’s biggest pharma and medical device companies

See Course Price

Apply NOW and Learn to Populate an IQ OQ PQ Validation Protocol

Developed in consultation with the pharma industry including Pfizer and MSD.

PLEASE NOTE! This program content was originally developed on a construction project (and in consultation with the pharma industry) by a team of scientists, chemical engineers and validation engineers working for an engineering consultancy to rapidly train its own staff to populate an equipment validation protocol.

Minimum Entry Requirements

This program is highly specialized so you MUST have one of the following:

You are a plumber/pipefitter/pipe welder (e.g. high purity pipe fitter and orbital welder) / site-foreman / instrument technician (i.e. you can interpret technical drawings, especially P&IDs and pipe skids) and you are fed up working outside on freezing cold construction sites.
Or
You have 1 year or more of GMP manufacturing experience or have a recognized GMP qualification.
Or
You have commissioning & qualification experience in ANY INDUSTRY e.g. Oil and Gas, Food Manufacturing, etc.
Or
You work in Quality Assurance or Quality Control in the pharma/medtech industry and are worried about having to sign off on validation documents you don’t fully understand!
Or
You are a chemical / process / petroleum / project / mechanical, etc engineer or a laboratory scientist and want to move into a validation role or learn how to correctly populate an equipment validation protocol.
Or
You already work in validation (e.g. mechanical contracting company carrying out high-purity pipework installations) but have no formal training on IQ OQ PQ equipment validation protocols.

What Kind of Roles Could I Retrain For?

You could retrain for the following roles;

Validation Technician – Some pharma companies call this role:
- CQV Specialist
- C&Q Specialist
- Associate QA Validation Specialist
- C&Q Junior Project Manager
- Equipment & Process Validation Specialist
- QA Validation Associate
- QA Validation Specialist
Validation Team Member

With validation roles, you could work directly for a pharmaceutical company on in-house projects or work for an engineering consultancy or engineering contractor as part of a project team on large capital projects.

Enroll in this program to learn…

How to prioritise which parts of the equipment system are critical to validate and which parts are not etc, using component impact assessments and risk management tools.
How to read/interpret the engineering documentation such as P&IDs, Piping Isometrics & Electrical Loop Drawings used to define the equipment system.
How the intent of a process (like maintaining the product at the required temperature) is linked to the equipment that will be used to do this.
The tests along with the functional test scripts necessary to confirm that the installed equipment is fit-for-purpose, i.e. that it will do what it states that it will do based on the User Requirement Specifications).
How to use a traceability matrix tool to ensure that all requirements defined within the User Requirement Specifications (URS) are tested in the protocol.
How to qualify equipment, instruments and piping systems, and automation controls.
How to document all of these steps in a 100 page plus equipment validation protocol which you will develop as your end of module assignment.

You’ll produce a number of deliverables throughout the program including…

Complete 5 Equipment Validation Protocol workshops on the following to prepare you to populate your own protocol:
- Component Level Impact Assessment
- Equipment Installation Verification
- Piping Installation Verification
- Instrument Installation Verification
- Functional Verification Test
Complete 8-question booklets (one for every week’s worth of content) which will summarise what you have learnt for the week and ensure you retain and understand the information.

And you’ll produce your own 100-page plus IQ OQ PQ Validation Protocol to commission and qualify a clean-in-place system…

The protocol will detail the following elements;

Product characteristics – showing what your system is looking to achieve/produce
Production equipment – detailing the equipment necessary
Test scripts and methods – telling you the steps involved in conducting a test
Test parameters and acceptance criteria – defining acceptable test results
Test checksheets – documenting and recording the test results
Final approval – documenting that the validation process has been successfully carried out

View Full 10 Week Syllabus

See Course Price

If you’re spending money on an education program, make sure you choose one you’ll finish!

With every GetReskilled ONLINE program;

We use one centralized platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires you to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.

This all helps us to spot any potential issues early and helps you completely finish the program.

Here from people who’ve taken this course

Renato Chato

“This course was very informative and could greatly enhance our knowledge and understanding on Pharma Manufacturing practices (GMP, GDP, etc.). The training experience was great and details were clear. Keep it up, guys!”

Michael Cheong Yim Poh

“Once you tune in your mind set to studying online, it’s a great way to learn as you manage the pace yourself.”

