University Certificate in eBioPharmaChem. Advance to Process Technician, QA, Validation, CQV Roles and More

Already working as an operator? Take our University Certificate in eBioPharmaChem (Level 7) – a part-time, online course developed with input from Pfizer and MSD. Advance to more senior roles with J&J, MSD, Pfizer Abbott, AbbVie, Lilly, Boston Scientific, Medtronic, Stryker, and more.

🏆 Winner of Best Online Learning Experience – Irish Education Awards
🎓 University Accredited by TU Dublin, Ireland | Level 7 | 15 ECTS credit

  • Move from entry-level jobs to more senior manufacturing roles.

  • Earn from €45,000 to €70,000 per year by switching roles to:

    • Process Technician
    • Quality Assurance Specialist
    • Validation Technician
    • CQV Technician

  • Work with a small dedicated team that really cares about your success.

  • Application Deadline: Wednesday 11th June

  • Study Part-Time Online
  • Course materials are available 24/7. There are NO ZOOM classes!
  • 14 hrs/week for 36 weeks or choose a faster/slower schedule
  • Join 2290 learners and growing

Support:

You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, answer your questions, check your progress every Monday, and follow up with you to help you finish the course.

Apply Now and Take Your First Step to More Senior Roles →

Get a more interesting job with a higher salary.

Contact Details For This Course

Geraldine Creaner

+353 (0)21 240 9016

+1 (617) 901 9268

+44 078 0237 0554

Course Price →

University Certificate in eBioPharmaChem. Advance to Process Technician, QA, Validation, CQV Roles and More

Already working as an operator? Take our University Certificate in eBioPharmaChem (Level 7) – a part-time, online course developed with input from Pfizer and MSD. Advance to more senior roles with J&J, MSD, Abbott, AbbVie, Lilly, Boston Scientific, Medtronic, Stryker, and more.

🏆 Winner of Best Online Learning Experience – Irish Education Awards
🎓 University Accredited by TU Dublin, Ireland | Level 7 | 15 ECTS credits

  • Move from entry-level jobs to more senior manufacturing roles.

  • Earn from €45,000 to €70,000 per year by switching roles to:

    • Process Technician
    • Quality Assurance Specialist
    • Validation Technician
    • CQV Technician

  • Work with a small dedicated team that really cares about your success.

  • Application Deadline: Wednesday 11th June

  • Study Part-Time Online
  • Course materials are available 24/7. There are NO ZOOM classes!
  • 14 hrs/week for 36 weeks or choose a faster/slower schedule
  • Join 2290 learners and growing

Support:

You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, answer your questions, check your progress every Monday, and follow up with you to help you finish the course.

Course Price

Apply Now and Take Your First Step to More Senior Roles →

Get a more interesting job with a higher salary.

Contact Details For This Course

Geraldine Creaner

+353 (0)21 240 9016

+1 (617) 901 9268

+44 078 0237 0554

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

Pfizer Logo

Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

Novartis Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

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

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

MSD Logo

Amgen Logo

Sanofi Logo

GSK Logo

This Program is Right For You If;

  • You work as an operator/technician and want to upskill for more senior manufacturing roles and get a higher salary.

  • You want to get a university certificate and give yourself a competitive edge in the job market.

  • You are a working parent with (young) kids or have other family and caring commitments.

  • You are fed up with working shifts as an operator with little chance of a pay rise or a promotion.

TU Dublin’s Minimum Entry Requirements

This program is university accreditated by TU Dublin, Ireland so you need one of the following to meet its entry requirements:

  • You have a minimum of 1-year’s work experience in a Good Manufacturing Practice (GMP) manufacturing environment e.g:
    • Pharmaceutical manufacturing
    • Medical device manufacturing
    • Nutritional, beverage, food or dairy manufacturing
  • Or
  • You have a relevant engineering or laboratory science degree.
    Or
  • You have successfully completed our Conversion Course into Pharmaceutical Manufacturing.

If you don’t meet TU Dublin’s entry requirements, first take our Conversion Course into Pharmaceutical Manufacturing Programme.

Certificate in eBioPharmaChem (DT 698)

Why choose the Certificate in eBioPharmaChem?

