Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems – For Starter Validation, CQV and C&Q Roles

Take this course and join a Validation Team in a Pharma Company or Engineering Consultancy or Contractor in 15-Weeks. Learn to read P&IDs and piping isometrics. Populate an IQ OQ PQ validation protocol. Validate equipment and systems. Developed in consultation with the pharma industry including Pfizer and MSD.

Develop an IQ OQ PQ validation protocol
Validate equipment and systems
Build on your industry experience and start a higher-paying career in validation
Application Deadline: Wednesday 7th October

Study Online part-time
15hrs/week for 15 Weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress every week and follow up with you to help you finish the course
Join 1654 Learners

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

Apply NOW and Learn to Populate an IQ OQ PQ Validation Protocol

Developed in consultation with the pharma industry including Pfizer and MSD.

Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems – For Starter Validation, CQV and C&Q Roles

Develop an IQ OQ PQ validation protocol
Validate equipment and systems
Build on your industry experience and start a higher-paying career in validation
Application Deadline: Wednesday 7th October

Study Online part-time
15hrs/week for 15 Weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress every week and follow up with you to help you finish the course
Join 1654 Learners

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

See Course Price

Apply NOW and Learn to Populate an IQ OQ PQ Validation Protocol

Developed in consultation with the pharma industry including Pfizer and MSD.

PLEASE NOTE! This program content was originally developed on a construction project (and in consultation with the pharma industry) by a team of scientists, chemical engineers and validation engineers working for an engineering consultancy to rapidly train its own staff to populate an equipment validation protocol.

Minimum Entry Requirements

Not everyone is accepted. We only train people who can do the job properly once hired — so you’ll need one of the following backgrounds:

Commissioning & Qualification Experience: In any industry, such as Oil and Gas, Food Manufacturing, etc.
Or
Plumber/Pipefitter/Pipe Welder (e.g. high purity pipe fitter and orbital welder): You can interpret P&IDs and pipe skids and are tired of working outside on freezing cold construction sites.
Or
GMP Manufacturing Experience: Over 18 months of factory floor experience.
Or
Quality Assurance or Quality Control in Pharma: You are worried about signing off on qualification documents you don’t fully understand.
Or
Engineer or Scientist: Chemical, process, petroleum, project, mechanical engineer, or a laboratory scientist.
Or
Validation Professional: You already work in qualification/validation (e.g., mechanical contracting company doing high-purity pipework installations) but lack formal training on IQ OQ PQ protocols.

What Kind of Roles Could I Retrain For?

You could retrain for the following roles;

Validation Technician – Some pharma companies call this role:
- CQV Specialist
- C&Q Specialist
- Associate QA Validation Specialist
- C&Q Junior Project Manager
- Equipment & Process Validation Specialist
- QA Validation Associate
- QA Validation Specialist
Validation Team Member

With validation roles, you could work directly for a pharmaceutical company on in-house projects or work for an engineering consultancy or engineering contractor as part of a project team on large capital projects.

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 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 8-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

View Full 15 Week Syllabus

Why are we called DPS Education?

DPS stands for Dedicated Pharmaceutical Specialists.

We started as DPS Engineering (Singapore) in 2005, a company of engineers and validation specialists who worked on biopharmaceutical plants and needed a fast, reliable way to train their own people. The name was a statement of intent: this one industry, nothing else.

The training worked well enough that the Workforce Development Agency asked us to open it up, and by 2008 we were retraining Singaporeans from other sectors for biopharma careers under government-backed conversion programmes. When teaching became the main business, “Engineering” became “Education”. The initials stayed, because the promise behind them hadn’t changed.

Nearly twenty years on, we still only teach pharmaceutical and medical device manufacturing. No general engineering, no generic management courses.

If it isn’t about making safe medicines, we don’t offer it.

Singaporean Dedicated Pharmaceutical Specialists since 2005.

Singapore is sixty years old. For twenty of those years — a third of the nation’s lifetime — DPS has been training the Singaporeans who make Singapore’s medicines and medical devices.

We began as DPS Engineering (Singapore): Dedicated Pharmaceutical Specialists, founded here by a Singapore PR with three decades in the industry, teaching from a training room on Battery Road with the city skyline behind the whiteboard.

Our first learners came to us in the wake of the 2008 financial crisis. The Workforce Development Agency partnered with us to deliver modules in biopharmaceutical manufacturing and validation, under Singapore’s SPUR retraining scheme. Engineers and scientists from electronics, infocomms, chemicals and food manufacturing came through our Professional Conversion and Re-Skilling programmes and went to work in the pharma and biologics plants then rising across the island.

