Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design?UntitledA Science-Led Approach to Pharma Development

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This Quality by Design training in Belgium gives scientists, engineers and quality professionals the tools to apply that approach on real work. The programme is grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH quality framework of Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Q11 (drug substances), the standards that regulators such as the FDA and EMA expect behind modern submissions. You learn to define the Quality Target Product Profile, identify critical quality attributes, run risk assessment and Design of Experiments, establish the design space and build a control strategy. Delivered in live virtual and classroom formats, the one-day course suits professionals in Belgium's pharma, biopharma, API and CDMO sector who want to move from trial-and-error development to predictable, well-understood quality. Start building your QbD capability with Invensis Learning.

    What Is Quality by Design?A Science-Led Approach to Pharma Development

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This Quality by Design training in Belgium gives scientists, engineers and quality professionals the tools to apply that approach on real work.

    The programme is grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH quality framework of Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Q11 (drug substances), the standards that regulators such as the FDA and EMA expect behind modern submissions. You learn to define the Quality Target Product Profile, identify critical quality attributes, run risk assessment and Design of Experiments, establish the design space and build a control strategy.

    Delivered in live virtual and classroom formats, the one-day course suits professionals in Belgium's pharma, biopharma, API and CDMO sector who want to move from trial-and-error development to predictable, well-understood quality. Start building your QbD capability with Invensis Learning.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Belgium 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 Belgium 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 Belgium

    • Instructor-led training formats available for individual learners and corporate teams across the Belgium
    • 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 Belgium
    • 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 Belgium 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 BelgiumWho 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 You Apply from Day One

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical and biopharmaceutical professionals build practical, science-based development skills. The course suits formulation and analytical scientists, process development engineers, QA specialists and regulatory affairs professionals who want to apply QbD on real work. Whether you are developing a new tablet formulation, characterising a biologic process or preparing a regulatory submission, the training turns ICH principles into tools you can use immediately.

    If you work in Belgium's life sciences sector and want to move from empirical, test-and-fix development to predictable quality, QbD is a capability employers increasingly expect. You leave able to construct a QTPP, run a risk assessment, plan a DoE and build a control strategy.

    • Design quality into products from the start instead of testing for it at the end
    • Apply QbD tools such as QTPP, CQA identification and risk assessment on live projects
    • Plan and interpret Design of Experiments to define a robust design space
    • Build control strategies that hold up to FDA and EMA expectations
    • Speak the ICH Q8 to Q11 language shared across Belgium's pharma employers
    • Reduce manufacturing deviations, rework and out-of-specification batches
    • Strengthen your profile for formulation, process, analytical and QA roles
    • Contribute to CTD Module 3 development submissions with confidence
    For Organizations

    For Organizations

    QbD group training helps pharmaceutical organisations embed a consistent, ICH-aligned approach to product and process development across teams. The training can be delivered for R&D groups, manufacturing sites, QA functions or cross-functional development teams. For companies looking to reduce deviations and build stronger regulatory submissions, this training provides a scalable, practical solution.

    If your teams still rely on trial-and-error development and end-product testing, QbD training creates a common framework for building quality in. Development, quality and regulatory colleagues gain a shared approach to QTPP, risk assessment, design space and control strategy.

    • Builds a shared QbD language across formulation, process, analytical, QA and regulatory teams
    • Reduces batch failures, deviations and costly late-stage development rework
    • Strengthens FDA and EMA submissions with documented design spaces and control strategies
    • Speeds technology transfer and scale-up through deeper process understanding
    • Supports continuous and modern manufacturing readiness
    • Delivered onsite or live virtual for cross-functional development teams
    • Aligns in-house practice with the ICH Q8 to Q11 framework

    Where QbD Skills Lead in BelgiumRoles and Demand in Life Sciences

    Quality by Design skills are in strong demand across Belgium, one of the world's leading biopharmaceutical hubs and the European country with the highest R&D spend per inhabitant. Major employers including Pfizer, UCB, GSK Vaccines, Janssen and Novartis run large development and manufacturing operations where ICH-aligned QbD capability is increasingly expected. Demand spans formulation, analytical, process development, QA and regulatory roles, and here is what the market is telling us right now.

