University Certificate in Pharmaceutical and Medicinal Product Manufacturing

Retrain or upskill ONLINE for a higher paying job in pharma and medical device manufacturing industry. Our level 4 university certificate, expert lecturers, and dedicated career coaches will retrain you for a career in these rapidly growing industries. Core content developed in consultation with the pharma industry including Pfizer and MSD. Accredited by the University of South Wales.
  • You DON’T need a science or chemistry degree to get a starter job

  • Stable and secure jobs that are free of the ups and downs of the economy
  • Estimated salaries £20,000 £36,000 (Based on UK job data)

  • Application Deadline: Friday 7th January

  • Course Starts: 29th January 2022

  • Study Online 14 hrs/week
  • 5 Modules spread over 11 Months – 9 Months of study + 2 Months off for summer holidays
  • End of week progress checks and follow up to help you finish the course
Certificate in Pharmaceutical and Medicinal Product Manufacturing
Apply NOW & Take Your First Steps to a Well Paid Career in Pharma

Accredited by University of South Wales

University Certificate in Pharmaceutical and Medicinal Product Manufacturing

Retrain or upskill ONLINE for a higher paying job in pharma and medical device manufacturing industry. Our level 4 university certificate, expert lecturers, and dedicated career coaches will retrain you for a career in these rapidly growing industries. Core content developed in consultation with the pharma industry including Pfizer and MSD. Accredited by the University of South Wales.

Certificate in Pharmaceutical and Medicinal Product Manufacturing
  • You DON’T need a science or chemistry qualification to get a starter job

  • Stable and secure jobs that are free of the ups and downs of the economy
  • Estimated salaries £20,000 £36,000 (Based on UK job data)

  • Application Deadline: Friday 7th January

  • Course Starts: 29th January 2022

  • Study Online 14 hrs/week
  • 5 Modules spread over 11 Months – 9 Months of study + 2 Months off for summer holidays
  • End of week progress checks and follow up to help you finish the course

This Certificate is University Accredited by the University of South Wales

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  • One of the Largest Universities in Wales

  • Ranked in top 100 by the Times Higher Education for universities under 50 in 2014 and 2015
  • 23,000 registered students

  • Over 2,700 members of staff

This Course is Right For You If;

  • You’re fed up and want to move jobs to earn a higher salary.
  • You need a unique course that allows you to study around family and caring commitments while maintaining a healthy work-life-study balance.
  • You need complete flexibility on where and when you can study. (NO ZOOM classes and NO WEBINARS)
  • You are not interested in the traditional student experience.

And…

  • It’s delivered Part-Time online so you can learn from home (or anywhere). Study after the kids have gone to bed or catch up with your studies on the weekend.

University Certificate in Pharmaceutical and Medicinal Product Manufacturing

Our students work for the world’s biggest pharmaceutical and medical device manufacturing companies

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GE Healthcare Logo

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Our students work for the world’s biggest pharmaceutical and medical device manufacturing companies

Pfizer Logo

Astra Zeneca Logo

J&J Logo

MSD Logo

GSK Logo

IPSEN Logo

Lonza Logo

GE Healthcare Logo

Apply NOW & Take Your First Steps to a Well Paid Career in Pharma

Accredited by University of South Wales

This Course is Right For You If;

  • You’re fed up and want to move jobs to earn a higher salary.
  • You need a unique course that allows you to study around family and caring commitments while maintaining a healthy work-life-study balance.
  • You need complete flexibility on where and when you can study. (NO ZOOM classes and NO WEBINARS)
  • You are not interested in the traditional student experience.

And…

  • It’s delivered Part-Time online so you can learn from home (or anywhere). Study after the kids have gone to bed or catch up with your studies on the weekend.

University Certificate in Pharmaceutical and Medicinal Product Manufacturing

Minimum Entry Requirements

You need ONE of the following entry requirements:

  • The equivalent of a Level 3 qualification (A-Levels or equivalent) or above
    OR
  • The equivalent of a Level 2 qualification (minimum 3 GCSEs including Mathematics and English at Grade C/Grade 4 or above,) AND a recent relevant industry foundation course.
    OR
  • Have taken our Conversion Course into Pharmaceutical Manufacturing

For non-native English speakers, applicants may need to take a Duolingo, IELTS, TOFEL or equivalent language test for this course. See the FAQ at the bottom of the page for more details.

