Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training in Ireland?UntitledDesigning Quality in from the Start

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This Quality by Design training in Ireland gives scientists, engineers and quality professionals the practical tools to apply QbD across product and process development, grounded in the ICH Q8, Q9, Q10 and Q11 guidelines that regulators such as the FDA and EMA now expect. Over a focused one-day programme you learn to define the Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run structured risk assessment, use Design of Experiments (DoE) to map the design space, and build a robust control strategy. Hands-on exercises apply each tool to realistic development scenarios so you can use them at work immediately. Ireland is Europe's leading biopharma manufacturing hub, home to most of the world's top pharmaceutical companies, and QbD fluency is increasingly expected of teams preparing regulatory submissions. Whether you work in formulation, process development, analytical science, regulatory affairs or quality assurance, this training helps you move from empirical trial-and-error to a controlled, predictable approach to quality.

    What Is Quality by Design Training in Ireland?Designing Quality in from the Start

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This Quality by Design training in Ireland gives scientists, engineers and quality professionals the practical tools to apply QbD across product and process development, grounded in the ICH Q8, Q9, Q10 and Q11 guidelines that regulators such as the FDA and EMA now expect.

    Over a focused one-day programme you learn to define the Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run structured risk assessment, use Design of Experiments (DoE) to map the design space, and build a robust control strategy. Hands-on exercises apply each tool to realistic development scenarios so you can use them at work immediately.

    Ireland is Europe's leading biopharma manufacturing hub, home to most of the world's top pharmaceutical companies, and QbD fluency is increasingly expected of teams preparing regulatory submissions. Whether you work in formulation, process development, analytical science, regulatory affairs or quality assurance, this training helps you move from empirical trial-and-error to a controlled, predictable approach to quality.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Ireland is designed to help learners understand QbD principles, regulatory frameworks, and pharmaceutical product development methodologies covered in the program
    • Course content aligned with current ICH Q8, Q9, and Q10 guideline expectations, real-world pharmaceutical quality requirements, and practical learning objectives for Ireland professionals delivered through a comprehensive Quality by Design training program
    • Real-world examples and scenario-based learning to help learners connect QbD concepts with everyday pharmaceutical development, manufacturing, and quality assurance situations
    • Guided learning support to help participants strengthen understanding, improve confidence, and apply QbD principles effectively across product development and manufacturing roles

    Structured Courseware and Learning Resources

    • Access to organized QbD course materials including QTPP definition worksheets, CQA and CMA identification templates, CPP mapping guides, and DoE reference cards designed to support step-by-step learning
    • Topic-wise learning resources, exercises, and knowledge checks to reinforce understanding of Design Space, control strategies, and risk assessment tools
    • Practice activities, assignments, and scenario-based exercises to help learners apply QbD concepts in realistic pharmaceutical product development and manufacturing quality situations
    • Supplementary learning aids such as risk assessment matrices, Design Space configuration worksheets, RTRT implementation checklists, and control strategy development guides

    Instructor-Led, Practical Learning Experience

    • Live interactive sessions delivered by experienced QbD practitioners with hands-on domain expertise across pharmaceutical, biotechnology, and manufacturing sectors
    • Real-world examples, case discussions, and applied QbD exercises to improve practical understanding of QTPP definition, CQA identification, DoE applications, and Design Space configuration
    • Opportunities to ask questions, clarify doubts, and participate in trainer-led discussions on risk assessment, CPP mapping, and regulatory compliance requirements
    • Training approach focused on helping learners apply QbD concepts confidently at work, not just complete the course content

    Flexible Learning Support in Ireland

    • Instructor-led training formats available for individual learners and corporate teams across the Ireland
    • Options include live virtual classroom training, onsite training, and customized group training depending on availability and organizational requirements
    • Learning support designed to help participants stay on track before, during, and after the Quality by Design training
    • Additional revision and post-training support may be available based on the selected course format

