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 15th February
  • 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 15th February

  • 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 GMP Training 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

Pfizer Logo

AstraZenega Logo

Novartis Logo

GSK Logo

Lilly Logo

Abbott Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

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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

Sanofi Logo

GSK Logo

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

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