Quality by Design Training in the Netherlands

Build Quality in by Design

Designed for formulation, analytical, process development, QA and CMC regulatory professionals across the Netherlands' life sciences sector, this instructor-led Quality by Design training programme shows you how to build quality into pharmaceutical products from the design stage using the ICH Q8 to Q11 framework, QTPP, CQAs, risk assessment, DoE, the design space and the control strategy.

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What Quality by Design Training in the Netherlands CoversBuild Quality in from First Principles

Quality by Design Training in the Netherlands teaches you to build quality into pharmaceutical and biopharmaceutical products from the design stage, rather than testing it in at the end. Quality by Design (QbD) is a systematic, science-based approach mandated by the ICH Q8(R2), Q9, Q10 and Q11 guidelines and increasingly expected by regulators including the EMA, whose headquarters sits in Amsterdam, and the FDA. Across one focused day you learn to apply the core QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy.

The programme suits formulation scientists, process development engineers, analytical scientists, QA professionals and CMC regulatory affairs specialists in the Netherlands' pharma, biopharma, API and CDMO organisations who want to replace trial-and-error development with a structured, regulator-ready method.

With major investment flowing into Dutch life sciences, from Leiden Bio Science Park to new large-scale manufacturing, QbD fluency is a practical, in-demand skill. Start building it with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Netherlands 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 Netherlands 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 Netherlands

Instructor-led training formats available for individual learners and corporate teams across the Netherlands
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 Netherlands
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 Netherlands 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 NetherlandsWho 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 QbD TrainingSkills That Transfer Straight to the Lab

For Individuals

Quality by Design training gives you a practical toolkit you can use the moment you return to work. You learn to define a QTPP, identify and classify CQAs, run structured risk assessment with Ishikawa diagrams and FMEA, and use DoE to understand how material and process variables shape product quality. Whether you develop small-molecule tablets or complex biologics, the method helps you predict and control quality instead of testing for it after the fact.

If you work in Dutch pharma, biopharma, API or CDMO organisations, QbD fluency is a clear, transferable strength. You gain the language regulators expect, the confidence to lead development decisions, and a structured approach that employers across the Netherlands increasingly value.

Design quality into products from the start, cutting costly end-stage testing and rework
Apply QTPP, CQA and risk-assessment tools to real formulation and process problems
Plan and interpret Design of Experiments to map a robust design space
Build control strategies that stand up to EMA and FDA scrutiny
Speak the language of CMC regulatory submissions with confidence
Move from trial-and-error development to a structured, science-based method
Strengthen your profile for roles across the Dutch life sciences sector

For Organizations

QbD group training helps organisations embed a shared, science-based approach to product and process development. Teams learn to link CQAs to critical material attributes and process parameters, define the design space through DoE, and build a control strategy that holds up in regulatory review. Delivered for R&D, manufacturing science, QA or regulatory groups, the training turns QbD from theory into everyday practice.

For Dutch life sciences organisations under pressure to submit faster and manufacture more consistently, QbD training creates one common language across functions. Teams gain a repeatable method for prioritisation, risk assessment and control that reduces deviations and strengthens regulatory relationships.

Standardise QbD practice across formulation, analytical, process and QA teams
Reduce manufacturing deviations and out-of-specification batches
Speed up regulator-ready CMC submissions with consistent QbD evidence
Cut post-approval change burden through a well-justified design space
Upskill cross-functional teams on their own live development projects
Build in-house capability that supports GMP and continuous improvement
Deliver training onsite, live virtual or blended to fit production schedules

Where QbD Skills Take You in Dutch PharmaRoles, 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.

