Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters for Pharma TeamsUntitledBuilt on the ICH Quality Guidelines

    The Quality by Design (QbD) Training in Norway is a one-day, practical programme that teaches pharmaceutical and biopharmaceutical professionals how to build quality into a product from the design stage rather than testing it in at the end. It is grounded in the ICH quality guidelines, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances, which underpin what regulators such as the FDA and EMA now expect in development and manufacturing submissions. You learn to apply the full QbD toolkit, from the Quality Target Product Profile and critical quality attributes through risk assessment, design of experiments, the design space and process analytical technology to a robust control strategy, with hands-on exercises drawn from realistic development scenarios. Ideal for formulation and analytical scientists, process development engineers, and quality and regulatory professionals at Norway's pharma, biopharma and API sites, the training builds skills you can apply straight away. Start your QbD journey with Invensis Learning.

    What Is Quality by Design and Why It Matters for Pharma TeamsBuilt on the ICH Quality Guidelines

    The Quality by Design (QbD) Training in Norway is a one-day, practical programme that teaches pharmaceutical and biopharmaceutical professionals how to build quality into a product from the design stage rather than testing it in at the end. It is grounded in the ICH quality guidelines, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances, which underpin what regulators such as the FDA and EMA now expect in development and manufacturing submissions.

    You learn to apply the full QbD toolkit, from the Quality Target Product Profile and critical quality attributes through risk assessment, design of experiments, the design space and process analytical technology to a robust control strategy, with hands-on exercises drawn from realistic development scenarios.

    Ideal for formulation and analytical scientists, process development engineers, and quality and regulatory professionals at Norway's pharma, biopharma and API sites, the training builds skills you can apply straight away. Start your QbD journey 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 Norway 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 Norway 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 Norway

    • Instructor-led training formats available for individual learners and corporate teams across the Norway
    • 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 Norway
    • 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 Norway 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 NorwayWho 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

    Why Quality by Design Skills Pay off at WorkFor Scientists, Engineers and Quality Teams

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical and biopharmaceutical professionals replace trial-and-error development with a systematic, science-based approach. It suits formulation and analytical scientists, process development engineers, and quality and regulatory professionals who want to design quality in rather than test it at the end. Whether you are moving into QbD for the first time or formalising skills you already use, the training gives you tools you can apply straight away on live development projects.

    If you want to build practical, in-demand skills that Norway's pharma and biopharma employers value, QbD is a clear step forward. You gain hands-on command of the QbD toolkit and a structured way to connect development to regulatory expectations.

    • Design quality into products from the start using proven QbD methods
    • Apply the ICH Q8 to Q11 framework to real development work
    • Build QTPPs and identify critical quality attributes with confidence
    • Run risk assessments and design experiments that map the design space
    • Develop control strategies and use PAT to hold quality in production
    • Structure QbD evidence for FDA and EMA regulatory submissions
    • Reduce deviations, rework and out-of-specification results at work
    • Strengthen your value across formulation, process and quality roles
    For Organizations

    For Organizations

    Quality by Design group training helps organisations build science-based development capability by equipping cross-functional teams with a shared QbD approach. It can be delivered for R&D, quality, process development and regulatory groups together. For pharma and biopharma organisations in Norway aiming to cut quality failures and strengthen regulatory submissions, the training provides a scalable, flexible solution.

    If your teams still test quality in rather than build it in, QbD group training creates a common methodology for prioritisation, design of experiments and control strategy that raises consistency across every product.

    • Standardise QbD practice across development, quality and regulatory teams
    • Reduce deviations, batch failures and costly rework
    • Strengthen readiness for FDA and EMA submissions
    • Build a shared language for QTPP, CQAs, design space and control strategy
    • Upskill cross-functional teams on live product development projects
    • Support scale-up and the move to continuous manufacturing
    • Flexible onsite, live virtual or hybrid delivery for teams
    • Customised content mapped to your products and processes

    Career Scope for QbD Professionals in NorwayRoles, Demand and Pay

    Quality by Design skills are increasingly valued across Norway's pharmaceutical and biopharmaceutical sector, where firms such as GE HealthCare, Vistin Pharma, Curida, Bayer and Thermo Fisher run development and manufacturing sites that must meet ICH and regulatory expectations. As Norway invests heavily in life sciences and biomanufacturing, professionals who can apply QbD across formulation, process development, quality and regulatory roles are in demand, and Quality by Design training helps professionals build the capability to move into these roles. Here is what the market is telling us right now.

