Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training?UntitledYour Route to Science-Based Development

    Quality by Design Training in Sweden introduces the Quality by Design (QbD) approach: a systematic, science-based way to build quality into pharmaceutical and biopharmaceutical products from the design stage rather than testing it in at the end. The one-day course is a practical, non-certification programme with no examination, and you leave with tools you can apply to live development projects. The training is grounded in the ICH guidelines that regulators now expect: ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. You learn to define the Quality Target Product Profile (QTPP), identify critical quality attributes, run risk assessments, apply design of experiments, set a design space and build a control strategy that stands up to FDA and EMA review. For scientists and engineers across Sweden's pharma clusters, from Gothenburg and Sodertalje to Uppsala, Solna and Lund, QbD fluency is becoming a core expectation. Start building it with Invensis Learning.

    What Is Quality by Design Training?Your Route to Science-Based Development

    Quality by Design Training in Sweden introduces the Quality by Design (QbD) approach: a systematic, science-based way to build quality into pharmaceutical and biopharmaceutical products from the design stage rather than testing it in at the end. The one-day course is a practical, non-certification programme with no examination, and you leave with tools you can apply to live development projects.

    The training is grounded in the ICH guidelines that regulators now expect: ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. You learn to define the Quality Target Product Profile (QTPP), identify critical quality attributes, run risk assessments, apply design of experiments, set a design space and build a control strategy that stands up to FDA and EMA review.

    For scientists and engineers across Sweden's pharma clusters, from Gothenburg and Sodertalje to Uppsala, Solna and Lund, QbD fluency is becoming a core expectation. Start building it 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 Sweden 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 Sweden 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 Sweden

    • Instructor-led training formats available for individual learners and corporate teams across the Sweden
    • 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 Sweden
    • 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 Sweden 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 SwedenWho 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

    The Practical Payoff of QbD TrainingReal Capability, Not Just Theory

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical and biopharma professionals replace trial-and-error development with a systematic, science-based method. In a single day you learn to define product quality up front and design a process that delivers it consistently. Whether you work in formulation, process development, analytical science, quality assurance or CMC regulatory affairs, the tools transfer straight to your live projects.

    If you want to lead QbD workshops, build a QTPP, run a risk assessment or plan a design space at work, this course gives you a practical, immediately usable foundation.

    • Build quality into pharmaceutical products from the design stage, not through end-product testing
    • Apply QTPP, critical quality attribute and risk-assessment tools to real development projects
    • Plan and interpret design of experiments to define a robust design space
    • Develop control strategies and PAT approaches that hold up to FDA and EMA scrutiny
    • Speak the ICH Q8 to Q11 language that Swedish pharma and biopharma employers expect
    • Move from empirical trial and error to systematic, science-based development
    • Strengthen your value in Sweden's growing advanced-therapies and CDMO sector
    • Earn a course completion record from Invensis Learning
    For Organizations

    For Organizations

    QbD group training equips a whole development team to design quality into products from the outset. Delivered onsite or live virtual for your Swedish sites, it aligns formulation, process, analytical, quality and regulatory colleagues around one ICH-based method. For organisations scaling biologics, advanced therapies or CDMO services, this shared capability reduces risk and strengthens submissions.

    If your teams struggle to connect development decisions to consistent manufacturing outcomes, QbD training creates a common framework for the QTPP, risk assessment, design space and control strategy.

    • Builds a shared QbD language across formulation, process, analytical, quality and regulatory teams
    • Reduces manufacturing deviations and out-of-specification batches through better process understanding
    • Strengthens ICH-aligned regulatory submissions and reduces the post-approval change burden
    • Upskills a cross-functional development team together on live product projects
    • Supports advanced-therapy, biologics and CDMO capability building
    • Flexible live virtual, onsite and customised delivery for Swedish sites
    • Improves product consistency and patient safety through designed-in quality
    • Standardises QbD practice across business units and locations

    The Career Value of QbD Skills in SwedenRoles, Demand and Earning Outlook

    QbD capability is increasingly sought across Sweden's pharma and biopharma employers, from AstraZeneca and Sobi to Recipharm, Octapharma and the Uppsala bioprocess cluster. As the sector scales biologics and advanced therapies, and as EMA and FDA expect QbD evidence in submissions, professionals who can apply these tools stand out. Demand spans formulation, process development, analytical science, quality assurance and CMC regulatory affairs, and here is what the market shows.

