Equipment Validation Training Course (ONLINE) – For Starter Validation, CQV and C&Q Roles. Join a Validation Team in a Pharma Company or Engineering Consultancy in 15-Weeks

Take this 2 module program including “Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems”. 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.

Build on your industry experience and start a higher-paying career in validation
Turn your practical work experience into an advanced certification

Estimated salaries $35,000 – $80,000 plus overtime, bonuses and allowances. (Based on US job data)

Estimated salaries €39,000 – €70,000 plus overtime, bonuses and allowances. (Based on Irish job data)

Application Deadline: Wednesday 5th October

Study Online part-time – Complete 2 modules
15hrs/week for 15 Weeks or choose a faster/slower schedule
You’ll get a dedicated course leader who’ll check your progress at the end of every single week and follow up with you to help you finish the course
Join 2340 Learners

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

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Apply NOW and Retrain For Entry-Level Validation, CQV And C&Q Roles

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Equipment Validation Training Course (ONLINE) – For Starter Validation, CQV and C&Q Roles. Join a Validation Team in a Pharma Company or Engineering Consultancy or Contractor in 15-Weeks

Take this 2 module program including “Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems”. Learn to read P&IDs. Populate an IQ OQ PQ Validation Protocol. Validate equipment and systems. Developed in consultation with the pharma industry including Pfizer and MSD.

Image: PM Group

Build on your industry experience and start a higher-paying career in validation
Turn your practical work experience into an advanced certification
Estimated salaries $35,000 – $80,000 plus overtime, bonuses and allowances. (Based on US job data)
Application Deadline: Wednesday 5th October

Build on your industry experience and start a higher-paying career in validation
Turn your practical work experience into an advanced certification
Estimated salaries €39,000 – €70,000 plus overtime, bonuses and allowances. (Based on Irish job data)
Application Deadline: Wednesday 5th October

Study Online part-time – Complete 2 modules
15hrs/week for 15 Weeks or choose a faster/slower schedule
You’ll get a dedicated course leader who’ll check your progress at the end of every single week and follow up with you to help you finish the course
Join 2340 Learners

See Course Price

Apply NOW and Retrain For Entry-Level Validation, CQV And C&Q Roles

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

NOTE:
This program was developed during the construction of a new pharmaceutical plant by a team of biochemists, chemical engineers and validation engineers working for an engineering consultancy to quickly train its own staff to populate an IQ OQ PQ 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.

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

What Equipment Validation Roles Could I Retrain For?

STEP 1, you take this “Equipment Validation Course” to retrain for the following roles;

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

With validation, CQV and C&Q roles, you could work directly for:

pharmaceutical companies on in-house projects
engineering consultancies as part of a project team on small to large capital projects
engineering contractors as part of a project team on small to large capital projects

View Salaries

STEP 2, then take our Pharmaceutical Validation Training Course – For Senior Validation Roles to get a level 7 university accredited “Certificate in Validation” from Technological University Dublin, Ireland and a more interesting job with a higher salary such as:

Validation Engineer
CQV Engineer
Senior Validation Specialist
C&Q Technician

STEP 3, take our Computer System Validation Course and extend your role to CSV Projects. Round out your qualifications and give yourself a competitive edge in the marketplace.

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 2 Quality Risk Management workshops on:
- Fault Tree Analysis (FTA)
- Failure Mode Effect Analysis (FMEA)
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 12-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

There are 2 modules in this 15-week program

Module 1 – Manufacturing Safe Medicines and Medical Devices (GMP) (Weeks 1-5)

In this module, you’ll learn about the systems used in pharmaceutical manufacturing. You’ll learn about the rules and regulations such as Good Manufacturing Practices (GMPs) that you need to follow. And you’ll learn enough technical information to get you talking to employers.

Module 2 – Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems (Weeks 6-15)

In this module, you will develop your own 100-page Validation Protocol to commission and qualify a clean-in-place system. You will also learn to read P&IDs, Piping Isometrics & Electrical Loop Drawings used to develop validation protocols. And you’ll learn how to qualify equipment, instruments and piping systems, along with automation controls and building facilities.

View Full 15 Week Syllabus

Already Have Equipment Validation Experience?

If you already have some experience working in Validation and know how to populate an IQ OQ PQ equipment validation protocol, check out our academically accredited Pharmaceutical Validation Training Course – For Senior Validation Roles.

So What Is Validation?

Pharmaceutical Validation creates a documented evidence trail (through rigorously checking and testing) to demonstrate that a system, procedure or process used in the production and testing of the pharmaceutical product:

maintains compliance at all stages
and leads to a consistent and reproducible result

There are many other definitions of validation but the essence of all these definitions seems to be “documented scientific proof of consistent performance“.

