Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training?UntitledA Science-Led Route to Building Quality In

    Quality by Design Training in Czechia gives pharmaceutical and biopharmaceutical professionals a systematic, science-based way to build quality into a product from the design stage, rather than testing it in at the end. Quality by Design (QbD) is the approach set out in the ICH Q8, Q9, Q10 and Q11 guidelines and increasingly expected by regulators including the FDA and EMA. Across the training you learn to apply the core QbD tools: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. The 1-day, 8-hour programme moves from QbD principles and the ICH regulatory context through to Process Analytical Technology and lifecycle management, with hands-on exercises on realistic development scenarios. It suits formulation and analytical scientists, process development engineers, and quality assurance and regulatory affairs specialists in Czech pharma, biotech, API and CDMO organisations. If you want to replace trial-and-error development with a proven, regulator-ready method, this is a practical place to start with Invensis Learning.

    What Is Quality by Design Training?A Science-Led Route to Building Quality In

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

    Across the training you learn to apply the core QbD tools: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. The 1-day, 8-hour programme moves from QbD principles and the ICH regulatory context through to Process Analytical Technology and lifecycle management, with hands-on exercises on realistic development scenarios.

    It suits formulation and analytical scientists, process development engineers, and quality assurance and regulatory affairs specialists in Czech pharma, biotech, API and CDMO organisations. If you want to replace trial-and-error development with a proven, regulator-ready method, this is a practical place to start 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 Czechia 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 Czechia 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 Czechia

    • Instructor-led training formats available for individual learners and corporate teams across the Czechia
    • 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 Czechia
    • 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 Czechia 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 CzechiaWho Can Enroll?

    • No formal prerequisites are required to enroll in the Quality by Design training program

    • Basic familiarity with quality assurance concepts is helpful but not mandatory for enrollment

    • Professionals from pharmaceutical, biotechnology, healthcare, and manufacturing industries are well-suited for this training

    • Individuals and corporate teams seeking to build QbD knowledge and apply regulatory-aligned product development principles are eligible to enroll

    • Learners with backgrounds in quality, regulatory affairs, process engineering, and production management will find the content directly applicable to their roles

    What You Gain from QbD TrainingPractical Value You Can Apply at Work

    For Individuals

    For Individuals

    QbD training equips you to design quality into pharmaceutical products from the outset, using the same ICH-aligned method that regulators expect. You build practical, job-ready capability in QTPP definition, CQA identification, risk assessment and design space thinking. Whether you work in formulation, analytical development, process engineering, quality assurance or regulatory affairs, the skills apply directly to your live development projects in Czech pharma and biotech.

    If you want to move from reactive end-product testing to proactive, science-based development, QbD is a capability employers across the sector value. You leave able to lead QbD activities on real products, not just describe the theory.

    • Design quality into products from the QTPP and CQAs, not end-product testing
    • Apply ICH Q8 to Q11 principles that FDA and EMA submissions now expect
    • Lead risk assessments using Ishikawa diagrams and FMEA with RPN scoring
    • Plan and interpret DoE studies and define a robust design space
    • Build a control strategy and use PAT for real-time quality assurance
    • Structure QbD evidence for CTD Section 3.2.P.2 submissions
    • Apply the method to both small molecule and biologic products
    For Organizations

    For Organizations

    QbD group training helps pharmaceutical and biotech organisations build a shared, science-based approach to product and process development. Teams learn to align on the QTPP, CQAs, risk assessment and control strategy so development is consistent and regulator-ready. Delivered for cross-functional development teams, the training is most effective when participants apply QbD tools to their own live projects during the session.

    For organisations facing rising regulatory expectations and cost-of-quality pressure, QbD capability reduces deviations, strengthens submissions and shortens the path from development to reliable manufacturing.

    • Builds a common QbD language across formulation, analytical, process and quality teams
    • Reduces deviations and out-of-specification results through built-in quality
    • Strengthens ICH-aligned regulatory submissions and post-approval flexibility
    • Applies QbD tools directly to your live product development projects
    • Supports the move to biologics, continuous manufacturing and PAT
    • Delivered flexibly onsite or live virtual for teams across Czechia
    • Develops in-house capability so expertise stays with your organisation

    Your Career Outlook in CzechiaRoles, Sectors and Demand Right Now

    QbD capability is becoming a clear differentiator across the Czech life sciences sector, valued by generic and biopharma manufacturers, API producers, CDMOs and regulatory teams that must meet ICH-aligned expectations. As employers such as Zentiva and Teva modernise development and the country builds new R&D capacity, professionals who can design quality into products, rather than test for it, are increasingly sought after. Demand spans formulation, analytical, process, quality and regulatory roles, and here is what the market is telling us right now.

