Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training in Poland?UntitledThe QbD Approach Explained

    The Quality by Design Training in Poland is a practical, one-day programme that shows pharmaceutical and biopharmaceutical professionals how to build quality into a product from the design stage rather than test it in at the end. Quality by Design (QbD) is the systematic, science-based approach set out in the ICH Q8(R2), Q9, Q10 and Q11 guidelines and expected by regulators including the EMA and FDA. You learn the full QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space, Process Analytical Technology and the control strategy, with hands-on exercises on realistic development scenarios. For scientists, engineers, QA and regulatory professionals across Poland's growing pharma, biotech and CDMO sector, this training turns QbD into day-to-day capability. Start building quality by design with Invensis Learning.

    What Is Quality by Design Training in Poland?The QbD Approach Explained

    The Quality by Design Training in Poland is a practical, one-day programme that shows pharmaceutical and biopharmaceutical professionals how to build quality into a product from the design stage rather than test it in at the end. Quality by Design (QbD) is the systematic, science-based approach set out in the ICH Q8(R2), Q9, Q10 and Q11 guidelines and expected by regulators including the EMA and FDA.

    You learn the full QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space, Process Analytical Technology and the control strategy, with hands-on exercises on realistic development scenarios.

    For scientists, engineers, QA and regulatory professionals across Poland's growing pharma, biotech and CDMO sector, this training turns QbD into day-to-day capability. Start building quality by design 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 Poland 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 Poland 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 Poland

    • Instructor-led training formats available for individual learners and corporate teams across the Poland
    • 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 Poland
    • 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 Poland 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 PolandWho 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 Are Worth ItFor Pharma Professionals and Teams

    For Individuals

    For Individuals

    This training helps pharmaceutical professionals move from testing quality in to designing it in. It suits formulation scientists, analytical scientists, process development engineers, QA professionals and regulatory affairs specialists who want to apply QbD on live projects. Whether you are formalising your development method, moving into a quality-focused role, or working in generics, biologics or contract manufacturing, this training builds capabilities employers across Poland increasingly expect.

    If you want a practical, science-based skill you can use straight away, QbD is a clear step forward. You gain the full toolkit, from QTPP and CQA identification through to design space and control strategy, with hands-on exercises that mirror real pharmaceutical development.

    • Apply QbD from day one to build quality into pharmaceutical products by design
    • Construct a Quality Target Product Profile and identify Critical Quality Attributes with confidence
    • Lead risk assessments using FMEA and Ishikawa diagrams on real development projects
    • Plan and interpret Design of Experiments to define a robust design space
    • Develop control strategies and PAT approaches that regulators expect
    • Speak the ICH Q8, Q9, Q10 and Q11 language valued by Polish pharma and CDMO employers
    • Strengthen your value to formulation, analytical, QA and regulatory teams
    • Gain a practical, immediately usable skill set with no examination to sit
    For Organizations

    For Organizations

    QbD group training helps organisations build quality-by-design capability by equipping cross-functional teams with a shared method and practical tools. The training can be delivered for development, quality and regulatory groups together. For pharmaceutical and CDMO organisations looking to reduce deviations and strengthen regulatory submissions, this training provides a scalable, flexible solution.

    If your teams still rely on end-product testing and trial-and-error scale-up, QbD group training creates a common development language. Staff gain a standardised approach to QTPP, risk assessment, DoE and control strategy that supports consistent, regulator-ready product development.

    • Upskill cross-functional development teams in one aligned QbD approach
    • Reduce manufacturing deviations and out-of-specification batches
    • Strengthen EU GMP and EMA-ready regulatory submissions
    • Embed a shared QTPP, CQA and design space language across sites
    • Deliver onsite or live virtual training tailored to your products
    • Build in-house capability for biologics and small-molecule QbD
    • Support faster, more predictable scale-up and technology transfer

    Where QbD Skills Take Your Pharma Career in PolandRoles and Sector Demand

    Quality by Design skills are in demand across Poland's pharmaceutical, biotech and contract manufacturing sector, one of Europe's fastest-growing pharma hubs. As Polish CDMOs scale biologics and sterile manufacturing and generics leaders move into innovative products, employers need formulation, analytical, process, QA and regulatory professionals who can apply QbD to meet EU GMP and EMA expectations. Practical Quality by Design training helps professionals build exactly these capabilities. These roles sit at the heart of product development, and here is what the market looks like now.

    zl135,700

    QA Specialist salary, Poland

    average per year, PayScale 2026

    zl145,300

    Regulatory Affairs Specialist, Poland

    average per year, ERI 2026

    EUR 5.1bn

    Pharma manufacturing market, Poland

    market size, IBISWorld 2026

    195

    Biotech companies, Poland

    sector estimate, 2026

    SECTORS HIRING

    • —Generic and Innovative Pharma Manufacturing
    • —Biotech and Biologics
    • —Contract Development and Manufacturing (CDMO)
    • —Active Pharmaceutical Ingredient (API) Production
    • —Regulatory Affairs and CMC Consulting
    • —Medical Devices and Sterile Products

