Fundamentals in Pharmaceutical Manufacturing Technologies
Retrain ONLINE for Development, Manufacturing, QA or QC Roles in Pharma Manufacturing in 10-Weeks

Quickly learn all you need to, to successfully move into science roles in Development, Manufacturing, and Quality in the Pharmaceutical manufacturing industry. Core content developed in consultation with the industry including Pfizer and MSD.

  • Start your path to a well-paid career in pharma manufacturing

  • Learn how safe medicines are made using GMPs
  • Application Deadline: Wednesday 3rd November
  • Approx. 130 hours to complete
  • Study Online 13hrs/week for 10 weeks or choose a faster/slower schedule
  • Weekly progress checks
  • Join 3220 Learners
Conversion Course into Science Roles in Pharma
Apply NOW & Retrain for Development, QA, QC or Manufacturing Roles

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

Fundamentals in Pharmaceutical Manufacturing Technologies
Retrain ONLINE for Development, Manufacturing, QA or QC Roles in Pharma Manufacturing in 10-Weeks

Quickly learn all you need to, to successfully move into science roles in Development, Manufacturing, and Quality in the Pharmaceutical manufacturing industry. Core content developed in consultation with the industry including Pfizer and MSD.

Why Switch to Pharma?

  • Start your path to a well-paid career in pharma manufacturing.
  • Learn how safe medicines are made using GMPs
  • Application Deadline: Wednesday 3rd November

  • Approx. 130 hours to complete
  • Study Online 13hrs/week for 10 weeks or choose a faster/slower schedule
  • Weekly progress checks
  • Join 3220 Learners
Apply NOW & Retrain for Development, QA, QC or Supporting Manufacturing Roles

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

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

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

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This Course is Right For You If;

  • You want to get from your current industry or academic sector to working in the Pharmaceutical and Medical Device manufacturing industry as fast as possible.

  • You already have a PhDMasters or a Degree and don’t want to spend huge amounts of your time or money getting another university qualification at the same or much lower level.

  • You work in academia or a research laboratory and want to move into the high paying manufacturing sector.

  • You need to learn about GMPs, Industry Regulations and Guidelines, Quality Risk Management Tools, Equipment and Cleaning Validation as quickly as possible.

And…

  • You want end-of-week progress checks and follow by us to MAKE SURE you finish the course.

  • Delivered Online you can work full time and still study without wasting your time or money commuting or getting stuck in traffic.

What Kind of Jobs Could I Get?

Depending on your previous experience, here are some of the most common job titles we see advertised;

Quality assurance is process-oriented and focuses on removing any variation from the processes of manufacturing. The role tends to be detail-orientated and documentation-focused.

  • Quality Assurance Specialist
  • Quality Assurance Associate
  • Associate Manager
  • Plant Quality Assurance Senior Associate
  • QA Specialist – Raw Materials
  • QA Compliance Specialist
  • QMS/QA Specialist
  • QA Internal Auditor
  • QA Compliance Manager
  • Quality Systems Coordinator

Quality control is product-oriented and focuses on testing samples from the manufacturing process to make sure they meet the required specifications and standards.

  • Quality Control Microbiology Analyst
  • Quality Control Specialist,
  • Quality Control Analyst FTC
  • Senior Quality Control Analyst
  • QC Analyst, QC Scientist
  • QC Micro Technician
  • QC Microbiology Analyst
  • QC Drug Product Technologist
  • QC Specialist -LIMS
  • QC Biochemist UA

Science roles that support manufacturing – Typical roles support the manufacturing process in a regulated environment and work within multidisciplinary teams to produce medicinal products.

  • Microbiology/Particle Analyst
  • Process Sciences Manager-Upstream
  • Environmental Microbiologist
  • Bioprocessing Scientist
  • Production Scientist
  • Senior Scientist Technical Support
  • Process Scientist / Specialist – Purification
  • Process Scientist / Specialist – In-Process Control

Development is the “D” part of “R&D”. Development is the phase after research where the creation of a proven drug is moved from the lab to the manufacturing plant.

  • Tech Transfer Scientist Jobs
  • Process Technology Transfer Scientist
  • Transfer Scientist
  • Product and Process development scientists

I already have a degree. So why take this course?

Your skills are a great foundation for a Quality Assurance, Quality Control Analyst or lab roles within the pharmaceutical manufacturing industry. But you need more…

You need to understand the industry regulations, the different regulatory standards (US, European, World Health Organisation, etc), work practices, approaches to risk management, data integrity approaches, and industry protocols that are critical in the manufacture of safe medicines.

But for specialist advice based on your degree subject, click on one of the links below:

Minimum Entry Requirements

Ph.D.Masters or a Degree in the following:

  • Laboratory Science
  • Biochemistry
  • Biotechnology
  • Food Science
  • Cell Biology/Molecular Biology
  • Chemistry
  • Immunology
  • Microbiology
  • Any other Biological Science
  • Any other Chemical Science
What is a quality engineer and what do they do?

