Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Quality by Design Training Delivers for Development TeamsUntitledA Science-Based Route to Built-In Quality

    Quality by Design Training (QbD) is a practical, non-certification program that teaches the systematic, science-based approach to building quality into pharmaceutical and biopharmaceutical products from the development stage rather than testing it in at the end. Grounded in the ICH Q8(R2), Q9, Q10, and Q11 guidelines, the training reflects how modern development and manufacturing submissions are now expected to work by regulators including the FDA and EMA. Across a focused curriculum you learn the complete QbD toolset: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT), and the control strategy. Hands-on exercises apply each tool to realistic product development scenarios. The course suits formulation and analytical scientists, process development engineers, QA professionals, and CMC regulatory specialists who want to replace trial-and-error development with predictable, well-documented quality. Start building the QbD capability your organization and regulators increasingly expect.

    What Quality by Design Training Delivers for Development TeamsA Science-Based Route to Built-In Quality

    Quality by Design Training (QbD) is a practical, non-certification program that teaches the systematic, science-based approach to building quality into pharmaceutical and biopharmaceutical products from the development stage rather than testing it in at the end. Grounded in the ICH Q8(R2), Q9, Q10, and Q11 guidelines, the training reflects how modern development and manufacturing submissions are now expected to work by regulators including the FDA and EMA.

    Across a focused curriculum you learn the complete QbD toolset: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT), and the control strategy. Hands-on exercises apply each tool to realistic product development scenarios.

    The course suits formulation and analytical scientists, process development engineers, QA professionals, and CMC regulatory specialists who want to replace trial-and-error development with predictable, well-documented quality. Start building the QbD capability your organization and regulators increasingly expect.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training 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 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

    • Instructor-led training formats available for individual learners and corporate teams across
    • 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
    • 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 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 EligibilityWho 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 Building QbD Skills Pays OffThe Practical Payoff of QbD

    For Individuals

    For Individuals

    Quality by Design training gives pharmaceutical and biopharmaceutical professionals a practical, science-based way to design quality into products rather than inspecting for it later. You learn the complete QbD toolset and apply it to realistic development scenarios during the program. Whether you develop formulations, characterize processes, assure quality, or prepare CMC submissions, the skills map directly to the work regulators and employers now expect.

    If you want to move from empirical trial-and-error to predictable, well-documented development, QbD is a foundational capability. You leave able to build QTPPs, run risk assessments, plan DoE studies, and shape control strategies with confidence.

    • Design quality into products from the start instead of testing it in at the end
    • Turn patient and clinical needs into clear design targets with the QTPP and CQAs
    • Focus development effort using Ishikawa diagrams and FMEA risk assessment
    • Plan and interpret Design of Experiments (DoE) to define a robust design space
    • Build control strategies that hold quality steady through scale-up and manufacturing
    • Speak the QbD language regulators expect in ICH-aligned CTD submissions
    • Move from trial-and-error to predictable, science-based development decisions
    • Gain a cross-functional skill valued across pharma, biopharma, and CDMOs
    For Organizations

    For Organizations

    QbD group training helps pharmaceutical organizations build a shared, cross-functional approach to product and process development. Delivered for formulation, analytical, process, quality, and regulatory teams together, it creates one common QbD language. For companies facing scale-up problems, recurring deviations, or heavy post-approval change burdens, QbD skills translate into more robust processes and stronger regulatory relationships.

    When development, manufacturing, and regulatory teams apply QbD consistently, quality becomes designed-in rather than tested-in. Corporate training lets your team practice the tools on your own live development projects during the session.