    GROWTH TRENDS

    • —Poland ranked a leading CDMO hub in Central and Eastern Europe
    • —Shift from generics towards biologics and precision medicine
    • —EMA and FDA expecting QbD evidence in submissions
    • —A 30 to 40 percent cost edge drawing global manufacturing
    • —Strong pipeline of bio-pharma graduates entering the sector
    • —Rising pharma exports demanding regulatory-grade dossiers

    Sources: PayScale, ERI SalaryExpert, Glassdoor (Poland) 2026; IBISWorld 2026; PAIH and PMR pharmaceutical sector data.

    What Is Fuelling Demand for QbD Skills in Polish Pharma

    EU GMP and EMA Compliance Pressure

    Polish manufacturers and CDMOs must meet full EU GMP and EMA expectations, and regulators increasingly want QbD evidence of design space and control strategy in submissions.

    QbD builds design space and control strategy skills

    Fast-Growing CDMO Sector

    Poland is one of Europe's fastest-growing contract manufacturing hubs, and sponsors expect QbD-based process understanding for reliable, right-first-time scale-up.

    QbD builds process understanding for scale-up

    Shift from Generics to Biologics

    As Polish firms move into biologics and precision medicine, teams need QbD skills to define CQAs and control strategies for complex, process-defined products.

    QbD builds CQA and control skills for biologics

    Quality Talent Shortage

    The sector has strong graduate numbers but a shortage of professionals who can lead QTPP, risk assessment and DoE work, making QbD-capable staff valuable.

    QbD makes development professionals stand out

    Cost-Competitive Manufacturing

    Poland's 30 to 40 percent cost edge only holds if quality stays high, and QbD reduces the deviations and out-of-specification batches that erode that advantage.

    QbD builds deviation-reducing quality skills

    Export-Driven Dossier Demand

    Rising pharmaceutical exports mean more regulatory dossiers, and QbD provides the structured pharmaceutical development evidence global health authorities expect.

    QbD builds regulatory-grade development evidence

    Sources: PAIH, PMR, IBISWorld (Poland pharma) 2026; PharmaSource, MAI CDMO 2026.

    QbD is more than a method. It is a career advantage in Poland's fast-growing pharma sector. Join professionals who design quality into products and meet EU GMP and EMA expectations. Start your journey today.

    Your Poland Pharma Career Move

    Your QbD Transformation in Poland

    Before and After the Training

    Poland's pharma and biotech sector increasingly separates teams that can design quality in from those that still test it in at the end. Here is the shift this training helps you make.

    Today

    Quality is checked by end-product testing, with deviations found late

    After Training

    You design quality in using QTPP, CQAs and a defined control strategy

    Today

    Process understanding is empirical, so scale-up is trial and error

    After Training

    DoE and the design space give you predictable, evidence-based scale-up

    Today

    Limited fluency in the ICH QbD language employers now expect

    After Training

    You apply ICH Q8, Q9, Q10 and Q11 thinking on live development projects

    You master QbD

    Before

    Development relies on personal experience, not a structured method

    Now you have

    A repeatable, science-based QbD toolkit you can use across products

    Before

    Risk assessment is informal and hard to defend to regulators

    Now you have

    FMEA and Ishikawa skills that stand up in EU GMP and EMA reviews

    Before

    Your role is seen as testing and checking, not designing quality

    Now you have

    Recognition as a professional who builds quality in by design

    Before

    Value is limited to one function or a single task

    Now you have

    Cross-functional QbD capability valued across Poland's pharma sector

    "In modern pharma, quality is designed into the product, not inspected into it, and the teams that understand this are the ones regulators and sponsors trust."

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

    Sources: PayScale, ERI SalaryExpert (Poland) 2026; PAIH and PMR pharmaceutical sector data.

    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 Poland 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 Be Able to ApplySkills You Use on Real Projects

    In this training you will learn to apply the complete Quality by Design toolkit to pharmaceutical development, from defining the product profile through to building the control strategy for regulatory submission.

    Define the Quality Target Product Profile

    Build a QTPP from clinical and patient needs, setting the quality, safety and efficacy targets that guide the entire development programme.

    Identify Critical Quality Attributes

    Determine which physical, chemical and biological attributes are critical to product quality for both small molecules and biologics, and justify your classification.

    Lead Risk Assessments with FMEA and Ishikawa

    Map material attributes and process parameters to CQAs, then prioritise them by risk using Ishikawa diagrams and FMEA with RPN scoring.