Our course have moved from classroom to online, but that DNA remains the same. It was first written on a live construction project by engineers who needed their own team populating IQ OQ PQ protocols quickly, then refined through more than 1,650 learners. It’s delivered by lecturers who have run projects on Singapore sites, and our graduates work at Pfizer, MSD, GSK, Novartis, Lonza and the other manufacturers that made Singapore a global hub – and as the courses are now online, they have been internationalised to the UK and Ireland.

We’re still here, on the same Singapore phone number, mapping the island’s hundred-odd pharma factories and telling you which of them are hiring.

Part of the fabric of Singapore.

See Course Price

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

With every DPS Education ONLINE program;

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.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
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.
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.

Here from people who’ve taken this course

Renato Chato

“This course was very informative and could greatly enhance our knowledge and understanding on Pharma Manufacturing practices (GMP, GDP, etc.). The training experience was great and details were clear. Keep it up, guys!”

Michael Cheong Yim Poh

“Once you tune in your mind set to studying online, it’s a great way to learn as you manage the pace yourself.”

Delivered by an Industry Expert

Dr. Joe Brady

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

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 Singapore, China, Ireland, The Netherlands, Belgium, France, and the USA.

Meet Your Online Classroom Support Team

When you learn at DPS Education, you can always rely on an in-house team of experts to provide guidance and support, whenever you need it.

Course Leaders

Your Course Leaders will onboard you on the program, and help keep you motivated throughout the course.

Course Coordinators

Your CC’s are here to provide you with answers, tips, and are going to check your progress weekly to keep you on track and will reach out to you by email or even by phone if you fall behind!

Your 15-Week Class Schedule

Your Class Director will check your study logs and only will release subsequent week’s materials to you if you have been logging in for more than 10 hours per week.

And he or she will proactively follow up with you to keep you on track.

Note: If you’ve worked in a GMP Regulated Pharmaceutical 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 - Week 1 - Industry Regulations and Guidelines

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.

Module 1 - Week 2 - Process Validation & Documentation and Risk Management Tools

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.

Module 1 - Week 3 - Key Manufacturing Technologies

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 biotechnological process and introduces the following process sequences:
- Stage-I – Upstream Processing
- Stage-II – Fermentation / Bio-reaction
- Stage-III – Downstream Processing

Session 6 – Tablet, Aseptic and Sterile Manufacturing

Topic-1 Tablet Manufacturing – In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
Topic-2 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.

Module 1 - Week 4 - Supporting Technologies and Cleanrooms

Session 7 – Purified Water, Clean Steam & Cleaning

Topic-1 Purified Water (PUW) Generation, Storage and Distribution – In these presentations, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
Topic-2 Clean Steam Generators – 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.

Session 8 – Cleanrooms

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– 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.

Deliverables

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

Module 1 - End of Module Assignment on GMP Content

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 - Week 1 – Interpreting P&ID’s

1.1 Design Documents Required for Generation of Installation and Functional Tests
In this lesson, you will get an overall concept of the course. We will learn about the design of equipment, instrumentation, piping and control elements of a typical process system. We will also learn about the development of a testing verification protocol that we could present to the regulatory authorities demonstrating the system is fit for its intended use.
1.2 User Specification for a Reactor
In this lesson, we will see the basic equipment configuration for a typical reactor system used for industrial chemical processing.
1.3 Equipment Configuration and Process Sequence for a Reactor
In this lesson, we will go through a typical process sequence when using a reactor for chemical processing.
1.4 Generation of Piping and Instrumentation Diagrams (P&ID)
In this lesson, we are going to look at a P&ID as a controlled document that is the basis of any process design. This is the first look we take at our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’. During the remainder of this course, we will extensively explore all design elements and generate an appropriate testing verification protocol.
1.5 URS for Hot Detergent and Hot PUW Generation and Distribution Skid System
We’ve already taken a first look take at our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’. Now we are going to examine the main equipment components and describe the major interconnectivity between them.
1.6 Equipment List
In this lesson, we are going to align the project equipment list against the P&ID.
1.7 Instrument List
In this lesson, we are going to align the project instrument list against the P&ID.
1.8 Inline Components List
In this lesson, we are going to align the project inline component list against the P&ID.