Process Validation Training Course

What Starter Level Roles Could I Retrain For?

STEP 1: Take our level 4 “University Certificate in Pharmaceutical and Medicinal Product Manufacturing” course to retrain for entry-level roles. Here are some of the most common job titles we see advertised on our pharma jobs board.

Process Technician Generally works in a pharmaceutical manufacturing plant. Some companies call this role:

  • Cleanroom Operator
  • Chemical Process Technician
  • BioProcess Technician
  • Process Operator

Manufacturing Technician – Generally works in a medical device manufacturing plant. Some companies call this role

  • Manufacturing Team Member
  • Product Assembler
  • Production Technician
  • Production Operator
  • Manufacturing Operator

Packaging Operators – Works in both pharmaceutical and medical device plants. Some companies call this role: 

  • Packaging Technician

Entry-level starting salaries range from £20,0000£26,000 plus overtime, bonuses and allowances. (Based on UK job data).

And for those who have worked in a GMP regulated manufacturing environment e.g. pharma, med device, nutritionalbeveragefood or dairy manufacturing.

And for those who have worked in maintenance in another industry sector.

Starting salaries range from £25,0000£36,000 plus overtime, bonuses and allowances. (Based on UK job data).

Male biotechnologist testing new chemical substances

Study all the Way to a Degree

STEP 2: Then you can take our level 5 University Higher Certificate in Pharmaceutical and Medicinal Product Manufacturing course to move into more senior roles with a higher salary. Typical roles 

  • Validation Technician – you work directly for a pharmaceutical company on ongoing projects. (Some pharma companies might call this role: CQV Specialist, Validation Specialist or C&Q Specialist)
  • Validation Team Member – you work with an engineering consultancy firm on capital projects. (Some engineering consultancies might also call this role: CQV Specialist, Validation Specialist or C&Q Specialist)

(Note that actual job titles will vary – the key distinction is between who’d employ you and what type of projects you’d work on).

And with more work experience

  • Validation Project Manager
  • Process Engineer
  • Cleaning Validation Specialist

Salaries range from £27,0000 – £45,000 plus overtime, bonuses and allowances. (Based on UK job data).

STEP 3: Take 6 more modules to get a  level 6 BSc (Hons) Degree in Pharmaceutical and Medicinal Product Manufacturing

What you’ll learn – There are five modules in this 1 year course

Module 1 – Fundamentals of Pharmaceutical Manufacturing (Weeks 1 -8) 

This module will give you a broad understanding of pharmaceutical products are made, the rules that govern manufacturing and the guidelines on how these rules are applied along with 6 different risk management tools used.

Module 2 – Advanced Writing Skills (Weeks 9 -12)

This module will give you 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. It will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry. You will be completing this module as you write your end of module assignment for PH1S082 Fundamentals of Pharmaceutical Manufacturing Technologies.

Module 3 – Pharmaceutical Facility Design (Weeks 13 – 26)

In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.

Module 4 – Advanced Career Coaching (Weeks 27 -30)

This is the career bit. In this module, you’ll navigate your way, step by step, through the job hunting process. We specifically designed and built this module for the pharma and med device sector. 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.

Summer Holidays (Weeks 30 to 37)

Module 5 – Fundamentals of Chemistry for the Pharmaceutical Industry (Week 38 – 47)

The aim of this module is to provide a foundation in the general chemistry necessary to appreciate the fundamental concepts involved in the chemistry of APIs required for the manufacture of medicinal products

Pharma Factories in UK

Are there Pharma Factories and Jobs Near Me?

Check out UK’s Largest Pharmaceutical Jobs Board to see the latest job openings in the UK.

Find out what pharma factories are near you – check out this Factory locator for the UK to see what factories are within a commutable distance for you

Check out this list of 250 pharmaceutical and medical device companies

Common Questions About the BioPharma/MedTech Industry

Why Choose a Pharmaceutical Career?
Job Descriptions and Salaries

GetReskilled Success Stories
Validation

Regina McNamara

Previous Background:
Professional Painter

Boston-Scientific-getreskilled-testimonial-logo

“I can Study Around Work and Family Commitments”

I’d recommend this course to anyone that wants to work in the Pharmaceutical and Medical Device Manufacturing industry and is interested in building a successful career in this area. The online experience is working well for me as I study around work and family commitments.