    Learn the Core Concepts Covered in the Course

    • Understand QbD fundamentals, background, key drivers, and the regulatory guidance documents including ICH Q8, Q9, and Q10 that shape modern pharmaceutical development
    • Learn how to define QTPP, identify CQAs, CMAs, and CPPs, apply DoE, configure Design Space, and develop control strategies based on the course curriculum
    • Explore practical use cases showing how QbD is applied in pharmaceutical, biotechnology, healthcare, and manufacturing environments
    • Build role-relevant knowledge of risk assessment and management, real-time release testing, and regulatory compliance that supports better quality decisions in product development

    Practice, Assessment, and Completion Support

    • Practice defining QTPP, identifying CQAs and CMAs, mapping CPPs, and applying DoE through exercises and scenario-based activities
    • Use assessments to identify knowledge gaps in QbD concepts and strengthen understanding of Design Space and control strategy development
    • Receive guidance from instructors to improve understanding of QbD tools and stay aligned with course objectives
    • Earn a course completion certificate after successfully meeting the training requirements

    Career and Workplace Application

    • Build practical QbD skills that can support career growth, role advancement, or improved pharmaceutical quality performance in the Ireland
    • Strengthen confidence in applying QTPP definition, CQA identification, DoE, Design Space, and risk management concepts to real-world product development challenges
    • Improve professional credibility through structured, skill-focused Quality by Design training recognized across Ireland pharmaceutical and manufacturing industries
    • Support enterprise capability building through Quality by Design corporate training for employees across pharmaceutical, biotechnology, healthcare, and manufacturing organizations.

    Quality by Design Training Eligibility in the IrelandWho Can Enroll?

    • No formal prerequisites are required to enroll in the Quality by Design training program

    • Basic familiarity with quality assurance concepts is helpful but not mandatory for enrollment

    • Professionals from pharmaceutical, biotechnology, healthcare, and manufacturing industries are well-suited for this training

    • Individuals and corporate teams seeking to build QbD knowledge and apply regulatory-aligned product development principles are eligible to enroll

    • Learners with backgrounds in quality, regulatory affairs, process engineering, and production management will find the content directly applicable to their roles

    Why QbD Skills Pay off in Pharma DevelopmentPractical Value from Day One

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical and biopharmaceutical professionals build quality into products from the outset instead of relying on end-product testing. The programme suits formulation scientists, process development engineers, analytical scientists, regulatory affairs specialists and QA professionals who want a systematic, ICH-aligned way of working. Whether you are developing a new tablet formulation, scaling a biologics process, or preparing a regulatory submission, the QbD toolkit gives you a repeatable method to design, understand and control quality.

    If you want to move beyond empirical development and apply a structured, regulator-expected approach, QbD is a skill that travels across every pharma and biopharma organisation in Ireland and beyond.

    • Apply QbD tools such as QTPP, CQA identification and DoE directly to your own development projects
    • Replace trial-and-error formulation with a controlled, science-based approach
    • Speak the ICH Q8 to Q11 language that regulators and quality teams expect
    • Lead risk assessments using Ishikawa diagrams and FMEA with confidence
    • Interpret a design space and set Normal Operating and Proven Acceptable Ranges
    • Contribute to stronger CTD regulatory submissions in Section 3.2.P.2
    • Build capability valued across Ireland's pharma and biopharma employers
    For Organizations

    For Organizations

    Quality by Design group training helps pharmaceutical organisations embed a systematic approach to product and process development across their teams. Delivered onsite or live virtual, it brings formulation, process, analytical, regulatory and quality colleagues onto the same ICH-aligned method. For companies preparing QbD-based submissions or maturing their pharmaceutical quality system, the training creates a shared toolkit for QTPP, CQA identification, risk assessment, DoE and control strategy.

    If your teams are moving from Quality by Testing to Quality by Design, corporate training builds the in-house capability to design quality in, control it, and defend it to the FDA and EMA.

