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Equipment Validation Training Course (ONLINE) – For Starter Validation, CQV and C&Q Roles
- 30 Day Money Back Guarantee
- Completion Certificate
- 24/7 Technical Support
Highlights
On-Demand course
Description
Take this 2-module program including “Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems”. Learn to read P&IDs. Learn how to populate a 120-page plus IQ OQ PQ Protocol and qualify 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 €39,000 – €70,000 plus overtime, bonuses and allowances. (Based on Irish job data)
Application Deadline: Wednesday 19th July
Study Online part-time
12hrs/week for 15 Weeks or choose the 15-Day Fast Track Option
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
Core content developed on a pharma construction project
This program was developed on-site by a team of senior chemical engineers, validation engineers, and biochemists working within an engineering consultancy during the construction of a new pharmaceutical plant to train its own engineers and technicians.
Learn how to fill out a 120-page plus IQ OQ PQ protocol
We will walk you through this step-by-step process and teach you how to populate a blank IQ OQ PQ template to qualify a Clean-in-Place System. The blank template is taken from the construction site of a pharmaceutical plant.
This is a fundamental skill for any validation professional and a key outcome for this program. You will be able to take this completed and substantial document to any job interview and demonstrate your ability to complete this task.
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) / 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 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 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 qualification protocols.
Our learners work for the world’s biggest pharma and medical device companies
What validation, CQV and C&Q 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 SpecialistEquipment Validation SpecialistQA Validation AssociateQA Validation Specialist
CQV Specialist – Some pharma companies call this role:CQV Junior EngineerC&Q SpecialistC&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
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 Qualification Protocol workshops on the following to prepare you to populate your own protocol:Component Level Impact AssessmentEquipment Installation VerificationPiping Installation VerificationInstrument Installation VerificationFunctional Verification Test
Complete 12-question booklets (one for every week’s worth of content) which will summarise what you have learned for the week and ensure you retain and understand the information.
Populate a 120-page plus IQ OQ PQ protocol
The end of the module assignment and key outcome for the program will be for you to populate an IQ OQ PQ protocol for 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
Complete 2 modules over 15-weeks
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 120-page Qualification Protocol to qualify a clean-in-place system. You will also learn to read P&IDs, Piping Isometrics & Electrical Loop Drawings used to develop qualification protocols. And you’ll learn how to qualify equipment, instruments and piping systems, along with automation controls and building facilities.
Already have equipment qualification experience?
If you already have some experience working in Validation and know how to populate an IQ OQ PQ equipment qualification 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 equipment, 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“.
Qualification is one part of a 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 Qualification Protocol is a written plan stating how qualification 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 qualification 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?
Commissioning vs Qualification vs Validation
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).
Hear from people who’ve taken this equipment qualification 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.”
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.
Your 10 or 15 week class schedule
Note: If you’ve worked in a GMP Regulated Pharmaceutical Manufacturing Environment, you are exempt from the first 5 weeks (Module 1) of the program. You also get a price reduction.
15-Day Fast Track Option Available – For an additional cost, you can request an immediate start and complete the 2-module 15-week program in 15 days. This is going to be tough but your course leader will check your progress every morning and follow up with you to keep you on schedule. START within 24 working hours upon receipt of payment.
Module 1 – Manufacturing Safe Medicines and Medical Devices (GMP) (Weeks 1-5)
Week 1 – Industry Regulations and GuidelinesWeek 2 – Process Validation & Documentation and Risk Management ToolsWeek 3 – Key Manufacturing TechnologiesWeek 4 – Supporting Technologies and CleanroomsWeek 5 – Assignment Part 1 focussed on GMP Manufacturing from content in Week’s 1-4
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’sWeek 7 – System Impact Assessment & Traceability MatrixWeek 8 – Installation Tests & Equipment VerificationWeek 9 – Piping Isometrics & ChecksheetsWeek 10 – Instrument Loops & ChecksheetsWeek 11 – URS & Functional TestingWeek 12 – Assembling the Validation ProtocolWeek 13 – Validation Protocol Final ReviewWeeks 14 -15 – Complete an End of Module AssignmentComplete the Following Activities and WorkshopsCertified by GetReskilled
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 equipment qualification course
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.
Start your application
Apply NOW and retrain for entry-level Validation, CQV and C&Q roles
Talk to our team
USA/World
Call: +1 (617) 901 9268
Ireland
Call Geraldine: +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.
Earn a Certificate of Award in “Commissioning & Qualification of Equipment and Systems”
Earn by successfully populating a 120-page IQ OQ PQ template to qualify a Clean-in-Place System and get a Certificate of Award in Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems.
Add details of your certificate to your CV/Resume or your LinkedIn profile.
Frequently Asked Questions
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.
Can I take this program at my own 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.
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.
I live in the UK/Europe/USA/Australia etc,. Can I still take this program?
Yes.
Can I have my employer pay for this?
Yes, a number of our students have their employers pay for this program.
Can I spread the payments over a couple of months?
Yes
Are there opportunities for further study after this program?
Yes, this program is a stepping-stone to our follow-on specialisation, Certificate in eValidation.
About The Provider
Getreskilled (UK)
Cardiff
GetReskilled is an awarding-winning education company. We'll retrain or upskill you ONLINE for a higher-paying career or a promotion in the Pharmaceutical and Medical Devi...
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