Pharmaceutical Validation Training Course (ONLINE)  – For More Senior Validation, CQV and C&Q Roles

Want a more senior validation engineer, CQV or C&Q job with a higher salary? Take our NFQ level 7 University Certificate in eValidation Training Course. Develop process validation protocols, Plan a validation strategy. Develop a validation master plan for the entire lifecycle of a product. Give yourself a competitive edge in the marketplace. Developed in consultation with the pharma industry including Pfizer and MSD. University Accredited by TU Dublin Ireland.
  • Turn your validation work experience into a university accredited certificate

  • Get a more interesting job with a higher salary. Charge higher hourly rates.

  • Estimated salaries $55,000 – $109,000 plus overtime, bonuses and allowances. (Based on the United States Bureau of Labor Statistics (BLS) data)
  • Application Deadline: Wednesday 17th April
  • Turn your validation work experience into a university accredited certificate

  • Get a more interesting job with a higher salary. Charge higher hourly rates.
  • Estimated salaries €45,000€100,000 plus overtime, bonuses and allowances. (Based on Irish job data)

  • Irish NFQ: Level 7

  • Application Deadline: Wednesday 17th April
  • Study Online anywhere, anytime
  • Course materials are available 24/7. There are NO ZOOM classes!
  • 3 Modules over 30 Weeks
  • Join 1330 Learners

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

University Accredited by TU Dublin Ireland

Contact Details For This Course

Geraldine Creaner

This Certificate is Accredited by a World Top 4% University

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

  • Named Best Institute of Technology by the Sunday Times in 2010

  • Ranked in the top 100 by the Times Higher Education for universities under 50 in 2014 and 2015

  • 30,000 registered students

  • Over 2,000 members of staff

Pharmaceutical Validation Training Course (ONLINE)  – For More Senior Validation, CQV and C&Q Roles

Want a more senior validation engineer, CQV or C&Q job with a higher salary? Take our NFQ level 7 University Certificate in eValidation Training Course. Develop process validation protocols, Plan a validation strategy. Develop a validation master plan for the entire lifecycle of a product. Give yourself a competitive edge in the marketplace. Developed in consultation with the pharma industry including Pfizer and MSD. University Accredited by TU Dublin Ireland.
Certificate in Validation
  • Turn your validation work experience into a university accredited certificate

  • Get a more interesting job with a higher salary. Charge higher hourly rates
  • Estimated salaries $55,000 – $109,000 plus overtime, bonuses and allowances. (Based on the United States Bureau of Labor Statistics (BLS) data)

  • Application Deadline: Wednesday 17th April
  • Turn your validation work experience into a university accredited certificate

  • Get a more interesting job with a higher salary. Charge higher hourly rates
  • Estimated salaries €41,000€100,000 plus overtime, bonuses and allowances. (Based on Irish job data)

  • Irish NFQ: Level 7

  • Application Deadline: Wednesday 17th April
  • Study Online anywhere, anytime
  • Course materials are available 24/7. There are NO ZOOM classes!
  • 3 Modules over 30 Weeks
  • Join 1330 Learners

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

This Certificate is Accredited by a World Top 4% University

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

  • Named Best Institute of Technology by the Sunday Times in 2010

  • Ranked in the top 100 by the Times Higher Education for universities under 50 in 2014 and 2015

  • 30,000 registered students

  • Over 3,000 members of staff

See Course Price →

University Accredited by TU Dublin Ireland

Contact Details For This Course

Geraldine Creaner

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 graduates 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

This course is right for you if:

  • You want to turn your validation work experience into a University Certification and charge higher hourly rates.

  • You want more Senior Validation Engineer, Technician, CQV or C&Q roles and higher pay.

  • Your work in Quality Assurance/Quality Control but have to sign off on validation documents you don’t fully understand!
  • You don’t want to waste your time or money on hotel or travel junkets.

  • Delivered part-time online so you can learn from home (or anywhere). Study after the kids have gone to bed.

Minimum Entry Requirements:

You must be able to answer “YES” to ALL of the following 4 questions for this “Certificate in eValidation”

  1. Do you have a sound understanding of GMP rules, regulations and guidelines?
  2. Can you read engineering documentation such as P&IDs and piping isometrics?
  3. Do you understand IQ, OQ and PQ?
  4. Can you populate an IQ OQ PQ Equipment Qualification protocol used in the BioPharma/Medtech Industry?