    • Equip cross-functional development teams with one shared QbD language
    • Strengthen ICH Q8 to Q11 alignment across formulation, process, analytical and quality functions
    • Reduce manufacturing deviations and post-approval changes through better process understanding
    • Build design space and control strategy capability for regulatory submissions
    • Apply QbD tools to your own live product development projects during training
    • Standardise risk assessment and DoE practice across sites and business units
    • Available as onsite, live virtual or customised corporate training for teams

    Your QbD Career in IrelandRoles, Demand and Irish Pharma Employers

    Quality by Design is now a core capability across Ireland's pharmaceutical and biopharmaceutical sector, which employs over 50,000 people and is forecast to add around 21,000 jobs by 2027. Employers from Pfizer and MSD to Regeneron and AbbVie increasingly expect QbD fluency from development, quality and regulatory teams. Demand spans formulation, process development, validation, analytical science and CMC regulatory roles, and here is what the Irish market is showing right now.

    50,000+

    Biopharma sector employment, Ireland

    IDA Ireland 2026

    21,000

    New biopharma jobs forecast

    by 2027, Life Science Consultants

    EUR 15bn+

    FDI into Irish biopharma

    past decade, IDA Ireland

    EUR 62,000

    Average formulation scientist salary

    Morgan McKinley 2026

    SECTORS HIRING

    • —Pharmaceutical and Biopharmaceutical Manufacturing
    • —Active Pharmaceutical Ingredient (API) Production
    • —Contract Development and Manufacturing (CDMOs)
    • —Regulatory Affairs and CMC
    • —Medical Devices and Combination Products
    • —Analytical and Quality Control Laboratories

    GROWTH TRENDS

    • —Over EUR 15bn of FDI into Irish biopharma in the past decade
    • —Forecast 21,000 new biopharma jobs by 2027
    • —Shift to biologics, advanced therapies and continuous manufacturing
    • —Tightening ICH and regulatory expectations for QbD submissions
    • —Skills shortage in QA, validation and regulatory expertise
    • —Growth beyond Dublin and Cork into Galway, Limerick and Sligo

    Sources: IDA Ireland, Life Science Consultants, Morgan McKinley, SalaryExpert, PayScale (Ireland) 2026.

    Market Pressures Making QbD Skills Essential in Ireland

    The Shift from Testing to Design

    Irish pharma is moving away from end-product testing toward building quality in. Teams that can apply QbD from the design stage are the ones regulators and employers now look for.

    QbD training builds a design-first approach

    Rising Regulatory Expectations

    The FDA and EMA increasingly expect QbD evidence in submissions. Professionals who can prepare QTPP, design space and control strategy content close a real compliance gap.

    QbD training builds submission-ready skills

    Biologics and Advanced Therapy Complexity

    As Ireland scales biologics, biosimilars and cell and gene therapies, process-defined products demand the structured understanding that QbD and Design of Experiments provide.

    QbD training builds process understanding

    QA and Validation Skills Shortage

    Ireland's manufacturing boom has outpaced the supply of quality, validation and regulatory talent. QbD-fluent professionals help close a shortage employers are actively hiring to fill.

    QbD training makes talent stand out

    Pressure to Reduce Deviations and Rework

    Costly manufacturing deviations and post-approval changes stem from weak process understanding. A robust QbD control strategy reduces variability and protects supply.

    QbD training builds control strategy skills

    Continuous Manufacturing Adoption

    The move to continuous and connected manufacturing needs design space thinking and real-time control. QbD gives teams the framework to design and run these modern processes.

    QbD training builds design space thinking

    Sources: IDA Ireland, Life Science Consultants, BioPharm International, Morgan McKinley (Ireland) 2026.

    Quality by Design is more than a compliance box. It is the modern operating system for pharmaceutical development. Build the skills Ireland's biopharma employers are hiring for and lead development that designs quality in.

    Your Ireland Career Transformation

    From Empirical Development to Designed-In Quality

    Your Before and After Picture

    Ireland's pharma and biopharma sector rewards professionals who can design quality in, not just test for it. Here is how QbD training shifts where you stand and what your development work looks like afterwards.

