Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Quality by Design Training in the Netherlands Covers

    Build Quality in from First Principles

    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 Netherlands

    Who Can Enrol?

    What You Gain from QbD Training

    Skills That Transfer Straight to the Lab

    Who Should Take Quality by Design Training in Netherlands?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Where QbD Skills Take You in Dutch Pharma

    Roles, Demand and Pay

    Quality by Design skills are in demand wherever pharmaceutical products are developed and made in the Netherlands, from Leiden Bio Science Park and Oss to biopharma and CDMO sites nationwide. Roles that value QbD fluency include formulation scientist, analytical scientist, process development engineer, QA manager and CMC regulatory affairs specialist. As regulators expect stronger process understanding and Dutch manufacturing capacity expands, professionals who can design quality in are increasingly sought after, and Quality by Design training is a direct route into these roles.

    What Is Driving Demand for QbD Skills in the Netherlands

    Quality by Design is a practical capability that pharmaceutical employers across the Netherlands need now. Join professionals who design quality in, not test it in, and lead development with confidence. Start your QbD journey today.

    Your Netherlands QbD Career Shift

    From Testing Quality in to Designing It In

    Your QbD Skills Upgrade

    The Dutch life sciences market is expanding with new manufacturing investment and stronger regulatory expectations, and employers increasingly separate professionals who can design quality in from those who only test it. Here is which side of that line you want to be on.

    Sources: PayScale, SalaryExpert (ERI), Glassdoor (Netherlands) 2026.

    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 Netherlands 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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    Skills You Will Build in This QbD Programme

    Tools You Can Apply to Live Projects

    This programme takes you through the full Quality by Design toolkit, from principles and the ICH regulatory context to QTPP, CQAs, risk assessment, DoE, the design space, PAT and the control strategy. Hands-on exercises apply each tool to realistic pharmaceutical development scenarios so you can use them straight away.

    Build a Quality Target Product Profile

    Learn what you will build in QbD training by starting with the QTPP: translate patient needs and clinical objectives into a prospective, measurable definition of the quality the product must achieve.

    Identify Critical Quality Attributes

    Identify and classify the physical, chemical, biological and microbiological CQAs that must stay within limits to ensure quality, safety and efficacy, for both small molecules and biologics.

    Run Risk Assessment with Ishikawa and FMEA

    Map potential sources of variation with Ishikawa diagrams and prioritise CMA and CPP relationships using FMEA and Risk Priority Number scoring to focus your development effort.

    Apply Design of Experiments and the Design Space

    Use screening and response-surface DoE to quantify how process parameters and material attributes drive CQAs, then define a design space with Normal Operating and Proven Acceptable Ranges.

    Use Process Analytical Technology

    Understand how PAT tools such as NIR and Raman spectroscopy enable real-time monitoring and real-time release testing, supplementing traditional end-product testing.

    Develop a Control Strategy for Submission

    Turn your risk assessment and DoE results into a control strategy covering material, process and in-process controls, and structure the evidence for a CTD regulatory submission.

    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 QbD Training

    Expert-Led, ICH-Aligned and Flexible

    Invensis Learning delivers structured, practical Quality by Design training for pharmaceutical and biopharmaceutical professionals who want to apply QbD to real development work. Our programmes combine experienced trainers, ICH-aligned content, hands-on tool exercises and flexible delivery. We are a trusted Quality by Design training company in the Netherlands. Whether you enrol as an individual or plan corporate training for your team, we focus on practical understanding, real-world application and measurable learning outcomes, backed by ISO-certified quality and information security standards.

    • Experienced trainers with real pharmaceutical and QbD practitioner backgrounds
    • Instruction aligned to the ICH Q8, Q9, Q10 and Q11 guidelines
    • Hands-on exercises using realistic QTPP, CQA, DoE and control-strategy scenarios
    • Flexible formats: live virtual, classroom and corporate onsite delivery
    • Course completion certificate from Invensis Learning on finishing the programme
    • ISO 9001:2015 quality and ISO 27001:2022 information security certified
    • Dedicated learner support before, during and after training
    • Scalable delivery for individuals and cross-functional teams in the Netherlands

    4

    Flexible Learning Modes

    99%

    Training Satisfaction

    5000+

    Accredited Trainers Globally

    4.7/5

    Rated by Learners Worldwide

    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 Netherlands

    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 Netherlands

    Lauswolt, Van Harinxma Weg 10, 9244 CJ Beetsterzwaag

    Quality by Design Training Location in Netherlands

    Hotel van Oranje, Kon. Wilhelmina Boulevard 20, 2202 GV Noordwijk

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    Corporate QbD Training for Teams

    Build Capability at Scale

    • Tailored QbD training for R&D, manufacturing science, QA and regulatory teams
    • Flexible delivery through onsite, live virtual, hybrid or blended formats
    • Schedules aligned with your development and production commitments
    • Trainers with hands-on pharmaceutical and QbD practitioner experience
    • Apply QTPP, CQA, DoE and control-strategy tools to your own live projects
    • Standardise QbD practice and reduce deviations across business units
    • Dedicated coordination and support for group training in the Netherlands

    Trusted by Leading Enterprises in Netherlands

    JanssenMSDGenmabAstellasByondisTakeda

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

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

    Quality by Design Training Course in AmsterdamQuality by Design Training Course in EindhovenQuality by Design Training Course in NijmegenQuality by Design Training Course in RotterdamQuality by Design Training Course in The HagueQuality by Design Training Course in Utrecht

    Frequently Asked Questions

    Here's everything you may ask...

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical development that builds quality into the product from the design stage rather than testing it in at the end. It matters because the ICH Q8 to Q11 guidelines mandate it and regulators such as the EMA and FDA increasingly expect QbD evidence in submissions.

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