    28%

    Pharma manufacturing pay premium, Belgium

    above national average, 2026

    $6.56bn

    Belgium biopharma R&D investment

    per year, trade.gov

    EUR 105,796

    Regulatory Affairs Manager salary

    average, SalaryExpert 2026

    $8.89bn

    Belgium pharma market by 2026

    Mordor Intelligence

    SECTORS HIRING

    • —Pharmaceutical Manufacturing and Development
    • —Biopharmaceuticals and Biotech
    • —Vaccine Development and Production
    • —Active Pharmaceutical Ingredient (API) Manufacturing
    • —Contract Development and Manufacturing (CDMOs)
    • —Regulatory Affairs and CMC Consulting

    GROWTH TRENDS

    • —Belgium ranks among the world's top pharmaceutical exporters
    • —Highest biopharma R&D spend per inhabitant in Europe
    • —Major investment by Pfizer Puurs, UCB, GSK Vaccines and Janssen
    • —Regulators increasingly expect QbD evidence in submissions
    • —Shift toward continuous and modern manufacturing
    • —Strong demand for scientists fluent in ICH Q8 to Q11

    Sources: trade.gov, Mordor Intelligence, PharmExec, SalaryExpert, PayScale, Paylab (Belgium) 2026.

    Why QbD Skills Are in Demand Across Belgian Pharma

    The Test-And-Fix Development Gap

    Many teams still set specifications empirically and rely on end-product testing. QbD replaces this with mechanistic understanding, and professionals who can apply it are increasingly sought after.

    QbD builds science-based development skills

    Rising Regulatory Expectations

    The FDA and EMA increasingly expect QbD evidence, including design space and control strategy, in submissions. Belgian exporters need staff who can build that evidence into CTD Module 3.

    QbD builds submission-ready evidence skills

    Biologics and Vaccine Complexity

    Belgium's vaccine and biologics base at GSK, UCB and Pfizer demands QbD for process-defined products, where CQAs such as glycosylation and aggregation must be understood and controlled.

    QbD builds CQA and process understanding

    Scale-Up and Technology Transfer Risk

    Transferring processes to commercial scale often fails through trial and error. Design space knowledge lets teams predict and control quality, cutting deviations during scale-up.

    QbD builds design space and control skills

    The Shift to Continuous Manufacturing

    Belgian sites are modernising toward continuous and real-time-release production. These lines depend on QbD process understanding and PAT to control quality in real time.

    QbD builds PAT and real-time control skills

    Scarcity of ICH-Fluent Talent

    The sector has deep GMP and QC talent but fewer people fluent in ICH Q8 to Q11 and DoE. QbD capability makes scientists and engineers stand out to Belgian employers.

    QbD makes scientists and engineers stand out

    Sources: trade.gov, PharmExec, Mordor Intelligence, ICH Q8 to Q11 (Belgium) 2026.

    QbD is more than a concept. It is a capability that Belgium's pharma and biopharma employers are actively hiring for. Join professionals who design quality in rather than test it in. Start your journey today.

    Your Belgium QbD Transformation

    From Test-And-Fix to Quality by Design

    The Shift QbD Training Delivers

    Belgium's pharmaceutical and biopharmaceutical sector is investing heavily and modernising fast, and employers increasingly separate professionals who can build quality in from those who only test for it. Here is which side of that line you want to be on.

    Today

    You set specifications empirically and rely on end-product testing

    After QbD

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

    Today

    Scale-up and technology transfer are managed by trial and error

    After QbD

    You use process understanding to predict and control quality at scale

    Today

    You react to deviations and out-of-specification results after the fact

    After QbD

    You prevent deviations through risk assessment and a robust control strategy

    You build QbD capability

    Before

    Development skills limited to your own trial-and-error experience

    Now you have

    A structured, ICH-aligned QbD toolkit recognised across the sector

    Before

    Little visibility of how inputs actually drive product quality

    Now you have

    The ability to link material and process variables to CQAs through DoE

    Before

    Submissions queried by regulators for weak development rationale

    Now you have

    Documented design space and control strategy evidence for CTD Module 3

    Before

    A profile that blends in among GMP and QC generalists

    Now you have

    A capability Belgian pharma and biopharma employers actively look for

    "The gap between testing quality in and designing it in is what regulators and employers now reward, and the organisations that matter already know it."