    Plan DoE and Define the Design Space

    Choose the right Design of Experiments approach, interpret the model, and define a design space with Normal Operating and Proven Acceptable Ranges.

    Apply PAT and Build a Control Strategy

    Use Process Analytical Technology such as NIR and Raman for real-time monitoring, and develop a risk-proportionate control strategy from your QbD outputs.

    Structure QbD Evidence for Submissions

    Present the QTPP, risk assessment, DoE and control strategy as the pharmaceutical development section of a CTD dossier for EMA and FDA submissions.

    Who Should TakeQuality by Design Training in Poland?

    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

    PLN 1580

    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

    PLN 1580

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

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

    Loading schedules…

    Why Choose Invensis Learning for QbD TrainingIn Poland and Beyond

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and teams who want to apply QbD, not just understand it. Our sessions are led by experienced quality and pharmaceutical development practitioners and use real development scenarios so you can act on what you learn. Whether you join as an individual or train a cross-functional team, you get structured courseware, hands-on QbD tool exercises and flexible delivery. As an ISO 9001:2015 and ISO 27001:2022 certified training company, Invensis Learning brings globally consistent quality and secure, professional learning operations.

    • Trainers who are experienced quality and pharmaceutical development practitioners
    • Hands-on QbD exercises using realistic development scenarios
    • Flexible live virtual, classroom and onsite delivery
    • Structured, up-to-date courseware aligned to ICH Q8, Q9, Q10 and Q11
    • ISO 9001:2015 certified training operations for consistent quality
    • ISO 27001:2022 certified information security
    • Corporate and group training tailored to your products and sites
    • Dedicated learner support before, during and after training

    100+

    Countries Served

    ISO 9001

    Quality Management

    200K+

    Professionals Trained

    12M+

    Hours of Training Delivered

    ISO 9001:2015 Certified

    ISO 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

    Secure SSL Encryption

    Leaders in Training industry for 12+ years

    Leaders in Training industry for 12+ years

    Over 5000 five star reviews

    Over 5000 five star reviews

    Level AA conformance, W3C WCAG 2.2

    Level AA conformance, W3C WCAG 2.2

    Quality by Design Training Locations in PolandAll our classroom training is now available online at your convenience

    Quality by Design in Poland

    InterContinental, 49, Emilii Plater, Żelazna Brama, Śródmieście Północne, Śródmieście, Warsaw, Masovian Voivodeship, 00-125, Poland

    Quality by Design in Poland

    The Westin Warsaw, 21, Aleja Jana Pawła II, Mirów, Wola, Warsaw, Masovian Voivodeship, 00-854, Poland

    corporate banner

    Corporate QbD Training for Pharma TeamsUpskill Whole Teams

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    • Train formulation, analytical, QA and regulatory teams together
    • Customised content mapped to your products and processes
    • Onsite, live virtual or hybrid delivery across your sites in Poland
    • Build a shared QTPP, CQA and design space language
    • Strengthen EU GMP and EMA-ready development practice
    • Flexible scheduling around production and shift patterns
    • Dedicated coordination and progress tracking for your group

    Pharma and Biotech Organisations

    PolpharmaAdamedGedeon Richter PolskaCelon PharmaPolfa TarchominMabion

    What Our Learners Say

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    QbD I Could Use the Next Day

    "The hands-on QTPP and CQA exercises made the whole approach click. I went back to my formulation project and immediately started mapping critical attributes to our process parameters."

    Katarzyna Wojcik

    Formulation Scientist

    Untitled

    0/0

    The DoE and Design Space Section Was Excellent

    "I finally understand how to plan a Design of Experiments and read the design space instead of running one factor at a time. The trainer used realistic pharma examples throughout."

    Piotr Kowalski

    Analytical Scientist

    Untitled

    0/0

    Clearer QbD Story for Our Dossiers

    "As a CMC regulatory specialist, the module on structuring QbD evidence for the CTD was exactly what I needed. Our pharmaceutical development sections are much stronger now."

    Anna Nowak

    Regulatory Affairs Specialist

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    Great Fit for a Cross-Functional Team

    "We trained formulation, QA and process staff together. Having one shared QbD language, from risk assessment to control strategy, has already reduced back-and-forth on deviations."

    Marek Zielinski

    Head of Quality, Pharmaceutical Manufacturer

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    Practical and Well Tailored to Us

    "Invensis Learning adapted the scenarios to our biologics work. The team came away able to apply DoE and PAT thinking on live client projects, which is exactly the capability we needed."

    Agnieszka Lewandowska

    Learning and Development Manager, CDMO

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

    Quality by Design training is a practical, one-day course that teaches pharmaceutical professionals to build quality into a product from the design stage. It covers the QbD approach set out in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, using tools such as the QTPP, CQAs, risk assessment, DoE and the control strategy.

    General

    What is Quality by Design (QbD) training?