    kr 559,000

    Regulatory Affairs (CMC) specialist salary, Sweden

    average per year, SalaryExpert 2026

    kr 508,000

    Pharmaceutical scientist salary, Stockholm

    average per year, SalaryExpert 2026

    40,000+

    Life-science sector employment, Sweden

    people employed, industry data 2026

    USD 6.21bn

    Pharma market size, Sweden

    2026, Mordor Intelligence

    SECTORS HIRING

    • —Pharmaceutical Manufacturing and Development
    • —Biopharmaceuticals and Advanced Therapies
    • —Active Pharmaceutical Ingredient (API) Production
    • —Contract Development and Manufacturing (CDMOs)
    • —CMC Regulatory Affairs and Quality Assurance
    • —Medical Devices and Diagnostics

    GROWTH TRENDS

    • —Government goal for Sweden to lead advanced therapies by 2030
    • —Pharma market growing to around USD 6.21 billion in 2026
    • —40,000+ people employed across the life-science sector
    • —EMA and FDA increasingly expect QbD evidence in submissions
    • —Recipharm and a strong CDMO base driving process-development demand
    • —Biologics and ATMP scale-up requiring QbD process understanding

    Sources: SalaryExpert / ERI, PayScale (Sweden) 2026; Mordor Intelligence, SwedenBIO, Statista 2026.

    Why QbD Skills Are in Demand Across Sweden

    Rising Regulatory Expectations

    EMA and FDA increasingly expect QbD evidence in pharmaceutical submissions. Swedish developers need people who can build QTPP, design space and control strategy documentation that reviewers accept.

    QbD training builds ICH-aligned submission skills

    Biologics and Advanced-Therapy Complexity

    Sweden's drive to lead advanced therapies by 2030 brings process-defined biologics that are highly sensitive to process conditions, exactly where QbD understanding keeps quality under control.

    QbD training builds process-understanding skills

    The Cost of Trial-And-Error Development

    Empirical, test-and-fix development drives deviations and out-of-specification batches. QbD replaces guesswork with mechanistic process understanding that predicts and controls quality.

    QbD training replaces guesswork with method

    Growing CDMO Demand

    With Recipharm and a strong contract-manufacturing base, QbD fluency sets teams apart. Clients expect CDMOs to characterise processes and define a robust, defensible design space.

    QbD training is a CDMO differentiator

    Scarce Cross-Functional QbD Talent

    Many sites hold deep formulation or analytical skills but few people who can lead a full QbD programme across functions, making trained practitioners genuinely valuable.

    QbD training makes practitioners stand out

    Post-Approval Change Burden

    Without a justified design space, every process change risks a costly regulatory filing. QbD gives manufacturers the flexibility that reduces post-approval change effort.

    QbD training builds design-space flexibility

    Sources: EMA and FDA QbD guidance; SwedenBIO Drug Discovery and Development Pipeline 2026; Mordor Intelligence, Statista 2026.

    QbD is fast becoming a core skill for Sweden's pharma and biopharma professionals. Build the tools to design quality in and lead development with confidence. Start your journey today.

    Your Sweden QbD Transformation

    Where You Stand Today,

    And Where QbD Skills Take You

    Sweden's pharma and biopharma sector is scaling biologics and advanced therapies, and employers increasingly separate people who can design quality in from those who only test it at the end. Here is the shift the training delivers.

    Today

    Seen as a strong specialist, but not a QbD lead

    After QbD

    Able to lead cross-functional QbD programmes across development and manufacturing

    Today

    Limited leverage when Swedish employers list QbD as preferred

    After QbD

    Positioned for roles across pharma, biopharma and CDMOs, where CMC specialist pay averages around kr 559,000

    Today

    Confident in your function, but not across the ICH framework

    After QbD

    Fluent in the ICH Q8 to Q11 framework and the tools regulators expect

    You master QbD

    Before

    Quality is checked by end-product testing after the batch is made

    Now you can

    You design quality into the product from the QTPP onward

    Before

    Development runs on empirical trial and error

    Now you can

    You use risk assessment and design of experiments to understand the process

    Before

    Process limits are set without mechanistic understanding

    Now you can

    You define a justified design space with clear operating ranges

    Before

    Submissions rely on fixed parameters and end-product testing

    Now you can

    You build ICH-aligned QTPP, design space and control strategy evidence

    "The gap between testing quality in and designing it in is increasingly what separates the professionals Swedish pharma wants to hire."

    Join the professionals who trained with Invensis Learning and made the shift.

    Sources: SalaryExpert / ERI (Sweden) 2026; SwedenBIO, Statista 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 Sweden 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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    Skills You Will Build in This CourseApplying the QbD Toolkit End to End

    You will learn to apply the full Quality by Design toolkit, from the Quality Target Product Profile through to the control strategy, on realistic pharmaceutical development scenarios. Each module pairs concept explanation with hands-on exercises so you can use the tools at work straight away.

