Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training?UntitledA Science-Based Route to Pharmaceutical Quality

    Quality by Design (QbD) Training in Denmark is a practical, non-certification programme that teaches pharmaceutical and biopharmaceutical teams how to build quality into a product from the design stage rather than testing it in at the end. Grounded in the ICH Q8, Q9, Q10 and Q11 guidelines that the FDA and EMA now expect in modern development submissions, the course moves you from empirical trial and error to a systematic, science-based way of working. Over one intensive day you learn the full QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT) and the control strategy. Denmark's Medicon Valley cluster, led by employers such as Novo Nordisk, Lundbeck and LEO Pharma, makes these skills directly relevant to the work in front of you. Whether you are a formulation scientist, process engineer, analytical scientist, QA professional or regulatory affairs specialist, you leave able to apply QbD tools to live development projects. Start building science-based quality capability with Invensis Learning.

    What Is Quality by Design Training?A Science-Based Route to Pharmaceutical Quality

    Quality by Design (QbD) Training in Denmark is a practical, non-certification programme that teaches pharmaceutical and biopharmaceutical teams how to build quality into a product from the design stage rather than testing it in at the end. Grounded in the ICH Q8, Q9, Q10 and Q11 guidelines that the FDA and EMA now expect in modern development submissions, the course moves you from empirical trial and error to a systematic, science-based way of working.

    Over one intensive day you learn the full QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT) and the control strategy. Denmark's Medicon Valley cluster, led by employers such as Novo Nordisk, Lundbeck and LEO Pharma, makes these skills directly relevant to the work in front of you.

    Whether you are a formulation scientist, process engineer, analytical scientist, QA professional or regulatory affairs specialist, you leave able to apply QbD tools to live development projects. Start building science-based quality capability with Invensis Learning.

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    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Denmark 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 Denmark 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 Denmark

    • Instructor-led training formats available for individual learners and corporate teams across the Denmark
    • 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 Denmark
    • 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 Denmark 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 DenmarkWho 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

    What You Gain from Building QbD CapabilitySkills You Apply from Day One

    For Individuals

    For Individuals

    QbD training helps pharmaceutical professionals build practical, science-based development skills that apply directly on the job. The programme suits formulation scientists, process engineers, analytical scientists, QA professionals and regulatory affairs specialists who want to work the way modern regulators expect. Whether you are moving from trial-and-error development, formalising your grasp of design space and control strategy, or preparing for a role at an expanding Danish manufacturer, this training builds capability aligned with what employers ask for.

    If you want to lead QbD work rather than follow it, this course gives you a clear, tool-by-tool route. You leave able to construct a QTPP, facilitate CQA and risk workshops, plan a DoE and shape a control strategy for review.

    • Design quality into products from the QTPP onwards instead of relying on end-product testing
    • Identify and classify Critical Quality Attributes for small molecules and biologics
    • Run structured risk assessments using Ishikawa diagrams and FMEA to focus development effort
    • Plan and interpret Design of Experiments and define a defensible design space
    • Apply PAT and build a control strategy that regulators expect in submissions
    • Speak the ICH Q8 to Q11 language valued across Danish pharma and biopharma
    • Stand out for process development, CMC and QA roles in Medicon Valley
    • Apply the tools immediately to your own live development projects
    For Organizations

    For Organizations

    QbD group training helps organisations embed a systematic approach to pharmaceutical development across cross-functional teams. Delivered for R&D groups, process development functions, QA teams or whole project squads, it turns QbD from theory into shared working practice. For organisations scaling development and manufacturing, this training creates the common understanding needed to run QbD projects efficiently and defend them to regulators.

    If your teams struggle to connect product understanding to a documented control strategy, QbD training gives them one framework. Groups gain a standardised approach to QTPP, criticality assessment, DoE and design space definition.