    Quality by Design training is a practical, one-day course that teaches pharmaceutical professionals to build quality into a product from the design stage. It covers the QbD approach set out in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, using tools such as the QTPP, CQAs, risk assessment, DoE and the control strategy.

    Is Quality by Design training worth it for pharma professionals in Poland?

    Yes. Poland is one of Europe's fastest-growing pharma and CDMO hubs, and employers increasingly expect QbD-based development that meets EU GMP and EMA standards. The training gives formulation, analytical, QA and regulatory professionals a practical, in-demand skill they can apply immediately.

    Who should attend this QbD training?

    The course suits formulation scientists, process development engineers, analytical scientists, QA professionals, regulatory affairs (CMC) specialists and manufacturing technical managers in pharmaceutical, biopharmaceutical, API and CDMO organisations who want to apply QbD.

    Do I need prior QbD experience to attend?

    No. The training introduces QbD from first principles in a pharmaceutical development context. Familiarity with pharmaceutical development or GMP is helpful but not required, so the course works for newcomers and experienced professionals alike.

    Which standards and guidelines does QbD training follow?

    The training is grounded in the ICH quality guidelines that underpin QbD: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances, along with FDA and EMA expectations for pharmaceutical development.

    Pricing

    How much does Quality by Design training cost in Poland?

    Pricing depends on the delivery format, whether you join a public session or book corporate training, and group size. For current fees in your preferred format, request a quote from a learning advisor.

    What is included in the course fee?

    The fee typically covers instructor-led training across all six QbD modules, structured courseware, hands-on tool exercises, realistic case scenarios, learner support and a course completion record from Invensis Learning.

    Do you offer group or corporate pricing?

    Yes. We offer corporate and group training with volume-based pricing for pharmaceutical and CDMO teams, delivered onsite or live virtual. Contact us for a tailored quote for your organisation.

    Are there savings for training a full team?

    Group training is priced per cohort, which is usually more cost-effective than enrolling individuals separately. Ask a learning advisor about corporate and group pricing for your team.

    In what currency is the training billed in Poland?

    Training for learners in Poland is typically quoted in local currency (PLN), though pricing can vary by delivery mode and region. A learning advisor can confirm the exact figure for your chosen format.

    Assessment

    Is there an examination for this QbD training?

    No. This is a practical, non-certification training course, so there is no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case scenarios and group discussion during the one-day programme.

    What will I receive after completing the training?

    You receive a course completion record from Invensis Learning confirming you have completed the Quality by Design training. The skills you gain are immediately applicable to pharmaceutical development work.

    How is learning reinforced during the course?

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

    Are there prerequisites to enrol?

    There are no formal prerequisites. The course is open to all, and it introduces QbD from first principles, so a science or pharmaceutical development background is helpful but not essential.

    Does this training expire or need renewing?

    No. Because this is a skills training course, there is nothing to renew. The QbD knowledge and tools you gain remain applicable to your pharmaceutical development projects.

    Course Content

    What topics does the QbD training cover?

    The course covers the full QbD framework: QbD principles and the ICH regulatory context; the QTPP and CQAs; risk assessment; Design of Experiments and the design space; Process Analytical Technology and the control strategy; and QbD in practice through case studies and regulatory submissions.

    Does the training cover both small molecules and biologics?

    Yes. The course applies QbD to small-molecule drug products such as tablets and injectables, and to biopharmaceuticals such as monoclonal antibodies and biosimilars, with case examples from both.

    Are there hands-on exercises in the course?

    Yes. You work through practical exercises including QTPP construction, CQA identification and criticality assessment, Ishikawa risk mapping, DoE design selection and design space interpretation, all based on realistic pharmaceutical scenarios.

    What will I be able to do after the training?

    You will be able to construct a QTPP, identify and classify CQAs, run FMEA-based risk assessments, plan a DoE for design space generation, develop a control strategy, and structure QbD evidence for a CTD regulatory submission.

    Is the course content up to date with current guidelines?

    Yes. The courseware is aligned to the current ICH Q8(R2), Q9, Q10 and Q11 guidelines and reflects FDA and EMA expectations for QbD in pharmaceutical development and manufacturing submissions.

    Enrollment

    How do I enrol in the Quality by Design training?

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

    What delivery formats are available in Poland?

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

    How long is the QbD training?

    The course runs as a one-day, eight-hour programme covering all six QbD modules with concept explanations, ICH regulatory context, case examples and hands-on tool exercises.

    Can the training be delivered onsite for our team?

    Yes. We deliver corporate onsite and live virtual training for pharmaceutical and CDMO teams in Poland, tailored to your products and processes. Contact us to arrange a session for your team.

    Can I reschedule my booking?

    Yes. Rescheduling options are available depending on your plan and notice. Contact learner support to move your booking to another session that suits you.