Validation Training Course (ONLINE) – For Starter Validation Roles. Learn Commissioning & Qualification (IQ OQ PQ)

Develop your own Validation Protocol. Validate Equipments & Systems. Read P&IDs & Piping Isometrics. Join a Validation or Qualification Team in a Pharmaceutical Company or Engineering Consultancy in 4 months.
  • Build on Your Industry Experience and Start a Higher-Paying Career in Validation
  • Turn Your Practical Work Experience into an Advanced Certification
  • Application Deadline: Wednesday 7th October

Image: PM Group

Validation Training Course (ONLINE) – For Starter Validation Roles. Learn Commissioning & Qualification (IQ OQ PQ)

Develop your own Validation Protocols. Validate Equipment and Systems. Read P&IDs & Piping Isometrics. Do Component Impact Assessments. Write Test Scripts. Join a validation or qualification team in a pharmaceutical company or engineering consultancy in 4 months.
Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems Course

Image: PM Group

ESTIMATED SALARY
$35k to $80k
Based on US job data

ESTIMATED SALARY
€35k to €65k
Based on Irish job data

DURATION
2 Modules over 15 Weeks
Study Online 15 hrs/week 

LEVEL
Beginner – Intermediate
Join 2340 Learners

APPLY BY
Wednesday 7th Oct
Class Starts: 15th Oct

Apply NOW to Start Your Validation Career
Apply NOW to Start Your Validation Career

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Take Back Control of Your Career

Do you feel you have plateaued at work? Has your job become has become routine and monotonous? Does it seem like you’ve learnt all can from your current sector? You’re not alone but this program can help you restart your career and join a validation or qualification team in a pharmaceutical company or engineering consultancy in 4 months.

Minimum Entry Requirements

You MUST have one of the following:

  • You are a pipefitter / plumber / pipe welder (e.g. high purity pipe fitter and orbital welder) / site-foreman / instrument or boiler technicians (i.e. you can interpret technical drawings).
    Or
  • You have 1 year or more of GMP manufacturing experience or you have a recognized GMP certificate or qualification.
    Or
  • You have commissioning & qualification experience in ANY INDUSTRY e.g. Oil and Gas, Food Manufacturing, Mechanical or Electrical Construction, etc.
    Or
  • You work in Quality Assurance or Quality Control in the pharma/medtech industry and are concerned about having to sign off on validation documents you don’t fully understand!
    Or
  • You are a mechanical / chemical / process / petroleum / project / civil engineer or a lab/scientist and want to move into validation.
    Or
  • You already work in validation but have no formal training on IQ OQ PQ validation protocols and want to learn more.

Our learners work at industry-leading companies such as:

Pfizer Logo

Abbott Logo

Lilly Logo

Novartis Logo

Amgen Logo

GSK Logo

Join our students who work at industry-leading companies such as:

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.

By the end of this program, you”ll be able to:

What you’ll learn – There are 2 modules in this 15-week program

Module 1 – Manufacturing Safe Medicines (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

“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

“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

“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

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

“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.

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

Charles O Neill

“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 (Weeks 1-5)

  • Finished Medicinal Products
  • Focus on Patient Safety and Product Quality
  • ISO-9001 ‘Quality Management Systems — Requirements’
  • Product Quality and cGMP Practices
  • Process Validation
  • ASTM E2500 ‘Specification, Design & Verification of Manufacturing Systems’
  • PQ, OQ and IQ (Performance Qualification, Operational Qualification, Installation Qualification)
  • Cleaning Validation
  • Batch Organic Chemical Synthesis
  • User specification for a Reactor
  • Biopharmaceutical Manufacturing
  • Tablet Manufacturing
  • Aseptic & Sterile Manufacturing
  • Purified Water Generation, Storage & Distribution
  • Clean Steam
  • Water for Injection, Storage and Distribution
  • Engineering Aspects of Cleaning
  • Chemistry Aspects of Cleaning
  • Steam Sterilization
  • HVAC for Non-Sterile Manufacturing
  • Cleanroom Layout
  • Design Documents Required for the Generation of Installation and Functional Tests
  • User specification for a Reactor
  • Equipment Configuration and Process Sequence for a Reactor
  • Generation of Piping and Instrumentation Diagrams (P&ID)
  • URS for Hot Detergent and Hot PUW Generation and Distribution Skid System
  • Equipment List
  • Instrument List
  • Inline Components List

Module 2 – Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems (Weeks 6-15)

  • Design Documents Required for the Generation of Installation and Functional Tests
  • User specification for a Reactor
  • Equipment Configuration and Process Sequence for a Reactor
  • Generation of Piping and Instrumentation Diagrams (P&ID)
  • URS for Hot Detergent and Hot PUW Generation and Distribution Skid System
  • Equipment List
  • Instrument List
  • Inline Components List
  • Protocol Content Part 1: Objective, System Description and Scope
  • System Impact Assessment
  • cGMP Testing Principles
  • Valves
  • Piping Line List
  • Testing Traceability Matrix for Equipment Systems
  • Protocol Content – Part 2: Responsibilities and Installation Testing
  • Minimum Elements of a Test Script
  • Good Documentation and Records Management
  • Component Level Impact Assessment – Part-1 Product Contact Components
  • Installation Test P&ID Walk-Down
  • Installation Test and Equipment Verification
  • Pumps
  • Piping Components
  • Piping Isometrics 2D P&ID and 3D CAD Images
  • Piping Isometrics and 3D CAD
  • Piping Material Traceability
  • Piping Tests
  • Heat Exchangers
  • Instrumentation Identification
  • Installation Test Piping Verification GMP-Checklist
  • Process Control
  • P&ID Instrument Identification
  • Input Output (1/O) List
  • Process Control Hardware Panels
  • Loop Signal Verification
  • Installation Test Instrument Verification
  • Proportional-Integral-Derivative Controller (PID Controller)
  • Protocol Content – Part-3 Operational/Functional Testing
  • Component Level Impact Assessment – Part-2
  • Operational Testing Primary Functions GMP Checksheet
  • Testing Traceability Matrix for Equipment System Second Pass
  • User Requirement Specifications (URS)
  • Protocol Content – Part – 4: General Attachments
  • Protocol General Attachments
  • General Contents of a Validation Master Plan
  • Protocol Deviation Procedure
  • Change Control Procedure
  • Protocol Testing Template
  • Testing Traceability Matrix for Equipment System
  • Conclude List of Installation Tests
  • Conclude List of Functional Tests
  • Final Protocol Template Review
  • Write an IQ OQ PQ protocol for a Clean-in-Place system.
You will become familiar with a range of documents used in projects including piping and instrumentation diagrams (P&ID), equipment specifications, instrument specifications, line lists, piping isometrics, 3D layouts, electrical and hardware control – panel diagrams, and wiring and loop diagrams. These design documents are used to generate IQ OQ PQ commissioning and qualification protocols.

You will also become familiar with:

  • User Requirement Specifications (URS)
  • cGMP impact-assessments
  • cGMP design reviews
  • Design Qualification (DQ) reports
  • Specification and testing traceability matrices
  • Typical testing IQ OQ PQ protocol templates
You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Technological University Dublin (Ireland) subject to the following criteria;

  • Passing a written or oral Exam on the materials.
  • The submission of all assessments and the end of module assignment.