The companies I applied for were very impressed. I am currently working in Boston Scientific manufacturing Balloon Catheters for Gallstone patients.

Validation

Mehmet Hascan

Previous Background:
Technical Support

Johnson&Johnson-getreskilled-testimonial-logo

“Material was Delivered in an Engaging, Interesting and Supportive Way”

Having faced a career change in the middle of an economic downturn, I lost some of myself confidence and needed a major boost. The area of Biopharmaceutical operations and validation was of interest to me as it does play an important role in the pharmaceutical industry at present.

I have now been working at Johnson and Johnson Vision Care as a Validation Engineer and I look forward to putting what I have learned into practice.

Validation

Sharon Egan

Previous Background:
Food Manufacturing

GSK-getreskilled-testimonial-logo

“Structurally Well Planned with the Opportunity for Practical Application”

I found the course to be interesting, structurally well planned with the opportunity for practical application of the course modules through various assignments.

I have worked in the Medical device/Pharmaceutical and Food industries and found the course to be extremely relevant to all industries.

We’ve got lots more success stories like these. Read them, or try GetReskilled and see for yourself.

Price & Start Dates

Application Deadline: Friday 7th January

Course Starts: 29th January 2022

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Take the First Step

Click below to start your journey to a higher-paying pharma career.

Apply NOW & Take Your First Steps to a Well Paid Career in Pharma

Accredited by University of South Wales

Delivered by Industry Experts

Dr.Joe Brady Lecturer at GetReskilled

Dr. Joe Brady

Full-Time Validation Lead
Lecturer, Technological University Dublin
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 programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institutions.

He is also a supervisor for MSc/MEngSc and Ph.D. 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.

Gerard Creaner President, GetReskilled

Gerard Creaner

Senior Lecturer with GetReskilled

Gerry Creaner has over 30-years of experience in the Life Sciences Manufacturing industry across a range of technical, managerial and business roles. He established a very successful engineering consultancy prior to founding GetReskilled, an online education and learning business, with offices in Singapore, Ireland and Boston (USA), focussed on the manufacture of safe and effective medicines for the public.

He is also a founding Director of two Singapore based philanthropic organizations, the Farmleigh Fellowship and the Singapore-Ireland Fund, both of which deepen the well established and historical Singapore – Ireland relationship and deliver long-term benefits to both countries.

Gerry has an undergraduate degree in Chemical Engineering (UCD, 1980) and an MSc (Management) from Trinity College Dublin (2003) and is currently doing research for his Ph.D.

Dr. Suzanna Kean

Head of Chemistry and Pharmaceutical Science at USW

Having completed her undergraduate degree and PhD in Chemistry at the University of Adelaide, Suzy has initially applied her skills working for global mining giant Rio Tinto before undertaking post doctoral research in some of the UK’s top chemistry departments (Durham and Bristol).

Suzy Kean has been a lecturer in academia now for over 15 years and has led on the development of the pharmaceutical industry focussed awards at USW. She has extensive experience as a chemical analyst, and specialises in NMR spectroscopy.

Meet Your Online Classroom Support Team

We have a team of in-house experts to provide guidance and support, whenever you need it.

Course Leaders & Coordinators

Your Course Leaders & Coordinators are here to provide you with answers, tips, and are going to check your progress weekly to keep you on track and will reach out to you by email or even by phone if you fall behind!

Career Coaching

Meet Claire who runs GetReskilled’s Advanced Career Coaching Programme – our specially devised job hunting course that helps our trainees take that final step into employment by leading them through the job hunting process.

If you’re spending money on an education course, make sure you choose one you’ll finish!

With every GetReskilled ONLINE course;

  1. You will have a dedicated course leader for the entire duration of the course.
  2. GetReskilled will use (Moodle) platform and USW will use Blackboard 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.
  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. Your dedicated course leader will email or telephone you if it looks like you’re starting to fall behind. She will work with you to develop a study plan to get you back on schedule and finish the course.

This helps us to spot any potential issues early and helps you completely finish the course.

How does Studying Online Work?

Your 47-Week Class Schedule

Core technical content developed in consultation with the pharma industry including Pfizer and MSD.

