Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Quality by Design Delivers for Swiss Pharma TeamsUntitledA Science-Based Route to Consistent Quality

    Quality by Design Training in Switzerland gives pharmaceutical and biopharmaceutical professionals a systematic, science-based way to build quality into a product from the design stage rather than testing it in at the end. Quality by Design (QbD) is the approach set out in the ICH Q8, Q9, Q10 and Q11 guidelines and increasingly expected by regulators such as the FDA and EMA in modern development and manufacturing submissions. Over 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. Hands-on exercises use realistic development scenarios, so you leave able to apply each tool at the bench, not just describe it. The course suits formulation and analytical scientists, process development engineers, QA and regulatory affairs specialists across Switzerland's Basel and Lake Geneva clusters who want to work the way ICH guidelines and health authorities now expect.

    What Quality by Design Delivers for Swiss Pharma TeamsA Science-Based Route to Consistent Quality

    Quality by Design Training in Switzerland gives pharmaceutical and biopharmaceutical professionals a systematic, science-based way to build quality into a product from the design stage rather than testing it in at the end. Quality by Design (QbD) is the approach set out in the ICH Q8, Q9, Q10 and Q11 guidelines and increasingly expected by regulators such as the FDA and EMA in modern development and manufacturing submissions.

    Over 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. Hands-on exercises use realistic development scenarios, so you leave able to apply each tool at the bench, not just describe it.

    The course suits formulation and analytical scientists, process development engineers, QA and regulatory affairs specialists across Switzerland's Basel and Lake Geneva clusters who want to work the way ICH guidelines and health authorities now expect.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Switzerland 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 Switzerland 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 Switzerland

    • Instructor-led training formats available for individual learners and corporate teams across the Switzerland
    • 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 Switzerland
    • 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 Switzerland 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 SwitzerlandWho 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 Applying QbDValue for Individuals and Pharma Teams

    For Individuals

    For Individuals

    QbD training helps scientists and engineers replace empirical trial and error with a structured, science-based method. You learn to define what a product must achieve, identify what is critical to quality, and control it through understanding rather than end-product testing. Whether you work in formulation, analytics, process development, QA or regulatory affairs, the course builds capabilities that Swiss pharmaceutical and biopharmaceutical employers actively look for.

    If you want practical, immediately usable skills that align with how ICH guidelines and regulators expect development to be done, QbD training is a clear step forward. You gain tool fluency, worked examples and confidence to apply each step on live projects.

    • Build quality into products from the design stage instead of testing it in later
    • Apply the full QbD toolkit: QTPP, CQAs, risk assessment, DoE and control strategy
    • Read and contribute to ICH Q8, Q9, Q10 and Q11 aligned development work with confidence
    • Lead CQA identification and FMEA risk workshops on your own projects
    • Plan and interpret Design of Experiments to define a robust design space
    • Translate process understanding into a defensible control strategy
    • Strengthen your value to Basel and Lake Geneva pharma and biotech employers
    • Gain skills you can use immediately, with a course completion certificate from Invensis Learning
    For Organizations

    For Organizations

    QbD group training helps organisations build development capability by equipping cross-functional teams with a common, structured approach. It can be delivered for formulation, analytical, process, QA and regulatory groups together. For pharmaceutical and biopharmaceutical organisations in Switzerland working to reduce deviations and strengthen submissions, this training provides a scalable, flexible solution.

    If your teams struggle to connect process understanding to consistent quality and to regulatory evidence, QbD group training creates a shared method. Teams gain a standardised approach to risk assessment, design space and control strategy.

    • Give development teams a shared, science-based QbD language across functions
    • Reduce manufacturing deviations and out-of-specification results through better process understanding
    • Strengthen regulatory submissions with QTPP, design space and control strategy evidence
    • Cut post-approval change burden by working within an approved design space
    • Align formulation, analytical, process, QA and regulatory teams on one approach
    • Support the shift to biologics, high-potency APIs and continuous manufacturing
    • Build in-house capability rather than relying on external consultants
    • Train cross-functional teams together on live product development projects

    Where QbD Skills Take You in SwitzerlandRoles, Sectors and Demand Now

    Quality by Design skills are in demand across Switzerland's life sciences heartland, from the Basel BioValley to the Lake Geneva region, where Roche, Novartis, Lonza and a dense cluster of biotech and CDMO employers run science-based development and manufacturing. As the sector shifts toward biologics, high-potency APIs and continuous manufacturing, professionals who can apply QbD to design, characterise and control processes are increasingly sought after, and here is what the Swiss market is telling us right now.