    400+

    Life sciences companies, Czechia

    CzechInvest, 2026

    12,000

    Life sciences students in the pipeline

    CzechInvest, 2026

    EUR 1.5bn

    FDI into Czech life sciences

    since 2003, CzechInvest

    USD 5bn+

    Pharma market size, Czechia

    Statista, 2025-2026

    Sectors Hiring

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

    Growth Trends

    • —ICH QbD expectations rising across FDA and EMA submissions
    • —MUNI BioPharma Hub adding R&D capacity from 2026 and 2027
    • —Prague hosting BioEquity Europe 2026, raising the sector profile
    • —Skilled, competitively priced talent base drawing pharma FDI
    • —Shift from traditional pharma toward high-value biotech
    • —Growing adoption of continuous manufacturing and PAT

    Sources: CzechInvest and Statista (Czech life sciences and pharma market) 2025-2026; SalaryExpert, platy.cz and worldsalaries (Czech pharma salaries) 2026.

    What Is Driving Demand for QbD Skills in Czechia

    Rising Regulatory Expectations

    The FDA and EMA increasingly expect QbD evidence in pharmaceutical submissions, so Czech developers need people who can produce QTPP, design space and control strategy documentation.

    QbD builds ICH-aligned submission skills

    Generics and Biosimilars Complexity

    Czechia's strong generic and OTC base, led by employers like Zentiva and Teva, needs science-based development that holds up across scale-up, transfer and lifecycle changes.

    QbD builds robust development capability

    The Shift to Biologics

    As Czech life sciences move toward high-value biologics and cell therapies, process-defined products demand the deep CQA and design space understanding that QbD provides.

    QbD builds process-understanding skills

    QbD Talent and Capability Gap

    The Czech talent pool is deep in general QA and QC but thinner in QbD practitioners who can lead QTPP, DoE and risk assessment, making trained professionals scarce and valued.

    QbD makes practitioners stand out

    Cost of Quality and Right-First-Time

    Margin and supply pressure push manufacturers to cut deviations and out-of-specification results, which QbD tackles by designing quality in rather than inspecting it at the end.

    QbD builds built-in quality skills

    Continuous Manufacturing and PAT

    New continuous lines and Process Analytical Technology need the process understanding and control strategy design that sit at the heart of the QbD approach.

    QbD builds real-time control skills

    Sources: CzechInvest and Statista (Czech life sciences) 2025-2026; ICH Q8 to Q11 guidelines; company hiring signals, Zentiva and Teva 2026.

    QbD is more than a method. It is the capability regulators expect and employers hire for. Join Czech pharma and biotech professionals who design quality into products from the start. Begin your QbD journey today.

    Your Czechia QbD Transformation

    Where You Stand Today Without QbD

    The Capability QbD Builds

    The Czech pharma and biotech market is shifting from traditional manufacturing toward high-value, regulator-ready development, and employers increasingly separate professionals who can design quality in from those who cannot. Here is which side of that line you want to be on.

    Today

    Seen as a QC or QA specialist with a narrow, reactive remit

    After QbD Training

    Recognised as a QbD practitioner who leads development, not just checks it

    Today

    Limited mobility across Czech pharma and biotech employers

    After QbD Training

    Skills valued across Zentiva, Teva, biotech and CDMO employers in Czechia

    Today

    Career progress capped without design-stage capability

    After QbD Training

    Positioned for senior formulation, process development and CMC roles

    You master QbD

    Before

    Quality is checked by end-product testing after manufacturing

    Now you have

    Quality is designed in from the QTPP and CQAs onward

    Before

    Process changes are managed by trial and error at scale-up

    Now you have

    A defined design space lets you predict and control quality

    Before

    Risk decisions rely on individual judgement and habit

    Now you have

    Structured FMEA and Ishikawa risk assessment guide your priorities

    Before

    Development evidence is hard to defend to regulators

    Now you have

    QbD documentation maps cleanly to ICH and CTD submissions

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

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

    Sources: SalaryExpert, platy.cz, worldsalaries (Czech pharma) 2026; CzechInvest 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 Czechia 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 ProgrammeThe Full QbD Toolkit in Practice

    This QbD training builds the practical skills to design quality into pharmaceutical products, from defining the QTPP to building a control strategy. Each skill maps to a QbD tool you can apply on real development projects, aligned to the ICH Q8 to Q11 guidelines.

