GMP Training Course ONLINE For Beginners in the Pharmaceutical Industry. For Individuals, Teams, Companies or Startups

Get a deep understanding of Good Manufacturing Practices (GMPs) with this 5-week online course. Learn how safe medicines and medical devices are made in a regulated GMP environment. Satisfy your GMP regulatory training requirements. Get a GMP Training Certification.

Get up to speed with the specialize concepts and terms used in pharma manufacturing
Extend your company or consultancy’s role into the pharmaceutical industry
5 week online course – No needless travel
Application Deadline: Wednesday 2nd April

Approx. 50 hours to complete
Study Online part-time 10hrs/week for 5 weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress at the end of every week and follow up with you to help you finish the course
Join 1340 Learners

GMP Manufacturing Training | Learn Good Manufacturing Practices

Apply NOW And Get a Deep Understanding of GMPs Really Fast

End-of-week progress checks and follow-up by us to MAKE SURE you or your team finish the course.

GMP Training Course ONLINE For Beginners in the Pharmaceutical Industry. For Individuals, Teams, Companies or Startups

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

Get up to speed with the specialize concepts and terms used in pharma manufacturing
Extend your company or consultancy’s role into the pharmaceutical industry
6 week online course – No needless travel
Application Deadline: Wednesday 2nd April

Approx. 50 hours to complete
Study Online part-time 10hrs/week for 5 weeks or choose a faster/slower schedule
Dedicated course leader who’ll check your progress at the end of every week and follow up with you to help you finish the course
Join 1340 Learners

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

See Course Price

Apply NOW And Get a Deep Understanding of GMPs Really Fast

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This Course is For You If;

You need to get a deep understanding of GMPs really fast and familiarise yourself with the specialized concepts involved.
You work in academia or a research laboratory and need to work with professionals in the pharmaceutical and med device manufacturing sector.
You have to train your team on how safe medicines and medical devices are made in a regulated GMP environment as part of a GMP compliance, GMP refresher or GMP induction training programme.

And…

You have a FULL-TIME job and need a program with a flexible delivery schedule so you can study whenever you have time.
You want end-of-week progress checks and follow-up by us to MAKE SURE you or your team finish the course.
You don’t want to waste your time, money or training budget on hotel or travel junkets.

Entry Requirements

None. This GMP Online Training Program is suitable for ALL backgrounds and All experience. Here are some examples:

PhD, Masters or a Degree in Biochemistry, Microbiology, Molecular Biology, Lab/Science, etc
Management or Engineering Consultancies
Engineers or Technicians
Front/Backend Development or Enterprise Software
Logistics – Supply Chain Managers, Procurement
Business – MBA’s, Finance, Accountants, etc
Quality Control or Quality Assurance Specialist
Sales – Pharma Sales, Business Development, etc
Packaging and labelling industry
HR/Recruitment Specialists focused on Life Sciences
People who work in Life Sciences but don’t have a degree/diploma

Note: If you want to retrain for an entry-level job in Pharmaceutical Manufacturing, check out our Conversion Course into Pharma.

Enroll in this course to learn…

Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems, regulation and validation
Industry regulations and guidelines – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation
FDA medical device rules – medical device regulations & guidelines
GMPs vs ISO 9001:2015 – what’s the difference and why we use both
Process validation and documentation – design and verification of manufacturing systems
Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic & sterile manufacturing
Supporting technologies – such as purified water generation, storage & distribution, clean steam, water for injection, storage and distribution
Introduction to Quality Risk Management (QRM) – and the importance of risk management and the basic steps involved in its application

You’ll produce a number of deliverables throughout the course including…

Complete the following 2 Quality Risk Management Tool workshops where you will learn to use worst-case scenario planning to figure out what could go wrong in the manufacturing process and come up with steps to mitigate those risks.
- Fault Tree Analysis (FTA)
- Failure Mode Effect Analysis (FMEA)
Complete four-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.
Complete an end of module 4-5 page assignment to include:
- The key requirements of a quality management system
- The cleaning validation sequence and how to determine cleanliness levels
- The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk.
- The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
- 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

And take the following skills and knowledge back to work…

You’ll have a foundation in how safe medicines and medical devices are made in a regulated GMP environment.
You’ll be able to participate in root cause analysis projects.
You’ll have enough technical knowledge and understanding of the quality culture necessary to work in this environment.
You’ll have the written communications skills to properly write reports and reference and cite source material in a manner that is consistent with the professional norms of this industry.
You’ll be able to work with professionals in this sector without feeling lost or intimidated by the specialised terms and frameworks used in this sector.

View Full 5 Week Syllabus

Syllabus Price

Hear From People Who’ve Taken This Course

John Ryan

“The professionalism and passion of the lecturers comes across in the tutorials which gives the student confidence and encouragement to keep on top of the course. The course content material is concise and interesting. The timing of the release of the lessons is perfect, the student moves at a comfortable pace, one step at a time.”

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.”

See Course Price

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

With every GetReskilled 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.

Meet Your Online Classroom Support Team

When you learn at GetReskilled, 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!

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.

Your 5-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.

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Week 1 – Industry Regulations and Guidelines

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.

Week 2 – Process Validation & Documentation and Risk Management Tools

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.

Week 3 – Key Manufacturing Technologies

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.

Week 4 – Supporting Technologies and Cleanrooms

Topic-1 Purified Water (PUW) Generation, Storage and Distribution
2-6-1, 2-6-2, 2-6-3 In these presentations we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
Topic -2 Clean Steam Generators – 2 videos
3-5-1, 3-5-2 the objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
Topic -3 WFI Storage and Distribution
In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification
Topic -4 Engineering Aspects of Cleaning, and Cleaning Equipment
This class discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), and automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning
Topic-5 Chemistry Aspects of Cleaning
This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
Topic -6 Steam Sterilization in Place
In this lesson, we look at the mechanism behind sterilization of process equipment using saturated steam.
Topic-7 HVAC Requirements for Non-Sterile API Manufacturing
In this lesson, we look at how to use airflow direction as a means of a containment barrier between
operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
Topic-8 Cleanroom Layout–2 videos
4-3-1, 4-3-2, In these presentations, we take a high-level look at a common cleanroom configuration and discuss items
such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
Topic -9 Area Classification Protection
In this lesson, we observe a range of airlock configurations typically used in combination with safety under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient.
Topic -10 Cleanroom Gowning
In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
Topic -11 Cleanroom Monitoring – Physical Tests
In this lesson we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.

Week 5 – Assignment - based on GMP Manufacturing from content in Week’s 1-4

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

Certified by GetReskilled

You will receive an end of course certificate from GetReskilled 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.

Show Off Your New Skills: Get a Certificate of Completion

Once the course is over, complete a written assignment to get certified in Manufacturing Safe Medicines & Medical Devices Course

Add it to your resume, your LinkedIn profile or just get that well-earned raise you’ve been waiting for.

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.

Will I have access to the materials after the course is finished?

Yes for 6 months.

Is this course relevant to both pharmaceutical and medical device manufacturing industries?

Yes, this course is relevant to both the pharmaceutical and medical device industries.

Price

One Person

Price For 1-Person

S$1,499

Application Deadline: Wednesday 2nd April

Program Starts: 9th April

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Hours

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Apply NOW And Get a Deep Understanding of GMPs Really Fast

Contact Us

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Call Geraldine: +(65) 6513 9500

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