    Join 50,000+ professionals who trained with Invensis Learning and built new capability.

    Sources: SalaryExpert, PayScale, Paylab, trade.gov (Belgium) 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 Belgium 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.

    image

    100% Secure and Safe download

    The QbD Tools You Will MasterApplied Skills for Real Development Work

    This Quality by Design course teaches the full QbD toolkit, from defining the Quality Target Product Profile through to building the control strategy. Each skill maps to the ICH Q8 to Q11 framework and to real pharmaceutical development and manufacturing work.

    Building the Quality Target Product Profile

    Construct a QTPP from clinical and patient needs, defining the dosage form, delivery, pharmacokinetic targets and quality standards that anchor the entire development programme.

    Identifying Critical Quality Attributes

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

    Risk Assessment with FMEA and Ishikawa

    Use fishbone diagrams and FMEA with Risk Priority Numbers to link critical material attributes and process parameters to CQAs and prioritise what needs formal study.

    Design of Experiments and the Design Space

    Plan screening and response-surface DoE, interpret the models, and define the design space with Normal Operating and Proven Acceptable Ranges instead of one-factor-at-a-time testing.

    Process Analytical Technology in Practice

    Apply PAT tools such as NIR and Raman for real-time monitoring, and understand how real-time release testing supports modern, in-line quality control.

    Building the Control Strategy

    Turn risk assessment and DoE results into a holistic control strategy covering material controls, process ranges, in-process controls and PAT, ready for CTD Module 3.

    Who Should TakeQuality by Design Training in Belgium?

    Process Engineers

    QC Analysts

    Engineering Teams

    Technical Staff

    Production Managers

    Distribution Managers

    Regulatory Affairs Specialists

    Quality Assurance Professionals

    Who Can Take This Certification Training

    Quality by Design Training Modesfor Professionals and Teams

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

    Quality by Design Live Virtual Training

    • Live online instructor-led sessions

    • Interactive discussions and virtual activities

    • Expert guidance from experienced trainers

    • Practice assessments and revision support

    • Dedicated Q&A sessions for concept clarification

    • Fixed schedules for accountability and momentum

    • Small batch sizes for personalized attention

    • Access from any location with internet connectivity

    EUR 430

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

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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

    EUR 430

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

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

    Loading schedules…

    Why Choose Invensis Learning for Quality by Design Training in BelgiumExpert-Led, Flexible and Practical

    Invensis Learning delivers practical, instructor-led Quality by Design training for pharmaceutical professionals and organisations across Belgium and worldwide. Our programmes combine experienced trainers with real-world pharma and quality expertise, flexible delivery formats and structured, hands-on courseware. As an ISO 9001:2015 and ISO 27001:2022 certified Quality by Design training company in Belgium, we bring proven quality and information-security standards to every engagement. Whether you enrol as an individual or arrange training for your team, you gain a professional learning experience built around practical understanding and real workplace application.

    • Experienced trainers with real pharmaceutical and quality management expertise
    • Live virtual and classroom formats that fit working professionals
    • Hands-on exercises in QTPP, CQA identification, risk assessment and DoE
    • Courseware grounded in the ICH Q8 to Q11 framework
    • ISO 9001:2015 certified for quality management
    • ISO 27001:2022 certified for information security
    • Customised corporate delivery for pharma and biopharma teams
    • Dedicated learner support before, during and after training

    12M+

    Hours of Training Delivered

    4

    Flexible Learning Modes

    98%

    First-Attempt Pass Rate

    5000+

    Accredited Trainers Globally

    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 BelgiumAll our classroom training is now available online at your convenience