Commission and Qualification is one part of a larger validation process for making sure that a facility – and the equipment in it – will function as required and be approved by the regulatory agencies that have jurisdiction over that facility.

An Equipment Validation Protocol is a written plan stating how validation will be conducted including test parameters, product characteristics, production equipment and decision points on what constitutes an acceptable result.

IQ OQ PQ or Installation Qualification, Operational Qualification and Performance Qualification are 3 independent and documented procedures used together (when executing a validation protocol) to check and test that a mechanical or software system is;

installed correctly
meets its design requirements and specifications
operates the way in which it was designed under load

Need More Detailed Information?

What are IQ OQ PQ?
What is an Equipment Validation Protocol?
IQ, OQ PQ Templates

Watch this Video on a Validation Engineer’s Role!

For a great insight into validation roles from someone actually in the job, check out this video from the About Bioscience website, produced by the North Carolina Association for Biomedical Research (NCABR).

See Course Price

Hear From People Who’ve Taken This Course

Regina McNamara

Previous background:
Professional Painter

“I Can Study Around Work and Family Commitments”

Studying online is working well for me as I study around work and family commitments.

I would recommend this course to anyone that wants a new career in the Pharmaceutical and Medical Device Manufacturing industry.

Mehmet Hascan

Previous background:
Technical Support

“Material was Delivered in an Engaging, Interesting and Supportive Way”

The administration staff and lecturers at Getreskilled are first class and the course material was delivered in an engaging, interesting and supportive way.

I have now been working at Johnson and Johnson Vision Care as Validation Engineer in Limerick and I look forward to put what I have learned into practice.

Sharon Egan

Previous background:
Food Manufacturing

“Structurally Well Planned with the Opportunity for Practical Application”

I found it to be interesting, structurally well planned with the opportunity for practical application of the course modules through various assignments.

I have worked in the Medical Device/Pharmaceutical and Food industries and found the course to be extremely relevant to all industries.

See Course Price

Your 10 or 15 Week Class Schedule

NOTE: If you worked in a GMP Regulated Pharmaceutical or Medical Device manufacturing environment, you are exempt from the first 5 weeks (Module 1) of the program and get a price reduction.

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Module 1 – Manufacturing Safe Medicines and Medical Devices (GMP) (Weeks 1-5)

Week 1 – Industry Regulations and Guidelines

Session 1 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 1

Topic-1 Finished Medicinal Products
In this lesson, we learn about medical products and the various ways drug products are administered.
Topic-2 Focus on Patient Safety and Product Quality
In this lesson, we will develop a deeper understanding of the importance of patient safety and product quality for medicines and medical devices.
Topic-3 ISO9001:2008 and ISO 9001:2015
This lesson is about the key requirements of a quality management system.
Topic-4 Product Quality and Current Good Manufacturing Practices [cGMP]
In this lesson, we learn how to scientifically define product quality. This lesson also gives an insight into the high-level principles of current good manufacturing practices (cGMP) including,

Session 2 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 2

Topic-5 API Regulatory Guidelines
In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
Topic-6 ISO-9001 ‘Continual Improvement’ & ICH Q10 Pharmaceutical Quality System
This lesson explains the concept of ‘continual improvement’ as part of a company’s quality management system and describes an effective corrective action process and a preventive action process (CAPA). It also gives details on the product lifecycle for a pharmaceutical product and describes the monitoring of process performance and product quality.
Topic-7 Quality Systems Approach to Pharmaceutical cGMP Regulations-The Quality Systems Mode
In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations, and evaluation activities.
Topic-8 FDA Medical Device Rules-CFR820
In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
Topic-9 Medical Device Regulations and Guidelines – ISO 13485 / CFR 820
In this lesson, we look at some GMP regulatory and ISO guidance documents that are associated with the manufacture of medical devices.

Deliverables

Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 2 – Process Validation & Documentation and Risk Management Tools

Session 3 – Process & Cleaning Validation and Documentation

Topic-1 Process Validation
In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’ and ‘verification.
Topic-2 ASTME2500 – Standard Guide for Specification, Design and Verification
In this lesson, we will describe a specification, design, and verification approach for equipment systems associated with the pharmaceutical, biopharmaceutical and medical device industries.
Topic-3 PQ, OQ and IQ
In this lesson, we are going to define the terms installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and we will also list what typical project design documents are required to prepare such testing protocols.
Topic-4 Cleaning Validation
This class takes a high-level look at a typical cleaning validation sequence. It looks at how to determine the basis for quantification limits and explains how to determine cleanliness levels on the basis of the analytical testing of representative samples. Sampling is described in terms of sampling-equipment, sampling -locations, and sampling –procedures.