Module 1 – Fundamentals of Pharmaceutical Manufacturing Technologies (PH1S082)

This module will give you a broad understanding of pharmaceutical manufacturing technologies, the rules that govern manufacturing and the guidelines on how these rules are applied along with the risk management tools to be used when making decisions that could impact the safety of the medicines being manufactured.

  • 1-1 Finished Medicinal Products
    In this lesson, we learn about medical products and the various ways drug products are administered.
  • 1-2 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.
  • 1-3 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.
  • 1-4 Clinical Trials
    In this lesson, we will gain an understanding of the purpose of clinical trials and learn about their four phases.
  • 1-5 Focus on Patient Safety and Product Quality
    In this class, we will develop a deeper understanding of the importance of patient safety and product quality for medicines and medical devices.
  • 1-6 Process Validation
    In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’, and ‘verification.
  • 2-1 ISPE Baseline Guide 5 – Commissioning Practices
    In this lesson, we learn about the commissioning and qualification of manufacturing equipment systems in the pharmaceutical industries and about the importance of doing system impact and component impact assessments.
  • 2-2 ISPE Baseline Guide 5 – Qualification Practices
    In this lesson, we look again at system and component impact assessment and specifically describe the qualification practices associated with direct impact systems that directly impact on product quality and patient safety.
  • 2-3 ISPE Baseline Guide 5 – Enhanced Design Review (EDR) / (DQ)
    In this lesson, we learn how to do a documented review of the design of the overall process and facility systems for conformance to operational and regulatory expectations.
  • 2-4 Cause and Effect – step 4 ‘Workshop’ exercise
    In this lesson, we learn about the risk management tool ‘Cause and Effect’ and see an example of where and
    how we can use it.
  • 2-5: ISO 9001:2008
    This lesson is about the key requirements of quality management systems.
  • 2-6: Good Engineering Practices (GEP)
    In this presentation, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
  • 2-7: ASTM E 2500 – 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.
  • 3-1: GAMP5 – Software Category
    This lesson, looks at the various GAMP categories of software and a ‘v-model’ approach to software projects? It also recommends a method on how to describe a critical computerized system to the regulatory authorities.
  • 3-2: GAMP5 – Scalable Validation Deliverables
    In this lesson, the general content of a computerized validation plan and a summary report is described. Described also is the ‘system implementation lifecycle’ (SILC) and the ‘software development lifecycle’ (SDLC) with associated validation deliverables.
  • 3-3: GAMP5 – Operation Activities
    This lesson describes the typical procedural activities associated with all commercial computerized systems in the operational stage of the lifecycle
  • 3-4: 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.
  • 3-5: GAMP5 – Risk-Based Decision Making
    This lesson explains how to apply risk-based decisions, making over the lifecycle of a computerized system: from the concept phase and through the project phase, into the operational phase and finally to the decommissioning stage.
  • 3-5: 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).
  • 4-1: Chemical Reactions
    In this lesson, we describe chemical reactions and list the substances involved, and explain what the rate-controlling steps are.
  • 4-2: Separation Technologies
    In this lesson, we explain how to purify a dissolved compound from a mixture of substances using ‘liquid-liquid extraction’, ‘phase separations’ and ‘crystallization’.
  • 4-3: 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.
  • 4-4: Preliminary Hazard Analysis (PHA) – step 4 ‘Workshop’ exercise
    This lesson, explains when and how to do a Preliminary Hazard Analysis (PHA) study on a project to analyze hazards, and suggests how to document the process and who should conduct the study.
  • 4-5: Multi-Stage Sequence API Synthesis
    In this lesson, we explore the typical sequence of deriving an API product using batch organic chemical synthesis and the types of facilities used
  • 4-6: API Regulatory Guidelines
    In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
  • 4-7: Relationship Between BPC and API
    In this lesson, we describe the similarities and differences between the terms ‘Active Pharmaceutical Ingredients’ (API) and ‘Bulk Pharmaceutical Chemicals’ (BPC), and we mention some typical material controls?
  • 5-1: 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
  • 5-2: Cellular Protein Synthesis
    This lesson explains the sequence of how a protein is created at a cellular level in terms of its contents and folded structure, and explains the template information necessary for its assembly process.
  • 5-3: Hazard Operability Analysis (HAZOP) – step 4 ‘Workshop’ exercise
    In this lesson, we will watch a practical application of HAZOP that will identify process risk events that are caused by deviations from a system’s design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called “guide-words” (e.g., No, More, Other Than, Part of, etc.) and applying them to relevant parameters (e.g., contamination, temperature) to help identify potential deviations from normal use or design intentions.
  • 5-4: Downstream Processing – Column Chromatography
    This lesson describes the basic principle behind the following column chromatography techniques:

    • Size Exclusion Chromatography (SEC).
    • ‘Ionic Exchange Chromatography (IEX).
    • Hydrophobic Interaction Chromatography (HIC).
    • ‘Affinity Chromatography
  • 5-5: Biopharmaceuticals Manufacturing: Special Considerations
    This lesson looks at general considerations for a conventional biopharmaceutical process in terms of cell line preservation and viral barrier and viral clearance techniques.
  • 6-1: Engineering Aspects of Cleaning, and Cleaning Equipment
    This lesson discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning.
  • 6-2: Chemistry Aspects of Cleaning
    This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
  • 6-3: Event Tree Analysis (ETA) – step 4 ‘Workshop’ exercise
    This lesson explores the application of Event tree analysis (ETA). Event tree analysis is an analysis technique for identifying and evaluating the sequence of events in a potential accident scenario following the occurrence of an initiating event. ETA utilizes a visual logic tree structure known as an event tree. The objective of ETA is to determine whether the initiating event will develop into a serious mishap or if the event is sufficiently controlled by the safety systems and procedures implemented in the system design.
  • 6-4: Cleaning Validation
    This lesson 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.
  • 6-5: 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.
  • 7-1: Tablet Manufacturing
    In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
  • 7-2: Vial Filling & Freeze Drying
    In this lesson, we will explore the critical process parameters and quality attributes associated with the filling of a medicinal vial and its subsequent freeze-drying.
  • 7-3: FDA Medical Device Rules – CFR 820
    In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
  • 7-4: Hazard Analysis and Critical Control Points (HACCP) – step 4 ‘Workshop’ exercise
    In this lesson, we are going to look at a full risk management process called Hazard Analysis and Critical
    Control Points (HACCP) and develop an understanding of the seven steps involved.
  • 7-5: Medical Devices – EU Classification
    In this lesson, we look at how medical devices are classified in the European Union, and we explore the basis of the classification system.
  • 7-6: 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.
  • 7-7: 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.
  • 8-1: 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.
  • 8-2: 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.
  • 8-3: Product Realization & Pharmaceutical Development
    In this lesson, we define the pharmaceutical product lifecycle in terms of development, technology transfer, commercial manufacturing and discontinuation.

Module 2 – Advanced Writing Skills (Weeks 9 – 12)

This module will give you 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. It will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry. You will be completing this module as you write your end of module assignment for PH1S082 Fundamentals of Pharmaceutical Manufacturing Technologies.

  • Write a paper on “Why cGMPs are required for the manufacture of a life sciences product” (in conjunction with writing skills training).

Module 3 – Pharmaceutical Facility Design (PH1S083)

In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.