    Quality by Design in Belgium

    Warwick Brussels Rue Duquesnoy 5, 1000 Bruxelles, Belgium

    Quality by Design in Belgium

    Hilton Antwerp Old Town Groenplaats 32, 2000 Antwerpen, Belgium

    corporate banner

    Corporate QbD Training for TeamsUpskill Your Pharma Teams

    Untitled

    • Suitable for small, medium and large development and quality teams
    • Customised schedules aligned with your site and project timelines
    • Delivered onsite, live virtual or in a blended format
    • Trainers with real pharmaceutical and QbD implementation experience
    • Role-based examples for formulation, process, analytical, QA and regulatory staff
    • Dedicated coordination and support for corporate programmes
    • Scalable delivery for teams across Belgium and global sites

    Trusted by Life Sciences Teams

    UCBGSKJanssenPfizerNovartisSanofi

    What Our Learners Say

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    QbD I Can Use on Real Formulations

    "The course finally connected the ICH theory to daily work. I now build a QTPP and identify CQAs at the start of a formulation project instead of chasing problems in end-product testing. The QTPP and risk assessment exercises were the highlight."

    Lien Vermeulen

    Formulation Scientist

    Untitled

    0/0

    DoE and Design Space Made Practical

    "The Design of Experiments and design space sessions changed how I approach scale-up. Understanding NOR and PAR gave me a much clearer way to characterise a process and defend the ranges we operate in. Very practical trainer."

    Thomas Dubois

    Process Development Engineer

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    Directly Relevant to Analytical Work

    "A clear, well-paced day. The risk assessment and PAT content was directly relevant to our analytical work, and the fishbone and FMEA exercises helped me see how to prioritise what actually drives quality. I would recommend it to any lab scientist."

    Sofie Janssens

    Analytical Scientist

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    A Shared Language Across Our Team

    "We ran this as an onsite session for a cross-functional development team. It gave formulation, process and QA colleagues a shared QbD language, and we have already seen fewer late-stage surprises. The delivery was tailored well to our projects."

    Marc Peeters

    Head of Pharmaceutical Development

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    Stronger Submissions from Our Teams

    "Strong corporate training. Our QA and regulatory staff now understand how design space and control strategy strengthen a submission, which has improved the quality of our development reports. Coordination and support from the team were excellent."

    Isabelle Laurent

    QA Director, Biopharma

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

    QbD training is a one-day, non-certification course on the science-based approach to pharmaceutical development, where quality is built into a product from the design stage rather than tested in at the end. It covers the ICH Q8 to Q11 framework and tools such as QTPP, CQAs, DoE and control strategy.

    General

    What is Quality by Design (QbD) training?

    QbD training is a one-day, non-certification course on the science-based approach to pharmaceutical development, where quality is built into a product from the design stage rather than tested in at the end. It covers the ICH Q8 to Q11 framework and tools such as QTPP, CQAs, DoE and control strategy.

    Is QbD training worth it for my career in Belgium?

    Yes. QbD is increasingly expected across Belgium's pharma and biopharma employers, from UCB and GSK to Pfizer and Janssen. The practical skills apply directly to formulation, process, analytical, QA and regulatory roles, making you more effective and more marketable.

    Which ICH guidelines does the training cover?

    The training is grounded in ICH Q8(R2) Pharmaceutical Development, supported by Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Q11 (drug substances). These are the internationally harmonised standards that regulators such as the FDA and EMA expect behind modern submissions.

    Who should attend the QbD course?

    The course suits formulation and analytical scientists, process development engineers, QA professionals, regulatory affairs and CMC specialists, and manufacturing technical managers in pharma, biopharma, API and CDMO organisations who want to apply QbD in their work.

    Do I need prior experience to attend?

    No formal prerequisites are required. Familiarity with pharmaceutical development or GMP is helpful but not essential, as the course introduces QbD from first principles in a development context.

    Is QbD relevant to both small molecules and biologics?