    • Build a shared, cross-functional QbD approach across development and quality teams
    • Reduce manufacturing deviations through deeper process understanding
    • Strengthen regulatory relationships with well-documented control strategies
    • Cut post-approval change burden by working within an approved design space
    • Standardize QTPP, CQA, and risk-assessment practice across projects
    • Improve scale-up and technology-transfer outcomes
    • Deliver flexible training for scientists, engineers, QA, and regulatory staff
    • Practice QbD tools on your own live development projects

    Where QbD Skills Take Your CareerDemand Across Pharma and Biopharma

    Quality by Design training builds QbD skills that open doors across the pharmaceutical value chain, from formulation and analytical science to process development, quality assurance, and CMC regulatory affairs. As regulators expect QbD evidence in submissions and manufacturers adopt continuous processes and PAT, professionals who can apply the full toolset are in growing demand, from scientist roles through to regulatory and quality leadership. Here is what the global market is telling us right now.

    $104K

    Formulation Scientist average pay

    per year, Salary.com 2026

    $156K

    CMC Regulatory Affairs Manager pay

    average per year, Salary.com 2026

    $9.1B

    Continuous manufacturing market

    by 2032, up from $2.7B in 2025

    ICH Q8-Q11

    Regulatory foundation for QbD

    FDA and EMA aligned

    SECTORS HIRING

    • —Pharmaceutical Manufacturing and Development
    • —Biopharmaceutical and Biotechnology
    • —Active Pharmaceutical Ingredient (API) Manufacturing
    • —Contract Development and Manufacturing Organizations (CDMOs)
    • —CMC Regulatory Affairs and Consulting
    • —Medical Devices and Combination Products

    GROWTH TRENDS

    • —Regulators increasingly expect QbD evidence in development submissions
    • —Continuous manufacturing scaling up under ICH Q13
    • —PAT and real-time release testing adoption rising
    • —QbD fluency now a differentiating capability for CDMOs
    • —Biologics, biosimilars, and cell and gene therapy driving demand
    • —Shortage of professionals fluent in the full QbD toolset

    Sources: Salary.com, Glassdoor, PayScale (US) 2026; PharmaSource and IntuitionLabs market analysis; FDA and EMA QbD guidance, 2026.

    Industry Pressures Driving Demand for QbD Skills

    The Test-And-Fix Trap

    Many teams still rely on end-product testing to catch quality problems, which drives rework, deviations, and delays. QbD builds quality into the product through mechanistic understanding instead.

    QbD replaces end-product testing with process understanding

    Rising Regulatory Expectations

    The FDA and EMA increasingly expect QbD evidence, QTPP, CQAs, design space, and control strategy, in CTD submissions. Teams without QbD fluency struggle to meet current review expectations.

    QbD skills prepare you for ICH-aligned submissions

    Scale-Up and Tech-Transfer Failures

    Processes fixed empirically at lab scale often fail on transfer to commercial manufacturing. DoE and design space knowledge give teams the process understanding to scale up predictably.

    QbD builds robust, transferable processes

    The Shift to Continuous Manufacturing

    As the industry moves from batch to continuous manufacturing under ICH Q13, QbD process understanding and PAT are essential to design the control systems these lines depend on.

    QbD underpins continuous manufacturing control

    Biologics and Advanced Therapy Complexity

    Biologics, biosimilars, and cell and gene therapies are process-defined and sensitive to conditions. Applying QbD to CQAs like glycosylation and aggregation is a fast-growing need.

    QbD applies to biologics and small molecules alike

    A Shortage of QbD Talent

    Employers have deep pools of traditional development staff but few who can lead QTPP workshops, run FMEA, and interpret DoE. That scarcity makes QbD capability a clear differentiator.

    QbD-fluent professionals stand out

    Sources: FDA and EMA QbD and continuous manufacturing guidance; ICH Q8 to Q13 guidelines; PharmaSource and IntuitionLabs market analysis, 2026.

    QbD is more than a compliance exercise. It is the modern operating model for pharmaceutical development. Join professionals who design quality into products and speak the language regulators expect. Start your QbD journey today.

    Your QbD Capability Shift

    Where You Stand Today

    The Shift QbD Skills Deliver

    Pharmaceutical development is moving from testing quality in to designing it in, and employers increasingly separate professionals who can lead that shift from those who cannot. Here is which side of that line you want to be on.