    USD 3.2bn

    Norway pharma market size, 2026

    Mordor Intelligence 2026

    kr 680,000

    QA Specialist average salary, Norway

    per year, SalaryExpert 2026

    kr 793,000

    Regulatory Affairs Specialist salary

    average, ERI 2026

    EUR 6bn

    National life-science plan investment

    Business Norway 2026

    SECTORS HIRING

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

    GROWTH TRENDS

    • —EUR 6bn national life-science plan and new Oslo university hospital
    • —Expanding API and contrast-media production in Lindesnes
    • —Growth in monoclonal antibody and immunotherapy manufacturing
    • —Rising regulatory expectation for QbD in FDA and EMA submissions
    • —Oslo Cancer Cluster and steady biopharma export growth
    • —Shift from batch toward continuous manufacturing

    Sources: Mordor Intelligence, Business Norway, SalaryExpert, ERI, Paylab (Norway) 2026.

    What's Driving Demand for QbD Skills in Norway

    Regulators Now Expect QbD Evidence

    The FDA and EMA increasingly expect QbD-based development and control strategies in submissions, so Norwegian pharma and biopharma teams need people who can produce that evidence.

    QbD training builds submission-ready development skills

    A Small, Specialised Talent Pool

    Norway's life-science sector is highly skilled but small, leaving QbD-literate formulation, process and quality professionals scarce and much sought-after by employers.

    QbD skills make you stand out in a lean market

    Scaling Biologics and Immunotherapy

    Growth in monoclonal antibodies and immunotherapy at sites such as Curida demands design-space and control-strategy expertise for complex, process-defined biologics.

    QbD training covers design space for biologics

    API and Contrast-Media Complexity

    Large API and contrast-media operations, including GE HealthCare in Lindesnes, need robust process understanding and control to hold quality consistent at global volume.

    QbD builds process understanding at scale

    Pressure to Cut Deviations and Rework

    Batch failures and out-of-specification results are costly, and QbD lowers them by building quality into the product rather than relying on end-product testing to catch problems.

    QbD reduces defects by building quality in

    The Move to Continuous Manufacturing

    Shifting from batch to continuous processes needs QbD process understanding and real-time PAT control, skills Norwegian manufacturers increasingly want in their teams.

    QbD underpins real-time process control

    Sources: Mordor Intelligence, Business Norway, Pharmaceutical Online (Norway) 2026.

    Quality by Design is a practical, career-building skill for pharma and biopharma professionals. Join teams across Norway who design quality in from the start. Start your journey today.

    Your Norway QbD Skills Upgrade

    From Testing Quality in to Building It from Design

    Your QbD Skills Transformation

    Norway's pharma and biopharma sector is raising the bar on science-based development, and employers increasingly separate professionals who can design quality in from those who only test it at the end. Here is the shift QbD skills make.

    Today

    You rely on end-product testing to catch quality problems late

    After QbD Training

    You build quality in from the design stage using QTPP and critical quality attributes

    Today

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

    After QbD Training

    You use design of experiments to map the design space with fewer, smarter runs

    Today

    Career reach capped without science-based development skills

    After QbD Training

    You qualify for higher-value roles across Norway's pharma, biopharma and API sites

    You master QbD

    Before

    Quality confidence depends on inspection and rework

    Now you have

    A structured, ICH-aligned QbD approach that prevents defects by design

    Before

    Limited grasp of how regulators assess pharmaceutical development

    Now you have

    The ability to structure QbD evidence for FDA and EMA submissions

    Before

    Risk assessment done informally and inconsistently

    Now you have

    Practical command of Ishikawa and FMEA to prioritise the critical few parameters

    Before

    Control strategy set by habit rather than evidence

    Now you have

    A robust control strategy built from design-space and PAT understanding

    "The difference between reacting to quality problems and designing them out is a set of skills, and the organisations that matter already know it."

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

    Sources: SalaryExpert, ERI, Paylab (Norway) 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 Norway 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 QbD TrainingThe Full QbD Toolkit in Practice

    Here is what you will learn in the Quality by Design Training: how to apply the ICH-based QbD framework and its core tools across pharmaceutical product and process development. By the end, you can build quality into a product from the design stage and support it through to manufacturing.

    Apply the ICH QbD Framework

    Understand how ICH Q8(R2), Q9, Q10 and Q11 shape modern pharmaceutical development, and why regulators such as the FDA and EMA expect quality to be built in from the design stage.

    Build a Quality Target Product Profile

    Construct a QTPP from patient and clinical needs that sets the design specification for the whole development programme and links quality to intended clinical use.

    Identify Critical Quality Attributes

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

    Run QbD Risk Assessments

    Use Ishikawa diagrams and FMEA with risk priority numbers to link material attributes and process parameters to CQAs and prioritise the critical few for study.