    Today

    Development runs on trial-and-error, with quality confirmed only by end-product testing

    After QbD

    You design quality in from the start using QTPP, CQAs and a defined design space

    Today

    Limited exposure to the ICH framework regulators expect

    After QbD

    Fluent in the ICH Q8 to Q11 guidelines that underpin modern pharma submissions

    Today

    Risk assessment feels ad hoc, without structured tools

    After QbD

    Confident leading FMEA and Ishikawa-based risk assessment for any CQA

    You master QbD

    Before

    Your value tied to a single project or process you know well

    Now you have

    A transferable QbD skillset valued across every pharma and biopharma employer in Ireland

    Before

    Working on the edge of regulatory submission activity

    Now you have

    The ability to build QTPP, design space and control strategy content for CTD submissions

    Before

    Reacting to manufacturing deviations after they happen

    Now you have

    The process understanding to predict and control quality before it fails

    Before

    Development capability without a recognised, structured method

    Now you have

    A systematic, regulator-expected approach you can apply on day one

    "In Irish pharma, the gap between running tests and designing quality in is the gap between following a process and owning it."

    Join the professionals who trained with Invensis Learning and built the skills that matter.

    Sources: Morgan McKinley, SalaryExpert, Glassdoor (Ireland) 2026.

    Module 1: Introduction to QbD

    • Background and key drivers that led to the adoption of Quality by Design in pharmaceutical development
    • Regulatory guidance documents including ICH Q8, Q9, and Q10 that define the QbD framework
    • QbD development process flow from concept and design through to manufacturing and regulatory submission

    Module 2: QbD Tools and Techniques

    • Risk management principles and tools used to identify, assess, and control quality risks in product development
    • Design of Experiments (DoE): fundamentals, design types, and how DoE is used to understand process variability
    • Design Space definition and control strategies: how boundaries are established and maintained throughout the product lifecycle

    Module 3: Industry and Regulatory Perspective

    • Regulatory framework for QbD including agency expectations from the FDA, EMA, and ICH guidelines
    • Implementation challenges organizations face when transitioning from traditional to QbD-based development approaches
    • Real-world industry examples demonstrating how pharmaceutical and biotechnology organizations have adopted QbD

    Module 4: Quality Target Product Profile (QTPP)

    • Definition of the Quality Target Product Profile and its role in guiding QbD-based product development decisions
    • How QTPP links patient needs and regulatory requirements to specific product quality attributes and design objectives
    • Practical steps for defining a QTPP for pharmaceutical and biotechnology products

    Module 5: Critical Quality Attributes, Critical Material Attributes, and Critical Process Parameters

    • Identifying Critical Quality Attributes (CQAs): what they are, how to define them, and why they are central to QbD
    • Critical Material Attributes (CMAs): how raw material properties influence product quality and must be controlled
    • Critical Process Parameters (CPPs): identifying process parameters that impact CQAs and require monitoring and control

    Module 6: Statistical Design of Experiments

    • Fundamentals of statistical DoE including full factorial, fractional factorial, and response surface methodologies
    • Applications of DoE in pharmaceutical process development and optimization
    • Interpreting DoE results to establish design space boundaries and process understanding

    Module 7: Design Space and Process Control

    • Design Space concept: defining the multidimensional combination of input variables and process parameters that provide quality assurance
    • Implementation of Design Space within regulatory submissions and manufacturing control strategies
    • Continuous process verification and how Design Space supports process control across the product lifecycle

    Module 8: Risk Assessment and Management

    • Risk assessment methodologies used in QbD including FMEA, Ishikawa diagrams, and risk ranking tools
    • Applying risk management principles to product development decisions, process design, and control strategy development
    • Linking risk assessment outcomes to Design Space boundaries and CQA control strategies

    Module 9: Real-time Release Testing (RTRT)

    • RTRT concept: replacing end-product testing with in-process monitoring and real-time quality assurance
    • Regulatory requirements and industry expectations for RTRT implementation in pharmaceutical manufacturing
    • Practical considerations for implementing RTRT as part of a QbD-based control strategy

