Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training in Poland?

    The QbD Approach Explained

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    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the Poland

    Who Can Enrol?

    Why Quality by Design Skills Are Worth It

    For Pharma Professionals and Teams

    Where QbD Skills Take Your Pharma Career in Poland

    Roles 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.

    What Is Fuelling Demand for QbD Skills in Polish Pharma

    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.

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

    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 optimisation
    • 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 Curriculum

    of 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.

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    The QbD Tools You Will Be Able to Apply

    Skills 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 Take

    Quality 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 Modes

    for 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 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

    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.

    Best For: Learners who prefer in-person interaction, structured schedules, and collaborative learning experiences.

    Quality by Design Corporate Group Training

    • Customised training aligned to organisational 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

    Designed for organizations that want to build capabilities at scale, standardise knowledge, and support workforce development through customised team learning initiatives.

    Best For: Organizations looking to upskill employees, address capability gaps, and deliver consistent training across teams.

    Quality by Design Focused 1-to-1 Training

    • One-to-one instructor attention

    • Customised 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

    Receive personalized instruction tailored to your goals, pace, and learning requirements through dedicated sessions from our trusted Quality by Design training company.

    Best For: Professionals seeking personalized guidance, accelerated learning, or focused support to achieve specific outcomes.

    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 1290

    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 Training

    In 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 Poland

    Instructor-led in-person Classroom training is available for group batches. All other public cohorts are delivered as Instructor-led Live Virtual. See available cohorts.

    Quality by Design Training Location in Poland

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

    Quality by Design Training Location in Poland

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

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    Corporate QbD Training for Pharma Teams

    Upskill Whole Teams

    • 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

    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

    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

    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

    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

    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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    Trustpilot

    4.6

    Ratings

    100K+

    Happy Learners

    100+

    Locations Worldwide

    99%

    Training Satisfaction

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    We also deliver Quality by Design Training across multiple cities

    Invensis Learning delivers industry-leading Quality by Design training solutions tailored for individuals and organizations.

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    Frequently Asked Questions

    Here'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.

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