    Define the Quality Target Product Profile

    By the end of the training you can construct a Quality Target Product Profile (QTPP) from clinical and patient needs, setting the design specification that drives the whole QbD programme.

    Identify and Classify Critical Quality Attributes

    Identify Critical Quality Attributes for small molecules and biologics, distinguish critical from non-critical characteristics, and link CQAs to material attributes and process parameters.

    Run Structured QbD Risk Assessments

    Apply Ishikawa diagrams and FMEA with Severity, Occurrence and Detectability scoring to prioritise the material and process variables that most influence product quality.

    Plan and Interpret Design of Experiments

    Choose the right DoE design, interpret the model output, and define a design space with Normal Operating Ranges and Proven Acceptable Ranges that regulators can accept.

    Apply PAT and Build a Control Strategy

    Use Process Analytical Technology such as NIR and Raman for real-time monitoring, and build a control strategy that ties material, process and in-process controls to your QbD understanding.

    Structure QbD Evidence for Submissions

    Present QbD outputs in the CTD Section 3.2.P.2 format, connect them across the submission, and manage post-approval change through the ICH Q12 lifecycle approach.

    Who Should TakeQuality by Design Training in Czechia?

    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

    CZK 8370

    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

    CZK 8370

    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 LearningFor Quality by Design Training in Czechia

    As a trusted Quality by Design training company, Invensis Learning delivers structured QbD training for pharmaceutical and biotech professionals and teams across Czechia who want to build quality into products from the design stage. Our programmes combine experienced ICH-aligned trainers, flexible delivery formats, organised courseware and practical, hands-on exercises. Whether you enrol as an individual or plan group training for your team, you get a professional learning experience built around practical understanding, real-world application and measurable outcomes.

    • Experienced, industry-practitioner trainers with real pharmaceutical development background
    • Content built on the ICH Q8, Q9, Q10 and Q11 guidelines, not generic theory
    • Flexible formats: live virtual, classroom and onsite delivery for teams
    • Hands-on QbD tool exercises on realistic development scenarios
    • ISO 9001:2015 quality-managed and ISO 27001:2022 information-secure delivery
    • Structured, well-organised courseware and reference materials
    • Dedicated learner support before, during and after the training
    • Trusted by professionals and organisations across many industries and regions

    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 CzechiaAll our classroom training is now available online at your convenience

    Quality by Design in Czechia

    Hilton Prague Atrium, 311, Pobřežní, Florenc, Karlín, Prague 8, district Prague 8, Prague, 186 00, Czech Republic

    Quality by Design in Czechia

    Grand Hotel Prague Towers, 1655/1, Kongresová, Nusle, Prague 4, district Prague 4, Prague, 140 00, Czech Republic

    corporate banner

    Corporate Quality by Design TrainingFor Your Teams in Czechia

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    • Suitable for small, medium and large cross-functional development teams
    • Customised schedules built around your team's availability
    • Flexible delivery through onsite, live virtual or hybrid formats
    • Trainers with real pharmaceutical and biotech development experience
    • QbD tools applied to your own live product development projects
    • Dedicated coordination and learner support for group programmes
    • Scalable delivery for teams across Czechia and other locations

    Leading Pharmaceutical Employers

    ZentivaTevaMSDSanofiContiproSotio Biotech

    What Our Learners Say

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    Practical QbD I Could Apply the Next Day

    "The training finally made QbD practical for me. Building a QTPP and running an FMEA on a real formulation during the session was exactly what I needed to take back to my development work."

    Petr Novak

    Formulation Scientist

    Untitled

    0/0

    Connected QbD to Real Submissions

    "As a regulatory affairs specialist, I now understand how QTPP, CQAs and the design space connect to what we write in Section 3.2.P.2. The ICH context was clear and well explained throughout."

    Jana Svobodova

    Regulatory Affairs Specialist

    Untitled

    0/0

    The DoE Session Changed How I Work

    "The DoE and design space session was the highlight. I came in doing one-factor-at-a-time work and left understanding how to plan experiments that actually show interactions."

    Tomas Prochazka

    Process Development Engineer

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    Gave Our Team a Shared QbD Language

    "We booked the programme for our cross-functional development team. Everyone now shares the same QbD language, and our risk assessments and control strategies are far more consistent."

    Katerina Dvorakova

    Head of Pharmaceutical Development

    Generic pharmaceutical manufacturer

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    ICH-Aligned and Genuinely Hands-On

    "As an L&D lead, I needed training that was ICH-aligned and hands-on rather than theory. The trainer worked our own project scenarios into the exercises, which made the value obvious to the team."

