GMP Training For Beginners in the Pharmaceutical Industry. ONLINE Course for Individuals, Teams 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.
  • Get up to speed with the specialized concepts and terms used in pharma manufacturing

  • Extend your company or consultancy’s role into the pharmaceutical industry

  • Application Deadline: Wednesday 26th May
  • Approx. 60 hours to complete
  • Study Online 12hrs/week for 5 weeks or choose a faster/slower schedule
  • Weekly progress checks
  • Join 1340 Learners
GMP Manufacturing Training | Learn Good Manufacturing Practices
Apply NOW And Get a Deep Understanding of GMPs Really Fast

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GMP Training For Beginners In The Pharmaceutical Industry. ONLINE Course for Individuals, Teams 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.
GMP training course for the pharmaceutical manufacturing industry
  • 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

  • Application Deadline: Wednesday 26th May
  • Approx. 60 hours to complete
  • Study Online 12hrs/week for 5 weeks or choose a faster/slower schedule
  • Weekly progress checks
  • Join 1340 Learners

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

Pfizer Logo

Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

Novartis Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

JNJ Logo

Apply NOW & Take Your First Steps to a New Career

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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 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 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

This GMP Online Training Program is suitable for ALL backgrounds and experience such as;

  • 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 labeling industry

Note: If you want to retrain for an entry-level job in Pharma, 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 vs regulation vs validation
  • Industry regulations and guidelines –  including, FDA GMPs for the United States, EMA GMPs for Europen 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 course including…

  • Complete two workshops on Fault Tree Analysis (FTA) and Failure Mode Effect Analysis (FMEA)
  • 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 be able to work with professionals in this sector without feeling lost or intimidated by the specialised terms and frameworks used in this sector

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

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

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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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.

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.

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.

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.

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!”

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 se