Get Ahead of Your Graduate Scheme Competition – Pharma Manufacturing Essentials Course

10-week ONLINE course to turn your degree into a place on a pharma industry graduate scheme

Your uni course will get you a degree but it probably won’t help you write the perfect CV for the pharma industry, tell you where to look for jobs or prepare you for answering technical interview questions. That’s exactly what this course does – walking you through the process step-by-step.

Why Pharma?

  • Excellent prospects for rapid promotion and a high salary

  • 69,000 are people directly employed with 6,300 new jobs on the way

  • Science and engineering graduates particularly sought after

  • 10-day Fast Track option available

  • Strong industry with excellent prospects for promotion and higher salaries

  • More jobs available now than ever before

  • Science and engineering graduates particularly sought after

  • 10-day Fast Track option available

  • Application Deadline: Wednesday 15th February

  • Study Online part-time 10hrs/week
  • 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 1120 Learners
GMP Manufacturing Training | Learn Good Manufacturing Practices

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

Get Ahead of Your Graduate Scheme Competition – Pharma Manufacturing Essentials Course

10-week ONLINE course to turn your degree into a place on a pharma industry graduate scheme

Your universtiy course will get you a degree but it probably won’t help you write the perfect CV for the pharma industry, tell you where to look for jobs or prepare you for answering technical interview questions. That’s exactly what this course does – walking you through the process step-by-step.

GMP training course for the pharmaceutical manufacturing industry

Why Pharma?

  • Excellent prospects for rapid promotion and a high salary

  • 69,000 are people directly employed with 6,300 new jobs on the way

  • Science and engineering graduates particularly sought after

  • 10-day Fast Track option available

  • Strong industry with excellent prospects for promotion and higher salaries

  • More jobs available now than ever before

  • Science and engineering graduates particularly sought after

  • 10-day Fast Track option available

  • Application Deadline: Wednesday 15th February
  • Study Online part-time 10hrs/week
  • 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 1120 Learners

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

Who is the course for?

  • Final year students of engineering or laboratory science degrees who want to join a pharmaceutical or medical device manufacturing industry graduate scheme when they graduate.
  • Recent graduates of engineering or laboratory science degrees who want to join the next intake of a pharmaceutical or medical device manufacturing industry graduate scheme.

The world’s biggest pharma and medical device manufacturing companies have hired our graduates after this 10-week program:

Pfizer Logo

AstraZenega Logo

Novartis Logo

GSK Logo

Lilly Logo

Abbott Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

JNJ Logo

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

Get a headstart over your classmates

You’re all going to leave with the same degree on paper, so how can you stand out from the crowd and set yourself apart?

The answer is simple…

  • Learn to “talk the talk” of the pharma industry so you can confidently answer interview questions and show a genuine understanding of this unique industry 
  • Don’t waste limited application opportunities making mistakes – know how to write a CV that really catches attention, learn how to answer different types of interview questions, and figure out how to sell the unique skills you already have 

This programme will give you all the technical and job application skills you need to turn your degree into a place in a pharma industry graduate scheme. After just 10 weeks (or 10 days in the Fast Track option), you’ll be ready for interviews and confident in what to say to employers.

We deliver the program online through one centralised platform (Moodle). This is where you can log into your classroom, get assignments and interact with faculty. Each week you’ll complete a series of videos, quizzes, interactive activities, and projects through our online platform, available to access 24/7.

You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind.

Please note: There are NO ZOOM classes or webinars!

What you’ll learn – there are 2 modules

Module 1 – Manufacturing Safe Medicines (6 weeks)

This is where you learn to “talk the talk”. 

Pharmaceutical and medical device manufacturing is a uniquely and strictly regulated environment. Wherever you want to end up, understanding those regulations and knowing what they mean in practice will give you a head start.  

In this module, you’ll learn about the rules as well as the systems used to implement them. 

Most new graduates don’t know this type of information so you’ll absolutely set yourself ahead of the pack when you can demonstrate this knowledge on your CV and at an interview.

You’ll spend 4 weeks learning new technical content and then 2 weeks writing your assignment (and we’ve got a professional writing skills programme to guide you through the assignment writing process and equip you with the written communication skills you need for starting in the industry).

Topics covered include (don’t worry if you don’t understand these right now, that exactly why you need this course):

  • 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
  • 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

Module 2 – Job Hunting Skills (4 weeks)

This is the job application bit. 

In this module, you’ll navigate your way, step by step, through the job application process for the pharma industry. By the end of it, you’ll know which jobs you’d be perfect for, where to find them, and how to make applications to give yourself the best chance at success.

Topics include:

  • CV writing – everyone thinks they know how to write a CV, most people don’t. There are some extremely common mistakes made by students and graduates – we’ll tell you what they are and how to avoid them so your CV really stands out as exceptional
  • Social media for a pharma job hunt – how to avoid common mistakes and harness the power of social media for your job hunt
  • Networking – why and how
  • Interview preparation – understand the types of questions you’ll get asked in a pharma interview and how to answer them

Some people think they don’t need the job-hunting module.

If you’re one of them, take this 30-second quiz to find out for sure…

Your Class Schedule

At the end of each week, your course coordinator will check your study logs and only will release next week’s materials to you if you have completed that week’s work.

If it looks like you’re falling behind, they will proactively follow up with you to help keep you on track.

Module 1 – Manufacturing Safe Medicines and Medical Devices (GMP) (Weeks 1-6)

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 directio