NOTE:

If you answer “NO” to any of the 4 questions above, you will first need to take our Equipment Validation Training Course (ONLINE) – For Starter Validation Roles and learn commissioning & qualification of equipment and systems and how to populate an IQ OQ PQ Equipment Qualification Protocol. This program covers all the entry requirements above.

What you’ll learn – There are three 10-week modules in this 30-week program

Module 1 – Pharmaceutical Facility Design (Weeks 1-10)

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

Module 2 – Planning a Validation Strategy (Weeks 11-20)

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

Module 3 – From URS to PQ – a Validation Project (Weeks 21-30)

This is a workshop driven module where you will develop a P&ID and then back-engineer it into a URS (User Requirement Specification) which will be used to identify the key process measurements that will form the basis of the Performance Qualification (PQ) test script

What Kind of Roles Would I be Suitable For?

The more validation work experience you have, the better positioned you’ll be to successfully apply for more senior roles upon completion of the program. Here are some of the most common job titles we see advertised and the expected salaries.

Validation Technician

Works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result.

Some companies might call this role:

  • CQV Specialist
  • C&Q Specialist
  • Associate QA Validation Specialist
  • C&Q Junior Project Manager
  • Equipment & Process Validation Specialist
  • QA Validation Associate
  • QA Validation Specialist
  • Validation & Technical Standards Specialist
  • Validation Analyst – Qualification section
  • Validation Specialist
validation engineer training
  • Starting Salary: €40,000 to €45,000
  • After 2 Years: €45,000 to €60,000
  • After 5 Years: €60,000 to €75,000

Validation Engineer

Rigorously test and pre-test the systems used to manufacture products and create and document an evidence trail to show that the systems and equipment used, produce a defect-free consistent result. This is a more senior role.

Some companies might call this role:

  • CQV Engineer
  • Manager / Associate Manager – QA Validation
  • Mgr/ Snr Mgr QA Validation Oversight
  • QA Validation Engineer
  • Quality & Validation Engineer
  • Senior Validation Engineer
  • Senior Validation Specialist
  • Staff Engineer, Quality/Validation
  • Validation Scientist
validation engineer certification
  • Starting Salary: €39,000 to €50,000
  • After 2 Years: €45,000 to €60,000
  • After 5 Years: €60,000 to €100,000

Validation Technician

Works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result.

Some companies might call this role:

  • CQV Specialist
  • C&Q Specialist
  • Associate QA Validation Specialist
  • C&Q Junior Project Manager
  • Equipment & Process Validation Specialist
  • QA Validation Associate
  • QA Validation Specialist
  • Validation & Technical Standards Specialist
  • Validation Analyst – Qualification section
  • Validation Specialist
e-Validation (DT 758A)
  • Starting Salary: $40,800
  • After 2 Years: $51,000
  • After 5 Years: $65,200

Validation Engineer

Rigorously test and pre-test the systems used to manufacture products and create and document an evidence trail to show that the systems and equipment used, produce a defect-free consistent result. This is a more senior role.

Some companies might call this role:

  • CQV Engineer
  • Manager / Associate Manager – QA Validation
  • Mgr/ Snr Mgr QA Validation Oversight
  • QA Validation Engineer
  • Quality & Validation Engineer
  • Senior Validation Engineer
  • Senior Validation Specialist
  • Staff Engineer, Quality/Validation
  • Validation Scientist
e-Validation (DT 758A)
  • Starting Salary: $54,400
  • After 2 Years: $68,000
  • After 5 Years: $90,000+

Process Validation Engineer

This is generally considered an advanced role and requires thorough process knowledge and experience with process validation engineers working in engineering design, tech-transfer, upstream and downstream manufacturing. Most practitioners tend to have a lab/science, chemistry or chemical/process engineering background although or have learnt experientially on the job through extensive work experience.

Cleaning Validation Engineer

Design and develop cleaning procedures for new products and manufacturing equipment and also investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations for non validated or underdeveloped cleaning procedures. This is a highly specialised role requiring in-depth knowledge of chemical cleaning processes so most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience or on-the-job training.

