Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters to Slovenian PharmaUntitledA Practical, Science-Based Approach

    Quality by Design (QbD) Training in Slovenia is a practical, one-day programme that teaches you to build quality into pharmaceutical products from the design stage rather than testing it in at the end. You learn the systematic, science-based approach that the ICH Q8(R2), Q9, Q10 and Q11 guidelines set out and that regulators such as the FDA and EMA now expect in modern development submissions. Across the day you work through the full QbD toolkit: defining the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), linking them to material attributes and process parameters through risk assessment, exploring the design space with Design of Experiments (DoE), and building a robust Control Strategy supported by Process Analytical Technology (PAT). Hands-on exercises use realistic pharmaceutical scenarios so the concepts translate straight to your projects. The course suits formulation scientists, process development engineers, analytical scientists, quality assurance staff and regulatory affairs professionals across Slovenia's pharmaceutical, biopharmaceutical, API and CDMO organisations. There is no examination; on completion you receive a course completion record from Invensis Learning and skills you can apply immediately.

    What Is Quality by Design and Why It Matters to Slovenian PharmaA Practical, Science-Based Approach

    Quality by Design (QbD) Training in Slovenia is a practical, one-day programme that teaches you to build quality into pharmaceutical products from the design stage rather than testing it in at the end. You learn the systematic, science-based approach that the ICH Q8(R2), Q9, Q10 and Q11 guidelines set out and that regulators such as the FDA and EMA now expect in modern development submissions.

    Across the day you work through the full QbD toolkit: defining the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), linking them to material attributes and process parameters through risk assessment, exploring the design space with Design of Experiments (DoE), and building a robust Control Strategy supported by Process Analytical Technology (PAT). Hands-on exercises use realistic pharmaceutical scenarios so the concepts translate straight to your projects.

    The course suits formulation scientists, process development engineers, analytical scientists, quality assurance staff and regulatory affairs professionals across Slovenia's pharmaceutical, biopharmaceutical, API and CDMO organisations. There is no examination; on completion you receive a course completion record from Invensis Learning and skills you can apply immediately.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Slovenia 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 Slovenia 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 Slovenia

    • Instructor-led training formats available for individual learners and corporate teams across the Slovenia
    • 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 Slovenia
    • 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 Slovenia 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 SloveniaWho 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 TrainingSkills That Deliver at Work

    For Individuals

    For Individuals

    QbD training helps you replace empirical, trial-and-error development with a systematic approach that connects product understanding to consistent quality. You learn the same tools that pharmaceutical and biopharmaceutical teams across Slovenia use every day, from QTPP and CQA identification through to design space and control strategy. Whether you work in formulation, analytical science, process development, quality assurance or regulatory affairs, the programme builds capability you can put to work on real projects the following week.

    If you want to move from reacting to deviations toward preventing them through built-in process understanding, this training is a clear step forward. You leave able to lead CQA workshops, facilitate risk assessments, plan DoE studies and shape control strategies for your organisation.

    • Design quality into products from the start instead of relying on end-product testing
    • Construct a Quality Target Product Profile and identify Critical Quality Attributes with confidence
    • Run structured risk assessments using FMEA and Ishikawa diagrams
    • Plan and interpret Design of Experiments to define a robust design space
    • Build a Control Strategy supported by Process Analytical Technology
    • Work fluently within the ICH Q8 to Q11 framework expected by FDA and EMA
    • Structure QbD evidence for ICH-aligned regulatory submissions
    • Apply the tools immediately to live formulation and process development work
    For Organizations

    For Organizations

    QbD group training helps organisations embed a proactive, science-based development culture by equipping cross-functional teams with the same structured tools and vocabulary. The training can be delivered for development, quality and regulatory teams together. For organisations looking to reduce manufacturing risk and strengthen regulatory relationships, this training provides a scalable, flexible way to raise capability across the team.

    If your teams work in silos or rely on end-product testing to catch problems, corporate QbD training creates a common approach to QTPP, CQA identification, risk assessment and control strategy that carries across every development project.