EUR 82,000

Average pharma QA Manager salary, Netherlands

per year, SalaryExpert 2026

EUR 81,000

Regulatory Affairs CMC specialist salary

average, Glassdoor 2026

EUR 74,000

Formulation scientist salary, Netherlands

average, ERI SalaryExpert 2026

150+

Life sciences companies at Leiden Bio Science Park

Leiden Bio Science Park 2026

SECTORS HIRING

—Pharmaceutical Manufacturing and Development
—Biopharmaceuticals and Biotechnology
—Active Pharmaceutical Ingredient (API) Producers
—Contract Development and Manufacturing (CDMOs)
—Regulatory Affairs and CMC Consulting
—Medical Devices and Vaccines

GROWTH TRENDS

—Eli Lilly's 3 billion euro Leiden manufacturing investment
—EMA headquarters in Amsterdam raising regulatory demand
—Leiden Bio Science Park, a leading European life sciences cluster
—Regulators increasingly expecting QbD evidence in submissions
—Growth in biologics, GLP-1 and cell and gene therapies
—Shift to continuous manufacturing and real-time release

Sources: PayScale, SalaryExpert (ERI), Glassdoor (Netherlands) 2026; Leiden Bio Science Park; Panda International Dutch Life Sciences 2026.

Designation

Quality by Design Professionals in Netherlands : Salary Insights and Trends

Hiring Companies in Netherlands

EUR44K

Min

EUR62K

Average

EUR90K

Max

PayScale, SalaryExpert (ERI) Netherlands 2026

JanssenAstellasByondisSynthon

Source: Janssen NL, Astellas, Byondis, Synthon

What Is Driving Demand for QbD Skills in the Netherlands

Regulator Expectations Are Rising

With the EMA based in Amsterdam and the FDA aligned on ICH, health authorities increasingly expect QbD evidence, QTPP, design space and control strategy, in pharmaceutical submissions.

QbD builds regulator-ready process understanding

Trial-And-Error Development Is Too Slow

Empirical, one-factor-at-a-time development wastes time and material. Dutch developers need DoE and design-space thinking to characterise processes faster and more reliably.

QbD replaces guesswork with structured DoE

A Wave of New Manufacturing

Large investments such as Eli Lilly's Leiden facility demand teams who understand critical process parameters and control strategy to bring new capacity online consistently.

QbD supports scale-up and tech transfer

Biologics Add Complexity

The Dutch biopharma base works on monoclonal antibodies, biosimilars and gene therapies, where CQAs like glycosylation and aggregation demand rigorous, science-based control.

QbD builds CQA control for complex products

The Shift to Continuous Manufacturing

As producers move from batch to continuous lines, Process Analytical Technology and a robust design space become essential to monitor and control quality in real time.

QbD underpins PAT and real-time release

A Cross-Functional Skills Gap

Formulation, analytical, process and regulatory teams often work in silos. Employers need a shared QbD language so quality decisions are consistent from development to submission.

QbD gives teams one shared method

Sources: Leiden Bio Science Park; Panda International Dutch Life Sciences 2026; ICH Q8 to Q11 guidelines; EMA (Amsterdam).

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.

Today

Limited visibility of how material and process variation affects quality

After QbD Training

A mechanistic understanding linking CMAs and CPPs to CQAs

Today

Limited visibility of how material and process variation affects quality

Today

Contribution limited to a single technical function

After QbD Training

Cross-functional value across formulation, analytical, QA and regulatory teams

Today

Contribution limited to a single technical function

Today

Overlooked for roles that expect science-based development skills

After QbD Training

Ready for QbD-focused roles at pharma, biopharma and CDMO employers in the Netherlands

Today

Overlooked for roles that expect science-based development skills

You master QbD

Before

Quality is checked at the end through end-product testing

Now you have

Quality is built into the product from the design stage

Before

Quality is checked at the end through end-product testing

Before

Development runs on trial-and-error, one factor at a time

Now you have

A structured DoE approach that maps a robust design space

Before

Development runs on trial-and-error, one factor at a time

Before

Risk is assessed informally, if it is assessed at all

Now you have

Formal QTPP, CQA and FMEA-based risk-assessment skills

Before

Risk is assessed informally, if it is assessed at all

Before

Submissions get queried on weak process understanding

Now you have

Regulator-ready control strategies aligned to ICH Q8 to Q11

Before

Submissions get queried on weak process understanding

"The gap between running experiments and engineering quality is a science-based method, and the pharmaceutical employers that matter already expect it."

