Core content developed on a pharma engineering 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.
You will fill out a 120-page plus IQ OQ PQ protocol
You cannot reliably learn how to fill in an IQ OQ PQ protocol by discussing it abstractly!
So 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.
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
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.
Entry Requirements
This program is highly specialized so you MUST have one of the following complementary skills or background:
- You are a plumber/pipefitter/pipe welder (e.g. high purity pipe fitter and orbital welder) / (i.e. you can interpret P&IDs and pipe skids) and you are fed up working outside on freezing cold construction sites.
Or - You have more than one year of GMP manufacturing experience.
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 qualification 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 qualification 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 protocols.
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 Specialist
- Equipment Validation Specialist
- QA Validation Associate
- QA Validation Specialist
- CQV Specialist – Some pharma companies call this role:
- CQV Junior Engineer
- 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
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
Enroll in this program to learn…
- How to prioritise which parts of the equipment system are critical to qualify 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 120-page plus equipment qualification protocol which you will populate 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 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 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.
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?
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
“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.
“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.”
“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)
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.
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
“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.
“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
Contact Details For This Course
Geraldine Creaner
How We Deliver Our Online Courses without ZOOM Classes
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.
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.
Price
$799/month
For 5 months
Or $3,499 in Advance
Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience
$2,899
Save $600
15 Day Fast Track Option with Priority Support
$3,999
- Complete this program in 15 days.
- 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.
€699/month
For 5 months
Or €3,199 in Advance
Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience
€2,699
Save €500
15 Day Fast Track Option with Priority Support
€3,999
- Complete this program in 15 days.
- 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.
£649/month
For 5 months
Or £2,799 in Advance
Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience
£2,299
Save £500
15 Day Fast Track Option with Priority Support
£3,499
- Complete this program in 15 days.
- 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.
Price
€699/month
For 5 months
Or €3,199 in Advance
Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience
€2,699
Save €500
15 Day Fast Track Option with Priority Support
€3,999
- Complete this program in 15 days.
- 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.
$799/month
For 5 months
Or $3,499 in Advance
Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience
$2,899
Save $600
15 Day Fast Track Option with Priority Support
$3,999
- Complete this program in 15 days.
- 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.
£649/month
For 5 months
Or £2,799 in Advance
Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience
£2,299
Save £500
15 Day Fast Track Option with Priority Support
£3,499
- Complete this program in 15 days.
- 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.
Price
£649/month
For 5 months
Or £2,799 in Advance
Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience
£2,299
Save £500
15 Day Fast Track Option with Priority Support
£3,499
- Complete this program in 15 days.
- 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.
€699/month
For 5 months
Or €3,199 in Advance
Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience
€2,699
Save €500
15 Day Fast Track Option with Priority Support
€3,999
- Complete this program in 15 days.
- 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.
$799/month
For 5 months
Or $3,499 in Advance
Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience
$2,899
Save $600
15 Day Fast Track Option with Priority Support
$3,999
- Complete this program in 15 days.
- 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.
Application Deadline: Wednesday 15th May
Program Starts: 23rd May
Contact Details For This Course
Geraldine Creaner
Got more questions?
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