    CHF 152bn

    Swiss life sciences exports

    2025 record, Swiss Biotech Report 2026

    900+

    Companies in the Basel cluster

    pharma and medtech, Swiss Biotech

    21,000+

    Biotech R&D employees, Switzerland

    record high, Swiss Biotech Report 2026

    CHF 102k

    QC and QA specialist pay, Basel

    average per year, Glassdoor 2026

    SECTORS HIRING

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

    GROWTH TRENDS

    • —Basel and Lake Geneva clusters anchoring global R&D
    • —Shift to biologics, cell and gene therapies
    • —High-potency API and continuous manufacturing growth
    • —Pharma 4.0 and AI-driven quality control adoption
    • —Rising regulatory expectation of QbD evidence
    • —Record biotech investment fuelling new capacity

    Sources: Swiss Biotech Report 2026 (scienceindustries, Swiss Biotech); Glassdoor, SalaryExpert, PayScale (Switzerland) 2026.

    Market Pressures Making QbD Skills Essential in Switzerland

    Biologics and Cell Therapy Complexity

    Switzerland's shift to biologics, cell and gene therapies brings process-defined products that are highly sensitive to conditions, demanding the process understanding QbD provides.

    QbD builds deep process understanding skills

    Continuous Manufacturing and Pharma 4.0

    As Swiss producers adopt continuous manufacturing and AI-driven quality control, teams need QbD design spaces and PAT to monitor and control quality in real time.

    QbD builds design space and PAT skills

    Rising Regulatory Expectations

    The FDA and EMA increasingly expect QbD evidence in submissions, so development teams must present QTPP, design space and control strategy to satisfy reviewers.

    QbD builds submission-ready evidence skills

    High-Potency API Handling

    Growth in high-potency APIs raises the stakes on process control, where risk assessment and a robust control strategy keep quality and safety consistent.

    QbD builds risk assessment and control skills

    Global Submission Portfolios

    Swiss firms file to health authorities worldwide, and CMC teams need QbD fluency to prepare and defend Section 3.2.P.2 pharmaceutical development sections.

    QbD builds CMC documentation skills

    Portfolio Talent Scarcity

    The cluster is deep in bench scientists but thin in professionals who can lead QbD end to end, making QbD capability a clear differentiator in the market.

    QbD makes end-to-end practitioners stand out

    Sources: Swiss Biotech Report 2026; scienceindustries; MarketsandMarkets, SIGTAX (Switzerland life sciences) 2026.

    QbD is fast becoming the default language of Swiss pharmaceutical development. Build the skills to design quality in and lead development the way ICH guidelines and regulators now expect. Start today.

    Your Switzerland Career Transformation

    How QbD Reshapes Your Development Work

    The Shift You Feel on the Job

    Switzerland's pharmaceutical sector is investing in biologics, high-potency APIs and continuous manufacturing, and employers increasingly separate people who can apply QbD from those who cannot. Here is which side of that line you want to be on.

    Today

    Development relies on trial and error, with quality checked at the end

    After QbD

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

    Today

    You react to deviations and out-of-specification results in manufacturing

    After QbD

    You predict and control quality through process understanding and a control strategy

    Today

    Your skills map to bench roles that Basel and Lake Geneva employers pay around CHF 90k

    After QbD

    You add QbD capability that senior QA, process and CMC roles reward more highly

    You master QbD

    Before

    Process knowledge that lives in individuals, not documented understanding

    Now you have

    A structured, science-based method your whole team can share

    Before

    Uncertainty about what regulators expect in a development section

    Now you have

    Confidence to build QTPP, design space and control strategy evidence for submissions

    Before

    Limited exposure to structured risk assessment and DoE tools

    Now you have

    Practical command of FMEA, Ishikawa and Design of Experiments

    Before

    Development that struggles to keep pace with biologics and continuous manufacturing

    Now you have

    Skills aligned to the technologies Swiss pharma is investing in now

    "The gap between running experiments and truly understanding a process is where quality is won or lost, and Swiss employers already know it."

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

    Sources: Swiss Biotech Report 2026; Glassdoor, PayScale, SalaryExpert (Switzerland) 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 Switzerland is structured across ten modules, taking learners from foundational QbD background and regulatory guidance through to real-world case studies and practical applications in pharmaceutical, biotechnology, and manufacturing environments.

    • Background and key drivers that led to the adoption of Quality by Design in pharmaceutical development
    • Regulatory guidance documents including ICH Q8, Q9, and Q10 that define the QbD framework
    • QbD development process flow from concept and design through to manufacturing and regulatory submission

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

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    100% Secure and Safe download

    The QbD Tools You Will Put to WorkQTPP Through to Control Strategy

    You will learn to apply the full Quality by Design toolkit to pharmaceutical development, from defining the target product profile through to a documented control strategy. By the end, you can run each step on your own projects.

    Build a Quality Target Product Profile

    Construct a QTPP from clinical and patient needs, setting the design specification that anchors the whole QbD programme and links quality to safety and efficacy.