Session 4 – Risk Management Tools for Scientific Based Decisions

Topic-5 Introduction to Quality Risk Management (QRM)
In this lesson, we will develop an understanding of the history and the crucial importance of risk management as well as the basic steps involved in its application.
Topic-6 Fault Tree Analysis (FTA) – step 4 ‘Workshop’ exercise
In this lesson, we learn about the risk management tool ‘Fault Tree Analysis’ and see an example of where and how we can use it.
Topic-7 Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC) – Step 4 ‘Workshop’ exercise
This presentation shows an example of the main steps in performing a ‘Failure Mode, Effects Analysis’ (FMEA) and describes how this risk management technique summarizes the important modes of (a) failure, (b) factors causing these failures, and (c) the likely effects of these failures.
Topic-8 Documenting the Quality Risk Management Process
In this lesson, we take a practical look at managing a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk, and controlling risk.

Deliverables

Complete two workshops on Fault Tree Analysis (FTA) and Failure Mode Effect Analysis (FMEA)
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 3 – Key Manufacturing Technologies

Session 5 – Chemical and Biopharmaceutical Manufacturing

Topic-1 Batch Organic Chemical Synthesis
In this lesson, we describe the typical equipment and process stages of the manufacture of active pharmaceutical ingredients (API) using batch organic chemistry synthesis
Topic-2 Biopharmaceuticals Manufacturing, Upstream, Fermentation
This lesson describes a conventional biotechnological process and introduces the following process sequences:
- Stage-I – Upstream Processing
- Stage-II – Fermentation / Bio-reaction
- Stage-III – Downstream Processing

Session 6 – Tablet, Aseptic and Sterile Manufacturing

Topic-1 Tablet Manufacturing
In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
Topic-2 Aseptic & Sterile Manufacturing
In this lesson, we look at critical process parameters and quality attributes associated with aseptic processing and terminal sterilization products for parenteral products.

Deliverables

Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 4 – Supporting Technologies and Cleanrooms

Session 7 – Purified Water, Clean Steam & Cleaning

Topic-1 Purified Water (PUW) Generation, Storage and Distribution
In these presentations, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
Topic-2 Clean Steam Generators – 2 videos
The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
Topic-3 WFI Storage and Distribution
In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification
Topic -4 Engineering Aspects of Cleaning, and Cleaning Equipment
This class discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), and automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning
Topic-5 Chemistry Aspects of Cleaning
This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
Topic-6 Steam Sterilization in Place
In this lesson, we look at the mechanism behind sterilization of process equipment using saturated steam.

Session 8 – Cleanrooms

Topic-7 HVAC Requirements for Non-Sterile API Manufacturing
In this lesson, we look at how to use airflow direction as a means of a containment barrier between
operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
Topic-8 Cleanroom Layout–2 videos
In these presentations, we take a high-level look at a common cleanroom configuration and discuss items
such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
Topic-9 Area Classification Protection
In this lesson, we observe a range of airlock configurations typically used in combination with safety under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient.
Topic-10 Cleanroom Gowning
In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
Topic-11 Cleanroom Monitoring – Physical Tests
In this lesson, we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.

Deliverables

Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 5 – Assignment Part 1 focussed on GMP Manufacturing from content in Week’s 1-4

Write a 4-5 page essay, which you could present at a job interview to clearly demonstrate your Technical Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment. It will confirm your understanding of how to Manufacture Safe Medicines and Medical Devices in a GMP regulated environment and will include the following topics:

The key requirements of a quality management system
The manufacturing responsibilities for quality systems
The cleaning validation sequence and how to determine cleanliness levels
The documentation of a complete risk management process in terms of identify risk, analyzing risk, evaluating risk and controlling risk.
The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
The critical process parameters and quality attributes associated with the manufacture of tablets.
The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

Module 2 – Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems (Weeks 6-15)

This module was developed in consultation with the pharma industry including Pfizer and MSD.

Week 6 – 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.

Deliverables

Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 7 – 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.

Deliverables

Complete a Component Level Impact Assessment workshop.
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 8 – 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.

Deliverables

Complete an Equipment Installation Verification workshop.
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 9 – 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.

Deliverables

Complete a Piping Installation Verification workshop.
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 10 – 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.

Deliverables

Complete an Instrument Installation Verification workshop.
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 11 – 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.

