Equipment Validation Training Course (ONLINE) – For Starter Validation, CQV and C&Q 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 populate an IQ OQ PQ validation protocol and validate 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 $35,000 – $80,000 plus overtime, bonuses and allowances. (Based on US job data)

  • Estimated salaries €39,000€70,000 plus overtime, bonuses and allowances. (Based on Irish job data)

  • Application Deadline: Wednesday 15th February
  • 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

Equipment Validation Training Course (ONLINE) – For Starter Validation, CQV and C&Q 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. Populate an IQ OQ PQ Validation Protocol. Validate equipment and systems. Developed in consultation with the pharma industry including Pfizer and MSD.

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 plus overtime, bonuses and allowances. (Based on US job data)

  • Application Deadline: Wednesday 15th February
  • 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 15th February
  • 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.

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 1 year 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.

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

GSK Logo

Lilly Logo

Abbott Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

JNJ Logo

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

Pharmaceutical Courses

What Equipment Validation 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 Engineer – Some pharma companies call this role:
    • CQV Specialist
    • 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

View Salaries

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:

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 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.

And 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

Complete 2 modules 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 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 Equipment Validation Experience?

If you already have some experience working in Validation and know how to populate an IQ OQ PQ equipment validation 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 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“.

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 Equipment 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 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 Validation Course

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.”

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.

Your 10 or 15 Week Class Schedule 

Note: If you’ve worked in a GMP Regulated Pharmaceutical or Medical Device 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)

Session 1 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 1

  • 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 and ISO 9001:2015
    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) including,

Session 2 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 2

  • 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 FDA Medical Device Rules-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.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Session 3 – Process & Cleaning Validation and Documentation

  • 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.

Session 4 – Risk Management Tools for Scientific Based Decisions

  • 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.

Deliverables

  • Complete two workshops on Fault Tree Analysis (FTA) and Failure Mode Effect Analysis (FMEA)
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

Session 5 – Chemical and Biopharmaceutical Manufacturing

  • 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 biotechnol