    • Builds a shared QbD language across formulation, analytical, process and quality teams
    • Strengthens process understanding to reduce deviations and out-of-specification results
    • Improves the quality and consistency of ICH-aligned regulatory submissions
    • Supports faster, more confident scale-up and technology transfer
    • Enables customised training mapped to your own product development projects
    • Standardises risk assessment and design space practice across sites
    • Provides flexible delivery for cross-functional development teams
    • Builds stronger in-house QbD and process development capability

    Where QbD Skills Take Your CareerRoles 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.

    13,500

    People employed in Slovenian pharma

    sector estimate, 2026

    3,650 euros

    Average gross pay, pharma sector

    per month, highest of any Slovenian sector

    500/yr

    New high-skill pharma jobs

    created annually, sector estimate

    300M euros

    Krka planned capital investment

    capex for 2026

    SECTORS HIRING

    • —Generic and Branded Pharmaceutical Manufacturing
    • —Biosimilars and Biologics
    • —Active Pharmaceutical Ingredient (API) Production
    • —Regulatory Affairs and CMC
    • —Contract Development and Manufacturing (CDMO)
    • —Analytical and Quality Control Laboratories

    GROWTH TRENDS

    • —Sandoz building a major biosimilar production site near Ljubljana
    • —Novartis cell and gene therapy manufacturing in Menges
    • —Krka investing around 300 million euros in 2026 capacity
    • —Shortage of Qualified Persons and senior technical talent
    • —Rising FDA and EMA expectations for QbD-based submissions
    • —Strong national biosimilars and biologics growth pipeline

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

    The Market Forces Making QbD Skills Essential in Slovenia

    Rising Regulatory Expectations

    The FDA and EMA increasingly expect QbD evidence in development submissions, so Slovenian manufacturers need staff who can build QTPP, CQA and control strategy rationale into their filings.

    QbD builds ICH-aligned submission skills

    Biosimilar and Biologic Complexity

    As Sandoz and Novartis expand biosimilar, cell and gene therapy work near Ljubljana and Menges, teams must apply QbD to process-defined products that are highly sensitive to process conditions.

    QbD builds design space and risk skills

    Qualified Talent Shortage

    Slovenia has fewer than 80 Qualified Persons and an ageing technical workforce, so professionals with modern QbD and process development skills are scarce and sought after.

    QbD makes technical professionals stand out

    Scale-Up and Technology Transfer

    New plants coming online demand smooth transfer from lab to commercial scale, exactly where a defined design space and control strategy prevent costly deviations and delays.

    QbD builds process understanding for scale-up

    Pressure on Cost and Right-First-Time

    Margin and capital discipline push manufacturers to cut batch failures and rework, and built-in quality through QbD is the proven route to consistent, right-first-time production.

    QbD builds efficiency and control skills

    Move Toward Continuous Manufacturing

    As the sector adopts continuous processing and real-time release, teams need PAT and control strategy expertise that only a structured QbD approach can provide.

    QbD builds PAT and control strategy skills

    Sources: Invest Slovenia, Fierce Pharma, JAZMP, US ITA Country Commercial Guide (Slovenia) 2025-2026.

    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.

    Today

    Your value rests on hands-on lab experience alone

    After QbD

    You bring a systematic QbD skill set that Slovenian pharma employers actively seek

    Today

    You react to deviations and out-of-specification results after they happen

    After QbD

    You prevent deviations through built-in process understanding and control

    Today

    You support submissions without owning the development rationale

    After QbD

    You lead QbD thinking across formulation, analytical and regulatory teams

    You Master QbD

    Before

    Quality is checked by testing finished batches, and failures surface late

    Now you have

    You design quality into the product from the development stage

    Before

    Development runs on trial and error and one-factor-at-a-time testing

    Now you have

    You use structured Design of Experiments to map the design space with confidence

    Before

    Risk is assessed informally, with no clear link to product quality

    Now you have

    You run FMEA and Ishikawa assessments that prioritise the real risks to quality

    Before

    Submissions lack a clear, science-based development rationale

    Now you have

    You structure QTPP, CQA and control strategy evidence for ICH-aligned filings

    "The gap between testing quality in and designing it in is increasingly a set of practical skills, and the pharma employers that matter already know it."