Some companies might call this role:

  • Cleaning Validation Specialist
  • QA Validation Specialist – Cleaning Validation
  • QA Validation – Clean Hold Executor

Your 30-week class schedule

Module 1 – Pharmaceutical Facility Design

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

  • 1.1 Manufacturing Logistics Calculations
    In this lesson, we learn how to determine the size and capacity of primary processing equipment based on patient dosage requirements and the number of potential patients.
  • 1.2 Process Flow Diagram (PFD) 
  • 1.3 Controlling Air Quality In this lesson, we take our first look at an air handling unit (AHU) and describe its functions.
  • 1.4 Heating, Ventilation, and Air Conditioning (HVAC) Systems In this lesson, we take a look at an overall heating and ventilation control (HVAC) system and explain its primary attributes.
  • 1.5 Basic Biopharmaceutical Unit Operations
    1-5-1 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug substance manufacturing operation.
    1-5-2 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug product formulation/fill-finish and packaging/labelling manufacturing operation.
  • 1.6 Pharmacopeia Grade Waters
  • 1.7 Process Support and Utilities
    In this lesson, we take a look at the clean utilities requirements for a biopharmaceutical drug substance manufacturing process.
  • 2.1 Introduction to ISO 9001:2008 and ISO9001:2015
    This lesson is about the key requirements of a quality management system.
  • 2.2 Typical GMP list for drug substance
    This lesson explores the content of ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”.
  • 2.3 Operational Activities
    In this lesson, we take a look at how to maintain a critical computerized system in a state of operational control using standard procedures.
  • 2.4 GMP for Personnel
  • 2.5 Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Mode
    In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations and evaluation activities.
  • 2.6 Maintenance: Good and Best Practices
    In this lesson, we describe basic and good practices associated with maintenance in a regulated environment.
  • 3.1 Project Lifecycle for New and Modified Facilities
    In this lesson, we describe the typical phases of a project lifecycle: conceptual design, tender contract analysis, basic engineering, detailed design, and project realization.
  • 3.2 Plant Layout
    In this lesson, we explore the vertical distribution of process equipment for a bulk process building, the horizontal layout for a bulk process building, and an entire site layout for an integrated biopharmaceutical manufacturing site.
  • 3.3 Zoned Air-Conditioning Systems
    In this lesson, we look at a practical example where a HVAC system can be dynamically operated to control the temperature of a room (space
  • 3.4 Isolator Technology
    In this lesson, we explain the principles behind the use of ‘isolators’ and Restricted Access Barrier Systems (RABs) for critical ‘open processing’ operation.
  • 3.5 Cell Breakage
    In this lesson, we describe a mechanism for bacterial cell disruption for the recovery of intracellular products.
  • 4.1 Purified Water (PUW) Generation, Storage and Distribution
    In these lessons, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • 4.2 Clean Room and Clean Air Device monitoring 
  • 4.3 Good Engineering Practices Procedures
    In this lesson, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
  • 4.4 GMPs for Buildings and Facilities 
  • 4.5 Quality Systems Approach to cGMP Regulations – Management Responsibilities
    In this lesson, we outline management’s role in the design, implementation, and management of the quality system.
  • 4.6 Maintenance Program
    In this lesson, we describe the key aspects of a typical maintenance program.
  • 5.1 Conceptual Design – Part-1
    In this lesson, we begin to explore a quantified effort in how to size, shape, program, and cost an investment.
  • 5.2 HVAC Requirements for Non-Sterile API Manufacturing
    In this lesson, we look at how to use airflow direction as a means of a containment barrier between operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
  • 5.3 Plant Automation
    This lesson is an introduction to conventional process control using one-way digital and analogue signals.
  • 5.4 Plant Steam
    In this lesson, we describe a process for generating and distributing plant steam to various processes within a manufacturing facility, and also describe how to manage any resultant condensate.
  • 5.5 Clean Steam Generators
    The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation. 
  • 5.6 Steam Sterilization in Place
    In these lessons, we look at the mechanism behind sterilization of process equipment using saturated steam.
  • 5.7 GMPs for Process Equipment 
  • 5.8 Quality Systems – Resources
    In this lesson, we describe what resources need to be allocated for a quality system and operational activities.
  • 6.1 Conceptual Design – Part-2
    This lesson describes what influences the layout of a facility in terms of: Layers, Preliminary Layout, Process Layouts, Media and Buffer Preparation, Clean Utilities and CIP, Access Corridors, Warehouse / Material Movements, Personnel Movements, Decisions on Height, Air Handling, General Utilities, Electrical, Controls & Automation, Finishes, Structural / Civil, Cost Estimate, and Schedule.
  • 6.2 Air Flow Patterns 
    In these lessons, we look at laminar air-flow patterns in the context of filling open vessels aseptically, and at the configuration and operation of both a laminar flow booth and a laminar flow cabinet typically found in the biopharmaceutical industry.
  • 6.3 Cleanroom Layout 
    In this lesson, we take a high-level look at a common cleanroom configuration and discuss items such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals. 
  • 6.4 Filter Ratings