  • 1.1 Manufacturing Logistics Calculations
    In this lesson, we learn how to determine the size and capacity of primary processing equipment based on patient dosage requirements and the number of potential patients.
  • 1.2 Process Flow Diagram (PFD) 
  • 1.3 Controlling Air Quality In this lesson, we take our first look at an air handling unit (AHU) and describe its functions.
  • 1.4 Heating, Ventilation, and Air Conditioning (HVAC) Systems In this lesson, we take a look at an overall heating and ventilation control (HVAC) system and explain its primary attributes.
  • 1.5 Basic Biopharmaceutical Unit Operations
    1-5-1 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug substance manufacturing operation.
    1-5-2 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug product formulation/fill-finish and packaging/labelling manufacturing operation.
  • 1.6 Pharmacopeia Grade Waters
  • 1.7 Process Support and Utilities
    In this lesson, we take a look at the clean utilities requirements for a biopharmaceutical drug substance manufacturing process.
  • 2.1 Introduction to ISO 9001:2008 and 2015
    This lesson is about the key requirements of a quality management system.
  • 2.2 Typical GMP list for drug substance
    This lesson explores the content of ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”.
  • 2.3 Operational Activities
    In this lesson, we take a look at how to maintain a critical computerized system in a state of operational control using standard procedures.
  • 2.4 GMP for Personnel
  • 2.5 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.
  • 2.6 Maintenance: Good and Best Practices
    In this lesson, we describe basic and good practices associated with maintenance in a regulated environment.
  • 3.1 Project Lifecycle for New and Modified Facilities
    In this lesson, we describe the typical phases of a project lifecycle: conceptual design, tender contract analysis, basic engineering, detailed design, and project realization.
  • 3.2 Plant Layout
    In this lesson, we explore the vertical distribution of process equipment for a bulk process building, the horizontal layout for a bulk process building, and an entire site layout for an integrated biopharmaceutical manufacturing site.
  • 3.3 Zoned Air-Conditioning Systems
    In this lesson, we look at a practical example where a HVAC system can be dynamically operated to control the temperature of a room (space).
  • 3.4 Isolator Technology
    In this lesson, we explain the principles behind the use of ‘isolators’ and Restricted Access Barrier Systems (RABs) for critical ‘open processing’ operation.
  • 3.5 Cell Breakage
    In this lesson, we describe a mechanism for bacterial cell disruption for the recovery of intracellular products.
  • 4.1 Purified Water (PUW) Generation, Storage and Distribution
    In these lessons, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • 4.2 Clean Room and Clean Air Device monitoring 
  • 4.3 Good Engineering Practices Procedures
    In this lesson, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
  • 4.4 GMPs for Buildings and Facilities 
  • 4.5 Quality Systems Approach to cGMP Regulations – Management Responsibilities
    In this lesson, we outline management’s role in the design, implementation, and management of the quality system.
  • 4.6 Maintenance Program
    In this lesson, we describe the key aspects of a typical maintenance program.
  • 5.1 Conceptual Design – Part-1
    In this lesson, we begin to explore a quantified effort in how to size, shape, program, and cost an investment.
  • 5.2 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.
  • 5.3 Plant Automation
    This lesson is an introduction to conventional process control using one-way digital and analogue signals.
  • 5.4 Plant Steam
    In this lesson, we describe a process for generating and distributing plant steam to various processes within a manufacturing facility, and also describe how to manage any resultant condensate.
  • 5.5 Clean Steam Generators
    The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation. 
  • 5.6 Steam Sterilization in Place
    In these lessons, we look at the mechanism behind sterilization of process equipment using saturated steam.
  • 5.7 GMPs for Process Equipment 
  • 5.8 Quality Systems – Resources
    In this lesson, we describe what resources need to be allocated for a quality system and operational activities.
  • 6.1 Conceptual Design – Part-2
    This lesson describes what influences the layout of a facility in terms of: Layers, Preliminary Layout, Process Layouts, Media and Buffer Preparation, Clean Utilities and CIP, Access Corridors, Warehouse / Material Movements, Personnel Movements, Decisions on Height, Air Handling, General Utilities, Electrical, Controls & Automation, Finishes, Structural / Civil, Cost Estimate, and Schedule.
  • 6.2 Air Flow Patterns 
    In these lessons, we look at laminar air-flow patterns in the context of filling open vessels aseptically, and at the configuration and operation of both a laminar flow booth and a laminar flow cabinet typically found in the biopharmaceutical industry.
  • 6.3 Cleanroom Layout 
    In this lesson, 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. 
  • 6.4 Filter Ratings
