Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design and Why It Matters to Slovenian Pharma

    A Practical, Science-Based Approach

    Quality by Design course badge

    What's Included in Your Quality by Design Training

    • One-day course spanning ten structured modules

    • 8 PDUs on completion of the training

    • Copy of course material and SME-prepared study guide

    • Case studies and practical applications module

    • Course completion certificate from Invensis Learning

    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the Slovenia

    Who Can Enrol?

    What You Gain from QbD Training

    Skills That Deliver at Work

    Who Should Take Quality by Design Training in Slovenia?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Where QbD Skills Take Your Career

    Roles and Demand in Slovenian Pharma

    Quality by Design skills are increasingly valued across Slovenia, home to one of Europe's most concentrated pharmaceutical clusters. Krka in Novo Mesto, Lek in Ljubljana and Novartis and Sandoz operations anchor a sector that employs around 13,500 people and pays the highest average wage of any industry in the country. With Sandoz building a major biosimilar site near Ljubljana and Novartis expanding cell and gene therapy in Menges, demand for professionals who can design quality into products is rising. Quality by Design training helps professionals meet that demand, and here is what the market is telling us right now.

    The Market Forces Making QbD Skills Essential in Slovenia

    QbD is more than a framework. It is the skill set that lets pharmaceutical teams design quality into products and satisfy modern regulators. Join professionals across Slovenia who are building process understanding that pays off. Start your journey today.

    Your Slovenia Career Shift

    Your Transformation with QbD Skills,

    Reactive Testing Becomes Built-In Quality

    Slovenia's pharmaceutical sector is expanding fast, with major biosimilar, biologic and cell and gene therapy investment near Ljubljana and Menges, 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.

    Sources: Boljsaplaca.si, Paylab, Invest Slovenia (Slovenia) 2025-2026.

    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 Slovenia 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 Skills You Will Build

    Tools You Can Apply on Monday

    Skills covered in QbD training run across the full Quality by Design toolkit, from QTPP and CQA identification through risk assessment, Design of Experiments, design space, PAT and control strategy. By the end of the one-day programme you can apply these tools to real pharmaceutical development scenarios.

    Building the Quality Target Product Profile

    Learn to construct a QTPP from clinical and patient requirements, defining the dosage form, delivery, pharmacokinetic targets and quality standards that anchor the entire development programme.

    Identifying Critical Quality Attributes

    Identify and classify the CQAs that must stay within limits to ensure quality, safety and efficacy, and link each one to critical material attributes and process parameters.

    Running Risk Assessments with FMEA and Ishikawa

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

    Designing Experiments and the Design Space

    Plan screening and response surface DoE studies, interpret the results, and define the design space along with Normal Operating Ranges and Proven Acceptable Ranges.

    Applying PAT and the Control Strategy

    Use Process Analytical Technology such as NIR and Raman for real-time monitoring, and build a Control Strategy that assures quality across materials, process and testing.

    Structuring QbD for Regulatory Submissions

    Organise your QbD evidence for the CTD Section 3.2.P.2, aligned to ICH Q8 to Q11, and understand how the design space supports flexible post-approval change management.

    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

    EUR 300

    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 Quality by Design Training in Slovenia

    Expert-Led, Flexible and Trusted

    As a trusted Quality by Design training company in Slovenia, Invensis Learning delivers structured, practical QbD training for individual professionals and pharmaceutical organisations building modern process development capability. Our programmes combine experienced trainers, a hands-on and tool-focused approach, organised courseware and learner-focused support. Whether you enrol as an individual or plan corporate training for a cross-functional team in Slovenia, we provide a professional learning experience designed around real-world application and measurable outcomes, backed by ISO-certified quality and information security standards.

    • Experienced trainers with real pharmaceutical quality and development expertise
    • Practical, tool-focused delivery built around hands-on QbD exercises
    • Flexible formats: live virtual, classroom, onsite and corporate group training
    • Structured courseware aligned to the ICH Q8 to Q11 framework
    • ISO 9001:2015 quality management and ISO 27001:2022 information security
    • Dedicated learner support before, during and after the programme
    • Scalable delivery for teams across Slovenia and global locations
    • Course completion record and skills you can apply immediately

    4

    Flexible Learning Modes

    99%

    Training Satisfaction

    5000+

    Accredited Trainers Globally

    4.7/5

    Rated by Learners Worldwide

    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 Slovenia

    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 Slovenia

    Exe Lev, 1, Vošnjakova ulica, Grajski grič, Quarter community Center, Ljubljana, Administrative Unit Ljubljana, 1000, Slovenia

    Quality by Design Training Location in Slovenia

    Grand Hotel Union Eurostars, 1, Miklošičeva cesta, Ledina, Grajski grič, Quarter community Center, Ljubljana, Administrative Unit Ljubljana, 1000, Slovenia

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    Corporate QbD Training in Slovenia

    Upskill Your Whole Team

    • Suitable for small, medium and large development and quality teams
    • Customised schedules built around your team's availability
    • Flexible delivery through onsite, live virtual or hybrid formats
    • Trainers with real pharmaceutical QbD and process development expertise
    • Exercises mapped to your own live product development projects
    • Dedicated coordination and learner support for group programmes
    • Scalable delivery for teams across Slovenia and global sites

    Trusted by Leading Enterprises in Slovenia

    KrkaLekSandozNovartisBelupoSartorius BIA Separations

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    We also deliver Quality by Design Training across multiple cities in Slovenia

    Quality by Design training for individuals and teams. Select a city in Slovenia to view upcoming dates, formats and pricing.

    Quality by Design Training Course in LjubljanaQuality by Design Training Course in Maribor

    Frequently Asked Questions

    Here's everything you may ask...

    Quality by Design training is a practical, one-day programme covering the QbD approach to pharmaceutical product and process development. It teaches you to design quality into products from the start using QTPP, CQA identification, risk assessment, Design of Experiments, design space, PAT and control strategy, aligned to the ICH Q8 to Q11 guidelines.