GMP Manufacturing Experience? Retrain Online for More Senior Roles and Higher Pay in Pharma Manufacturing in 9 Months

Our award-winning level 7 “Certificate in eBioPharmaChem-DT698” program and dedicated career coaches have helped over 2,300 people get better jobs. Developed in consultation with the pharma industry including Pfizer and MSD. University Accredited by TU Dublin Ireland.
  • Move from entry-level jobs to more senior manufacturing roles

  • Turn your knowledge into a university accredited certificate

  • Estimated salaries €32,000€70,000 (Based on Irish job data)

  • Application Deadline: Wednesday 3rd November
  • Move from entry-level jobs to more senior manufacturing roles

  • Turn your knowledge into a university accredited certificate

  • Estimated salaries $35,000 – $75,000 (Based on US job data)

  • Application Deadline: Wednesday 3rd November
  • Study Online 14 hrs/week
  • 3 Modules over 37 Weeks
  • End of week progress checks and follow up to help you finish the course
  • Join 2290 Learners
Pharmaceutical Courses
UNIVERSITY ACCREDITED
Apply NOW & Take Your First Step to More Senior Roles

This program was the WINNER of Best Online Learning Experience at the Irish Education Awards 2018

GMP Manufacturing Experience? Retrain Online for More Senior Roles and Higher Pay in Pharma Manufacturing in 9 Months

Our award-winning level 7 “Certificate in eBioPharmaChem” program and dedicated career coaches have helped over 2,300 people get better jobs. Developed in consultation with the pharma industry including Pfizer and MSD. University Accredited by TU Dublin Ireland.
UNIVERSITY ACCREDITED
  • Move from entry-level jobs to more senior manufacturing roles

  • Turn your knowledge into a university accredited certificate

  • Estimated salaries €32,000€70,000 (Based on Irish job data)

  • Application Deadline: Wednesday 3rd November
  • Move from entry-level jobs to more senior manufacturing roles

  • Turn your knowledge into a university accredited certificate

  • Estimated salaries $32,000 – $75,000 (Based on US job data)

  • Application Deadline: Wednesday 3rd November
  • Study Online 14 hrs/week
  • 3 Modules over 37 Weeks
  • End of week progress checks and follow up to help you finish the course
  • Join 2290 Learners

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

GSK Logo

Lilly Logo

Abbott Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

JNJ Logo

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

Apply NOW & Take Your First Step to More Senior Roles

This programme was the WINNER of Best Online Learning Experience at the Irish Education Awards 2018

This Course is Right For You If;

  • You want to move into more senior manufacturing roles, do more interesting work and get a higher salary.

  • You work in pharma but have no university qualifications.
  • You want to move from medical device, nutritional, beverage, food or dairy manufacturing to pharmaceutical manufacturing.

  • You’re fed up working shifts with little chance of a pay rise or a promotion.

And…

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

  • This programme was the WINNER of Best Online Learning Experience at the Irish Education Awards 2018.

Minimum Entry Requirements

ANY one off the following;

  • You have worked in a GMP regulated manufacturing environment e.g. pharma, med device, nutritional, beverage, food or dairy manufacturing
    Or
  • You have a sound understanding of GMP rules, regulations and guidelines
    Or
  • You have successfully completed our Conversion Course into Pharma
Pharma Manufacturing Essentials Course

What Roles Could I Retrain For?

STEP 1: Take this Level 7 “Certificate in eBioPharmaChem” program to move into more senior roles with a higher salary. Typical roles

And with experience

Male biotechnologist testing new chemical substances

Study all the Way to a Degree

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

  • Senior Validation Technician
  • CQV Specialist

And with more work experience

  • Validation Engineer
  • Process Validation Engineer
  • Clean Validation Engineer

STEP 3: If you have completed our Certificate in eBioPharmaChem and 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

What you’ll learn – There are three modules in this 37-week program

Module 1 – Fundamentals of Pharmaceutical Manufacturing Technologies (Weeks 1 -13) 

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 – Commissioning & Qualification of Equipment and Systems (Weeks 14 – 25)

This module will explain the engineering documentation such as P&IDs, piping isometrics, e.t.c used to specify and design equipment or systems in a manufacturing facility and walk you through on how to develop a 100-page validation test (IQ, OQ, PQ) protocol.

Module 3 – Chemistry for API’s (Week 26 – 37))

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

Pharma Factories in IrelandPharma Factories in UKCommon Questions About the BioPharma/MedTech IndustryCommon Questions About the BioPharma/MedTech Industry

Are there Pharma Factories and Jobs Near Me?