    Module 10: Case Studies and Practical Applications

    • Pharmaceutical and biotechnology case studies demonstrating end-to-end QbD implementation from QTPP to RTRT
    • Practical group exercises and scenario analysis applying QbD tools including QTPP definition, CQA identification, DoE, and risk assessment
    • Lessons learned and best practices from real QbD projects in pharmaceutical, biotechnology, and manufacturing environments

    Course Curriculumof the Quality by Design Training

    The online Quality by Design training course curriculum in the Ireland is structured across ten modules, taking learners from foundational QbD background and regulatory guidance through to real-world case studies and practical applications in pharmaceutical, biotechnology, and manufacturing environments.

    • Background and key drivers that led to the adoption of Quality by Design in pharmaceutical development
    • Regulatory guidance documents including ICH Q8, Q9, and Q10 that define the QbD framework
    • QbD development process flow from concept and design through to manufacturing and regulatory submission

    Shifts your thinking from testing quality in at the end to designing it in from the start.

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    The QbD Toolkit You Will MasterTools You Can Apply at Work

    This Quality by Design programme builds hands-on skills across the full QbD workflow. By the end, you can define a QTPP, identify and classify CQAs, run risk assessment and DoE, interpret a design space, and build a control strategy for pharmaceutical development.

    Building the Quality Target Product Profile

    Construct a QTPP from clinical and patient needs, translating dosage form, route, strength and pharmacokinetic targets into a clear design specification for your development programme.

    Identifying Critical Quality Attributes

    Identify and classify the CQAs, from assay and dissolution to glycosylation and aggregation, that must stay within limits to ensure product quality, safety and efficacy.

    Structured Risk Assessment

    Apply Ishikawa diagrams and FMEA to link Critical Material Attributes and Critical Process Parameters to each CQA, prioritising risks by RPN so you focus development effort where it counts.

    Design of Experiments and the Design Space

    Use DoE to quantify how material and process variables affect CQAs, define the design space, and set Normal Operating and Proven Acceptable Ranges with confidence.

    Process Analytical Technology and Control

    Apply PAT tools such as NIR and Raman for real-time monitoring, and build a control strategy that assures quality within the design space across the manufacturing process.

    QbD in Regulatory Submissions

    Structure QbD evidence for CTD Section 3.2.P.2, connect risk assessment and DoE results to your control strategy, and support smoother post-approval change management.

    Who Should TakeQuality by Design Training in Ireland?

    Process Engineers

    QC Analysts

    Engineering Teams

    Technical Staff

    Production Managers

    Distribution Managers

    Regulatory Affairs Specialists

    Quality Assurance Professionals

    Who Can Take This Certification Training

    Quality by Design Training Modesfor Professionals and Teams

    We offer flexible training formats designed to suit different learning preferences, schedules, and professional goals. Whether you prefer self-paced learning or a structured, corporate, instructor-led experience, choose the option that best supports your skill development journey with the best Quality by Design online training options.

    Quality by Design Live Virtual Training

    • Live online instructor-led sessions

    • Interactive discussions and virtual activities

    • Expert guidance from experienced trainers

    • Practice assessments and revision support

    • Dedicated Q&A sessions for concept clarification

    • Fixed schedules for accountability and momentum

    • Small batch sizes for personalized attention

    • Access from any location with internet connectivity

    EUR 430

    Attend fully interactive weekday Quality by Design training sessions from anywhere while benefiting from real-time instructor guidance and collaborative learning experiences.

    Untitled

    Best For: Professionals seeking the flexibility of online learning without compromising on live instructor interaction.

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    Quality by Design Classroom Training

    • Instructor-led classroom sessions

    • Interactive discussions and group activities

    • Real-world examples and practical exercises

    • Structured learning with fixed schedules

    • Opportunities for peer networking and collaboration

    • Practice assessments and knowledge checks

    • Dedicated Q&A and concept clarification

    • Immediate trainer feedback and support

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    Learn through face-to-face sessions led by experienced instructors in a collaborative classroom environment. This classroom Quality by Design training combines expert guidance, peer interaction, and hands-on activities to create an engaging learning experience.