    In these lessons, we look at the particle retention efficiencies of air filters of various grades rated in accordance with European normalisation standards EN779 and EN1822. We also look at the particle arrestance efficiency of air filters of various grades rated in accordance with the ASHRAE standard 52-2 ‘Minimum Efficiency Reporting Value (MERV Rating)’.
  • 6.5 Logic Gates Functions and PLC 
  • 6.6 WFI Storage and Distribution
    In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification.
  • 6.7 Good Engineering Practices Procedures
  • 6.8 Quality systems Approach- Manufacturing
    In this lesson we describe Manufacturing’s responsibilities for (a) designing, developing, and documenting product and processes, (b) examining inputs, (c) performing and monitoring operations, and (d) addressing nonconformities.
  • 6.9 Maintenance- Work Executions
    In this lesson we describe the following Maintenance tasks and activities: (a) work request, (b) work order management, (c) information requirements for work orders, and (d) performance measurement.
  • 7.1 Site Master Planning – Part-I
    In this lesson, we take our first look at site master planning based on: planning rationale, assumptions, prerequisites, typical bulk production unit, site scope, flexibility, expandability, & future-proofing, determining size requirements, sizing & shaping, and broad rules.
  • 7.2 Classification of Clean Areas – Vial Filling 
    In these lessons, we look at: (1) how to classify areas for aseptic operations, (2) typical configurations of air handling units (AHU’s), terminal filters, zone air-inlets and -exhausts to support various classified environments, (3) filter arrangements in air handling units and in their supply air ducting, (4) particles limits associated with various classified air environments, and (5) viable microbial limits, measured as Colony Forming Units (CFU), associated with various classified air environments.
  • 7.3 Area Classification Protection
    In this lesson, we observe a range of airlock configurations typically used in combination under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient. 
  • 7.4 Compress Air and Pneumatics 
  • 7.5 Aseptic Filling
    In this lesson, we describe the process equipment for the filling of medicinal vials aseptically in the sequence of: washing, dehydrogenation, filling and their subsequent inspection.
  • 7.6 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment.
  • 7.7 Aseptic Processing 
    In these lessons, we look at various manual and automated processes and facility layouts for vial filling operations.
  • 7.8 Cleanroom Monitoring – Physical Tests
    In this lesson, we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.
  • 7.9 Quality System – Evaluation Activities 
  • 7.10 Maintenance Management
    This lesson describes the processes and controls used in the delivery of maintenance services and work execution.
  • 8.1 Site Master Planning – Part-II
    We continue in this lesson exploring the configuration philosophy for a site specifically layering configuration options, fermentation/bioreactor, media and buffer preparation. We also look at the shaping and sizing options for fermentation, media preparation, buffer preparation, downstream processing, process and general utilities, buildings, and expansion.
  • 8.2 Open Versus Closed Processing  
  • 8.3 Facility Layout Concept 
  • 8.4 Blow/Fill/Seal Technology 
  • 8.5 PLC Programming
    In this lesson, we describe how to program a PLC to automate a machine using ladder logic diagrams.
  • 8.6 PLC Program Case Studies 
  • 8.7 Cleanroom Monitoring – Microbiological Tests
    In this lesson, we look at a range of typical microbiological measurements to monitor a cleanroom environment for conformance to specifications.
  • 8.8 Cleanroom Monitoring – Cleanrooms Cleaning Procedures 
  • 8.9 Terminally Sterilised Products 
  • 8.10 EU Guidelines on Cleanroom Aseptic Preparation 
  • 9.1 HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing 
  • 9.2 Batch Process Control
    In this lesson, we discuss the ISA-88.01 modularization software standard for segmenting a process into physical entities, and into procedural models for instructional recipes. The physical model is used to describe equipment, and the procedural model used to describe recipes (process sequencing).
  • 9.3 Nitrogen Supply and Distribution
  • 9.4 Environmental Monitoring Program 
    In this lesson, we describe how to monitor a cleanroom environment in order to identify actual and potential sources of contamination using both physical and microbiological techniques.
  • 9.5 ICH Q10 – Pharmaceutical Quality System
    This lesson explains the concept of ‘continual improvement’ as part of a company’s quality management system and describes an effective corrective action process and a preventive action process (CAPA). It also gives details on the product-lifecycle for a pharmaceutical product and describes the monitoring of process performance and product quality.
  • 9.6 FDA Guidance on Aseptic Processing 
  • 10.1 Construction Lifecycle
    In the first lesson for construction lifecycle, we explore the following: choosing a construction type, substructure, options for super-structure, internal building fabric, mechanical installation, electrical & instrumentation, construction sequence for new build, constructability, construction management, construction safety, construction costs, schedule, and quality management. In the second lesson, we look at the contents of clean utility piping test packs. In the third lesson, we look at modular construction and sustainable construction.
  • 10.2 Software Functional Block Diagram (FBD)
  • 10.3 ASTM E 2500
    In this lesson, we review the ASTM International standard E 2500 – 07 ‘Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment’.
You will produce a number of deliverables during the course including:

  • Calculating Mass Balances and Equipment Sizing
  • Designing a Clean Utility generation and distribution system
  • Defining the cleanroom layout for safe material and personnel flows
  • Describing the Quality System necessary for manufacturing safe medicines
Develop a site master plan for an aseptic manufacturing process and the design of its environmental control and clean utility systems.

Module 2 – Planning a Validation Strategy

This module will give you a broad understanding of how to develop a Validation Master Plan (VMP) for a typical product lifecycle and to prepare the Process Validation Protocol for presentation during a regulatory audit.

  • What’s new in Quality and in Validation
  • International Conference on Harmonization (ICH) Overview
  • ICH Q8, Q9, Q10 & Q11
  • Regulatory & Industry Reaction to ICH Guidelines
  • The Concept of Quality
  • Evolution of Regulations in the EU & US
  • Quality Management Systems
  • The Quality Manual
  • Validation Master Plan
  • Supplier & Vendor Qualification
  • Process Validation – Critical Quality Attributes (CQA’s)
  • Process Validation – Critical Process Parameters (CPP’s)
  • Process Validation Protocol
  • Executing the Process Validation Study4
  • Process Validation Report
  • Preparing for the Regulatory Audit
  • Periodic Review & Continuous Validation
  • The Operator/Product Interface
  • Health & Safety Regulations

Complete this module with 8 weeks of study and an extra 2 weeks to complete the end of module assignment.

You will produce a number of deliverables during the course including:

  • Risk management during validation planning
  • Auditing suppliers and vendors and their quality plans and documentation
  • Prepare a product validation strategy and plan
  • Prepare a summary validation report

Module 3 – From URS to PQ – a Validation Project 

This is a workshop driven module where you will develop a P&ID and then back-engineer it into a URS (User Requirement Specification) which will be used to identify the key process measurements that will form the basis of the Performance Qualification (PQ) test script.

Week 21 to 22 – Supplementary Content: Generation of Piping and Instrumentation Diagrams, URS for Hot Detergent and Hot PUW Generation and Distribution Skid System, Equipment List, Instrument List (Incl. both an Attachment and Video Link), Inline Components List (Incl. both an Attachment and Video Link), Piping Line List (Incl. both an Attachment and Video Link), P&ID Instrument Identification (Incl. Video Link Only)
Week 23 – P&IDs
Week 24 – URS Matrix
Week 25 – Workshop
Week 26 – Workshop
Week 27 – Workshop
Week 28 – Workshop
Week 29 – PQ Template
Week 30 – PQ Template

University Accredited by Technological University Dublin (TU Dublin)

This CPD Certificate (Continuous Professional Development) is university-accredited by Technological University Dublin (TU Dublin), Ireland subject to the submission of all assessments and end-of-module assignments.

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

Available Worldwide

This Pharmaceutical Validation Training Course (Certificate in eValidation) is available worldwide.

Hear from people who taken this program

pharmaceutical validation courses

Regina McNamara

“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

“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 engineer courses

Sharon Egan

“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.

Agnes Hove

Domagoj Wunderlich

Patricia Radulescu

Kieran Mac Namara

And delivered by industry experts

Dr. Joe Brady

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

Dr. Joe Brady is 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 institution.

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

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.

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 NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
  2. Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
  3. We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
  4. You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.

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

How does Studying Online Work?

Price & Start Dates

Price & Start Dates

Price & Start Dates

Price & Start Dates

Application Deadline: Wednesday 17th April

Program Starts: 25th April

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Contact Details For This Course

Geraldine Creaner

11 Frequently Asked Questions

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, this 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. If you can’t answer these questions, you should revisit that topic’s learning materials.
  • Any follow up assessments or assignments.

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.

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

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

No, I’m afraid we can’t do that.

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.

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USA/World
Call: +1 (617) 901 9268

Ireland
Call Geraldine: +353 (0)21 2409016

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