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

Check out 190 Pharma Factories overlaid on a Google Map to see what factories are near you.

Check out this table of 190 pharmaceutical and medical device factories sorted by county for all Ireland and see what factories are located near your home.

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

Are there Pharma Factories and Jobs Near Me?

Check out the Top 10 Pharmaceutical & Medical Device Industry Hubs in the USA

Common Questions About the BioPharma/MedTech Industry

Why Choose a Pharmaceutical Career?
Job Descriptions and Salaries

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 ‘em, or try GetReskilled and see the difference yourself.

Price & Start Dates

Price & Start Dates

Price & Start Dates

€ 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

Application Deadline: Wednesday 3rd November

Program Starts: 11th November

0
0
0
0
Days
0
0
Hours
0
0
Minutes
0
0
Seconds

Take the First Step

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

Apply NOW & Take Your First Step to More Senior Roles

This program was the WINNER of Best Online Learning Experience at the Irish Education Awards 2018

This program was the WINNER of Best Online Learning Experience at the Irish Education Awards 2018

GetReskilled Success Stories
Validation

Trish Kineen

Previous Background:
Homemaker

Johnson&Johnson-getreskilled-testimonial-logo

“You can study in your own time & at home (so you don’t have travel & child minding costs”

“It has been a great course to re-familiarize myself with the area after such a long time away and it’s brilliant that you can study in your own time & at home (so you don’t have travel & child minding costs)”

Validation

Declan O’Shea

Previous Background:
Construction

Logo

“I landed my Dream Role as a C&Q Specialist”

“I took GetReskilled’s 8 month eBioPharmaChem Course and started in an entry-level role at Pfizer. I kept studying and I eventually leveraged my experience and academic qualifications and landed my dream job as a C&Q Specialist.

Validation

Jeffery Kophamel

Previous Background:
Engineering

Johnson&Johnson-getreskilled-testimonial-logo

“All of a Sudden People were Interested in Me”

When Jeffery Kophamel started his reskilling journey into pharmaceutical and medical device manufacturing, he already had a Masters in Mechanical Engineering and had over twenty-five years of engineering experience but couldn’t find a job. He began applying for jobs while his course was ongoing and remembers that, “all of a sudden people were interested in me”

We’ve got lots more success stories like these. Read ‘em, or try GetReskilled and see the difference yourself.

This Certificate is Accredited by a World Top 4% University

TUD Logo
  • Technological University Dublin (TU Dublin) is one of the largest University in Ireland

  • Ranked in top 100 by the Times Higher Education for universities under 50 in 2014 and 2015
  • Named Best Institute of Technology by the Sunday Times in 2010
  • 28,500 registered students

  • Over 2,000 members of staff
  • Member of the European University Association

And 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.

about getreskilled

Professor Anne Greene

Lecturer, Technological University Dublin

Professor Anne Greene is the pharmaceutical technology and pharmaceutical projects manager in Ireland and is a Lecturer in Pharmaceutical Technology, Validation and Pharmaceutical Quality Assurance to undergraduate and postgraduate students at Technological University Dublin in Ireland.

In addition, she 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.

Your 37-Week Class Schedule

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

Download Brochure

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.

  • 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”. (in conjunction with writing skills training)

Module 2 – 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 3 – 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 26 – Chemistry and Matter; Atomic Theory
Week 27 – The Periodic Table and Bonding
Week 28 – Stoichiometry
Week 29 – Acids and Bases Recrystallisation
Week 30 – Introduction to Organic Chemistry

Laboratory

Week 31 – Overview of Safety in Chemical Laboratories
Week 32 – Virtual Practical 1 – Separation of a 3 component mixture
Week 33 – Virtual Practical 2 – Synthesis of Aspirin
Week 34 – Virtual Practical 3 – Preparation for Volumetric Analysis
Week 35 – Virtual Practical 4 – Analysis of Baking Soda

Week 36 – Revision Week
Week 37 – Online Exam

Academically Accredited by Technological University Dublin (TU Dublin)

This Certificate in BioPharmaChem is academically accredited by Technological University Dublin (TU Dublin), Ireland subject to the submission of all assessments and end of module assignments.

  • Level 7
  • Program Credits (ECTS): 15
  • Awarding Body: TU Dublin

Available Worldwide

This Certificate in BioPharmaChem is available worldwide.

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

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 regular NO ZOOM classes. 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?

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