    Today

    Shortlisted less often for roles that list QbD experience as preferred

    After QbD

    Ready for scientist, QA, and CMC regulatory roles where QbD is expected

    Today

    Confident in the lab, but not leading structured QbD activities

    After QbD

    Able to run QTPP workshops, FMEA sessions, and DoE studies with confidence

    Today

    Managing recurring deviations with limited process understanding

    After QbD

    Able to reduce deviations and post-approval changes through design space thinking

    You build QbD capability

    Before

    Quality confirmed mainly through end-product testing after the fact

    Now you have

    A structured, science-based method to design quality into every product

    Before

    Familiar with individual tools but not a connected QbD framework

    Now you have

    Command of QTPP, CQAs, risk assessment, DoE, and control strategy

    Before

    Unsure how regulators expect QbD data to be structured

    Now you have

    The fluency to prepare and defend QbD evidence in ICH-aligned submissions

    Before

    A single-function view of development with limited mobility

    Now you have

    A cross-functional skill recognized across pharma, biopharma, and CDMOs

    "The gap between testing quality in and designing it in is exactly what modern regulators reward, and the teams that lead already know it."

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

    Sources: Salary.com, Glassdoor, PayScale (US) 2026; FDA and EMA QbD guidance.

    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 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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    The QbD Tools You Will Learn to ApplyQTPP, DoE, PAT, and Control Strategy

    In this Quality by Design training you will learn to apply the full QbD toolset to realistic pharmaceutical development scenarios. By the end of the program you can build a QTPP, identify CQAs, run risk assessments, plan DoE studies, and shape a control strategy.

    Build a Quality Target Product Profile (QTPP)

    In this Quality by Design training you will learn to translate patient, clinical, and regulatory needs into a QTPP that sets the design specification for the entire development program, from dosage form and route to pharmacokinetic and quality targets.

    Identify and Classify Critical Quality Attributes

    Learn to identify CQAs for small molecules and biologics, distinguish critical from non-critical attributes, and link each CQA to Critical Material Attributes and Critical Process Parameters using prior knowledge and structured assessment.

    Run Risk Assessments with Ishikawa and FMEA

    Apply Ishikawa (fishbone) diagrams and FMEA to map and prioritize the material and process variables that most affect quality, using Severity, Occurrence, and Detectability to focus experimental effort where it matters most.

    Design and Interpret DoE for the Design Space

    Learn how Design of Experiments replaces one-factor-at-a-time testing, which screening and response-surface designs to use, and how to read DoE outputs to define a design space with Normal Operating and Proven Acceptable Ranges.

    Apply PAT and Real-Time Monitoring

    Understand how Process Analytical Technology tools such as NIR and Raman enable in-process monitoring and real-time release testing, so quality is measured during manufacturing rather than only at the end.

    Develop a Control Strategy for Submission

    Learn to build a risk-proportionate control strategy from your risk assessment and DoE outputs, and to structure QbD evidence for CTD submissions in line with ICH Q8 to Q11 expectations.

    Who Should TakeQuality by Design Training?

    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

    USD 425

    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

    USD 425

    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 for QbD TrainingTrusted Training for Life Sciences Teams

    As a trusted Quality by Design training company, Invensis Learning delivers practical QbD training for pharmaceutical and biopharmaceutical professionals and teams who want to build quality into products by design. Our programs combine experienced instructors, hands-on tool exercises, and courseware grounded in the ICH Q8 to Q11 guidelines. Whether you enroll as an individual or arrange training for a cross-functional team, you get a professional learning experience built around real-world application and measurable capability, backed by our ISO 9001:2015 and ISO 27001:2022 certified operations.