    Yes. The training covers QbD for small molecule drug products such as tablets and injectables, and for biologics such as monoclonal antibodies and vaccines. That balance is especially relevant in Belgium's strong vaccine and biopharma sector.

    Pricing

    How much does QbD training cost in Belgium?

    Fees vary by delivery format (live virtual, classroom or corporate) and group size. Pricing is available on request, so contact a learning advisor for a quote tailored to your needs.

    What is included in the course fee?

    The fee typically covers instructor-led training across all six QbD modules, hands-on tool exercises, courseware and learning materials, learner support, and a certificate of completion from Invensis Learning. Request a quote for exact inclusions.

    Do you offer group or corporate pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for pharma and biopharma teams. Ask about corporate pricing for a tailored quote.

    What payment options are available?

    We accept major cards and bank transfers, and offer instalment options on selected plans. Speak with a learning advisor to choose the option that suits you.

    Is the fee the same across delivery formats?

    Pricing varies by format and group size. Live virtual, classroom and onsite corporate delivery are each quoted separately. Request a quote for current pricing in Belgium.

    Assessment

    How is learning assessed on the course?

    There is no formal assessment. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and group discussion throughout the one-day programme, so you apply each tool as you learn it.

    Do I receive anything on completion?

    Yes. You receive a certificate of completion from Invensis Learning. This confirms attendance and the skills covered; it is a practical skills training course, not a credential awarded by an external body.

    What will I be able to do after the training?

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

    Are the QbD tools practised during the session?

    Yes. The course includes hands-on exercises applying QTPP construction, CQA identification, risk assessment and design space interpretation to realistic pharmaceutical development scenarios.

    Does the training align to current regulatory expectations?

    Yes. The content follows the ICH Q8(R2) guideline and the wider Q9, Q10 and Q11 framework, aligned to FDA and EMA expectations for QbD evidence in pharmaceutical submissions.

    Course Content

    What topics does the QbD course cover?

    The one-day course spans six modules: QbD principles and the ICH framework, QTPP and CQAs, risk assessment, Design of Experiments and design space, PAT and control strategy, and QbD in practice through case studies and lifecycle management.

    What learning materials are provided?

    You receive structured courseware, QbD tool templates, worked case studies and exercise materials covering QTPP, CQA identification, risk assessment, DoE and control strategy.

    Are there hands-on exercises?

    Yes. Practical exercises run throughout, including QTPP construction, CQA and criticality assessment, Ishikawa and FMEA risk assessment, and design space interpretation using realistic development scenarios.

    Does the course cover Design of Experiments in depth?

    Yes. You learn why DoE replaces one-factor-at-a-time testing, the main design types (screening, response surface, mixture), how to interpret the models, and how to define the design space, NOR and PAR.

    How long is the QbD training?

    The programme runs for one day, totalling eight hours. It can be delivered as a full day or as two half-days, covering all six QbD modules with exercises throughout.

    Is PAT and control strategy included?

    Yes. The course covers Process Analytical Technology tools such as NIR and Raman, real-time release testing, and how to build a holistic control strategy from your risk assessment and DoE outputs.

    Enrollment

    How do I enrol in the QbD training?

    You can enrol through the Invensis Learning website. Choose your preferred format, complete payment, and you will receive access to schedules, courseware and learning resources. Talk to a learning advisor to get started.

    What delivery formats are available?

    The course is available as live virtual instructor-led training, classroom training, and customised corporate onsite delivery, so you can choose the format that fits your schedule and team.

    When are the next sessions?

    New sessions run regularly in live virtual and classroom formats. See upcoming schedules or ask an advisor about the next available dates in Belgium.

    Can you deliver training onsite for our team?

    Yes. We deliver QbD training onsite or live virtual for pharma and biopharma teams across Belgium, with content and schedules tailored to your projects. Request corporate training for details.

    Can I reschedule my booking?

    Yes. Flexi options let you reschedule to another session. Contact support to arrange a change to your booking.

    What is the refund or cancellation policy?

    Refunds and cancellations follow our published policy. Reach out to our team for the details that apply to your enrolment.