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

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

    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 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.

    • 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 Skills You Will BuildTools 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.

    Who Should TakeQuality by Design Training in Slovenia?

    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

    EUR 400

    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

    EUR 400

    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 Quality by Design Training in SloveniaExpert-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

    98%

    First-Attempt Pass Rate

    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

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    Leaders in Training industry for 12+ years

    Leaders in Training industry for 12+ years

    Over 5000 five star reviews

    Over 5000 five star reviews

    Level AA conformance, W3C WCAG 2.2

    Level AA conformance, W3C WCAG 2.2

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

    Quality by Design in Slovenia

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

    Quality by Design 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 SloveniaUpskill Your Whole Team

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    • 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

    Pharma and Biopharma Organisations

    KrkaLekSandozNovartisBelupoSartorius BIA Separations

    What Learners Across Slovenia Say

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    Tools I Could Apply Straight Away

    "The QbD training finally connected the tools I use day to day. Building a QTPP and mapping CQAs to process parameters made immediate sense, and I ran my first proper FMEA at work the following week."

    Nina Kovac

    Formulation Scientist

    Untitled

    0/0

    DoE and Design Space Clicked

    "The Design of Experiments and design space sections were the highlight. I understand now why one-factor-at-a-time was holding us back, and how NOR and PAR give us room to operate without triggering changes."

    Luka Zupancic

    Analytical / QC Scientist

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    Clear on the ICH Framework

    "Very practical coverage of ICH Q8 to Q11 and how QbD evidence fits the CTD. As a regulatory professional I now understand the control strategy rationale far better when reviewing development reports."

    Maja Novak

    Regulatory Affairs Specialist

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    A Shared Language for the Team

    "We ran this as onsite training for our cross-functional team. It gave formulation, analytical and quality staff a shared QbD language, and our risk assessments are noticeably more structured since."

    Tomaz Horvat

    Head of Quality, Pharmaceutical Manufacturer

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    Tailored to Our Biopharma Projects

    "The trainer tailored the exercises to a biosimilar context that matched our work. The group came away able to apply QTPP, CQA and control strategy thinking to real projects, which is exactly what we needed."

    Petra Kralj

    L&D Manager, Biopharma Organisation

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    Frequently Asked QuestionsHere'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.

    General

    What is Quality by Design (QbD) training?

    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.

    Is QbD training worth it for professionals in Slovenia?

    Yes. Slovenia hosts one of Europe's densest pharma clusters, anchored by Krka, Lek, Novartis and Sandoz, with major biosimilar and biologic investment underway. Professionals who can apply QbD tools are in demand across formulation, analytical, process, quality and regulatory teams.

    Who should attend this course?

    The training suits formulation scientists, process development engineers, analytical scientists, quality assurance staff and regulatory affairs professionals in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations who want to understand and apply QbD in development and submissions.

    Do I need prior QbD knowledge to join?

    No. The course introduces QbD from first principles in a pharmaceutical development context. Familiarity with pharmaceutical development or GMP concepts is helpful but not required, so the programme works for professionals new to QbD as well as those refreshing their skills.

    What standards and guidelines does the training follow?

    The training is grounded in the ICH quality guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. It also references FDA and EMA expectations and the PAT framework used in modern manufacturing.

    Pricing

    How much does QbD training cost in Slovenia?

    Pricing depends on the delivery format, group size and whether you enrol individually or as a corporate team. Fees are available on request. Contact a learning advisor for a tailored quote for public or in-house delivery in Slovenia.

    What is included in the course fee?

    The fee typically includes instructor-led delivery across all six QbD modules, structured courseware, hands-on tool exercises, case study materials, learner support and a course completion record from Invensis Learning. Request a quote to confirm the inclusions for your chosen format.