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

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

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

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

100% Secure and Safe download

Skills You Will Build in This QbD ProgrammeTools 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.

Who Should TakeQuality by Design Training in Netherlands?

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 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 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.

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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 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 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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Please Note: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.

Loading schedules…

Why Choose Invensis Learning for QbD TrainingExpert-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

Flexible Learning Modes

98%

First-Attempt Pass Rate

5000+

Accredited Trainers Globally

4.7/5

Rated by Learners Worldwide

ISO 9001:2015 Certified

ISO 27001:2022 Certified

Secure SSL Encryption

Leaders in Training industry for 12+ years

Over 5000 five star reviews

Level AA conformance, W3C WCAG 2.2

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

Quality by Design in Netherlands

Lauswolt, Van Harinxma Weg 10, 9244 CJ Beetsterzwaag

Quality by Design in Netherlands

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

Quality by Design in Netherlands

Lauswolt, Van Harinxma Weg 10, 9244 CJ Beetsterzwaag

Quality by Design in Netherlands

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

Corporate QbD Training for TeamsBuild Capability at Scale

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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

What Our Learners Say

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A Structured Way to Design Quality In

"The QTPP and CQA sessions completely changed how I scope a new formulation. I now start from the target quality and work back to the process, instead of testing my way to an answer at the end."

Sanne de Vries

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DoE Finally Made Sense

"The Design of Experiments and design-space exercises were the highlight. As an analytical scientist I finally understand how our method data feeds into the control strategy that regulators want to see."

Bram Jansen

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Practical Risk-Assessment Skills

"Clear, practical and well paced. The risk-assessment tools, Ishikawa and FMEA, gave me a repeatable way to prioritise critical process parameters on our tech-transfer projects."

Ingrid Bakker

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One Shared QbD Language Across Teams

"We ran this as an onsite programme for our QA and regulatory teams. Everyone now shares the same QbD language, and our pharmaceutical development reports are far more consistent and submission-ready."

Joost Willemsen

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Tailored and Relevant for Our Pipeline

"The trainer tailored the case studies to our biologics pipeline, which made the CQA and control-strategy content directly relevant. A strong, practical investment in our development team."

Marloes Peters

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4.6

Ratings

100K+

Happy Learners

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Locations Worldwide

99%

Training Satisfaction

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Invensis Learning delivers industry-leading Quality by Design training solutions tailored for individuals and organizations.

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Frequently Asked QuestionsHere'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.

General

What is Quality by Design and why does it matter?

Who should attend QbD training in the Netherlands?

The training suits formulation scientists, process development engineers, analytical scientists, QA professionals and CMC regulatory affairs specialists in Dutch pharma, biopharma, API, CDMO and medical device organisations who want to apply QbD in development and submissions.

Is Quality by Design training worth it for my career?

Yes. QbD is a practical, in-demand skill across the Netherlands' life sciences sector, where roles from formulation scientist to QA manager and CMC regulatory specialist value it. As Dutch manufacturing expands and regulators raise expectations, professionals who can design quality in stand out.

Do I need prior QbD experience to join?

No. The course introduces QbD from first principles in a pharmaceutical development context. Familiarity with pharmaceutical development or GMP is helpful but not required, so scientists new to QbD can follow along comfortably.

Which ICH guidelines does the training cover?

The programme is grounded in ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 Development and Manufacture of Drug Substances, the framework that defines the modern QbD approach.

Pricing

How much does Quality by Design training cost in the Netherlands?