    • Builds a shared QbD language across formulation, analytical, process, QA and regulatory teams
    • Reduces manufacturing deviations through stronger process understanding
    • Strengthens ICH-aligned development and submission readiness for the FDA and EMA
    • Cuts the experimental burden by focusing DoE on the highest-risk variables
    • Supports fewer post-approval changes through robust design space and control strategy
    • Enables customised training mapped to your own products and processes
    • Delivers consistent QbD practice across sites and business units
    • Builds in-house capability that lowers reliance on external consultants

    Where QbD Skills Take Your Career in DenmarkRoles, Demand and Pay

    Quality by Design training builds the QbD capability that has become a clear differentiator across Danish pharma and biopharma. As Novo Nordisk, Lundbeck, LEO Pharma and a dense cluster of CDMOs scale development and manufacturing, employers want scientists and engineers who can design quality in, not test it in. Demand runs from formulation and analytical scientists to process development engineers, QA specialists and CMC regulatory professionals, and here is what the Danish market is telling us right now.

    USD 4.18bn

    Denmark pharmaceutical market, 2026

    Mordor Intelligence, rising to USD 4.89bn by 2031

    65,000+

    Life science jobs, Eastern Denmark and S. Sweden

    Medicon Valley Alliance

    40%

    New technical hires absorbed by Novo Nordisk

    Medicon Valley Alliance, 2023-2024

    kr 500k+

    Senior pharmaceutical scientist salary, Denmark

    ERI SalaryExpert 2026

    SECTORS HIRING

    • —Pharmaceutical Manufacturing and Development
    • —Biopharmaceutical and Biotechnology
    • —API and Fine Chemicals
    • —Contract Development and Manufacturing (CDMOs)
    • —Regulatory Affairs and CMC
    • —Medical Devices

    GROWTH TRENDS

    • —GLP-1 demand driving Novo Nordisk expansion in Kalundborg, Hillerod and Odense
    • —Heavy CDMO investment across Medicon Valley by Fujifilm Diosynth and AGC Biologics
    • —FDA and EMA increasingly expecting QbD evidence in development submissions
    • —Shift from batch to continuous manufacturing raising process-understanding demand
    • —Growing biologics and rare-disease pipelines needing CQA and design space rigour
    • —Deep GMP talent pool but a shortage of QbD-fluent scientists

    Sources: Mordor Intelligence, Medicon Valley Alliance, ERI SalaryExpert, Pharmadanmark, PharmaBoardroom (Denmark) 2026.

    Industry Challenges Driving Demand for QbD Skills in Denmark

    GLP-1 Manufacturing Surge

    Novo Nordisk is expanding aggressively across Kalundborg, Hillerod and Odense, creating secondary demand for CMC specialists, process engineers and QbD-literate scientists who can characterise and control large-scale processes.

    QbD builds the process understanding this scale-up needs

    Rising Regulatory Expectation

    The FDA and EMA increasingly expect QbD evidence, design space and control strategy in submissions. Teams without this fluency face slower approvals and heavier post-approval change burdens.

    QbD builds ICH-aligned submission skills

    CDMO Capacity Boom

    Medicon Valley hosts the highest density of CDMO sites in Europe, with Fujifilm Diosynth and AGC Biologics investing heavily. QbD expertise is a capability clients now expect their contract partners to hold.

    QbD is a differentiating CDMO capability

    Biologics Complexity

    Monoclonal antibodies, biosimilars and rare-disease therapies are process-defined and sensitive to conditions, demanding disciplined CQA identification, risk assessment and design space work that QbD provides.

    QbD builds CQA and design space rigour

    QbD Talent Scarcity

    Denmark has a deep GMP and laboratory talent pool but relatively few scientists fluent in QTPP, DoE and control strategy, making QbD-capable professionals rare and sought after.

    QbD makes scientists stand out

    Move to Continuous Manufacturing

    As manufacturers shift from batch to continuous production and real-time release, robust QbD process understanding and PAT integration become essential to designing reliable control systems.

    QbD underpins continuous process control

    Sources: PharmaBoardroom, Mordor Intelligence, Medicon Valley Alliance, BioPharma Dive, FiercePharma (Denmark) 2026.

    QbD is more than a framework. It is the working method Danish pharma now expects. Join scientists and engineers who design quality in and lead development at the standard regulators want. Start your journey today.