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    Best For: Learners who prefer in-person interaction, structured schedules, and collaborative learning experiences.

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    Quality by Design Corporate Group Training

    • Customized training aligned to organizational goals

    • Flexible delivery: onsite, virtual, hybrid, or blended

    • Scheduling tailored to business availability

    • Role-based examples and industry-relevant discussions

    • Progress tracking and learner assessments where applicable

    • Dedicated coordination and administrative support

    • Consistent learning experiences across teams

    • Scalable delivery for local, regional, or global workforces

    Untitled

    Designed for organizations that want to build capabilities at scale, standardize knowledge, and support workforce development through customized team learning initiatives.

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    Best For: Organizations looking to upskill employees, address capability gaps, and deliver consistent training across teams.

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    Quality by Design Focused 1-to-1 Training

    • One-to-one instructor attention

    • Customized learning plans and objectives

    • Flexible scheduling based on availability

    • Personalized feedback and coaching

    • Additional focus on challenging topics

    • Targeted practice and revision support

    • Faster clarification of questions and concepts

    • Learning pace is adapted to individual needs

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    Receive personalized instruction tailored to your goals, pace, and learning requirements through dedicated sessions from our trusted Quality by Design training company.

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    Best For: Professionals seeking personalized guidance, accelerated learning, or focused support to achieve specific outcomes.

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    Quality by Design Live Virtual Training

    Quality by Design Live Virtual Training

    Live online instructor-led sessions

    Interactive discussions and virtual activities

    Expert guidance from experienced trainers

    Practice assessments and revision support

    Dedicated Q&A sessions for concept clarification

    Fixed schedules for accountability and momentum

    Small batch sizes for personalized attention

    Access from any location with internet connectivity

    Starts from

    EUR 430

    Please Note:Attend fully interactive weekday Quality by Design training sessions from anywhere while benefiting from real-time instructor guidance and collaborative learning experiences.

    Best For: Professionals seeking the flexibility of online learning without compromising on live instructor interaction.

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    Why Choose Invensis Learning for Your QbD TrainingExpert-Led Learning You Can Trust

    Invensis Learning delivers instructor-led Quality by Design training for individual professionals and pharmaceutical teams across Ireland. Our programmes combine experienced, industry-practitioner trainers, flexible delivery formats, and structured, practical courseware focused on applying QbD at work. As an ISO 9001:2015 and ISO 27001:2022 certified training organisation and a trusted Quality by Design training company in Ireland, Invensis Learning brings a global track record in quality management training and a learner-focused approach built around real-world application and measurable outcomes.

    • Experienced trainers with real pharmaceutical and quality management expertise
    • Instructor-led online (live virtual), classroom and onsite delivery formats
    • Hands-on QbD exercises using realistic pharmaceutical development scenarios
    • ISO 9001:2015 certified for quality management systems
    • ISO 27001:2022 certified for information security
    • Flexible corporate and group training for pharma and biopharma teams
    • Practical courseware focused on applying QbD tools on the job
    • Dedicated learner support before, during and after training

    200K+

    Professionals Trained

    12M+

    Hours of Training Delivered

    4

    Flexible Learning Modes

    98%

    First-Attempt Pass Rate

    ISO 9001:2015 Certified

    ISO 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

    Secure SSL Encryption

    Leaders in Training industry for 12+ years

    Leaders in Training industry for 12+ years

    Over 5000 five star reviews

    Over 5000 five star reviews

    Level AA conformance, W3C WCAG 2.2

    Level AA conformance, W3C WCAG 2.2

    Quality by Design Training Locations in IrelandAll our classroom training is now available online at your convenience