Study at a time and place that suits you

All materials are delivered asynchronously online, meaning that you never have to be available at a certain time or place to study. There are no zoom classes and no long commutes to a classroom.

Study at your own pace

Your individual materials will be released by your dedicated Course Coordinator who’ll keep a weekly check on your progress. So you’ll never feel like you’re rushing to keep up with others and you’ll never be in a position where you feel overwhelmed by what’s waiting for you when you log in. 

You will always be working at a pace that is comfortable for you.

Get started now

There’s no need to wait until the next academic year, we have multiple course start dates throughout the year to fit in with the schedules of the professionals we’re working with.

Why choose GetReskilled?

Have your own “Personal Trainer”

You’ll be assigned a dedicated Course Coordinator who’ll work with you from day one until you successfully complete the programme. They’ll check your progress every Monday, help keep you on track, and serve as your single point of contact for any questions. And they’ll be your biggest supporter – our course coordinators pride themselves on knowing their students by name and do anything they can to help them succeed.

Award Winning Programmes

We’ve won pharma industry awards… we’ve won education sector awards… we even placed 2nd in a Europe-wide vocational training award. Our team has published research and presented at international conferences.

What new roles could I retrain for?

STEP 1: Take this Level 7 “University Certificate in eBioPharmaChem.

If you just started in an entry-level role (process operator, cleanroom operator) you could retrain for:

  • Process Technician
  • Chemical Process Technician
  • BioProcess Technician
  • BioProcess Associate
  • Manufacturing Biotech Associate

And with more experience

If you have a few years work experience and want to move away from manufacturing roles:

  • Quality Assurance Specialist – Some companies call this role:
    • Quality Assurance Associate
    • Quality Assurance (QA) Technician
    • QMS/QA Specialist
    • Quality Systems Coordinator
  • Documentation Specialist – Some companies call this role:
    • Document Controller
    • Documentation Coordinator
  • Validation Technician – Some pharma companies call this role:
    • Associate QA Validation Specialist
    • Equipment Validation Specialist
    • QA Validation Associate
    • QA Validation Specialist
  • CQV Specialist – Some pharma companies call this role:
    • CQV Engineer
    • C&Q Specialist
    • C&Q Junior Project Manager
Pharma Manufacturing Essentials Course

Study all the way to a degree

Once you have completed the University Certificate in eBioPharmaChem Manufacturing, take the next steps to build your qualification all the way to a degree.

STEP 2: Then you can take our Level 7 Certificate in Validation program to move into more senior validation roles with a higher salary. Typical roles

  • Senior Validation Technician
  • CQV Technician

And with more work experience

  • Validation Engineer
  • Process Validation Engineer
  • Cleaning Validation Engineer

STEP 3: If you have completed our University Certificate in eBioPharmaChem Manufacturing and University Certificate in Validation which are standalone programs, you are already halfway to a Level 7 Degree. Take 6 more modules to get a BSc degree in Degree in Manufacture of Medicinal Products (DT 291)

Graphic of a jigsaw puzzle showing how GetReskilled courses work together to build a degree

Your 37-week class schedule

The core content of these modules was developed in consultation with the pharma industry including Pfizer and MSD.

Module 1 – Fundamentals of Pharmaceutical Manufacturing Technologies 

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.

Week 1 – Manufacturing Safe Medicines

  • 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.

Deliverables

  • Complete a workshop on Fault Tree Analysis (FTA).
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 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.

Deliverables

  • Complete a workshop on Cause and Effect (Fishbone Diagram).
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 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).

Deliverables

  • Complete a workshop on 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.

  • 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?

Deliverables

  • Complete a workshop on Preliminary Hazard Analysis (PHA).
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 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.

Deliverables

  • Complete a workshop on Hazard Operability Analysis (HAZOP).
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 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.

Deliverables

  • Complete a workshop on Event Tree Analysis (ETA).
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 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.

Deliverables

  • Complete a workshop on Hazard Analysis and Critical Control Points (HACCP).
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 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”. (in conjunction with writing skills training)

Module 2 – Advanced Writing Skills 

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.