    • Experienced trainers with real pharmaceutical development and quality experience
    • Live virtual, classroom, and corporate on-site delivery to fit any schedule
    • Hands-on exercises using realistic drug and biologic development scenarios
    • Structured, up-to-date courseware grounded in the ICH QbD guidelines
    • Training available for individuals and cross-functional corporate teams
    • Dedicated learner support before, during, and after the program
    • ISO 9001:2015 quality and ISO 27001:2022 information-security certified operations
    • Global delivery with regional support across time zones

    98%

    First-Attempt Pass Rate

    5000+

    Accredited Trainers Globally

    4.7/5

    Rated by Learners Worldwide

    500+

    Corporate Clients

    ISO 9001:2015 Certified

    ISO 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

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    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

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    Corporate QbD TrainingUpskill Development and Quality Teams

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    • Train formulation, process, QA, and regulatory teams together
    • Customized schedules aligned to your project and release timelines
    • Live virtual, on-site, or hybrid delivery for local and global teams
    • Apply QbD tools to your own live development projects in the session
    • Experienced trainers with pharmaceutical and biopharma expertise
    • Progress tracking and dedicated coordination for group programs
    • Scalable delivery across sites, business units, and regions

    Trusted by Global Life Sciences Teams

    PfizerNovartisRocheGSKSanofiAstraZeneca

    What Our Learners Say

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    From Guesswork to a Real Design Space

    "The training finally connected the QbD tools for me. I now run QTPP and CQA sessions with my formulation team and plan DoE studies instead of guessing at process parameters. The hands-on scenarios made it click."

    Elena Fischer

    Formulation Scientist

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    Clearer View of QbD Submissions

    "As a CMC regulatory specialist I needed to understand how QbD evidence is built and defended. The sessions on risk assessment and control strategy gave me exactly the structure I use when reviewing pharmaceutical development sections."

    David Okoro

    CMC Regulatory Affairs Specialist

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    Practical and Well Paced

    "The FMEA and Ishikawa exercises were the highlight. I came in strong on analytics but weak on linking material attributes to CQAs, and the trainer walked us through it with real product examples."

    Priya Sharma

    Analytical Scientist

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    One Shared QbD Language for the Team

    "We booked the corporate session for our process development and QA groups. Having everyone learn one QbD language shortened our review cycles and improved how we document design space decisions. Delivery was flexible around our shift patterns."

    Marcus Lindqvist

    Head of Process Development

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    Tailored and Immediately Useful

    "As an L&D lead in a biopharma organization, I needed training that our scientists and regulatory staff could both use. The trainer tailored the biologics case studies to our work, and the team applied the tools to a live project the same week."

    Aisha Rahman

    Learning and Development Lead

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

    Quality by Design training is a practical program that teaches the systematic, science-based approach to building quality into pharmaceutical and biopharmaceutical products from the development stage. It covers the QbD toolset, QTPP, CQAs, risk assessment, DoE, design space, PAT, and control strategy, aligned to the ICH Q8 to Q11 guidelines.

    General

    What is Quality by Design (QbD) training?

    Quality by Design training is a practical program that teaches the systematic, science-based approach to building quality into pharmaceutical and biopharmaceutical products from the development stage. It covers the QbD toolset, QTPP, CQAs, risk assessment, DoE, design space, PAT, and control strategy, aligned to the ICH Q8 to Q11 guidelines.

    Who should attend QbD training?

    The course suits formulation and analytical scientists, process development engineers, QA professionals, and CMC regulatory specialists in pharmaceutical, biopharmaceutical, API, CDMO, and medical device organizations who want to understand and apply QbD in development and submissions.

    Is QbD training worth it for my career?

    Yes. QbD is now the expected operating model for pharmaceutical development, so the skills apply directly across scientist, quality, and CMC regulatory roles. As regulators expect QbD evidence and manufacturers adopt continuous processes, professionals fluent in the toolset are increasingly in demand worldwide.

    Do I need prior experience to take QbD training?

    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 before applying the tools to worked scenarios.

    Is QbD relevant for both small molecule and biologic products?

    Yes. The training covers QbD for small molecule drug products such as tablets and injectables, and for biopharmaceutical products such as monoclonal antibodies and biosimilars. Case examples from both product types are included so you can apply the tools in either context.

    Pricing

    How much does QbD training cost?

    Pricing varies by delivery format, region, and group size, so the current fee is available on request. Live virtual, classroom, and corporate on-site options are priced differently. Request a quote and a learning advisor will share the options that fit your needs.

    What is included in the QbD training fee?