    Do you offer group or corporate rates?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for development, quality and regulatory teams. It is a cost-effective way to build capability across your organisation. Ask about corporate pricing for your team.

    What payment options are available?

    We accept major credit and debit cards and bank transfers, with invoicing available for corporate bookings. Speak with a learning advisor to choose the option that suits you or your organisation.

    Is there any cost to sit an exam?

    No. This is a non-certification skills course with no examination, so there is no separate exam fee. The programme fee covers the training, materials and your course completion record. Request a quote for the full breakdown.

    Assessment

    Is there an exam for this course?

    No. QbD training is a non-certification course with no examination. Learning is reinforced through hands-on tool exercises, pharmaceutical case study examples and team discussion across the one-day programme rather than a formal test.

    What do I receive on completion?

    You receive a course completion record from Invensis Learning. It confirms you have completed the programme and built practical QbD skills that you can apply immediately to product and process development projects.

    How is learning reinforced during the training?

    Learning is reinforced through practical exercises applying QbD tools to realistic scenarios: constructing a QTPP, identifying CQAs, building Ishikawa diagrams, selecting DoE designs and interpreting a design space. These activities help you apply the concepts with confidence at work.

    Will this course prepare me for a credential?

    This is a skills-building course rather than a credential programme, so it does not lead to a formal qualification or awarding body assessment. It focuses on practical capability you can use straight away in pharmaceutical development and manufacturing roles.

    Can I apply these skills without a science degree?

    The tools are most relevant to those working in pharmaceutical or biopharmaceutical development, but there is no formal education requirement. The course introduces every concept from first principles, so motivated professionals across quality, regulatory and manufacturing roles can apply what they learn.

    Course Content

    What topics does the QbD training cover?

    The course covers six modules: QbD principles and the ICH framework; QTPP and CQAs; risk assessment; Design of Experiments and design space; Process Analytical Technology and control strategy; and QbD in practice through case studies, CTD submissions and lifecycle management.

    Does the course cover both small molecules and biologics?

    Yes. The training covers QbD principles for both small molecule drug products, such as tablets and injectables, and biopharmaceutical products, such as monoclonal antibodies and biosimilars, with case study examples from both, which is especially relevant to Slovenia's biosimilar sector.

    Are there hands-on exercises?

    Yes. Hands-on QbD tool exercises run throughout the day, including QTPP construction, CQA identification and criticality assessment, Ishikawa diagrams for risk, DoE design selection and design space interpretation, all applied to realistic pharmaceutical development scenarios.

    How long is the training and what is the format?

    The programme is delivered in one day of eight hours, or as two half-days, covering all six QbD modules. It is available as live virtual, classroom and corporate onsite training, so you can choose the format that fits your schedule.

    What materials are provided?

    You receive structured courseware covering the full QbD framework, worked pharmaceutical case study examples, and exercise materials for QTPP, CQA, risk assessment, DoE and control strategy. These reinforce the concepts and serve as a reference for your projects afterwards.

    Enrolment

    How do I enrol in the QbD course?

    You can enrol through Invensis Learning. Choose your preferred format, confirm your booking, and you will receive access to the schedule, courseware and joining details. See upcoming batches or talk to a learning advisor to get started.

    What training formats are available in Slovenia?

    We offer online (live virtual) instructor-led training, classroom sessions and customised corporate onsite training for teams across Slovenia. This lets individuals and organisations pick the delivery mode that best fits their schedule and location.

    How soon can I start?

    Public sessions run on a scheduled basis, and corporate onsite training can be arranged around your team's availability. Contact a learning advisor to see the next available dates and reserve your place.

    Can you deliver the course in-house for our team?

    Yes. Corporate onsite delivery is available and works well for pharmaceutical organisations training a cross-functional team together, as participants can apply the QbD tools to their own live development projects during the session. Ask about corporate group training.

    What is the reschedule or cancellation policy?

    Rescheduling and cancellations are handled per our published policy, with flexible options for corporate bookings. Reach out to our team for the details that apply to your enrolment.