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

Module 3 – Commissioning & Qualification of Equipment and Systems (VOMP 3002)

This program explains the engineering documentation used to specify and design equipment or systems in a manufacturing facility – and how to develop an IQ OQ PQ validation test protocols to ensure that it operates as intended and meets the regulatory requirements.

  • 1.1 Design Documents Required for Generation of Installation and Functional Tests
    In this lesson, you will get an overall concept of the course. We will learn about the design of equipment, instrumentation, piping and control elements of a typical process system. We will also learn about the development of a testing verification protocol that we could present to the regulatory authorities demonstrating the system is fit for its intended use.
  • 1.2 User Specification for a Reactor
    In this lesson, we will see the basic equipment configuration for a typical reactor system used for industrial chemical processing.
  • 1.3 Equipment Configuration and Process Sequence for a Reactor
    In this lesson, we will go through a typical process sequence when using a reactor for chemical processing.
  • 1.4 Generation of Piping and Instrumentation Diagrams (P&ID)
    In this lesson, we are going to look at a P&ID as a controlled document that is the basis of any process design. This is the first look we take at our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’. During the remainder of this course, we will extensively explore all design elements and generate an appropriate testing verification protocol.
  • 1.5 URS for Hot Detergent and Hot PUW Generation and Distribution Skid System
    We’ve already taken a first look take at our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’. Now we are going to examine the main equipment components and describe the major interconnectivity between them.
  • 1.6 Equipment List
    In this lesson, we are going to align the project equipment list against the P&ID.
  • 1.7 Instrument List
    In this lesson, we are going to align the project instrument list against the P&ID.
  • 1.8 Inline Components List
    In this lesson, we are going to align the project inline component list against the P&ID.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 2.1 Protocol Content – Part-1: Objective, System Description and Scope
    In this lesson, we’ll start the process of developing a testing verification (qualification) protocol beginning with objective, system description and scope.
  • 2.2 System Impact Assessment
    The objective of this lesson is to determine whether or not our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’ is a direct impact system in the context of product quality and patient safety.
  • 2.3 cGMP Testing Principles
    This lesson considers high-level requirements when preparing a standard testing document.
  • 2.4 Valves
    In this lesson, we take a look at valves as part of inline pipe fittings.
  • 2.5 Piping (Line) List
    In this lesson, we are going to align the project piping (line) list against the P&ID.
  • 2.6 Testing Traceability Matrix for Equipment System – First Pass
    In this lesson, we take our first look at the traceability matrix. This is a mechanism for tracing requirements through to the testing documents. Here we are using the matrix as a method to help plan necessary installation and functional/operational tests. We will also reference the project validation plan.

Deliverables

  • Complete a Component Level Impact Assessment workshop.
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 3.1 Protocol Content – Part-2: Responsibilities and Installation Testing
    Resuming with the process of developing our testing verification (qualification) protocol we continue with responsibilities and introduce installation-testing.
  • 3.2 Minimum Elements of a Test Script
    Having already considered high-level requirements when preparing a standard testing document, this document proposes a formatting structure for a test script.
  • 3.3 Good Documentation and Records Management
    The objective of this lesson is to give guidance on how to complete any written record, e.g. test script, batch sheet, training record, etc., to ensure the present and future integrity of that record.
  • 3.4 Component Level Impact Assessment: Part-1 – Product Contact Components
    In order to begin determining the content of our testing verification (qualification) protocol, we need to establish which components have an impact on product quality and product safety. Here
    we begin by first taking a look at product-contact critical components.
  • 3.5 Installation Test: P&ID Walk-Down
    The objective of this lesson is to describe a visual-installation test for equipment, instrumentation, piping and inline components in the form of a ‘P&ID Walkdown’.
  • 3.6 Installation Test: Equipment Verification
    The objective of this lesson is to describe an installation test for equipment in terms of both visual and documentation checks.
  • 3.7 Pumps
    In this lesson, we look at certain pumps used in the process industry and describe their operation.