    Design Experiments and the Design Space

    Plan design of experiments (DoE) to quantify how parameters affect quality, then define the design space, normal operating ranges and proven acceptable ranges.

    Apply Process Analytical Technology

    Use PAT tools such as NIR and Raman spectroscopy to monitor and control critical attributes in real time during manufacturing rather than only testing at the end.

    Develop a Robust Control Strategy

    Turn risk assessment and DoE results into a control strategy spanning material, process and in-process controls that holds quality within the design space.

    Structure QbD for Submissions

    Organise QbD evidence for regulatory submissions and apply it across the product lifecycle, from development through to post-approval change management.

    Who Should TakeQuality by Design Training in Norway?

    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

    NOK 4140

    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

    NOK 4140

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

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

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    Why Choose Invensis Learning in NorwayExpert-Led for Individuals and Teams

    Invensis Learning is a trusted Quality by Design training company in Norway, delivering practical training for individual professionals and pharma teams that want to build science-based development capability. Our programmes combine experienced trainers, ICH-aligned courseware, flexible delivery and learner-focused support. Whether you join as an individual or arrange training for your team in Oslo, Bergen or Stavanger, you get a professional learning experience built around real-world application and measurable outcomes.

    • Experienced trainers with real pharmaceutical and QbD practitioner expertise
    • ICH-aligned courseware covering Q8 to Q11 and the full QbD toolkit
    • Flexible formats: live online, classroom, onsite and corporate group training
    • Hands-on exercises using realistic pharma development scenarios
    • Customised schedules for organisations and team programmes across Norway
    • Dedicated learner support before, during and after training
    • ISO 9001:2015 and ISO 27001:2022 certified training operations

    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 NorwayAll our classroom training is now available online at your convenience

    Quality by Design in Norway

    Britannia Hotel Dronningens gate 5, 7 011 Trondheim, Norway

    Quality by Design in Norway

    Snowhotel Kirkenes & Gamme Northern Lights Cabins Sandnesdalen 14, 9910 Bjørnevatn, Norway

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    Corporate QbD TrainingUpskill Your Whole Pharma Team

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    • Tailored QbD curriculum mapped to your products and processes
    • Onsite, live virtual or hybrid delivery for teams of any size
    • Cross-functional training for formulation, process, quality and regulatory staff
    • Flexible scheduling around production and project timelines
    • Progress tracking and post-training learner support
    • Volume-based pricing for group enrolments

    Trusted by Pharma and Life Science Teams

    GE HealthCareBayerThermo Fisher ScientificVistin PharmaCuridaFresenius Kabi

    What Our Learners Say

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    Applied QbD to My Next Project Immediately

    "The course made the ICH framework practical. I built a QTPP and mapped critical quality attributes for a real formulation the week after training, and the DoE session changed how I plan experiments."

    Ingrid Halvorsen

    Formulation Scientist

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    Clear, Hands-On and Relevant

    "The risk assessment and PAT sessions were excellent. Using Ishikawa and FMEA to focus on the critical parameters has made our method development far more efficient and defensible."

    Lars Berg

    Analytical Scientist

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    Exactly What CMC Teams Need

    "I finally understand how QbD evidence fits a submission. Structuring the design space and control strategy for the pharmaceutical development section is much clearer to me now."

    Sofie Andersen

    Regulatory Affairs Specialist

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    Our Whole Team Now Shares a QbD Language

    "We ran this as onsite training for our process and quality teams. The shared approach to QTPP, design space and control strategy has already reduced deviations on our lines."

    Henrik Johansen

    Quality Manager, Pharmaceutical Manufacturing

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    Strong Fit for Biologics Development

    "The biologics case studies matched our monoclonal antibody work closely. The trainer tailored the design-space exercises to our process, and the value for the team was clear."

    Marte Kristiansen

    Head of Process Development, Biopharmaceuticals

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

    Quality by Design (QbD) training is a practical, one-day programme that teaches professionals how to build quality into pharmaceutical products from the design stage rather than testing it in at the end. It covers the ICH Q8 to Q11 framework and core QbD tools such as QTPP, critical quality attributes, design of experiments and control strategy.

    General

    What is Quality by Design (QbD) training?

    Quality by Design (QbD) training is a practical, one-day programme that teaches professionals how to build quality into pharmaceutical products from the design stage rather than testing it in at the end. It covers the ICH Q8 to Q11 framework and core QbD tools such as QTPP, critical quality attributes, design of experiments and control strategy.

    Who should attend the QbD training in Norway?