Module 2 - Week 2 – System Impact Assessment & Traceability Matrix

2.1 Protocol Content – Part-1: Objective, System Description and Scope
In this lesson, we’ll start the process of developing a testing verification (qualification) protocol beginning with objective, system description and scope.
2.2 System Impact Assessment
The objective of this lesson is to determine whether or not our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’ is a direct impact system in the context of product quality and patient safety.
2.3 Component Level Impact Assessment: Part-1 – Product Contact Components
In order to begin determining the content of our testing verification (qualification) protocol, we need to establish which components have an impact on product quality and product safety. Here we begin by first taking a look at product-contact critical components.
2.4 Component Level Impact Assessment: Part-2 – Operationally Critical Components
Determining the content of our testing verification (qualification) protocol we also need to establish which functions have an impact on product quality and product safety. In this lesson, we establish those operationally critical components.
2.5 cGMP Testing Principles
This lesson considers high-level requirements when preparing a standard testing document.
2.6 Valves
In this lesson, we take a look at valves as part of inline pipe fittings.
2.7 Piping (Line) List
In this lesson, we are going to align the project piping (line) list against the P&ID.
2.8 Testing Traceability Matrix for Equipment System – First Pass
In this lesson, we take our first look at the traceability matrix. This is a mechanism for tracing requirements through to the testing documents. Here we are using the matrix as a method to help plan necessary installation and functional/operational tests. We will also reference the project validation plan.

Module 2 - Week 3 – Installation Tests & Equipment Verification

3.1 Protocol Content – Part-2: Responsibilities and Installation Testing
Resuming with the process of developing our testing verification (qualification) protocol we continue with responsibilities and introduce installation-testing.
3.2 Minimum Elements of a Test Script
Having already considered high-level requirements when preparing a standard testing document, this document proposes a formatting structure for a test script.
3.3 Good Documentation and Records Management
The objective of this lesson is to give guidance on how to complete any written record, e.g. test script, batch sheet, training record, etc., to ensure the present and future integrity of that record.
3.4 Component Level Impact Assessment: Part-1 – Product Contact Components
In order to begin determining the content of our testing verification (qualification) protocol, we need to establish which components have an impact on product quality and product safety. Here
we begin by first taking a look at product-contact critical components.
3.5 Installation Test: P&ID Walk-Down
The objective of this lesson is to describe a visual-installation test for equipment, instrumentation, piping and inline components in the form of a ‘P&ID Walkdown’.
3.6 Installation Test: Equipment Verification
The objective of this lesson is to describe an installation test for equipment in terms of both visual and documentation checks.
3.7 Pumps
In this lesson, we look at certain pumps used in the process industry and describe their operation.

Module 2 - Week 4 – Piping Isometrics & Checksheets

4.1 Piping Components
This lesson is an introduction to the various components that make up a complete section of the pipeline.
4.2 Relating P&IDs and Piping Isometrics
This lesson describes piping isometric as a detailed design specification providing information for fabrication and installation of pipes.
4.3 Relating Piping Isometrics and 3D CAD Images
In this lesson, we overlay the P&ID content and the isometric details onto the CAD (computer-aided design) design.
4.4 Material Traceability
The objective of this lesson is to demonstrate how a mechanical contractor would keep a material record of all piping components during the fabrication and installation of a pipeline section.
4.5 Piping Tests
The objective of this lesson is to describe a range of non-destructive testing (NDT) routinely conducted on newly installed piping.
4.6 Heat Exchangers
This lesson is an introduction to heat exchangers where we use a thermal utility service to heat or cool a process fluid.
4.7 Instrumentation Symbols and Identification
In this lesson, we are going to look at how most industries tag an instrument using alphabetical identifiers.
4.8 Installation Test: Piping Verification
The objective of this lesson is to describe an installation test for piping in terms of both visual and documentation checks.

Module 2 - Week 5 – Instrument Loops & Checksheets

5.1 Process Control
This lesson is an introduction to conventional process control using one-way digital and analog signals.
5.2 P&ID Instrumentation Identification
In this lesson, we are again going to identify the instrumentation type on the P&ID but this time using the alphabetical identifiers.
5.3 Input-Output (I/O) List
In this lesson, we are going to align the project Input-Output (I/O) list against the P&ID and identify signal types.
5.4 Process Control Hardware Panels
In this lesson, we take a look inside a traditional process control cabinet and identify the various components within. We also look at digital and analog wiring diagrams.
5.5 Loop Signal Verification
In this lesson, we learn how to ‘tune’ control loops, typically, during the commissioning phase of the project.
5.6 Installation Test: Instrument Verification
The objective of this lesson is to describe an installation test for instrumentation in terms of both visual and documentation checks.
5.7 Proportional–Integral–Derivative Controller (PID controller)
This lesson describes how a PID controller is used to adjust a dynamic process via a control element to maintain the desired process value.