Deliverables

  • Complete an Equipment Installation Verification workshop.
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 4.1 Piping Components
    This lesson is an introduction to the various components that make up a complete section of the pipeline.
  • 4.2 Relating P&IDs and Piping Isometrics
    This lesson describes piping isometric as a detailed design specification providing information for fabrication and installation of pipes.
  • 4.3 Relating Piping Isometrics and 3D CAD Images
    In this lesson, we overlay the P&ID content and the isometric details onto the CAD (computer-aided design) design.
  • 4.4 Material Traceability
    The objective of this lesson is to demonstrate how a mechanical contractor would keep a material record of all piping components during the fabrication and installation of a pipeline section.
  • 4.5 Piping Tests
    The objective of this lesson is to describe a range of non-destructive testing (NDT) routinely conducted on newly installed piping.
  • 4.6 Heat Exchangers
    This lesson is an introduction to heat exchangers where we use a thermal utility service to heat or cool a process fluid.
  • 4.7 Instrumentation Symbols and Identification
    In this lesson, we are going to look at how most industries tag an instrument using alphabetical identifiers.
  • 4.8 Installation Test: Piping Verification
    The objective of this lesson is to describe an installation test for piping in terms of both visual and documentation checks.

Deliverables

  • Complete a Piping Installation Verification workshop.
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 5.1 Process Control
    This lesson is an introduction to conventional process control using one-way digital and analog signals.
  • 5.2 P&ID Instrumentation Identification
    In this lesson, we are again going to identify the instrumentation type on the P&ID but this time using the alphabetical identifiers.
  • 5.3 Input-Output (I/O) List
    In this lesson, we are going to align the project Input-Output (I/O) list against the P&ID and identify signal types.
  • 5.4 Process Control Hardware Panels
    In this lesson, we take a look inside a traditional process control cabinet and identify the various components within. We also look at digital and analog wiring diagrams.
  • 5.5 Loop Signal Verification
    In this lesson, we learn how to ‘tune’ control loops, typically, during the commissioning phase of the project.
  • 5.6 Installation Test: Instrument Verification
    The objective of this lesson is to describe an installation test for instrumentation in terms of both visual and documentation checks.
  • 5.7 Proportional–Integral–Derivative Controller (PID controller)
    This lesson describes how a PID controller is used to adjust a dynamic process via a control element to maintain the desired process value.

Deliverables

  • Complete an Instrument Installation Verification workshop.
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 6.1 Protocol Content – Part-3: Operational/Functional Testing
    This is our third lesson on the development of our testing verification (qualification) protocol where we consider operational/functional testing.
  • 6.2 Component Level Impact Assessment: Part-2 – Operationally Critical Components
    Determining the content of our testing verification (qualification) protocol we also need to establish which functions have an impact on product quality and product safety. In this lesson, we establish those operationally critical components.
  • 6.3 Operational Testing: Primary Functions
    The objective of this lesson is to determine the primary/critical functions of the ‘hot detergent’ and ‘hot PUW2 process water’ generation and distribution systems.
  • 6.4 Testing Traceability Matrix for Equipment System –Second Pass
    In this lesson, we take our second look at the traceability matrix – a mechanism for tracing requirements through to the testing documents. At this stage we can add the details of our already established installation tests; and we now also use the matrix as a method to further plan and refine the necessary functional/operational tests.
  • 6.5 Functional Design/Requirement Specification
    In this lesson, we look at the functional design/requirement specification that will describe the necessary automated functions needed to meet the desired user’s performance requirements.

Deliverables

  • Complete a Functional Verification Test workshop.
  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 7.1 Protocol Content – Part-4: Protocol General Attachments, and Deviation and Change Control Procedures
    This is our fourth and final lesson on the development of our testing verification (qualification) protocol where we introduce protocol general attachments, and deviation and change control procedures.
  • 7.2 General Contents of a Validation (Master) Plan
    This lesson describes typical high-level corporate / site validation policy documents. It also describes the typical content and structure of a validation master plan (VMP), subordinate level validation plans, and validation reports to conclude the planning activities.
  • 7.3 Protocol General Attachments
    This lesson describes the process for compiling and completing the protocol’s general attachments, and advises on how to making entries by hand into the protocol script?
  • 7.4 Protocol Deviation Procedure
    This lesson describes how and where to use a verification protocol’s deviation procedure and associated deviation log.
  • 7.5 Project Specific Change Control Procedure
    This lesson describes how and where to use a verification protocol’s change control procedure and associated change control log.
  • 7.6 Protocol Template
    Ultimately, having studied in-depth both our process system and the content of protocols, we are now in a position to formulate a template for our very own verification/qualification protocol – that will incorporate both installation and functional/operational tests – to prove that our ‘Hot Detergent and Hot PUW Generation and Distribution Skid System’ is fit for its intended use.
  • 7.7 Testing Traceability Matrix for Equipment System –Third Pass
    In this lesson, we take our third and final look at the traceability matrix – a mechanism for tracing requirements through to the testing documents. Having now formalized our protocol template we can now add the specific document-section details to the matrix for both our established installation and functional/operational tests.

