Are you a Process, Chemical, Petroleum or Project Engineer?

Take our “Commissioning & Qualification of Equipment & Systems” Program

Commissioning and Qualification (IQ OQ PQ) Protocols form a crucial part of pharmaceutical plant projects. Having a fundamental understanding of how IQ OQ PQ protocols are put together and interpreted is a fundamental skill set for any engineer cross-training to work in this area. Developed in consultation with the pharma industry including Pfizer and MSD.

  • Learn how to populate a 120-page plus IQ OQ PQ equipment qualification protocol for a Clean in Place (CIP) System.

  • Qualify equipment, instruments and systems.

  • Hit the ground running from day one with this fundamental skill.

  • Application Deadline: Wednesday 7th August
  • Study Part-Time Online
  • Course materials are available 24/7. There are NO ZOOM classes!
  • 10hrs/week for 15 Weeks or choose a faster/slower schedule
  • Join 2340 learners

NOTE: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course.

ebiopharmachem

Contact Details For This Course

Geraldine Creaner

Are you a Process, Chemical, Petroleum or Project Engineer?

Take our “Commissioning & Qualification of Equipment & Systems” Program

Commissioning and Qualification (IQ OQ PQ) Protocols form a crucial part of pharmaceutical plant projects. Having a fundamental understanding of how IQ OQ PQ protocols are put together and interpreted is a fundamental skill set for any engineer cross-training to work in this area. Developed in consultation with the pharma industry including Pfizer and MSD.

Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems Course
  • Learn how to populate a 120-page plus IQ OQ PQ equipment qualification protocol for a Clean in Place (CIP) System.

  • Qualify equipment, instrument and systems.

  • Hit the ground running from day one with this fundamental skill.

  • Application Deadline: Wednesday 7th August

  • Study Part-Time Online
  • Course materials are available 24/7. There are NO ZOOM classes!
  • 10hrs/week for 15 Weeks or choose a faster/slower schedule
  • Join 2340 learners

NOTE: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course.

Course Price →

Contact Details For This Course

Geraldine Creaner

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.

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.

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

Pfizer Logo

Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

Novartis Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

JNJ Logo

Our graduates 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

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.

Hear from people who’ve taken this equipment qualification course

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.

If you’re spending money on an education program, make sure you choose one you’ll finish!

With every GetReskilled ONLINE program;

  1. We use one centralized platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires you to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
  2. Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
  3. We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
  4. You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.

This all helps us to spot any potential issues early and helps you completely finish the program.

How does Studying Online Work?

Contact Details For This Course

Geraldine Creaner

Hear from people who’ve taken this equipment qualification course

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 a Practicing Industry Expert

Dr. Joe Brady

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

Dr. Joe Brady is a 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 institutions.

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. 

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.

Deliverables

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

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.
  • 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.

Deliverables

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