Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design and Why It Matters for Icelandic Pharma

    A Science-Based Route to Consistent Quality

    Quality by Design course badge

    What's Included in Your Quality by Design Training

    • One-day course spanning ten structured modules

    • 8 PDUs on completion of the training

    • Copy of course material and SME-prepared study guide

    • Case studies and practical applications module

    • Course completion certificate from Invensis Learning

    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the Iceland

    Who Can Enrol?

    The On-The-Job Payoff of Learning Quality by Design

    Skills You Can Apply from Day One

    Who Should Take Quality by Design Training in Iceland?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Where QbD Skills Take Your Career in Iceland

    Roles and Pharma Demand

    Quality by Design skills are increasingly sought across Iceland's compact but R&D-intensive pharmaceutical cluster, and focused Quality by Design training is a direct route to building them. Employers such as Alvotech in biosimilars and Coripharma in generics and contract development want QbD-literate scientists and engineers who can build quality into products and support EMA and FDA submissions. Demand sits with formulation and process development scientists, analytical and QC scientists, and quality and regulatory professionals, and here is what the market is telling us right now.

    Market Forces Making QbD Skills Essential in Iceland

    Quality by Design is fast becoming the standard for pharmaceutical development in Iceland. Build the skills employers and regulators now expect, and start your QbD journey today.

    Your Iceland QbD Transformation

    From Testing Quality in to Designing It In

    Your QbD Transformation

    Iceland's pharmaceutical sector is moving from empirical development to the science-based, QbD-driven design that regulators now expect. Here is how building these skills changes your day-to-day work and your standing.

    Sources: SalaryExpert / ERI (Iceland) 2026; ICH Q8(R2), Q9, Q10 and Q11 guidelines.

    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 optimisation
    • 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 Curriculum

    of the Quality by Design Training

    The online Quality by Design training course curriculum in the Iceland 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.

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    The QbD Skills You Will Build

    Practical Tools for Real Development

    By the end of this Quality by Design course you will be able to apply the full QbD toolkit to pharmaceutical development. You will construct a QTPP, identify Critical Quality Attributes, run risk assessments, plan a Design of Experiments and build a control strategy for regulatory submission.

    Quality Target Product Profile (QTPP)

    Construct a QTPP from clinical and patient needs to define the quality, safety and efficacy targets that guide the entire development programme.

    Critical Quality Attributes (CQAs)

    Identify and classify the physical, chemical and biological attributes that must stay within limits, and link them to material attributes and process parameters.

    Risk Assessment with FMEA and Ishikawa

    Use fishbone diagrams and Failure Mode and Effects Analysis with RPN scoring to prioritise the material attributes and process parameters that most affect quality.

    Design of Experiments and the Design Space

    Plan screening and response-surface experiments, interpret the model, and define the design space, including Normal Operating and Proven Acceptable Ranges.

    Process Analytical Technology and Control Strategy

    Apply PAT tools such as NIR and Raman and build a control strategy that keeps quality within the design space across manufacturing.

    QbD in Regulatory Submissions

    Structure QbD evidence for the CTD Section 3.2.P.2, aligning with ICH Q8(R2) through Q11 for EMA and FDA submissions across small molecules and biologics.

    Quality by Design Training Modes

    for 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 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

    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.

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

    Quality by Design Corporate Group Training

    • Customised training aligned to organisational 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

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

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

    Quality by Design Focused 1-to-1 Training

    • One-to-one instructor attention

    • Customised 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

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

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

    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 340

    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 Iceland

    Practical, Expert-Led and Flexible

    Invensis Learning delivers practical, instructor-led Quality by Design training for individuals and teams across Iceland's pharmaceutical and medical device sector. Our trainers are experienced quality and development practitioners, and our programmes combine clear explanation of the ICH framework with hands-on exercises on real development scenarios, making Invensis Learning a trusted Quality by Design training company in Iceland. As an ISO 9001:2015 and ISO 27001:2022 certified global training provider, we offer flexible live virtual and onsite delivery, structured courseware and dedicated learner support, so you move from concept to confident application.

    • Experienced trainers with real pharmaceutical quality and development expertise
    • Practical, hands-on exercises using the QTPP, CQAs, risk assessment and DoE
    • Aligned to the ICH Q8(R2), Q9, Q10 and Q11 quality guidelines
    • Flexible live virtual (online) and onsite delivery for Iceland
    • ISO 9001:2015 certified for quality management
    • ISO 27001:2022 certified for information security
    • Structured courseware, case studies and post-training support
    • Trusted by professionals and organisations across many industries

    24/7

    Learner Support

    50+

    Industries Served

    1-to-1

    Doubt-Clearing Sessions

    60+

    Global Course Portfolio

    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 Iceland

    Instructor-led in-person Classroom training is available for group batches. All other public cohorts are delivered as Instructor-led Live Virtual. See available cohorts.

    Quality by Design Training Location in Iceland

    Hilton Reykjavik Nordica, 2, Suðurlandsbraut, Háaleiti, Háaleiti og Bústaðir, Reykjavíkurborg, Höfuðborgarsvæðið, 108, Ísland

    Quality by Design Training Location in Iceland

    Grand Hotel Reykjavik, 38, Sigtún, Teigar, Laugardalur, Reykjavíkurborg, Höfuðborgarsvæðið, 105, Ísland

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    Corporate QbD Training

    Upskill Your Iceland Pharma Teams

    • Tailored QbD training for formulation, process, quality and regulatory teams
    • Onsite, live virtual or blended delivery across Iceland
    • Apply QbD tools to your own live development projects
    • Build a shared, science-based development language across sites
    • Flexible scheduling aligned to team and shift availability
    • Experienced trainers with pharmaceutical and biopharma expertise
    • Scalable delivery for local and multinational teams

    Trusted by Leading Enterprises in Iceland

    AlvotechCoripharmaEpiEndo PharmaceuticalsFlorealisKerecisOssur

    Enquire with us now

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    We also deliver Quality by Design Training across multiple cities in Iceland

    Quality by Design training for individuals and teams. Select a city in Iceland to view upcoming dates, formats and pricing.

    Quality by Design Training Course in Reykjavik

    Frequently Asked Questions

    Here's everything you may ask...

    Quality by Design is a systematic, science-based approach to pharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. It is defined by ICH Q8(R2) and supported by ICH Q9, Q10 and Q11, using tools such as the QTPP, Critical Quality Attributes, risk assessment, Design of Experiments and the control strategy.

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