Delivered by an Industry Expert

Dr. Joe Brady

Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, DPS Education

Dr. Joe Brady is a full-time practicing Validation Lead and an assistant lecturer with Technological University Dublin (TU Dublin), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer and highly experienced in competency-based training. He designs and prepares educational modules and full academic programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institutions.

He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over twenty years of project experience in the pharmaceutical, biopharmaceutical and medical device industries in Singapore, China, Ireland, The Netherlands, Belgium, France, and the USA.

Meet Your Online Classroom Support Team

When you learn at GetReskilled, you can always rely on an in-house team of experts to provide guidance and support, whenever you need it.

Course Leaders

Your Course Leaders will onboard you on the program, and help keep you motivated throughout the course.

Course Coordinators

Your CC’s are here to provide you with answers, tips, and are going to check your progress weekly to keep you on track and will reach out to you by email or even by phone if you fall behind!

Your 10-Week Class Schedule

Your Class Director will check your study logs and only will release subsequent week’s materials to you if you have been logging in for more than 10 hours per week.

And he or she will proactively follow up with you to keep you on track.

Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems

Week 1 – Interpreting P&ID’s

1.1 Design Documents Required for Generation of Installation and Functional Tests
In this lesson, you will get an overall concept of the course. We will learn about the design of equipment, instrumentation, piping and control elements of a typical process system. We will also learn about the development of a testing verification protocol that we could present to the regulatory authorities demonstrating the system is fit for its intended use.
1.2 User Specification for a Reactor
In this lesson, we will see the basic equipment configuration for a typical reactor system used for industrial chemical processing.
1.3 Equipment Configuration and Process Sequence for a Reactor
In this lesson, we will go through a typical process sequence when using a reactor for chemical processing.
1.4 Generation of Piping and Instrumentation Diagrams (P&ID)
In this lesson, we are going to look at a P&ID as a controlled document that is the basis of any process design. This is the first look we take at our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’. During the remainder of this course, we will extensively explore all design elements and generate an appropriate testing verification protocol.
1.5 URS for Hot Detergent and Hot PUW Generation and Distribution Skid System
We’ve already taken a first look take at our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’. Now we are going to examine the main equipment components and describe the major interconnectivity between them.
1.6 Equipment List
In this lesson, we are going to align the project equipment list against the P&ID.
1.7 Instrument List
In this lesson, we are going to align the project instrument list against the P&ID.
1.8 Inline Components List
In this lesson, we are going to align the project inline component list against the P&ID.

Week 2 – System Impact Assessment & Traceability Matrix

2.1 Protocol Content – Part-1: Objective, System Description and Scope
In this lesson, we’ll start the process of developing a testing verification (qualification) protocol beginning with objective, system description and scope.
2.2 System Impact Assessment
The objective of this lesson is to determine whether or not our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’ is a direct impact system in the context of product quality and patient safety.
2.3 Component Level Impact Assessment: Part-1 – Product Contact Components
In order to begin determining the content of our testing verification (qualification) protocol, we need to establish which components have an impact on product quality and product safety. Here we begin by first taking a look at product-contact critical components.
2.4 Component Level Impact Assessment: Part-2 – Operationally Critical Components
Determining the content of our testing verification (qualification) protocol we also need to establish which functions have an impact on product quality and product safety. In this lesson, we establish those operationally critical components.
2.5 cGMP Testing Principles
This lesson considers high-level requirements when preparing a standard testing document.
2.6 Valves
In this lesson, we take a look at valves as part of inline pipe fittings.
2.7 Piping (Line) List
In this lesson, we are going to align the project piping (line) list against the P&ID.
2.8 Testing Traceability Matrix for Equipment System – First Pass
In this lesson, we take our first look at the traceability matrix. This is a mechanism for tracing requirements through to the testing documents. Here we are using the matrix as a method to help plan necessary installation and functional/operational tests. We will also reference the project validation plan.