    In these lessons, we look at the particle retention efficiencies of air filters of various grades rated in accordance with European normalisation standards EN779 and EN1822. We also look at the particle arrestance efficiency of air filters of various grades rated in accordance with the ASHRAE standard 52-2 ‘Minimum Efficiency Reporting Value (MERV Rating)’.
  • 6.5 Logic Gates Functions and PLC 
  • 6.6 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.
  • 6.7 Good Engineering Practices Procedures
  • 6.8 Quality systems Approach- Manufacturing
    In this lesson we describe Manufacturing’s responsibilities for (a) designing, developing, and documenting product and processes, (b) examining inputs, (c) performing and monitoring operations, and (d) addressing nonconformities.
  • 6.9 Maintenance- Work Executions
    In this lesson we describe the following Maintenance tasks and activities: (a) work request, (b) work order management, (c) information requirements for work orders, and (d) performance measurement.
  • 7.1 Site Master Planning – Part-I
    In this lesson, we take our first look at site master planning based on: planning rationale, assumptions, prerequisites, typical bulk production unit, site scope, flexibility, expandability, & future-proofing, determining size requirements, sizing & shaping, and broad rules.
  • 7.2 Classification of Clean Areas – Vial Filling 
    In these lessons, we look at: (1) how to classify areas for aseptic operations, (2) typical configurations of air handling units (AHU’s), terminal filters, zone air-inlets and -exhausts to support various classified environments, (3) filter arrangements in air handling units and in their supply air ducting, (4) particles limits associated with various classified air environments, and (5) viable microbial limits, measured as Colony Forming Units (CFU), associated with various classified air environments.
  • 7.3 Area Classification Protection
    In this lesson, we observe a range of airlock configurations typically used in combination 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. 
  • 7.4 Compress Air and Pneumatics 
  • 7.5 Aseptic Filling
    In this lesson, we describe the process equipment for the filling of medicinal vials aseptically in the sequence of: washing, dehydrogenation, filling and their subsequent inspection.
  • 7.6 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment.
  • 7.7 Aseptic Processing 
    In these lessons, we look at various manual and automated processes and facility layouts for vial filling operations.
  • 7.8 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.
  • 7.9 Quality System – Evaluation Activities 
  • 7.10 Maintenance Management
    This lesson describes the processes and controls used in the delivery of maintenance services and work execution.
  • 8.1 Site Master Planning – Part-II
    We continue in this lesson exploring the configuration philosophy for a site specifically layering configuration options, fermentation/bioreactor, media and buffer preparation. We also look at the shaping and sizing options for fermentation, media preparation, buffer preparation, downstream processing, process and general utilities, buildings, and expansion.
  • 8.2 Open Versus Closed Processing  
  • 8.3 Facility Layout Concept 
  • 8.4 Blow/Fill/Seal Technology 
  • 8.5 PLC Programming
    In this lesson, we describe how to program a PLC to automate a machine using ladder logic diagrams.
  • 8.6 PLC Program Case Studies 
  • 8.7 Cleanroom Monitoring – Microbiological Tests
    In this lesson, we look at a range of typical microbiological measurements to monitor a cleanroom environment for conformance to specifications.
  • 8.8 Cleanroom Monitoring – Cleanrooms Cleaning Procedures 
  • 8.9 Terminally Sterilised Products 
  • 8.10 EU Guidelines on Cleanroom Aseptic Preparation 
  • 9.1 HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing 
  • 9.2 Batch Process Control
    In this lesson, we discuss the ISA-88.01 modularization software standard for segmenting a process into physical entities, and into procedural models for instructional recipes. The physical model is used to describe equipment, and the procedural model used to describe recipes (process sequencing).
  • 9.3 Nitrogen Supply and Distribution
  • 9.4 Environmental Monitoring Program 
    In this lesson, we describe how to monitor a cleanroom environment in order to identify actual and potential sources of contamination using both physical and microbiological techniques.
  • 9.5 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.
  • 9.6 FDA Guidance on Aseptic Processing 
  • 10.1 Construction Lifecycle
    In the first lesson for construction lifecycle, we explore the following: choosing a construction type, substructure, options for super-structure, internal building fabric, mechanical installation, electrical & instrumentation, construction sequence for new build, constructability, construction management, construction safety, construction costs, schedule, and quality management. In the second lesson, we look at the contents of clean utility piping test packs. In the third lesson, we look at modular construction and sustainable construction.
  • 10.2 Software Functional Block Diagram (FBD)
  • 10.3 ASTM E 2500
    In this lesson, we review the ASTM International standard E 2500 – 07 ‘Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment’.