  • 8.1 Conclude List of Installation Tests
    The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required installation test procedures and GMP checksheets.
  • 8.2 Conclude List of Functional Tests
    The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required functional test procedures and GMP checksheets.
  • 8.3 Final Protocol Template Review
    The objective of this lesson is simply to review the verification protocol template to ensure that we’ve made provisions for all the required installation and functional tests and included all the necessary protocol attachments.

  • Write an IQ OQ PQ protocol for a Clean-in-Place system.

You will become familiar with a range of documents used in projects including piping and instrumentation diagrams (P&ID), equipment specifications, instrument specifications, line lists, piping isometrics, 3D layouts, electrical and hardware control – panel diagrams, and wiring and loop diagrams. These design documents are used to generate IQ OQ PQ commissioning and qualification protocols.

You will also become familiar with:

  • User Requirement Specifications (URS)
  • cGMP impact-assessments
  • cGMP design reviews
  • Design Qualification (DQ) reports
  • Specification and testing traceability matrices
  • Typical testing IQ OQ PQ protocol templates

Module 4 – Chemistry for API’s (VOMP 3003)

This module will provide a foundation in the general chemistry necessary to understand the fundamental concepts involved in the chemistry of API (Active Pharmaceutical Ingredients) required for the manufacture of medicinal products.

Please note: This module is run as a group module (3 times a year) and you will be required to keep pace with the class during the running of this module. This is the only module that you won’t be able to control the pace of your study on.

Theory
Week 25 – Chemistry and Matter; Atomic Theory
Week 26 – The Periodic Table and Bonding
Week 27 – Stoichiometry
Week 28 – Acids and Bases Recrystallisation
Week 29 – Introduction to Organic Chemistry

Laboratory – Due to Covid 19, all laboratory sessions have been modified to be delivered 100% online.

Week 30 – Overview of Safety in Chemical Laboratories
Week 31 – Virtual Practical 1 – Separation of a 3 component mixture
Week 32 – Virtual Practical 2 – Synthesis of Aspirin
Week 33 – Virtual Practical 3 – Preparation for Volumetric Analysis
Week 34 – Virtual Practical 4 – Analysis of Baking Soda

Week 35 – Revision Week
Week 36 – Online Exam

Price & Start Dates

$ 7,499

Or $799/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University (TU) Dublin, Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees

Please Note: This price is only available to tax residents of Ireland.

€ 2,580

Or €299/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University Dublin (TU Dublin), Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees

Save 60% off the Price
Reduced from € 6,499 to € 2,580 if you move and live in Ireland.
Over 6,000 new pharma jobs available over the next 3 Years

€ 6,499

Or €699/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University Dublin (TU Dublin), Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees

Save 60% off the Price
Reduced from £ 5,999 to € 2,580 if you move and live in Ireland.
Over 6,000 new pharma jobs available over the next 3 Years

£ 5,999

Or £649/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University Dublin (TU Dublin), Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees

Price & Start Dates

€ 6,499

Or €699/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University (TU) Dublin, Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees

Please Note: This price is only available to tax residents of Ireland.

€ 2,580

Or €299/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by the Technological University (TU) Dublin, Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees
$ 7,499

Or $799/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University (TU) Dublin, Ireland, Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees
£ 5,999

Or £649/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University (TU) Dublin, Ireland, Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees

Price & Start Dates

Please Note: This price is only available to tax residents of Ireland.

€ 2,580

Or €299/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University Dublin (TU Dublin), Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees

Price & Start Dates

£ 5,999

Or £649/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University Dublin (TU Dublin), Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees

Please Note: This price is only available to tax residents of Ireland.

