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 18 months 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 industry and are worried about having to sign off on validation documents you don’t fully understand!
Or - You are a chemical / process / petroleum / project / mechanical, etc engineer or a laboratory scientist and want to move into a validation role or learn how to correctly populate an equipment validation protocol.
Or - You already work in validation (e.g. mechanical contracting company carrying out high-purity pipework installations) but have no formal training on IQ OQ PQ equipment validation protocols.
What 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
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 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.
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.”