    Your Denmark Career Transformation

    Where You Stand Today,

    And Where QbD Skills Take You

    Denmark's pharma and biopharma sector is expanding with GLP-1 demand, rare-disease pipelines and heavy CDMO investment, and employers increasingly separate scientists who can run QbD from those who cannot. Here is which side of that line you want to be on.

    Today

    Confident in the lab, but unsure of design space or control strategy

    After Training

    Fluent in defining a design space and building a control strategy

    Today

    Passed over for QbD-focused roles at expanding Danish pharma

    After Training

    Ready for process development, CMC and QA roles that ask for QbD

    Today

    Pay tracks a generalist scientist band

    After Training

    Positioned for senior scientist bands where QbD skills are valued, around kr 500k and above

    You build QbD capability

    Before

    Quality is checked by end-product testing after manufacture

    Now you have

    You design quality into the product from the QTPP onwards

    Before

    Development runs on empirical trial and error

    Now you have

    You work systematically with CQAs, risk assessment and DoE

    Before

    Limited grasp of what the FDA and EMA expect in a submission

    Now you have

    You can structure QbD evidence for ICH-aligned submissions

    Before

    Skills tied to one employer, product or process

    Now you have

    Transferable QbD capability valued right across Medicon Valley

    "The gap between running experiments and designing quality in is increasingly a defined skill set, and the Danish employers that matter already know it."

    Join thousands of professionals who trained with Invensis Learning and changed how they work.

    Sources: ERI SalaryExpert, Pharmadanmark, Medicon Valley Alliance (Denmark) 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 Denmark 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 Skills You Will BuildFrom QTPP to Control Strategy

    This QbD training builds the practical skills covered across the full Quality by Design workflow, from defining a product profile to documenting a control strategy for regulators. Each capability is applied to realistic pharmaceutical development scenarios through hands-on exercises.

    Build a Quality Target Product Profile

    Construct a QTPP from clinical and patient needs, defining the design target that anchors the whole QbD programme across dosage form, delivery, pharmacokinetics and quality standards.

    Identify and Classify Critical Quality Attributes

    Determine the CQAs that matter for small molecules and biologics, distinguishing critical from non-critical attributes and linking each to material attributes and process parameters.

    Run Risk Assessments with Ishikawa and FMEA

    Map potential sources of variation with fishbone diagrams and prioritise CMA and CPP risks using FMEA and Risk Priority Numbers, so development effort targets the highest-impact variables.

    Design Experiments and Map the Design Space

    Select and interpret screening and response surface DoE, define the design space, and set Normal Operating Ranges and Proven Acceptable Ranges with a clear edge of failure.

    Apply PAT and Build a Control Strategy

    Use PAT tools such as NIR and Raman for real-time monitoring, and assemble a risk-proportionate control strategy spanning material, process and in-process controls.

    Structure QbD Evidence for Submission

    Present QbD outputs in the CTD Section 3.2.P.2 format and manage the QbD lifecycle, including post-approval change and ICH Q12 considerations, ready for regulatory review.

    Who Should TakeQuality by Design Training in Denmark?

    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

    DKK 2760

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

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    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

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    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

    DKK 2760

    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 Quality by Design Training in DenmarkExpert-Led, ISO-Certified Training

    As a specialist Quality by Design training company in Denmark, Invensis Learning delivers practical, instructor-led QbD training for pharmaceutical professionals and organisations who want to build science-based development capability. Our programmes combine experienced practitioner trainers, hands-on tool exercises and flexible delivery, grounded in the ICH guidelines that shape modern pharmaceutical development. Whether you enrol as an individual or arrange group training for a cross-functional team, you get a professional learning experience built around real-world application and measurable outcomes, backed by our ISO-certified quality and security standards.