Module 2 - Week 6 – URS & Functional Testing

6.1 Protocol Content – Part-3: Operational/Functional Testing
This is our third lesson on the development of our testing verification (qualification) protocol where we consider operational/functional testing.
6.2 Component Level Impact Assessment: Part-2 – Operationally Critical Components
Determining the content of our testing verification (qualification) protocol we also need to establish which functions have an impact on product quality and product safety. In this lesson, we establish those operationally critical components.
6.3 Operational Testing: Primary Functions
The objective of this lesson is to determine the primary/critical functions of the ‘hot detergent’ and ‘hot PUW2 process water’ generation and distribution systems.
6.4 Testing Traceability Matrix for Equipment System –Second Pass
In this lesson, we take our second look at the traceability matrix – a mechanism for tracing requirements through to the testing documents. At this stage we can add the details of our already established installation tests; and we now also use the matrix as a method to further plan and refine the necessary functional/operational tests.
6.5 Functional Design/Requirement Specification
In this lesson, we look at the functional design/requirement specification that will describe the necessary automated functions needed to meet the desired user’s performance requirements.

Module 2 - Week 7 – Assembling the Validation Protocol

7.1 Protocol Content – Part-4: Protocol General Attachments, and Deviation and Change Control Procedures
This is our fourth and final lesson on the development of our testing verification (qualification) protocol where we introduce protocol general attachments, and deviation and change control procedures.
7.2 General Contents of a Validation (Master) Plan
This lesson describes typical high-level corporate / site validation policy documents. It also describes the typical content and structure of a validation master plan (VMP), subordinate level validation plans, and validation reports to conclude the planning activities.
7.3 Protocol General Attachments
This lesson describes the process for compiling and completing the protocol’s general attachments, and advises on how to making entries by hand into the protocol script?
7.4 Protocol Deviation Procedure
This lesson describes how and where to use a verification protocol’s deviation procedure and associated deviation log.
7.5 Project Specific Change Control Procedure
This lesson describes how and where to use a verification protocol’s change control procedure and associated change control log.
7.6 Protocol Template
Ultimately, having studied in-depth both our process system and the content of protocols, we are now in a position to formulate a template for our very own verification/qualification protocol – that will incorporate both installation and functional/operational tests – to prove that our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’ is fit for its intended use.
7.7 Testing Traceability Matrix for Equipment System –Third Pass
In this lesson, we take our third and final look at the traceability matrix – a mechanism for tracing requirements through to the testing documents. Having now formalized our protocol template we can now add the specific document-section details to the matrix for both our established installation and functional/operational tests.

Module 2 - Week 8 – Validation Protocol Final Review

8.1 Conclude List of Installation Tests
The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required installation test procedures and GMP checksheets.
8.2 Conclude List of Functional Tests
The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required functional test procedures and GMP checksheets.
8.3 Final Protocol Template Review
The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required installation and functional tests and included all the necessary protocol attachments.

Module 2 - Week 9 & 10 - Competency Based Assessment

The end of module assessment is a competency based open book assignment. Your answer will be assessed as either competent or not yet competent.

Module 2 - Complete the Following Activities and Workshops

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

Certified by DPS Education

You will receive an end of course certificate from DPS Education subject to the following criteria;

The submission of all assessments and the end of module assignment.

Show Off Your New Skills: Get a Certificate of Completion

Complete all assessments and the end of module written assignment to receive a Certificate of Award in “Commissioning and Qualification of Equipment and Systems“.

Add details of your certificate to your CV/Resume or your LinkedIn profile.

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

Price

S$999/month

For 5 Months

S$4,499 in Advance

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Reduced Price After Skipping First 5 Weeks. Only available if you’ve GMP Pharmaceutical Manufacturing Experience

S$3,999 in Advance

Save S$500

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Application Deadline: Wednesday 7th October

Course Starts: 12th October

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Frequently Asked Questions

How do you keep track of my progress on the course?

We release only one week’s worth of material at a time and then 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. There is a “Progress Bar “on your course which is helpful to you and us to know how you are doing.

You have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind. She’ll also be in touch weekly to let you know when new content is open for you.

Is this program delivered online?

Yes, this program is delivered fully online.

What does a typical week look like?

Each week of online content typically includes 6-10 topics.

Each topic includes:

A set of course notes – these provide additional depth to the video content.
Warm-up self-assessment question – to recap or activate any relevant prior learning.
A video – these are typically 5-10 minutes long and deliver 80% of the course content.
Post video self-assessment questions to check how well you can recall this new material from memory. If you can’t answer these questions, you should revisit that topic’s learning materials.
Any follow up assessments or assignments.

How many hours a week must I do for the course?

Most students report between 8-14 hours per week.

Do I need to be online all the time?

No you don’t. The online classroom is open 24 hours a day so you do not have to login at any particular time. We will give you a Username and Password on the day the program starts and this allows you 24 hours a day access.

Can I pause the class if I get to busy at work or because of family commitments?

Yes.

Can I take this course at a faster pace?

Yes, you can speed up or slow down the rate of delivery to suit your requirements. The most important thing is communication between you and your course coordinator. If you are taking a break or are busy at work and do not have time to study you need to tell her or him. Similarly, if you want to study at a faster rate, then just email in good time and ask for more course content.