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. Satisfy your 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: Wednesday 25th May
  • Approx. 60 hours to complete
  • Study Online part-time 10hrs/week for 6 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.

See Course Pricing

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. Satisfy your GMP regulatory training requirements. Get a GMP Training Certification.
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 25th May

  • Approx. 60 hours to complete
  • Study Online part-time 10hrs/week for 6 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

See Course Pricing

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.

This Course is Right For You If;

  • You want to learn how safe medicines and medical devices are made in a regulated 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.

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
    • Business – MBA’s, Finance, Accountants, etc
    • Sales – Pharma Sales, Business Development, etc
    • Packaging and labelling industry
    • HR/Recruitment Specialists focused on life sciences, pharmaceutical, biotech or medical device industry

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

If you want to retrain for a new career in the pharmaceutical manufacturing industry…

Choose from the following backgrounds to find the most suitable course.

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

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

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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 –  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
  • 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 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.

See Pricing Faq

Your 6-Week Class Schedule

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.

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-1 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-2 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-3 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-4 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.

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-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.

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-1 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-2 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-3 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-4 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
  • Topic-5 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.

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.

See Pricing Faq

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!”

Pharmaceutical Facility Design

Noel O’Brien

“The quality of the course content was excellent and very substantial and covered all aspects associated within the Pharmaceutical, Bio-Pharmaceutical and Medical Device industries. Information that I feel could and would be very much a requirement for the type of work I would be seeking, within such companies.”

Pharmaceutical Facility Design

Anne Reilly

“Very important to do a course if you have been absent from workplace for a relatively long period. It just gives you the confidence to do interviews etc.”

Pharmaceutical Facility Design

Louise McManus

“Excellent course, well set out.”

Andy Wnuk, MSc (Eng) MIEI

“Along with the technical training in I would rate the course 10 out 10 and would highly recommend to others, very interesting, informative and very well presented. Relevant totally to my needs and expectations.”

David O’Shea, March 2012

“I found this course very beneficial and I am delighted that, even at early stages in the course, it has already provided me with the opportunity to secure a position within the pharmaceutical industry.”

Denis Hegarty, May 2012

“I found the course was run very professionally, The course notes and videos supplied were excellent, the notes tied in very efficiently and accurately with the videos. Dr Joe Brady’s presentation on the videos and his expertise and help at the webinars was outstanding. I found it very easy to continue studying even though I found employment two months into the course. I would highly recommend this course to anyone hoping to further their education in this field.”

Tan Sear Enyu, Venture Corporation Limited, SA

“The lecturers have vast knowledge to share and are technical specialists within the Life Sciences Industry…there was a lot of encouragement and team exchange of experience to bring in for class work and assignment participation.”

Delivered by a Practicing Industry Expert

Dr.Joe Brady Lecturer at GetTeskilled

Dr. Joe Brady

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

Dr. Joe Brady is 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

Show Off Your New Skills: Get a Certificate of Completion

Complete all assessments and the end of module written assignment to get certified in Good Manufacturing Practices (GMPs) and receive a Certificate of Completion.

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

GMP training certification

Syllabus   Faq   Price

16 Frequently Asked Questions

Is this course delivered online?

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.

Yes

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, you can.

Yes for 6 months.

Yes, you can study all the way to a Degree.

STEP 1,  this program is a stepping-stone to our follow-on specialisation, Certificate in eBioPharmaChem. Take this Certificate to get a level 7 university qualification from Technological University Dublin, Ireland to get a more interesting job with a higher salary

STEP 2, then take our Certificate in Validation to move into a validation role.

STEP 3, Finally, if you have completed our Certificate in eBioPharmaChem and Certificate in Validation which are standalone programs, you are already halfway to a level 7 Degree. Take 6 more modules to get a degree in Degree in Manufacture of Medicinal Products (DT 291)

Yes, you can. You don’t need to have a degree or diploma to take this course.

No

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.

Price