Title of Assignment. – Site master plan for a new aseptic manufacturing facility, and the design of its environmental control and clean utility systems.

Write a 3,000-word report to give senior management the information they need to make informed decisions about a new aseptic manufacturing facility. The report should cover the 5 key sections of:

  1. Production Logistics
  2. Process Flow
  3. Site Master Plan
  4. Cleanroom Layout
  5. Utility Support Systems

Module 4 – Advanced Career Coaching (Weeks 26 – 29)

  • Topic 1: Starter Pack
  • Topic 2: Get to Know the Industry
  • Topic 3: Analysing Job Adverts
  • Topic 4: Skills Assessment
  • Topic 5: Your Personal Pitch
  • Topic 1: CV Writing 1
  • Topic 2: CV Writing 2
  • Topic 3: Tailoring Your CV
  • Topic 4: Cover Letters
  • Topic 5: Speculative Applications
  • Topic 1: Network Mapping and Growing Your Network
  • Topic 2: Online Networking
  • Topic 3: Interviews
  • Topic 4: Interview and Psychometric Testing Practice

Summer Holidays (Week 30 – 37)

Module 5 – Fundamentals of Chemistry for the Pharmaceutical Industry (PH1S084)

The aim of this module is to provide a foundation in the general chemistry necessary to appreciate the fundamental concepts involved in the chemistry of APIs required for the manufacture of medicinal products

Syllabus:

  • General chemistry
  • Introduction to Atomic theory. Solid-state: Amorphous and crystalline. SI system of units. Mole concept, reactions and balancing equations. Stoichiometry: limiting reagents, percentage yields. Concentration, molarity, and percentage composition.
  • Acids and Bases.
  • Genetics:- rate laws, reaction order and activation energy.
  • Introduction to organic chemistry:- functional groups and isomerisation. Concepts underpinned by a practical component.
  • Virtual Lab practicals

Why GetReskilled?

  • 100% ONLINE delivery  –  We deliver the program using a series of videos, quizzes, interactive activities, and projects. This means:
    • You can learn from home or anywhere you have a decent internet connection.
    • You don’t need to waste your time or money commuting to class or on expensive hotel or travel junkets.
    • Study at a time that suits you. There are no fixed schedules or Zoom classes.
    • Family-friendly – You’ve got kids? Not a problem. Study after they have gone to bed.
  • Dedicated course leader  – As a GetReskilled student, you will have a named course leader that stays with you throughout your course – this is a single point of contact for all queries and questions.
  • Developed on-site by scientists and engineers – Our programs were developed by working scientists and engineers in the pharmaceutical industry. They have decades of experience so you get the most practical and up-to-date course content.
  • Over 11-year experience delivering courses ONLINE – We’ve been delivering our programs online for almost 10 years so you are in safe hands.

Our Additional Support:

  • Talk to us anytime – Our support extends beyond the end of your technical course – GetReskilled students are always welcome to get in touch with industry or job hunting questions
  • More than technical training – We offer more than just technical training – depending on your course choice you might be eligible for our Advanced Career Coaching module, Professional Writing Skills module, Graduate Career Job Action Plan module, or Graduate Career Roadmap module
  • Free job hunting resources – As part of our commitment to helping our students, we provide high-quality free of charge industry resources such as our Irish and UK Pharma Jobs boards

11 Frequently Asked Questions

The course is delivered fully online.

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 have grasped the material.
  • 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 10-16 hours per week.

Don’t worry, You have a dedicated course coordinator you can reach out to and two sets of office hours (live chat) with the delivery team to answer any specific technical questions you may have.

The applicants will need to get the following test scores to meet the  English language requirements for the University of South Wales.

  • Duolingo Scores: 100 overall, with 90 in each component. See https://englishtest.duolingo.com/
    OR
  • GCSE pass in English at Grade C or above
    Or
  • IELTS with an overall score of 6.0 with at least 5.5 in each component*
    Or
  • TOEFL with a score of 72 overall and a minimum of 18 in reading, 17 in listening, 20 in speaking and 17 in writing (including Home Edition for September 2021 only)

No, we can’t. But we can guarantee you that the average wages are at least 25% above average.

Yes, this course is relevant to both the pharmaceutical and medical device industries.

Yes, this course is a stepping-stone to our follow-on specialisation, Validation and Quality Systems

University of South Wales’s exam board meets twice a year so it can take from 2 to 8 months after the final completion of the program before you get your results.

If you are job hunting and need written proof of your studies before your certificate has been issued, that is no problem. Just speak to your course advisor and they will organise that for you.

Take the First Step

Click below to start your application.

Apply NOW & Take Your First Steps to a Well Paid Career in Pharma

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