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

Take our GMP Training Course. Get a deep understanding of Good Manufacturing Practices (GMPs) with this 6-week online course. Learn to work with your clients in the pharmaceutical industry. Help satisfy your company’s GMP regulatory training requirements. Get a GMP Training Certification.
  • Get a deep understanding of GMPs really fast and familiarise yourself with the specialized concepts involved.

  • Work with professionals in this sector without feeling lost or intimidated by the specialised terms and frameworks used.

  • Extend your company or consultancy’s role into the pharmaceutical industry. Charge higher hourly rates.

  • Application Deadline: Thursday 21st March
  • Approx. 60 hours to complete.
  • 10hrs/week for 6 weeks or choose a faster/slower schedule
  • Study Part-Time Online. Course materials are available 24/7. There are NO ZOOM classes
  • Join 1340 Learners
GMP Manufacturing Training | Learn Good Manufacturing Practices

Contact Details For This Course

Geraldine Creaner

Note:

1) This is a proper course with weekly coursework, deadlines, workshops, and an end-of-module assignment that will be run through an anti-plagiarism checker and checked for the use of ChatGPT. And you will get feedback on your assignment from a chemical engineer.

We don’t do the “Watch a video, Complete an MCQ (multiple choice question), Get a Certificate” approach!  
Or
Listen to somebody talk on ZOOM for days

2) 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.

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

Get a deep understanding of Good Manufacturing Practices (GMPs) with this 6-week online course. Learn to work with your clients in the pharmaceutical industry. Help satisfy your company’s GMP regulatory training requirements. Get a GMP Certificate of Completion.
GMP training course for the pharmaceutical manufacturing industry
  • Get up to speed with the specialize concepts and terms used in pharma manufacturing

  • Work with professionals in this sector without feeling lost or intimidated by the specialised terms and frameworks used.

  • Extend your company or consultancy’s role into the pharmaceutical industry. Charge higher hourly rates.

  • Application Deadline: Wednesday 7th August

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.

  • Approx. 60 hours to complete.
  • 10hrs/week for 6 weeks or choose a faster/slower schedule
  • Study Part-Time Online. Course materials are available 24/7. There are NO ZOOM classes
  • Join 1340 Learners

MOST ONLINE GMP COURSES SUCK! 

So we changed that:

1) This is a proper course with weekly coursework, deadlines, workshops, and an end-of-module assignment that will be run through an anti-plagiarism checker and checked for the use of ChatGPT. And you will get feedback on your assignment from a chemical engineer.

We don’t do the “Watch a video, Complete an MCQ (multiple choice question), Get a Certificate” approach!  
Or
Listen to somebody talk on ZOOM for days

2) 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

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

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AstraZenega Logo

Novartis Logo

GSK Logo

Lilly Logo

Abbott Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

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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

You will write a technical report on cGMPs

As part of this course, you will write a 1,200-word report on the cGMPs required to consistently manufacture safe medicines, vaccines and medical devices for patients. It will include:

  • The key regulatory 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 pharmacopoeia-grade Purified Water (PUW).
  • The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

Our chemical engineers will give you written feedback on your report.

This GMP Training Course is right for you if;

  • You want to learn how safe medicines and medical devices are made in a regulated Good Manufacturing Practice GMP environment.
  • 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.

This Course in NOT right for you if you want to retrain for a job in pharma manufacturing

Minimum Entry Requirements

  • You have one of the following qualifications or work in any of the following:
    • PhD, Masters, Degree or Diploma in Biochemistry, Microbiology, Molecular Biology, Laboratory/Science
    • Management or Engineering Consultant
    • Engineers or Technicians
    • Quality Control or Quality Assurance
    • Frontend/Backend/Full Stack or Enterprise Software Developer
    • Logistics – Supply Chain Managers, Procurement
    • Packaging and labelling industry
    • HR/Recruitment Specialists focused on life sciences, pharmaceutical, biotech or medical device industry