.

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.
  • Quality Risk Management (QRM) – the huge importance of risk management and the steps involved in its application.
  • GMPs vs Quality Management Systems – GMPs vs ISO 9001:2015 and why use them both.
  • Industry Regulations and Guidelines – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation
  • Good Automated Manufacturing Practices (GAMP) – software categories, scalable validation deliverables, and operation activities.
  • API Manufacturing Technologies – organic chemical synthesis, aseptic & sterile manufacturing, separation technologies, and multi-stage sequence API synthesis.
  • Biopharmaceutical Manufacturing Technologies – upstream processing, fermentation cellular protein synthesis, downstream processing, and column chromatography.
  • Process Validation and Documentation – design and verification of manufacturing systems
  • Cleaning Validation – engineering and chemical aspects of cleaning and cleaning equipment
  • Key Manufacturing Technologies – tablet manufacturing, vial filling, and freeze-drying FDA vs EU medical device regulations and classification.
  • Equipment Validation – IQ OQ PQ and Baseline Guide 5

You’ll produce a number of deliverables throughout the course including…

  • Complete 8-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 7 Quality Risk Management workshops on:
    • Fault Tree Analysis (FTA)
    • Cause and Effect Analysis
    • Failure Mode Effect Analysis (FMEA)
    • Preliminary Hazard Analysis (PHA)
    • Hazard Operability Analysis (HAZOP)
    • Event Tree Analysis (ETA)
    • Hazard Analysis and Critical Control Points (HACCP)
  • Complete an end of module 10 page essay assignment on “Why cGMPs are required for the manufacture of a life sciences product”.
Hear From People Who’ve Taken This Course
Pharmaceutical Degree

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.”

Pharmaceutical Degree

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.”

Pharmaceutical Degree

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!”

Delivered by a Practicing Industry Expert

Dr.Joe Brady Lecturer at GetTeskilled

Dr. Joe Brady

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

Dr. Joe Brady is a full-time practicing Validation Lead and an assistant lecturer with Technological University Dublin (TU Dublin), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer and highly experienced in competency-based training. He designs and prepares educational modules and full academic courses ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.

He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over twenty years of project experience in the pharmaceutical, biopharmaceutical, and medical device industries in Ireland, Singapore, China, The Netherlands, France, and the USA.

What Does the Online Classroom Look Like?

With every GetReskilled ONLINE program;

  1. We use one centralized platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires you to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
  2. Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
  3. We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
  4. You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.

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

How does Studying Online Work?

Your 10-Week Class Schedule

Fundamentals in Pharmaceutical Manufacturing (Weeks 1-10)

This module was developed in consultation with the pharmaceutical manufacturing industry including Pfizer and MSD.

  • 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.
Write a paper on “Why cGMPs are required for the manufacture of a life sciences product”.

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.

This Certificate along with 2 other modules can be combined into a Certificate in eBioPharmaChem which is university accredited by Technological University Dublin, Ireland.

Show Off Your New Skills: Get a Certificate of Completion

Once the course is over, complete a written assignment to get certified in The Fundamentals of Pharmaceutical Manufacturing Technologies

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

Fundamentals of Pharmaceutical Manufacturing Technologies Course Certificate

See Course Price

10 Frequently Asked Questions

Yes, this program is delivered fully online so you can learn from home (or anywhere). Study after the kids have gone to bed.

There are a total of 15 sessions of online content, one per week. Each session of online content typically includes 6-10 topics.

Each topic includes:

  • A set of course notes – these provide additional depth to the video content.
  • Warm-up self-assessment question – to recap or activate any relevant prior learning.
  • A video – these are typically 5-10 minutes long and deliver 80% of the course content.
  • Post video self-assessment questions to check how well you can recall this new material from memory.
  • 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.

Yes, you can speed up or slow down the rate of delivery to suit your requirements. The most important thing is communication between you and your course coordinator.

If you are taking a break or are busy at work and do not have time to study you need to tell her or him. Similarly, if you want to study at a faster rate, then just email in good time and ask for more course content.

No you don’t. The online classroom is open 24 hours a day so you do not have to login at any particular time. We will give you a Username and Password on the day the program starts and this allows you 24 hours a day access.
Yes, a number of our students have their employers pay for this program as a lot of companies would have training budget available to pay for further education. Do let us know and we can raise and invoice for your company.

No, I’m afraid we can’t do that.

Price & Start Dates

Price & Start Dates

Price & Start Dates

Application Deadline: Wednesday 3rd November

Program Starts: 11th November

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Call Geraldine: +1 (617) 901 9268

Ireland
Call Sinead: +353 (0)21 2409016

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