    Martin Kral

    Learning and Development Lead

    Biotechnology organisation

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

    Quality by Design training is a practical, non-certification course that teaches the QbD approach to pharmaceutical development, where quality is built into a product from the design stage. It covers the QTPP, CQAs, risk assessment, DoE, design space, PAT and control strategy, aligned to the ICH Q8, Q9, Q10 and Q11 guidelines.

    General

    What is Quality by Design training?

    Quality by Design training is a practical, non-certification course that teaches the QbD approach to pharmaceutical development, where quality is built into a product from the design stage. It covers the QTPP, CQAs, risk assessment, DoE, design space, PAT and control strategy, aligned to the ICH Q8, Q9, Q10 and Q11 guidelines.

    Who should attend this QbD course in Czechia?

    The course suits formulation and analytical scientists, process development engineers, and quality assurance and regulatory affairs professionals in Czech pharma, biotech, API and CDMO organisations. It is ideal for anyone who wants to understand and apply QbD in product and process development.

    Do I need prior pharmaceutical experience?

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

    Which regulatory framework does the training follow?

    The training is grounded in the ICH guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 Drug Substances. It also reflects FDA and EMA expectations for QbD evidence in submissions.

    Is QbD relevant to both small molecules and biologics?

    Yes. The course covers QbD for small molecule drug products such as tablets and injectables, and for biopharmaceuticals such as monoclonal antibodies and biosimilars, with case study examples drawn from both.

    What do I receive on completion?

    This is a skills-focused course with no examination. On completing the programme you receive a course completion record from Invensis Learning, and the practical QbD skills are immediately applicable to your development projects.

    Pricing

    How much does the QbD training cost in Czechia?

    Pricing depends on the delivery format, group size and whether the training is public or corporate, so a current quote is available on request. Speak with a learning advisor for pricing tailored to your needs.

    What is included in the course fee?

    The fee typically includes instructor-led delivery, structured courseware and reference materials, hands-on QbD tool exercises, case study scenarios and a course completion record. Contact us to confirm the inclusions for your chosen format.

    Do you offer group or corporate pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for development teams, PMOs and quality functions. Ask about corporate and 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. Talk to a learning advisor to choose the option that suits you.

    Is there a discount for team enrolments?

    Group and team enrolments are usually more cost-effective per learner than individual bookings. Share your team size and preferred format and we will prepare a group quote.

    Course Content

    What topics does the QbD training cover?

    The training covers QbD principles and the ICH regulatory context, the QTPP and CQAs, risk assessment with Ishikawa and FMEA, DoE and design space definition, PAT and control strategy, and QbD in practice through case studies and lifecycle management.

    Which QbD tools will I practise?

    You will practise the core QbD toolkit: constructing a QTPP, identifying and classifying CQAs, running Ishikawa and FMEA risk assessments, selecting a DoE design, and interpreting a design space with Normal Operating Ranges and Proven Acceptable Ranges.

    How long is the QbD training?

    The programme runs for one day, totalling eight hours. It covers all six QbD modules with concept explanations, ICH regulatory context, case study examples and hands-on exercises throughout.

    Are there hands-on exercises?

    Yes. Learning is reinforced through hands-on exercises on realistic development scenarios, including QTPP construction, CQA identification, risk assessment and design space interpretation, rather than a formal assessment.

    Is the content aligned to the latest ICH guidelines?

    Yes. The courseware reflects the current ICH Q8(R2), Q9, Q10 and Q11 guidelines and the ICH Q12 lifecycle framework, so what you learn matches what regulators expect in QbD-based submissions.

    What learning materials are provided?

    You receive structured courseware, reference materials on the ICH QbD framework, worked case study scenarios and exercise templates for the QbD tools, all designed to support application back at work.

    Enrollment

    How do I enrol in the QbD course?

    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. Reach out to a learning advisor if you need help choosing.

    What delivery formats are available?

    The Quality by Design course online is delivered as live virtual, instructor-led sessions, and it is also available in classroom sessions and as onsite corporate training. You can pick the format that best fits your schedule and team.

    Can the course be delivered onsite for my team in Czechia?

    Yes. We deliver onsite and live virtual group training for teams across Czechia, with schedules and case scenarios tailored to your organisation's live development projects. Ask about corporate delivery for your team.

    How soon can I start?

    Public sessions run on a regular schedule, and corporate sessions are arranged around your team's availability. See upcoming schedules or talk to an advisor to confirm the next available dates.

    What is the reschedule or refund policy?

    Rescheduling and refunds are handled under our published policy, and selected plans include flexible reschedule options. Contact our team for the details that apply to your enrolment.