Validation Training Course (ONLINE) – For Starter Validation 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 & piping isometrics. Develop an IQ OQ PQ Validation Protocol. Validate equipments & systems.
  • 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 (Based on US job data)

  • Application Deadline: Wednesday 2nd December
  • 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€65,000 (Based on Irish job data)

  • Application Deadline: Wednesday 2nd December
  • Study Online 15 hrs/week
  • 2 Modules over 15 Weeks
  • Join 2340 Learners
ebiopharmachem

Image: PM Group

Apply NOW to Start Your Validation Career

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

Validation Training Course (ONLINE) – For Starter Validation 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. Develop an IQ OQ PQ Validation Protocol. Validate equipment & systems.
Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems Course

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 (Based on US job data)

  • Application Deadline: Wednesday 2nd December
  • 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€65,000 (Based on Irish job data)

  • Application Deadline: Wednesday 2nd December
  • Study Online 15 hrs/week
  • 2 Modules over 15 Weeks
  • Join 2340 Learners

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

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Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

Novartis Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

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Apply NOW to Start Your Validation Career

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

Have you plateaued at work? Has your job become routine and monotonous? Has your salary growth flatlined? Does it seem like you’ve learnt all can at your current job? You’re not alone but this program could help you restart your career.

Minimum Entry Requirements

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 or boiler technicians (i.e. you can interpret technical drawings, especially P&IDs and pipe skids).
    Or
  • You have 1 year or more of GMP manufacturing experience or have a recognized GMP certificate or qualification.
    Or
  • You have commissioning & qualification experience in ANY INDUSTRY e.g. Oil and Gas, Food Manufacturing, Mechanical Construction, 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 mechanical / chemical / process / petroleum / project / engineer or a lab/scientist and want to move into validation.
    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 validation protocols and want to learn more.

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

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

Pharmaceutical Courses

What Validation Roles Could I Retrain For?

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

(Note that actual job titles may vary – the distinction is more between who’d employ you and what type of projects you’d work on).

View Salaries

STEP 2, then take our Certificate in Validation program for Senior Validation Roles to get a level 7 university qualification from Technological University Dublin, Ireland and a more interesting job with a higher salary such as;

Some companies might call this role: CQV Engineer, Validation Specialist or C&Q Specialist

View Salaries

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 base 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.

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)

This is the validation bit. 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 Senior Validation Roles.

So What Is Validation?

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

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 IQ OQ PQ 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 QualificationOperational 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 and PQ?
What is a 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).

GetReskilled Success Stories

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

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

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

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.

What Does the Online Classroom Look Like?

How-does-Studying-Online-Work

We use one centralized platform where you can log into your classroom. There you will get your weekly program materials and assignments, ask questions, reply to messages, and more.

Each week, you’ll complete a series of videos, quizzes, interactive activities and validation focused projects through our online platform, available to access 24/7.
We release only one week’s worth of material at a time and then MANUALLY 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. And you’ll have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.

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 to Start Your Validation Career

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

Talk To Our Team

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

Ireland
Call Sinead: +353 (0)21 2409016

GetReskilled Success Stories

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

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

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.”

Delivered by an Industry Expert

Dr.Joe Brady Lecturer at GetTeskilled

Dr. Joe Brady

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

Dr. Joe Brady is 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 institution.

He is also a supervisor for MSc/MEngSc and PhD 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.

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. 

Download Brochure

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

  • 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
    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).
  • 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 FDAMedicalDeviceRules-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.
  • 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.
  • 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.
  • 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
  • Topic -3 Tablet Manufacturing
    In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
  • Topic -4 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.
  • Topic-1 Purified Water (PUW) Generation, Storage and Distribution
    2-6-1, 2-6-2, 2-6-3 In these presentations we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • Topic -2 Clean Steam Generators – 2 videos
    3-5-1, 3-5-2 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.
  • 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
    4-3-1, 4-3-2, 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.

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)