    Identify Critical Quality Attributes

    Classify the physical, chemical and biological attributes critical to quality, safety and efficacy, and link them to the material attributes and process parameters that drive them.

    Run Structured Risk Assessments

    Use Ishikawa diagrams and FMEA with risk priority numbers to rank which material attributes and process parameters most affect quality and warrant formal study.

    Design Experiments and the Design Space

    Plan screening and response surface DoE, interpret the models, and define the design space with normal operating ranges and proven acceptable ranges.

    Apply PAT and Build a Control Strategy

    Use process analytical technology for real-time monitoring and translate your process understanding into a risk-proportionate control strategy.

    Structure QbD Evidence for Submissions

    Present QTPP, risk assessment, DoE and control strategy in CTD Section 3.2.P.2, the way FDA and EMA reviewers expect to see it documented.

    Who Should TakeQuality by Design Training in Switzerland?

    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

    CHF 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

    CHF 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.

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    Why Professionals Choose Our Quality by Design Training in SwitzerlandExpert-Led and Built for the Bench

    As a trusted Quality by Design training company, Invensis Learning delivers practical courses for pharmaceutical professionals and organisations across Switzerland who want to design quality into products from the start. Our programmes combine experienced trainers, ICH-aligned content, hands-on tool exercises and flexible delivery. Whether you enrol as an individual or plan corporate training for a cross-functional team, you gain a professional learning experience built around real-world application and measurable capability, backed by our ISO 9001 and ISO 27001 certifications.

    • Experienced trainers with real pharmaceutical and QbD delivery experience
    • Instruction grounded in the ICH Q8, Q9, Q10 and Q11 guidelines
    • Hands-on exercises using realistic pharmaceutical development scenarios
    • Flexible live virtual, classroom and onsite delivery across Switzerland
    • Structured courseware, tool templates and practical worked examples
    • Support for individual learners and cross-functional corporate teams
    • Course completion certificate from Invensis Learning on finishing the programme
    • ISO 9001 and ISO 27001 certified provider trusted by professionals worldwide

    15+

    Years of Training Excellence

    24/7

    Learner Support

    50+

    Industries Served

    1-to-1

    Doubt-Clearing Sessions

    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 SwitzerlandAll our classroom training is now available online at your convenience

    Quality by Design in Switzerland

    Tschuggen Grand Hotel, Tschuggen Torweg 1, 7050 Arosa

    Quality by Design in Switzerland

    Hotel Les Trois, Rois Blumenrain 8, 4001 Basel

    corporate banner

    Corporate QbD Training for TeamsBuilt Around Your Pipeline

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    • Tailored QbD training built around your live development projects
    • Flexible onsite, live virtual or hybrid delivery for teams in Switzerland
    • Train formulation, analytical, process, QA and regulatory staff together
    • Role-based examples drawn from your product types and processes
    • Consistent QbD methodology across sites and business units
    • Dedicated coordination and learner support for group programmes

    Leading Swiss Life Sciences Employers

    NovartisRocheLonzaCSL BehringFerringSandoz

    What Our Learners Say

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    Finally Applied QbD End to End

    "The training took me from QTPP through to control strategy on a realistic case. I now lead CQA identification and FMEA sessions on my own formulation projects with real confidence."

    Nadia Brunner

    Formulation Scientist

    Untitled

    0/0

    DoE and Design Space Made Practical

    "The Design of Experiments and design space sections were exactly what I needed. The worked examples helped me plan a proper screening study back at work rather than one-factor-at-a-time trials."

    Luca Ferrari

    Process Development Engineer

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    Clear on What Reviewers Expect

    "I finally understand how QbD evidence fits into Section 3.2.P.2. Mapping QTPP, design space and control strategy to the submission structure was the most useful part for my CMC work."

    Sophie Meyer

    Regulatory Affairs Specialist

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    Our Team Now Shares One QbD Language

    "We trained a cross-functional group together and it standardised how formulation, analytical and QA colleagues approach risk assessment and design space. Deviations in scale-up have noticeably dropped."

    Thomas Widmer

    Head of Pharmaceutical Development

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    Practical and Well Pitched for Our Teams

    "Invensis tailored the sessions around our biologics pipeline. The trainer's real-world experience and hands-on exercises made it immediately relevant for our process and quality teams."

    Isabelle Rochat

    L&D Manager, Biotech Manufacturer

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

    Quality by Design training teaches a systematic, science-based approach to building quality into pharmaceutical products from the design stage rather than testing it in at the end. It covers the QbD toolkit and the ICH Q8, Q9, Q10 and Q11 framework across a focused one-day programme.

    General

    What is Quality by Design (QbD) training?

    Quality by Design training teaches a systematic, science-based approach to building quality into pharmaceutical products from the design stage rather than testing it in at the end. It covers the QbD toolkit and the ICH Q8, Q9, Q10 and Q11 framework across a focused one-day programme.