Deliverables

Complete a Functional Verification Test workshop.
Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 12 – 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.

Deliverables

Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Week 13 – 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.

Deliverables

Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Weeks 14 -15 – Complete an End of Module Assignment

Write an IQ OQ PQ protocol for a Clean-in-Place system.

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 GetReskilled

You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Technological University Dublin (Ireland) subject to the following criteria;

Passing a written or oral Exam on the materials.
The submission of all assessments and the end of module assignment.

Delivered by a Practicing Industry Expert

Dr. Joe Brady

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

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 Ph.D. theses. Joe has over twenty years of project experience in the pharmaceutical, biopharmaceutical, and medical device industries in Ireland, Singapore, China, The Netherlands, France, and the USA.

Hear From People Who’ve Taken This Course

Colin Lane

Previous background:
Med device manufacturing

“Validation – A Career Move to Tell Your Friends About”

“I would say to anybody out there, if you’re thinking about doing this validation course, just go for it. Do it.

There’s a great opportunity within the course to learn. There’s a lot of detail about what goes on in the industry, on the floor, how things happen. Focus just as much on learning to actually educate yourself as much as passing exams. You actually have to embrace it and really get interested in the course material.

Hear more and read how Colin moved from medical device manufacturing into validation.

Charles O Neill

Previous background: Pipefitter/Plumber

“With hard work and determination, you can achieve your goal”

“As a pipefitter/Plumber who worked within the pharmaceutical industry for the last 20yrs, this program gave me the tools I required for a career change and to upskill for a job in pharmaceutical manufacturing. Without this course, I don’t think I would have achieved this. I am happy to say that I have been successful in my employment search.

It is worth the challenge and with hard work and determination, you can achieve your goal.

It gave me a better understanding of pharmaceutical protocols and how the pharmaceutical industry works as a whole.”

Start Your Application

Click below to learn how to develop test protocols for an equipment system and to read and interpret P&IDs.

Apply NOW and Retrain For Entry-Level Validation, CQV And C&Q Roles

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Talk To Our Team

USA/World
Call Geraldine: +1 (617) 901 9268

Ireland
Call Sinead: +353 (0)21 2409016

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.

Add On Program – 5-Week Advanced Career Coaching – Open Your Eyes to Modern Job Hunting

This is a practical course, not a theoretical one. There is no “filler” content. Each and every task is specially designed to take you one step closer to the job you want in a structured way.

The course is assessed using a mock application for a real job advert. You’ll complete a 9-step application process simulation for a BioPharma/MedTech job, using the relevant tools and techniques.

“I never realised how much I didn’t know”

That’s the most common feedback we get when people finish this programme. And it really doesn’t take that long to get that new knowledge and start putting it to good use…

Week 1 – Get a comprehensive understanding of BioPharma/MedTech Industry and figure out jobs you can do
Week 2 – Practice skills assessments, write, rewrite and customize CVs and resumes
Week 3 – Speculative job applications and how to research jobs available
Week 4 – Social Media, networking and interview preparation
Week 5 – End of Module assignment. Complete a 9-step application process simulation for a BioPharma/MedTech job, using the relevant tools and techniques.

On completion of this module you’ll be able to:

Discuss your local BioPharma/MedTech manufacturing industry
List the departments and job roles where your skills are best suited
Understand your current skill set and how to discuss that with employers
Network effectively both on and offline
Write a CV and cover letter that are highly tailored to a job advert
Write a speculative application and have a list of local companies appropriate for such an application
Prepare for an interview

You’ll also have access to a program advisor who is there to offer support and guidance, offer personalized feedback and provide additional resources in any areas you need a little extra help.

At the end of the course, you’ll have confidence through a more strategic approach to job hunting. You’ll have a complete tool kit for modern job hunting.

Meet Claire

Claire runs GetReskilled’s Advanced Career Coaching Program – our specially devised job hunting program that will help you find a job.

Show Off Your New Skills: Get a Certificate of Completion

Once the program is over, complete a written assignment to get certified in Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems.

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

See Course Price

12 Frequently Asked Questions

Is this course delivered online?

Yes, this program is delivered fully online so you can learn from home (or anywhere). Study after the kids have gone to bed.

Will I be ready to join a Validation Team in 4-months?

Yes, provided you’ve met our minimum requirements and successfully finished the program, you to be able to join a validation or qualification team at an entry-level position or higher (depending on your experience) after 4 months.

What does a typical week look like?

There are a total of 15 sessions of online content, one per week. Each session 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.
Any follow up assessments or assignments.

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.