    Quality by Design in Ireland

    Adare Manor, Adare, Co. Limerick, V94 W8WR, Ireland

    Quality by Design in Ireland

    Ballyfin Demesne, Ballyfin, Co. Laois, Ireland

    corporate banner

    Corporate QbD TrainingUpskill Your Entire Team

    Untitled

    • Customised QbD training aligned to your products and processes
    • Onsite, live virtual or blended delivery for teams of any size
    • Apply QbD tools to your own live development projects in the session
    • Bring formulation, process, analytical and quality teams onto one method
    • Experienced pharmaceutical trainers with hands-on industry expertise
    • Flexible scheduling around your production and project timelines
    • Dedicated coordination and support for group training programmes

    Trusted Across Ireland's Pharma Sector

    PfizerMSDAbbVieRegeneronEli LillyTakeda

    What Our Learners Say

    Untitled

    Finally a Structured Way to Design Quality In

    "I came in doing formulation by trial and error. The QbD training gave me a clear method, from building a QTPP to running DoE and defining a design space. I applied it to a live project the week after."

    Aoife Byrne

    Formulation Scientist

    Untitled

    0/0

    The Risk Assessment Tools Alone Were Worth It

    "The sessions on Ishikawa diagrams and FMEA changed how our team prioritises development work. Linking CMAs and CPPs to each CQA finally made risk assessment feel systematic rather than guesswork."

    Conor Walsh

    Process Development Engineer

    Untitled

    0/0

    Cleared up the ICH Framework for Me

    "As a regulatory professional I needed to understand QbD to defend our submissions. The trainer connected Q8 to Q11 to real CTD content, and the design space and control strategy sections were especially useful."

    Niamh O'Sullivan

    Regulatory Affairs Specialist

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    Our Whole QA Team Now Speaks One Language

    "We ran this as onsite training for our quality and process teams. Everyone now shares the same QbD vocabulary, which has made our development reviews far more productive."

    Declan Murphy

    Quality Assurance Manager, Biopharma Manufacturer

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    Practical, Tailored and Well Delivered

    "Invensis tailored the corporate programme to our biologics processes and let our teams apply the tools to real projects. A measurable step up in how we approach process understanding."

    Sarah Fitzgerald

    Learning and Development Lead, Pharmaceutical Company

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    Frequently Asked QuestionsHere's everything you may ask...

    Quality by Design (QbD) training is a practical, one-day programme that teaches a systematic, science-based approach to pharmaceutical product and process development. You learn to build quality in from the design stage using the ICH Q8 to Q11 framework, QTPP, CQAs, risk assessment, DoE and control strategy.

    General

    What is Quality by Design training?

    Quality by Design (QbD) training is a practical, one-day programme that teaches a systematic, science-based approach to pharmaceutical product and process development. You learn to build quality in from the design stage using the ICH Q8 to Q11 framework, QTPP, CQAs, risk assessment, DoE and control strategy.

    Who should attend QbD training in Ireland?

    The training suits formulation scientists, process development engineers, analytical scientists, regulatory affairs and CMC professionals, and quality assurance staff across Ireland's pharma, biopharma, API, CDMO and medical device organisations who want to apply QbD in their daily work.

    Is Quality by Design training worth it?

    Yes. QbD is increasingly expected by the FDA and EMA and by Ireland's biopharma employers. The skills apply immediately to development, quality and regulatory work, and they travel across every pharmaceutical organisation, making them a strong long-term investment in your career.

    Do I need prior experience to take QbD training?

    No formal prerequisites are required. Familiarity with pharmaceutical development or GMP is helpful but not essential, as the course introduces QbD from first principles in a development context. Talk to a learning advisor if you are unsure about fit.

    Which framework is QbD training based on?

    The training is grounded in the ICH guidelines that define modern pharmaceutical development: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, alongside FDA and EMA expectations.

    Pricing

    How much does QbD training cost in Ireland?

    Fees vary by delivery format (live virtual, classroom or corporate) and group size. Pricing for scheduled and corporate sessions is available on request. Request a quote and a learning advisor will share the current options for Ireland.

    What is included in the QbD course fee?