Pricing depends on the delivery format, group size and whether you enrol as an individual or a corporate team. For current fees and available dates, request a quote and a learning advisor will share the options that suit you.

What is included in the QbD course fee?

The fee typically covers instructor-led training across all QbD modules, hands-on tool exercises, learning materials and a course completion certificate from Invensis Learning. Ask about the exact inclusions for your chosen format.

Do you offer group or corporate pricing?

Yes. We offer corporate group training with tailored content and volume-based pricing for teams in R&D, manufacturing science, QA and regulatory functions. Contact us for a group quote for your organisation.

What payment options are available?

We accept major cards and bank transfers, and can arrange invoicing for corporate bookings. Speak with a learning advisor to choose the option that works for you or your team.

Is there a discount for team enrolments?

Group enrolments are priced on a per-team basis, so larger cohorts benefit from better rates than individual bookings. Ask about corporate or group pricing when you request a quote.

Assessment

Is there an exam for the QbD course?

No. Quality by Design training is a non-certification skills course with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and group discussion during the programme.

Do I receive a certificate after the training?

Yes. You receive a course completion certificate from Invensis Learning once you finish the programme. This recognises your participation and the practical QbD skills you have built, and does not expire.

How is learning assessed during the programme?

Learning is assessed informally through hands-on exercises rather than a formal test. You construct a QTPP, identify CQAs, build an Ishikawa diagram, select a DoE design and interpret a design space using realistic development scenarios.

What will I be able to do after completing the training?

You will be able to construct a QTPP, identify and classify CQAs, run risk assessment with Ishikawa and FMEA, plan and interpret a DoE, define a design space, and develop a control strategy for a regulatory submission.

Is this a certification course?

No. This is a practical, non-certification training course focused on building workplace QbD skills. There is no governing body or credential; the value is the method and tools you can apply immediately at work.

Course Content

What topics does the QbD training cover?

The course covers QbD principles and the ICH regulatory context, the QTPP and CQAs, risk assessment, Design of Experiments and the design space, Process Analytical Technology, the control strategy, and QbD in practice through case studies and lifecycle management.

Does the course cover both small molecules and biologics?

Yes. The training addresses QbD for both small-molecule drug products, such as tablets and injectables, and biopharmaceutical products such as monoclonal antibodies and biosimilars, with case study examples from both.

Is Design of Experiments covered hands-on?

Yes. DoE is a core module, covered through worked examples and a design-selection exercise. You learn screening and response-surface designs, how to interpret the model output, and how the results define the design space.

What is Process Analytical Technology in QbD?

PAT is a system for monitoring critical quality and process attributes in real time during manufacturing. The course explains tools such as NIR and Raman spectroscopy and how PAT supports real-time release testing within a QbD control strategy.

What learning materials are provided?

You receive structured course materials covering all QbD modules, worked case studies and tool exercise templates for the QTPP, CQA identification, risk assessment and design space, so you can reuse the approach on your own projects.

Enrollment

How do I enrol in the QbD course?

You can enrol through the Invensis Learning website. Choose your preferred format, complete the booking, and you will receive access to the schedule, joining details and learning materials. A learning advisor can help you pick a date.

What training formats are available?

The course is available as live virtual instructor-led training, classroom training and corporate onsite delivery. You can choose the format that best fits your schedule, or ask about a tailored programme for your team.

How long is the Quality by Design training?

The programme runs for one day, around eight hours, covering all QbD modules with concept explanations, the ICH regulatory context and hands-on tool exercises. Corporate sessions can be arranged over a schedule that suits your team.

Can the course be delivered onsite for our team in the Netherlands?

Yes. We deliver QbD training onsite at your Dutch site, or live virtual and blended for distributed teams. Onsite delivery works well because participants can apply the tools to their own live development projects. Request corporate training to arrange it.

Can I reschedule my booking?

Yes. Flexible options let you reschedule or transfer to another session where needed. Contact our support team and they will help you move to a date that works for you.