    Build a Quality Target Product Profile

    Translate patient and clinical needs into a QTPP that defines the quality, safety and efficacy targets your product must meet, then use it as the design specification for the whole programme.

    Identify and Classify Critical Quality Attributes

    Determine which physical, chemical, biological and microbiological attributes are critical to product quality for both small molecules and biologics, and link them to material and process factors.

    Run QbD Risk Assessments

    Apply Ishikawa (fishbone) diagrams and FMEA with Risk Priority Numbers to prioritise the critical material attributes and process parameters that most affect your critical quality attributes.

    Design and Interpret Experiments (DoE)

    Select screening, response-surface and mixture designs, then read the models to define a design space with normal operating ranges and proven acceptable ranges.

    Apply PAT and Build a Control Strategy

    Use process analytical technology such as NIR and Raman for real-time monitoring, and assemble a risk-proportionate control strategy from material, process and in-process controls.

    Document QbD for Regulatory Submission

    Structure QTPP, risk assessment, design space and control strategy evidence for CTD Section 3.2.P.2, and manage post-approval change under ICH Q12.

    Who Should TakeQuality by Design Training in Sweden?

    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

    SEK 4040

    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

    SEK 4040

    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 SwedenExpert-Led, ICH-Aligned Delivery

    As a trusted Quality by Design training company in Sweden, Invensis Learning is an ISO 9001:2015 and ISO 27001:2022 certified training provider, delivering QbD training for individual professionals and pharmaceutical organisations across Sweden and worldwide. Our programmes combine experienced, practitioner trainers, flexible delivery formats and structured, ICH-aligned courseware. Whether you enrol as an individual or arrange corporate training for your team, you get a practical learning experience focused on real-world application and immediately usable QbD skills.

    • Experienced trainers with real pharmaceutical and QbD practitioner expertise
    • Courseware aligned to the ICH Q8, Q9, Q10 and Q11 guidelines
    • Flexible live virtual, classroom and onsite delivery for Swedish teams
    • Hands-on QTPP, CQA, risk-assessment and design-space exercises
    • ISO 9001:2015 and ISO 27001:2022 certified training provider
    • Dedicated learner support before, during and after training
    • Customised corporate programmes for pharma and biopharma sites
    • Course completion record on finishing the programme

    100+

    Countries Served

    ISO 9001

    Quality Management

    200K+

    Professionals Trained

    12M+

    Hours of Training Delivered

    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 SwedenAll our classroom training is now available online at your convenience

    Quality by Design in Sweden

    Upper House, 25 Gothia Towers, Mässans gata 24, 402 26 Göteborg

    Quality by Design in Sweden

    Grand Hôtel, Södra Blasieholmshamnen 8, 103 27 Stockholm

    corporate banner

    Corporate Quality by Design TrainingFor Your Teams in Sweden

    Untitled

    • Suitable for small, medium and large pharmaceutical teams
    • Customised schedules built around your project and site availability
    • Flexible onsite, live virtual or hybrid delivery across Sweden
    • Practitioner trainers with pharma and biopharma QbD experience
    • Role-based exercises using your own live development projects
    • Dedicated coordination and learner support for group programmes
    • Scalable delivery for teams across Swedish and global sites

    Leading Life-Science Employers in Sweden

    AstraZenecaSobiRecipharmOctapharmaFresenius KabiCytiva

    What Our Learners Say

    Untitled

    Tools I Could Use Straight Away

    "The course finally made the QTPP and critical quality attributes click for me. Within a week I had mapped CMAs and CPPs for a formulation project using the Ishikawa and FMEA approach from the training."

    Erik Lindqvist

    Formulation Scientist

    Untitled

    0/0

    Practical Grounding in DoE and Design Space

    "Clear, practical and well paced. The design of experiments and design space sections gave me a much better grasp of how our analytical data supports process understanding and the control strategy."

    Anna Bergstrom

    Analytical Scientist

    Untitled

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    Directly Relevant to CMC Submissions

    "As someone in CMC regulatory work, the mapping of QbD outputs to CTD Section 3.2.P.2 was exactly what I needed. It has already improved how I review pharmaceutical development sections."

    Johan Nilsson

    CMC Regulatory Affairs Specialist

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    A Shared QbD Language for Our Team

    "We ran the course onsite for a cross-functional team. Formulation, process and quality colleagues now share one QbD language, and our risk assessments and control strategies are noticeably more consistent."

    Karin Sundberg

    Quality Manager, Biopharmaceutical Manufacturer

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    Real-World CDMO Relevance

    "The trainer used realistic case studies that matched our CDMO work. Our process development group came away better able to characterise processes and justify a design space to clients."