€ 2,580

Or €299/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University Dublin (TU Dublin), Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees
€ 6,499

Or €699/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University Dublin (TU Dublin), Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees
$ 7,499

Or $799/month for 10 months.

Price Includes:

  • End of week progress checks by us to MAKE SURE you finish the program
  • University accreditation by Technological University Dublin, Ireland
  • Delivered online so you can learn from home (or anywhere) on your own schedule
  • Robust job hunting program that will help you find a job
  • Regular & ongoing access to a dedicated career coaching counsellor

No Hidden Fees

  • No application fees
  • No registration fees
  • No resource/book fees
  • No graduation fees
  • No certificate fees

Application Deadline: Wednesday 11th June

Program Starts: 18th June

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Apply Now and Take Your First Step to More Senior Roles →

The application process is a 5 step process:

  1. Complete the application form – click on the big red “Apply NOW” button.
  2. Speak to a course advisor – they will let you know if you’re a good fit for the program and answer any questions you have.
  3. Complete the registration form – you’ll be sent this by email after you’ve spoken to a course advisor
  4. Make payment – successful applicants will then make payment. It is only at this stage that a place on the course is secured. Payments can be made in full or set up as monthly instalments to fit your budget.
  5. Begin your course!

We’ll be right there with you every step of the way. If you have any questions, please get in touch!

Hear from people who taken this program

Validation

Regina McNamara

Previous Background:
Professional Painter

“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

“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

“Structurally well planned with the opportunity for practical application”

I found the course to be interesting, and 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.

Agnes Hove

Domagoj Wunderlich

Patricia Radulescu

Kieran Mac Namara

Read over 81 reviews and graduate success stories like these.

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.

our team

Professor Anne Greene

Senior Lecturer, Technological University Dublin

Professor Anne Greene is a Senior Lecturer in Pharmaceutical Technology, Validation and Pharmaceutical Quality Assurance to undergraduate and postgraduate students and a Pharmaceutical Projects Manager at Technological University Dublin, Ireland.

In addition, Anne is the Director of the Pharmaceutical Regulatory Science Team and is also secretary of the Parenteral Drug Association (PDA) Secretary, Irish Chapter. Her experience ranges from a technical service chemist, Sterling Wintrop Dungarvan, (now GSK), validation manager at startup Wyeth Newbridge, (now Pfizer) and is a Training Director at NIBIRT in Ireland.

How We Deliver Our Online Courses without ZOOM Classes

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 quizzes, tests, interactive activities, and projects. Course materials are available 24/7, and there are no scheduled Zoom classes, so you can study whenever it suits you—for example, after the kids have gone to bed, on the weekend, or whenever you have free time.
  2. Your working schedules are unpredictable, so we offer flexible delivery. Slow down, speed up, or pause the delivery of the program as needed.
  3. We release only one week’s worth of material at a time and manually check your activity logs at the beginning of every week to make sure you’re on track.
  4. You’ll also get a dedicated course leader who will:
    • Help you create a weekly study plan
    • Answer any questions
    • Check your progress every Monday
    • Follow up regularly to support you through to completion

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

Meet your online classroom support team

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

Career Coaching

Safe Medicine Course Director

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.

Classroom Support Team

Safe Medicine Course Coordinators

Your Course Leaders, Coordinators, and members of the Classroom Support Team 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!

13 frequently asked questions

Is this program delivered online?

The program 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.

Most students report between 10-16 hours per week.

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, a number of our students have their employers pay for this program.

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

Yes, you can.

Yes, you can take it from anywhere you have a decent Internet connection.

Yes for 6 months.

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

Yes, this program is a stepping-stone to our follow-on specialisation, Certificate in eValidation.

TU Dublin’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.

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 leader or 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.

The Certificate in eBioPharmaChem program is priced at € 6,499 in advance for non-Irish residents.

So let’s get started…

Apply Now and Take Your First Step to More Senior Roles →

Contact Details For This Course

Geraldine Creaner

+353 (0)21 240 9016

+1 (617) 901 9268

+44 078 0237 0554

Got more questions?

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