    The fee typically includes instructor-led sessions, structured courseware grounded in the ICH QbD guidelines, hands-on tool exercises, case studies, and learner support. You also receive a course completion record from Invensis Learning on finishing the program.

    Do you offer corporate or group pricing for QbD training?

    Yes. We offer corporate group training with customized schedules and volume-based pricing for development, quality, and regulatory teams. It is especially effective when a cross-functional team trains together on live projects. Ask about group pricing for a tailored quote.

    What payment options are available?

    We accept major credit and debit cards and bank transfers, with instalment options on selected plans. Speak with a learning advisor to choose the payment option that suits you or your organization.

    Is there a discount for enrolling a team?

    Yes. Volume-based pricing applies when you enroll multiple team members or book a dedicated corporate cohort. Contact us with your team size and preferred format for a customized quote.

    Assessment And Completion

    How is learning assessed in QbD training?

    Learning is reinforced through hands-on tool exercises, case study activities, and team discussion rather than a formal test. You apply QTPP construction, CQA identification, risk assessment, and design space interpretation to realistic development scenarios during the program.

    Does this course include a formal test?

    No. This is a practical, non-certification skills course, so there is no formal test. The focus is on building QbD knowledge and tool skills you can apply immediately at work, reinforced by exercises and worked examples.

    What will I be able to do after the training?

    You will be able to construct a QTPP, identify and classify CQAs, map risks with Ishikawa diagrams and FMEA, plan and interpret DoE for a design space, apply PAT concepts, and build a control strategy structured for ICH-aligned submissions.

    Do I receive anything on completing the course?

    Yes. On completing the program you receive a course completion record from Invensis Learning. The training builds practical QbD skills that are immediately applicable to pharmaceutical product and process development work.

    Is this a certification course?

    No. It is a skills training course focused on applying QbD concepts, tools, and best practices. It is grounded in the ICH Q8 to Q11 guidelines and the recognized QbD framework rather than a formal credential program.

    Course Content

    What topics does QbD training cover?

    The course covers QbD principles and the ICH regulatory context, QTPP and CQA identification, risk assessment with Ishikawa and FMEA, DoE and design space, PAT and control strategy, and QbD in practice through case studies and CTD submission structure.

    Can a beginner take QbD training?

    Yes. The course introduces QbD from first principles, so it suits professionals new to the approach as well as those refreshing their skills. A science or engineering background in a pharmaceutical setting helps you get the most from the exercises.

    Does the course include hands-on DoE and tool exercises?

    Yes. Hands-on exercises run throughout, including QTPP construction, CQA and criticality assessment, Ishikawa and FMEA risk assessment, and DoE and design space interpretation, all applied to realistic pharmaceutical development scenarios.

    Which guidelines does the course align to?

    The training is aligned to the ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System, and Q11 drug substance guidelines, and reflects current FDA and EMA expectations for QbD in development submissions.

    What learning materials are provided?

    You receive structured courseware, worked case studies for small molecules and biologics, and QbD tool exercises and templates. Materials are grounded in the ICH QbD guidelines and the established QbD body of knowledge.

    Enrollment

    How do I enroll in QbD training?

    You can enroll through the Invensis Learning website. Choose your preferred format, complete your booking, and you will receive access to the schedule, 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 online (live virtual instructor-led), in a classroom, and as corporate on-site training for teams. Choose the format that fits your schedule, location, and learning preference.

    How long is the QbD training?

    The program runs for one day (about eight hours) and can also be delivered as two half-days. It covers the full QbD framework with concept explanations, the ICH regulatory context, and hands-on tool exercises throughout.

    Can QbD training be delivered on-site for my team?

    Yes. Corporate on-site delivery lets a cross-functional team train together and apply the tools to your own live development projects during the session. Contact us to arrange scheduling and tailored case examples for your organization.

    Can I reschedule my enrollment?

    Yes. Flexible options let you reschedule or transfer to another session where available. Contact our support team to arrange a change that works for you, and ask about upcoming schedules for the format you prefer.