    • Experienced, industry-practitioner trainers with real pharmaceutical development exposure
    • Instruction grounded in the ICH Q8 to Q11 framework and current QbD best practice
    • Flexible formats: live virtual, classroom and onsite delivery for individuals and teams
    • Hands-on QbD exercises using realistic development scenarios, not slide-only theory
    • Customised corporate delivery mapped to your own products and processes
    • Structured courseware and learning support before, during and after the programme
    • ISO 9001:2015 and ISO 27001:2022 certified quality and information-security standards
    • Scalable delivery for local Danish teams and global, multi-site organisations

    ISO 9001

    Quality Management

    200K+

    Professionals Trained

    12M+

    Hours of Training Delivered

    4

    Flexible Learning Modes

    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 DenmarkAll our classroom training is now available online at your convenience

    Quality by Design in Denmark

    Villa Provence Hotel, Fredens Torv 12, 8000 Aarhus

    Quality by Design in Denmark

    Hotel Royal, Store Torv 4, 8000 Aarhus

    corporate banner

    Corporate QbD Training for Danish TeamsFor Pharma and Biotech

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    • Customised QbD training built around your own products, processes and pipelines
    • Flexible delivery through onsite, live virtual or hybrid formats for your teams
    • Schedules aligned with shift patterns and project timelines across your sites
    • Practitioner trainers with real pharmaceutical and biopharmaceutical experience
    • Cross-functional focus spanning formulation, analytical, process, QA and regulatory
    • Progress tracking, exercises and coordinated support for group programmes
    • Scalable delivery for teams across Denmark and global, multi-site organisations

    Relevant Danish Pharma and Biotech Employers

    Novo NordiskLundbeckLEO PharmaNovonesisBavarian NordicGenmab

    What Our Learners Say

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    From Theory to a Live Project in Days

    "The training finally connected the dots between QTPP, CQAs and the control strategy for me. I went back to my formulation project and rebuilt the risk assessment with FMEA the same week. Genuinely practical, not just theory."

    Mette Sorensen

    Formulation Scientist

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    DoE and Design Space Finally Clicked

    "As a process engineer moving into CMC, the DoE and design space sessions were exactly what I needed. The worked examples for both small molecules and biologics made the design space concept click."

    Anders Kristensen

    Process Development Engineer

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    Grounded in the ICH Framework

    "Clear, well-paced and grounded in the ICH guidelines we actually work to. The PAT and control strategy content helped me review a development report far more confidently."

    Camilla Holm

    Regulatory Affairs Specialist

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    A Shared QbD Language for the Team

    "We ran this as an onsite programme for a cross-functional team. It gave formulation, analytical and QA a shared QbD vocabulary, which has already made our development reviews sharper and faster."

    Henrik Poulsen

    Head of Process Development

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    Tailored to Our Biologics Pipeline

    "The customised corporate session mapped QbD tools to our own biologics pipeline. Our QA and CMC colleagues left able to facilitate CQA and risk workshops themselves, which was exactly the outcome we wanted."

    Louise Dahl

    Learning and Development Lead

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

    Yes. QbD is the science-based development method that Danish pharma and biopharma employers, from Novo Nordisk to a dense CDMO cluster, increasingly expect. The skills apply directly to development and manufacturing roles and are valued as the FDA and EMA look for QbD evidence in submissions.

    General

    Is Quality by Design training worth it for pharma professionals in Denmark?

    Yes. QbD is the science-based development method that Danish pharma and biopharma employers, from Novo Nordisk to a dense CDMO cluster, increasingly expect. The skills apply directly to development and manufacturing roles and are valued as the FDA and EMA look for QbD evidence in submissions.

    What is Quality by Design (QbD)?

    QbD is a systematic, science-based approach to pharmaceutical development in which quality is built into the product from the design stage rather than tested in at the end. It is grounded in the ICH Q8, Q9, Q10 and Q11 guidelines and uses tools such as the QTPP, CQAs, risk assessment, DoE, the design space and a control strategy.

    Who should attend this QbD training?

    The programme suits formulation scientists, process development engineers, analytical scientists, QA professionals, regulatory affairs and CMC specialists, and manufacturing technical managers in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations who want to apply QbD in their work.

    Do I need prior QbD experience to attend?

    No. There are no formal prerequisites. Familiarity with pharmaceutical development or GMP is helpful but not required, as the course introduces QbD from first principles before moving into the tools and worked examples.

    How long is the QbD training?