    The fee typically includes instructor-led training across all six QbD modules, structured courseware, hands-on tool exercises, case studies, and a course completion certificate from Invensis Learning. Contact us to confirm what each format includes.

    Do you offer corporate or group pricing?

    Yes. We offer customised corporate QbD training with volume-based pricing for pharmaceutical and biopharma teams, delivered onsite or live virtual. Ask about group pricing for a tailored quote for your organisation.

    Are there payment or instalment options?

    Payment options vary by region and enrolment type. We accept major cards and bank transfers, with instalment options on selected plans. Speak with a learning advisor to choose the option that suits you.

    Is the price the same for online and classroom training?

    Pricing can differ across live virtual, classroom and onsite corporate formats. If you prefer to take the Quality by Design course online, request a quote to compare the current options and choose the delivery mode that best fits your schedule and budget.

    Assessment

    Is there an exam for QbD training?

    No. Quality by Design training is a non-certification course with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and discussion during the programme, so you can apply the tools straight away.

    Do I receive a certificate after the training?

    You receive a course completion certificate from Invensis Learning after completing the one-day programme. This recognises your participation and the practical QbD skills you have built; it is not an external certification, as QbD training has no awarding body.

    How is my learning assessed?

    There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, risk assessment and design space interpretation to realistic scenarios throughout the day, reinforcing the skills you will use at work.

    Does QbD training lead to a formal qualification?

    No formal qualification or credential is awarded, as this is a practical skills course rather than a certification. The value lies in immediately applicable QbD capability that Ireland's pharma and biopharma employers recognise and expect.

    Will the training help with regulatory submissions?

    Yes. You learn how QbD outputs, the QTPP, CQAs, risk assessment, design space and control strategy, feed into CTD Section 3.2.P.2 of regulatory submissions, helping you contribute to stronger FDA and EMA filings.

    Course Content

    What topics does QbD training cover?

    The programme covers six modules: QbD principles and the ICH framework, QTPP and CQAs, risk assessment, Design of Experiments and the design space, Process Analytical Technology and control strategy, and QbD in practice through case studies and regulatory submissions.

    Does the course cover both small molecules and biologics?

    Yes. QbD training covers principles that apply to both small molecule drug products such as tablets and injectables, and biopharmaceuticals such as monoclonal antibodies and biosimilars, with case study examples from both product types.

    Are there hands-on exercises in the training?

    Yes. Hands-on QbD tool exercises run throughout the day, including QTPP construction, CQA identification and criticality assessment, Ishikawa and FMEA risk assessment, and design space interpretation, all applied to realistic pharmaceutical development scenarios.

    Does the training cover Design of Experiments?

    Yes. You learn how DoE is used within QbD to quantify how material and process variables affect CQAs, how to select screening and response surface designs, and how DoE results define the design space and its operating ranges.

    How long is the QbD training programme?

    The course is delivered in one day (eight hours), covering all six QbD modules with concept explanations, ICH regulatory context, case studies and hands-on tool exercises. A half-day format across two days is also available.

    Enrollment

    How do I enrol in QbD training?

    You can enrol through the Invensis Learning website. Choose your preferred format, complete payment, and you will receive access to the schedule, courseware and learning resources. A learning advisor can help you pick the right session.

    What training formats are available?

    QbD training is available as online (live virtual) instructor-led sessions, in-person classroom training, and customised corporate onsite training for teams, so you can choose the format that fits your schedule and location in Ireland.

    When are the next QbD training sessions?

    Scheduled public sessions and corporate dates run throughout the year across live virtual and classroom formats. Request upcoming schedules and a learning advisor will share the next available dates for Ireland.

    Can I book QbD training for my team?

    Yes. We deliver corporate QbD training onsite or live virtual for pharmaceutical and biopharma teams, tailored to your products and processes. Contact us to arrange a group session and get a tailored quote.

    Can I reschedule my enrolment?

    Yes. Selected plans allow you to reschedule or transfer to another session. Contact our support team and they will help you move to a batch that works for you.