    The training suits formulation and analytical scientists, process development engineers, quality assurance professionals and regulatory affairs (CMC) specialists in pharma, biopharma, API, CDMO and medical device organisations. It is relevant to anyone who wants to design quality into products and processes.

    Is Quality by Design worth learning?

    Yes. QbD is a practical, in-demand skill because the FDA and EMA increasingly expect QbD-based development, and the methods apply to live projects straight away. In Norway's growing life-science sector, professionals who can design quality in are highly valued across development, quality and regulatory roles.

    Do I need prior experience to take the course?

    No. The course has no formal prerequisites and introduces QbD from first principles. Familiarity with pharmaceutical development or GMP is helpful but not required, as the training builds each concept in a clear, applied context.

    What framework is the QbD training based on?

    The training is grounded in the ICH quality guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. These underpin what regulators such as the FDA and EMA expect in modern development and manufacturing submissions.

    Pricing

    How much does the QbD training cost in Norway?

    Pricing is available on request and varies by delivery format, whether live virtual, classroom or corporate, and by group size. Request a quote and a learning advisor will share the current options for individuals and teams in Norway.

    What is included in the course fee?

    The fee typically includes instruction across all QbD modules, ICH-aligned courseware, hands-on tool exercises, learning resources and a course completion record from Invensis Learning. Exact inclusions depend on the format you choose.

    Do you offer corporate or group pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for R&D, quality, process and regulatory teams. Ask about group pricing for a tailored quote for your organisation.

    What payment options are available?

    We accept major credit and debit 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 training available for individuals as well as teams?

    Yes. You can enrol as an individual in a scheduled session, or arrange a dedicated group programme for your team. Request a quote to see the format and pricing that fits your needs.

    Assessment

    Is there an exam for the QbD training?

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

    Do I receive anything on completing the course?

    You receive a course completion record from Invensis Learning. The training builds practical QbD methodology and tool skills that you can apply straight away; it is not an external credential from an awarding body.

    How is learning assessed during the course?

    Learning is applied rather than examined. You work through practical exercises such as building a QTPP, identifying critical quality attributes, running risk assessments and interpreting a design space, using realistic development scenarios.

    Will I be able to use QbD at work straight away?

    Yes. After the training you can construct QTPPs, lead CQA identification workshops, facilitate Ishikawa and FMEA risk assessments, plan and interpret DoE studies, define design spaces and develop control strategies for your projects.

    Is prior QbD knowledge required for the course?

    No. The course introduces QbD from first principles in a pharmaceutical development context, so you do not need previous QbD experience to follow and apply the material.

    Course Content

    What topics does the QbD training cover?

    The programme covers six areas: QbD principles and the ICH framework; QTPP and critical quality attributes; risk assessment; design of experiments and the design space; process analytical technology and the control strategy; and QbD in practice through case studies, submissions and lifecycle management.

    Does the course cover both small molecules and biologics?

    Yes. The training includes case examples for small molecule drug products such as tablets and injectables, and for biologics such as monoclonal antibodies and biosimilars, so it fits a range of development work.

    Are there hands-on exercises in the training?

    Yes. Hands-on exercises run throughout the day, including QTPP construction, CQA identification and criticality assessment, Ishikawa and FMEA risk assessment, DoE design selection and design-space interpretation using realistic scenarios.

    What learning materials are provided?

    You receive ICH-aligned courseware, worked case studies, tool templates and exercise materials that support each QbD module. These help you apply the methods to your own products and processes after the course.

    How long is the QbD training?

    The training runs for one day (8 hours) and can also be delivered as two half-days totalling the same 8 hours. It covers all QbD modules with hands-on exercises throughout, whichever schedule you choose.

    Enrollment

    How do I enrol in the QbD training in Norway?

    You can enrol through the Invensis Learning website. Choose your preferred format, complete registration and you will receive access to schedules, courseware and learning resources. See upcoming batches or talk to a learning advisor to get started.

    What training formats are available?

    The course is available online (live virtual) instructor-led, in classroom, onsite at your premises, and as customised corporate group training. You can choose the format that best fits your schedule and team.

    When can I start the training?

    Public scheduled sessions run regularly in live virtual and in-person formats, and corporate sessions are arranged to suit your team's availability. See upcoming batches to find a date that works for you.

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

    Yes. We deliver onsite and corporate QbD training for teams in Oslo, Bergen, Stavanger and across Norway, with content tailored to your products and processes. Contact us to arrange a session for your organisation.

    What is the reschedule or cancellation policy?

    Flexible options let you reschedule or transfer to another session, and refunds are handled per our published policy. Reach out to our team for the details that apply to your enrolment.