Week 3 – Installation Tests & Equipment Verification

3.1 Protocol Content – Part-2: Responsibilities and Installation Testing
Resuming with the process of developing our testing verification (qualification) protocol we continue with responsibilities and introduce installation-testing.
3.2 Minimum Elements of a Test Script
Having already considered high-level requirements when preparing a standard testing document, this document proposes a formatting structure for a test script.
3.3 Good Documentation and Records Management
The objective of this lesson is to give guidance on how to complete any written record, e.g. test script, batch sheet, training record, etc., to ensure the present and future integrity of that record.
3.4 Component Level Impact Assessment: Part-1 – Product Contact Components
In order to begin determining the content of our testing verification (qualification) protocol, we need to establish which components have an impact on product quality and product safety. Here
we begin by first taking a look at product-contact critical components.
3.5 Installation Test: P&ID Walk-Down
The objective of this lesson is to describe a visual-installation test for equipment, instrumentation, piping and inline components in the form of a ‘P&ID Walkdown’.
3.6 Installation Test: Equipment Verification
The objective of this lesson is to describe an installation test for equipment in terms of both visual and documentation checks.
3.7 Pumps
In this lesson, we look at certain pumps used in the process industry and describe their operation.

Week 4 – Piping Isometrics & Checksheets

4.1 Piping Components
This lesson is an introduction to the various components that make up a complete section of the pipeline.
4.2 Relating P&IDs and Piping Isometrics
This lesson describes piping isometric as a detailed design specification providing information for fabrication and installation of pipes.
4.3 Relating Piping Isometrics and 3D CAD Images
In this lesson, we overlay the P&ID content and the isometric details onto the CAD (computer-aided design) design.
4.4 Material Traceability
The objective of this lesson is to demonstrate how a mechanical contractor would keep a material record of all piping components during the fabrication and installation of a pipeline section.
4.5 Piping Tests
The objective of this lesson is to describe a range of non-destructive testing (NDT) routinely conducted on newly installed piping.
4.6 Heat Exchangers
This lesson is an introduction to heat exchangers where we use a thermal utility service to heat or cool a process fluid.
4.7 Instrumentation Symbols and Identification
In this lesson, we are going to look at how most industries tag an instrument using alphabetical identifiers.
4.8 Installation Test: Piping Verification
The objective of this lesson is to describe an installation test for piping in terms of both visual and documentation checks.

Week 5 – Instrument Loops & Checksheets

5.1 Process Control
This lesson is an introduction to conventional process control using one-way digital and analog signals.
5.2 P&ID Instrumentation Identification
In this lesson, we are again going to identify the instrumentation type on the P&ID but this time using the alphabetical identifiers.
5.3 Input-Output (I/O) List
In this lesson, we are going to align the project Input-Output (I/O) list against the P&ID and identify signal types.
5.4 Process Control Hardware Panels
In this lesson, we take a look inside a traditional process control cabinet and identify the various components within. We also look at digital and analog wiring diagrams.
5.5 Loop Signal Verification
In this lesson, we learn how to ‘tune’ control loops, typically, during the commissioning phase of the project.
5.6 Installation Test: Instrument Verification
The objective of this lesson is to describe an installation test for instrumentation in terms of both visual and documentation checks.
5.7 Proportional–Integral–Derivative Controller (PID controller)
This lesson describes how a PID controller is used to adjust a dynamic process via a control element to maintain the desired process value.

Week 6 – URS & Functional Testing

6.1 Protocol Content – Part-3: Operational/Functional Testing
This is our third lesson on the development of our testing verification (qualification) protocol where we consider operational/functional testing.
6.2 Component Level Impact Assessment: Part-2 – Operationally Critical Components
Determining the content of our testing verification (qualification) protocol we also need to establish which functions have an impact on product quality and product safety. In this lesson, we establish those operationally critical components.
6.3 Operational Testing: Primary Functions
The objective of this lesson is to determine the primary/critical functions of the ‘hot detergent’ and ‘hot PUW2 process water’ generation and distribution systems.
6.4 Testing Traceability Matrix for Equipment System –Second Pass
In this lesson, we take our second look at the traceability matrix – a mechanism for tracing requirements through to the testing documents. At this stage we can add the details of our already established installation tests; and we now also use the matrix as a method to further plan and refine the necessary functional/operational tests.
6.5 Functional Design/Requirement Specification
In this lesson, we look at the functional design/requirement specification that will describe the necessary automated functions needed to meet the desired user’s performance requirements.

