Commissioning & Qualification (IQ OQ PQ)of Equipment

Build on your industry experience and start a higher-paying career in validation. Join a validation team in a Pharma Company or Engineering Consultancy.

  • WSQ Accredited as (Develop a Validation Protocol for Equipment PI-PH-308E-1)

  • Develop an IQ OQ PQ validation protocol

  • Validate equipment and systems

  • Application Deadline: Wednesday 3rd November
  • Study Online 14 hrs/week
  • 1 Module over 10 Weeks
  • Join 1320 Learners
Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems Course
Apply NOW and Learn to Populate an IQ OQ PQ Validation Protocol

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Commissioning & Qualification (IQ OQ PQ)of Equipment

Build on your industry experience and start a higher-paying career in validation. Join a validation team in a Pharma Company or Engineering Consultancy.

Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems Course
  • WSQ Accredited as (Develop a Validation Protocol for Equipment PI-PH-308E-1)

  • Develop an IQ OQ PQ validation protocol

  • Validate equipment and systems

  • Application Deadline: Wednesday 3rd November

  • Study Online 14 hrs/week
  • 1 Module over 10 Weeks
  • Join 1320 Learners

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

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

Novartis Logo
GSK Logo
Lonza Logo
Pfizer Logo
Roche Logo
Amgen Logo
Apply NOW and Learn to Populate an IQ OQ PQ Validation Protocol

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Programme Highlights

Commissioning and qualification of equipment and systems is a critical process in making sure safe medicines are being manufactured. In addition, this module is one of the first steps you’d take to specialise in Validation – where there is currently an acute shortage trained validation professionals.

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 base 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 validation protocol which you will develop as your end of module assignment.

You’ll learn how an IQ OQ PQ Validation Protocol is produced 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

What Does the Online Classroom Look Like?

We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
We release only one week’s worth of material at a time and then MANUALLY 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. And you’ll have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
How-does-Studying-Online-Work

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.

Lecturers

Safe Medicine Lecturers

Learn the systems, protocols, tools, vocabulary, and best practices from our Lecturer’s who have had decades of on the job experience.

Course Leaders

Safe Medicine Course Director

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

Course Coordinators

Safe Medicine 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!

Hear From People Who’ve Taken This Course
Pharmaceutical Manufacturing

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!”

Pharmaceutical Manufacturing

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 Lecturer

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.

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.

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

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

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.

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
This module is accredited under the WSQ programme as (Develop a Validation Protocol for Equipment PI-PH-308E-1) subject to the following criteria. Passing a written and oral Exam on the materials.

Show Off Your New Skills: Get a Certificate of Completion

Once the course is over, complete your competency based assessment and the end of module interview webinar to get your WSQ Certificate.

Add it to your resume, your LinkedIn profile or just get that well-earned raise you’ve been waiting for.

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Price

S$1,299/month

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S$3,499 in Advance

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Application Deadline: Wednesday 3rd November 2021

Course Starts: 11th November

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    Frequently Asked Questions

    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.

    Yes, this program is delivered fully online.

    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.

    Most students report between 8-14 hours per week.

    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.

    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.

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