    Who should attend QbD training in Switzerland?

    The course suits formulation and analytical scientists, process development engineers, QA professionals and regulatory affairs specialists in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations across Switzerland who apply QbD in development and submissions.

    Is QbD training worth it for my career?

    Yes. QbD is increasingly the default language of pharmaceutical development, and Switzerland's Basel and Lake Geneva clusters value professionals who can apply it. The skills are immediately usable at the bench and support progression into senior process, QA and CMC roles.

    Are there any prerequisites for the course?

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

    Does QbD apply to both small molecules and biologics?

    Yes. The training covers QbD for small molecule drug products such as tablets and injectables and for biopharmaceuticals such as monoclonal antibodies and biosimilars, with case examples from both, reflecting Switzerland's strong biologics sector.

    Pricing

    How much does QbD training cost in Switzerland?

    Fees depend on the delivery format, whether virtual, classroom or corporate, and on group size, so pricing is available on request. Contact a learning advisor for a quote tailored to individual or team enrolment.

    What is included in the course fee?

    The fee typically includes instructor-led training across all six QbD modules, hands-on tool exercises, courseware and templates, and a course completion certificate from Invensis Learning. Request a quote to confirm what your chosen format includes.

    Do you offer corporate or group pricing?

    Yes. We offer group and corporate pricing for teams, with tailored content and flexible scheduling, which is often the best value for cross-functional pharmaceutical teams. Ask about corporate pricing for your team.

    Are there discounts for multiple participants?

    Group and volume pricing is available for organisations enrolling several participants. Speak with a learning advisor for a tailored quote based on your team size and preferred delivery format.

    What payment options are available?

    We accept major cards and bank transfers, and can arrange invoicing for corporate bookings. A learning advisor can walk you through the options that suit an individual or an organisation.

    Assessment

    Is there an exam for QbD training?

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

    Do I receive a certificate on completion?

    Yes. You receive a course completion certificate from Invensis Learning after finishing the programme. It recognises attendance and the practical QbD skills you have built, and the learning is immediately applicable at work.

    How is learning assessed during the course?

    There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, risk assessment and design space interpretation to realistic scenarios throughout the day, so you practise each step as you learn it.

    Is this a certification or accreditation?

    No. QbD training builds practical workplace skills and does not award a certification or involve an awarding body. It focuses on applying the ICH-aligned QbD framework and tools rather than preparing for an examination.

    Will the skills expire or need renewal?

    No. The QbD methodology and tools you learn do not expire and require no renewal. They remain immediately applicable to pharmaceutical product and process development throughout your career.

    Course Content

    What topics does the QbD course cover?

    The course covers QbD principles and the ICH Q8, Q9, Q10 and Q11 framework, the QTPP and Critical Quality Attributes, risk assessment, Design of Experiments and the design space, process analytical technology and control strategy, plus case studies and lifecycle management.

    Will I learn Design of Experiments (DoE)?

    Yes. The course explains why DoE replaces one-factor-at-a-time work, covers screening and response surface designs, and shows how DoE results define the design space with normal operating and proven acceptable ranges.

    Does the course cover regulatory submissions?

    Yes. You learn how QbD outputs, the QTPP, risk assessment, design space and control strategy, are presented in CTD Section 3.2.P.2, and what FDA and EMA reviewers expect from a pharmaceutical development section.

    Are there hands-on exercises?

    Yes. Practical exercises run throughout the day, including QTPP construction, CQA identification, Ishikawa and FMEA risk assessment, and design space interpretation, all applied to realistic pharmaceutical development scenarios.

    How long is the training and what materials are provided?

    The programme runs as a focused one-day, eight-hour course. You receive structured courseware, tool templates and worked examples that you can reuse on your own development projects afterwards.

    Enrollment

    How do I enrol in QbD training?

    You can enrol through the Invensis Learning website. Choose your preferred format, complete your booking, and you receive access to schedules, courseware and learning resources. Talk to a learning advisor if you need help choosing a format.

    What delivery formats are available?

    The course is available as live virtual (online) instructor-led training, in-person classroom training, and corporate onsite delivery for teams. You can choose the format that best fits your schedule and location in Switzerland.

    Can the course be delivered onsite for our team?

    Yes. We deliver corporate onsite and live virtual sessions for pharmaceutical teams, tailored around your product pipeline. Cross-functional teams can apply QbD tools to their own live projects during the session. Ask about corporate training for your team.

    When can I start?

    Public sessions run on a regular schedule, and corporate sessions are arranged to suit your team's availability. Contact a learning advisor to see upcoming batches and find a date that works for you.

    Can I reschedule my booking?

    Yes. Flexible options let you reschedule to another session where needed. Contact our support team to arrange a change to your booking.