    Mats Ekstrom

    Head of Process Development, Contract Development Organisation

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

    Quality by Design (QbD) training is a one-day, non-certification course that teaches pharmaceutical and biopharma professionals to build quality into products from the design stage. It covers the ICH Q8 to Q11 framework and tools such as the QTPP, critical quality attributes, risk assessment, design of experiments, design space and control strategy.

    General

    What is Quality by Design training?

    Quality by Design (QbD) training is a one-day, non-certification course that teaches pharmaceutical and biopharma professionals to build quality into products from the design stage. It covers the ICH Q8 to Q11 framework and tools such as the QTPP, critical quality attributes, risk assessment, design of experiments, design space and control strategy.

    Is the QbD course worth it for professionals in Sweden?

    Yes. As Sweden scales biologics and advanced therapies and regulators expect QbD evidence, professionals who can apply these tools are in demand across pharma, biopharma and CDMOs. Roles from formulation science to CMC regulatory affairs value the capability, with CMC specialist pay averaging around kr 559,000 a year.

    Who should attend QbD training?

    The course suits formulation, process development and analytical scientists, quality assurance professionals, CMC regulatory affairs specialists and manufacturing technical managers in pharmaceutical, biopharmaceutical, API, CDMO and medical-device organisations.

    Do I need prior experience to take this course?

    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.

    What standard is the training based on?

    The training is grounded in the ICH guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances, the same framework FDA and EMA expect in submissions.

    Pricing

    How much does QbD training cost in Sweden?

    Fees vary by delivery format, group size and schedule, so pricing is available on request. Live virtual, classroom and corporate options are quoted separately. Request a quote for current Sweden pricing.

    What is included in the course fee?

    The fee typically includes instructor-led training across all six QbD modules, hands-on tool exercises, structured courseware and learner support, plus a course completion record. Ask a learning advisor for the full inclusions.

    Do you offer corporate or group pricing?

    Yes. Group and corporate pricing is available for teams trained together, whether onsite or live virtual. Contact us for a tailored quote for your Swedish site.

    Is there a separate fee for an exam or credential?

    No. This is a non-certification course with no examination, so there is no separate exam or credentialing fee to budget for. You pay only the training fee.

    What payment options are available?

    We accept major cards and bank transfers, with instalment options on selected plans. Speak with a learning advisor to arrange payment.

    Assessment

    Is there an exam for QbD training?

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

    Do I receive a credential after the course?

    No external certification is awarded. You receive a course completion record from Invensis Learning, and the practical skills apply immediately to development projects.

    How is learning checked during the course?

    There is no formal assessment. You apply QbD tools such as QTPP construction, CQA identification, risk assessment and design-space interpretation to realistic scenarios throughout the day.

    Does the completion record expire?

    No. There is no renewal or maintenance requirement. The QbD skills you learn do not expire and can be applied to any pharmaceutical or biopharma development project.

    Will this help with regulatory submissions?

    Yes. You learn to structure QTPP, risk assessment, design space and control strategy evidence for CTD Section 3.2.P.2, which supports QbD-based submissions to EMA, FDA and other authorities.

    Course Content

    What topics does the QbD course cover?

    The course covers six modules: QbD principles and the ICH framework; the QTPP and critical quality attributes; risk assessment; design of experiments and the design space; PAT and control strategy; and QbD in practice with case studies and lifecycle management.

    What will I be able to do after the training?

    You will be able to build a QTPP, identify and classify CQAs, run FMEA-based risk assessments, plan and interpret DoE, define a design space with NOR and PAR, develop a control strategy and document QbD evidence for submissions.

    Does it cover both small molecules and biologics?

    Yes. The course includes QbD case studies for small-molecule drug products such as tablets and injectables, and for biologics such as monoclonal antibodies, biosimilars and advanced therapies.

    Are the sessions hands-on?

    Yes. Hands-on exercises run throughout the day, applying QTPP construction, CQA identification, Ishikawa diagrams, FMEA and design-space interpretation to realistic pharmaceutical development scenarios.

    How long is the course?

    The course runs for one day (eight hours), or as two half-days totalling eight hours. It covers all six QbD modules with concept explanations and hands-on tool exercises.

    Enrollment

    How do I enrol in QbD training in Sweden?

    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 pick a batch.

    What delivery formats are available?

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

    When are the next sessions?

    New public and corporate sessions run regularly across Sweden and live virtual. See upcoming schedules or ask an advisor for the next available dates.

    Can you deliver the course at our site?

    Yes. We deliver customised onsite and live virtual corporate training for pharmaceutical and biopharma teams across Sweden, tailored to your live development projects.

    Can I reschedule my booking?

    Yes. Flexi options let you reschedule to another batch on selected plans. Contact support to arrange a change.

    What is the refund policy?

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