    The programme runs as one intensive day of eight hours, covering QbD principles and the ICH framework, QTPP and CQAs, risk assessment, DoE and design space, PAT and control strategy, and QbD in practice, with hands-on exercises throughout.

    Pricing

    How much does the QbD training cost in Denmark?

    Fees vary by delivery format, group size and whether the training is public or corporate. Because pricing depends on your needs, it is available on request. Contact a learning advisor for a quote tailored to individual or group enrolment.

    What is included in the course fee?

    The fee includes instructor-led delivery across all six QbD modules, hands-on tool exercises, structured courseware and learning resources, and a course completion record from Invensis Learning. Request a quote to confirm what is included in your chosen format.

    Do you offer group or corporate pricing?

    Yes. We offer customised corporate training with volume-based pricing for R&D groups, process development functions, QA teams and cross-functional squads. Ask about corporate and group pricing for a tailored quote.

    What payment options are available?

    We accept major cards and bank transfer, and can arrange invoicing for corporate bookings. Speak with a learning advisor to choose the option that suits your enrolment.

    Is the training good value for the outcome?

    The programme turns QbD from theory into working practice in a single day, so teams can apply the tools to live projects immediately. Given the demand for QbD-fluent scientists in Denmark, it is a focused, high-return investment. Request a quote to compare formats.

    Assessment

    Is there an exam for this QbD training?

    No. This is a non-certification skills programme with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case study examples and group discussion during the day.

    Do I receive a certificate after the training?

    You receive a course completion record from Invensis Learning. No external credential or certification is awarded, as this is a practical skills course rather than an accredited qualification.

    How is learning assessed during the course?

    There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, Ishikawa and FMEA risk assessment and design space interpretation to realistic scenarios throughout the programme.

    Which standards and guidelines does the course follow?

    The training is grounded in the ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Q11 (Drug Substances) guidelines, alongside FDA and EMA expectations for QbD in modern submissions.

    Will I be able to apply QbD at work afterwards?

    Yes. You leave able to construct a QTPP, lead CQA and risk workshops, plan and interpret a DoE, define a design space and Proven Acceptable Ranges, and shape a control strategy for regulatory review.

    Course Content

    What topics does the QbD training cover?

    The course covers QbD principles and the ICH framework, the QTPP and CQAs, risk assessment with Ishikawa and FMEA, DoE and design space definition, PAT and the control strategy, and QbD in practice including case studies, CTD submission and lifecycle management.

    Does the course cover both small molecules and biologics?

    Yes. QbD principles are applied to both small molecule drug products, such as tablets and injectables, and biopharmaceuticals, such as monoclonal antibodies and biosimilars, with worked case study examples from both.

    Are there hands-on exercises?

    Yes. You work through QTPP construction, CQA identification and criticality assessment, Ishikawa diagrams, FMEA prioritisation and design space interpretation, all applied to realistic pharmaceutical development scenarios.

    Does the course cover Design of Experiments and PAT?

    Yes. DoE is covered from screening and response surface designs through to interpreting the model and defining the design space, and PAT is covered with tools such as NIR and Raman and their role in real-time release testing.

    What materials are provided?

    You receive structured courseware covering all six QbD modules, exercise scenarios and reference materials, plus a course completion record on finishing the programme.

    Enrollment

    How do I enrol in the QbD training?

    You can enrol through Invensis Learning by choosing your preferred format and completing booking. You then receive schedule details, courseware and joining information. Talk to a learning advisor to pick the right session.

    What delivery formats are available in Denmark?

    The training is available as live virtual instructor-led sessions, classroom delivery and onsite corporate programmes, so individuals and teams across Denmark can choose the format that fits their schedule.

    Can the course be delivered onsite for our team?

    Yes. Corporate onsite delivery is popular with Danish pharma teams because participants can apply QbD tools to their own live products and processes during the session. Ask about corporate training to arrange a tailored programme.

    How soon can I start?

    Public sessions run on a regular schedule and corporate dates are arranged around your team's availability. See upcoming schedules or talk to a learning advisor to find the next suitable session.

    What is the reschedule policy?

    Flexible options let you reschedule to another session where needed. Contact our support team to confirm the details that apply to your booking.