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 for GMPs from various regulatory authorities –  including, FDA GMPs for the United States, EMA GMPs for the European Union, ICH, and PICs GMP regulation, GMP requirements and GMP principles
  • FDA medical device rules – medical device regulations & guidelines
  • GMP Guidelines vs ISO 9001:2015 – what’s the difference and why we use both
  • Process validation and documentation –  design and verification of manufacturing systems and good documentation practices
  • 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 systems, 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
  • Working in a cleanroom environment – layout, classification, gowning and monitoring
  • Professional Writing Skills Program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry

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 a 4-5 page technical report on the cGMPs that are required to consistently manufacture safe medicines, vaccines, and medical devices for patients.

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.

Your 6-Week Class Schedule

  • 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).
  • 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  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-8 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.

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 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-2 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-3 Process Validation
    In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’ and ‘verification.
  • 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 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-7 Steam Sterilization in Place
    In this lesson, we look at the mechanism behind the sterilization of process equipment using saturated steam.
  • Topic-8 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.

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 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-2 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-3 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.
  • Topic-4 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-5 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-6 Tablet Manufacturing
    In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
  • Topic-7 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 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 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.
  • Topic-2 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-3 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-4 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-5 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-6 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-7 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
  • Topic-8 What’s Next?
    In this lesson, we look at what is next after you’ve finished Manufacturing Safe Medicines and 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.

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 identifying 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

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.

Hear From People Who’ve Taken This Course

Manufacturing Safe Medicines

John Ryan

“The course content material is concise and interesting”

“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.”

Manufacturing Safe Medicines

Ronan Balfe

“I would have no hesitation in recommending these courses”

“Studying online gives you the time to do the course in your own time yet with assignment deadlines this made you disciplined to meet the deadlines set. I would have no hesitation in recommending these courses to anyone wishing to gain an education in the pharmaceutical sector.”

Manufacturing Safe Medicines

Edel Harkins

“Highly recommended to anyone who has been out of the industry for a period of time”

“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”

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 courses 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.

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

Earn a Certificate of Award in “Good Manufacturing Practices (GMPs)

Earn by successfully completing an end-of-module written technical report on cGMPS and passing all assessments.

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

GMP training certification

15 Frequently Asked Questions

Yes, this program is delivered fully online.

  1. Click on the “Apply Now” button and fill out the application form.
  2. A member of our team will telephone you (within one or two working days) and chat through your application and make sure both you and the course are a good fit for each other. Please note: We may sometimes suggest a different course to the one you’ve applied for if it’s a better fit or a better way to get you to an employable level of knowledge sooner.
  3. After the telephone call, we will email you details of the telephone conversation covering:
    1. Course Overview
    2. Course Content
    3. Course Delivery & Certification
    4. Course Fees
    5. Registration Deadline, Start Dates and How to Register
    6. Link on the Online Registration Form
  4. You MUST complete the Online Registration Form to confirm your place on the course (It should take about 5 to 10 minutes to fill out the online registration form). Once completed, we will send an email acknowledgement confirming your registration.
  5. Our Course Director will telephone you just after the application deadline to arrange payment details.
  6. We will email your username, password and a link to your course on the course start date.
  7. Start your course!

Yes, that’s no problem.

We can invoice your employer (with or without a purchase order) for payment. First, you need to provide us with your employer details so we can prepare the invoice. You can share these details in our follow-up phone call or we can email you an outline of the information we need and have your employer respond.

Or you can pay by company credit card or bank transfer.

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.

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.

Most students report between 8-12 hours per week.

No – there are no specific times that you need to be online to take this course. There are NO ZOOM classes or live webinars! The online classroom is open 24-hours a day, you do not have to login at any particular time. The day the course starts, we will give you a username and password and this allows you 24/7 access to your course.

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.

Yes, our programs are recognised by all the world’s leading pharmaceutical and medical device manufactures. In addition, we can provide an education verification check (assuming you have successfully completed this program) to meet any employer or other third parties requests.

No, we provide certificates in PDF form only. Each certificate will have a unique reference number for traceability.