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
You MUST have one of the following:
- You are a process / chemical / petroleum / project / mechanical engineer or a lab/scientist and want to move into validation.
Or - You have commissioning & qualification experience in ANY INDUSTRY e.g. Oil and Gas, Food Manufacturing, Mechanical Construction, etc.
Or - You already work in validation but have no formal training on IQ OQ PQ validation protocols and want to learn more.
Or - You work in a mechanical contracting company carrying out high-purity pipework installations in the pharmaceutical sector.
Who uses IQ OQ PQ qualification protocols?
- Pharmaceutical companies working on ongoing projects.
- Engineering consultancies or engineering contractors working on capital projects for this sector.
How will learning qualification protocols help my career?
- Validation Protocols form a fundamental building block of any capital project within this sector.
- Being able to read and interpret a validation protocol is a fundamental skillset of any process, chemical, petroleum, project or any engineer cross-training to work in this area.
- It will boost your qualification for any pharmaceutical companies, engineering consultancies or engineering contractors working on ongoing projects.
- Hit the ground running from day one with this fundamental skillset. Don’t waste months of your time trying to muddle through.
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 validation protocol which you will develop as your end of module assignment.
And
- 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.
You’ll produce your own 120-page plus IQ OQ PQ qualification 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.
Already have validation experience?
If you already have some experience working in Validation and know how to populate an IQ OQ PQ validation protocol, check out our academically accredited Pharmaceutical Validation Training Course (Online) – For More Senior Validation, CQV and C&Q Roles.