Week 7 – Assembling the Validation Protocol

7.1 Protocol Content – Part-4: Protocol General Attachments, and Deviation and Change Control Procedures
This is our fourth and final lesson on the development of our testing verification (qualification) protocol where we introduce protocol general attachments, and deviation and change control procedures.
7.2 General Contents of a Validation (Master) Plan
This lesson describes typical high-level corporate / site validation policy documents. It also describes the typical content and structure of a validation master plan (VMP), subordinate level validation plans, and validation reports to conclude the planning activities.
7.3 Protocol General Attachments
This lesson describes the process for compiling and completing the protocol’s general attachments, and advises on how to making entries by hand into the protocol script?
7.4 Protocol Deviation Procedure
This lesson describes how and where to use a verification protocol’s deviation procedure and associated deviation log.
7.5 Project Specific Change Control Procedure
This lesson describes how and where to use a verification protocol’s change control procedure and associated change control log.
7.6 Protocol Template
Ultimately, having studied in-depth both our process system and the content of protocols, we are now in a position to formulate a template for our very own verification/qualification protocol – that will incorporate both installation and functional/operational tests – to prove that our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’ is fit for its intended use.
7.7 Testing Traceability Matrix for Equipment System –Third Pass
In this lesson, we take our third and final look at the traceability matrix – a mechanism for tracing requirements through to the testing documents. Having now formalized our protocol template we can now add the specific document-section details to the matrix for both our established installation and functional/operational tests.

Week 8 – Validation Protocol Final Review

8.1 Conclude List of Installation Tests
The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required installation test procedures and GMP checksheets.
8.2 Conclude List of Functional Tests
The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required functional test procedures and GMP checksheets.
8.3 Final Protocol Template Review
The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required installation and functional tests and included all the necessary protocol attachments.

Week 9 & 10 - Competency Based Assessment

The end of module assessment is a competency based open book exam where you will need to answer 8 essay style questions. Each essay will require about half a page to one page to answer. Your answer will be assessed as either competent or not yet competent. In addition, you will also have a 15 minute oral interview with our Subject Matter Experts.

Complete the Following Activities and Workshops

You will become familiar with a range of documents used in projects including piping and instrumentation diagrams (P&ID), equipment specifications, instrument specifications, line lists, piping isometrics, 3D layouts, electrical and hardware control – panel diagrams, and wiring and loop diagrams. These design documents are used to generate IQ OQ PQ commissioning and qualification protocols.

You will also become familiar with:

User Requirement Specifications (URS)
cGMP impact-assessments
cGMP design reviews
Design Qualification (DQ) reports
Specification and testing traceability matrices
Typical testing IQ OQ PQ protocol templates

Certified by DPS Education

You will receive an end of course certificate from DPS Education subject to the following criteria;

The submission of all assessments and the end of module assignment.

Show Off Your New Skills: Get a Certificate of Completion

Complete all assessments and the end of module written assignment to receive a Certificate of Award in “Commissioning and Qualification of Equipment and Systems“.

Add details of your certificate to your CV/Resume or your LinkedIn profile.

Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems Certificate

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S$3,499 in Advance

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Application Deadline: Wednesday 27th November

Course Starts: 4th December

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Frequently Asked Questions

How do you keep track of my progress on the course?

We release only one week’s worth of material at a time and then check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. There is a “Progress Bar “on your course which is helpful to you and us to know how you are doing.

You have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind. She’ll also be in touch weekly to let you know when new content is open for you.

Is this program delivered online?

Yes, this program is delivered fully online.

What does a typical week look like?

Each week of online content typically includes 6-10 topics.

Each topic includes:

A set of course notes – these provide additional depth to the video content.
Warm-up self-assessment question – to recap or activate any relevant prior learning.
A video – these are typically 5-10 minutes long and deliver 80% of the course content.
Post video self-assessment questions to check how well you can recall this new material from memory. If you can’t answer these questions, you should revisit that topic’s learning materials.
Any follow up assessments or assignments.

How many hours a week must I do for the course?

Most students report between 8-14 hours per week.

Do I need to be online all the time?

No you don’t. The online classroom is open 24 hours a day so you do not have to login at any particular time. We will give you a Username and Password on the day the program starts and this allows you 24 hours a day access.

Can I pause the class if I get to busy at work or because of family commitments?

Yes.

Can I take this course at a faster pace?

Yes, you can speed up or slow down the rate of delivery to suit your requirements. The most important thing is communication between you and your course coordinator. If you are taking a break or are busy at work and do not have time to study you need to tell her or him. Similarly, if you want to study at a faster rate, then just email in good time and ask for more course content.

Will I have access to the materials after the course is finished?

Yes for 6 months.

Is this course relevant to both pharmaceutical and medical device manufacturing industries?

Yes, this course is relevant to both the pharmaceutical and medical device industries.