Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design and Why It Matters

    A Science-Led Route to Built-In Quality

    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 Croatia

    Who Can Enrol?

    What This Training Does for You

    Practical QbD Skills You Can Use at Work

    Who Should Take Quality by Design Training in Croatia?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Why QbD Fluency Pays off in Croatia

    Roles and Demand Across Pharma

    Quality by Design skills are increasingly sought across Croatia's pharmaceutical and biopharmaceutical sector, where EMA-aligned manufacturers, biosimilar developers, API producers and CDMOs are expanding capacity and modernising development. QbD-fluent formulation, analytical, process and quality professionals help employers meet regulatory expectations and reduce costly rework. Demand spans roles from QC analyst and formulation scientist to QA and regulatory affairs manager, and here is what the market is showing.

    Why Croatian Pharma Needs QbD Skills Now

    QbD is a practical, high-value skill for pharmaceutical professionals in Croatia. Build the capability to design quality into every product and process. Start your training today.

    Your Croatia QbD Transformation

    Where You Stand Today

    The Shift QbD Skills Deliver

    Croatia's pharmaceutical sector is modernising fast, with new biotech and generic capacity and rising regulatory expectations. Employers increasingly separate professionals who can design quality in from those who only test it out. Here is which side of that line QbD training puts you on.

    Sources: EIZG 2025; Mordor Intelligence 2026; ICH Q8(R2), Q9, Q10 and Q11 guidelines.

    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 Croatia 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.

    image

    100% Secure and Safe download

    The QbD Tools You Will Master

    From QTPP to Control Strategy

    This Quality by Design training teaches you to apply each QbD tool end to end, from defining what a product must achieve to controlling how it is made. You leave able to run the full ICH-aligned QbD workflow on real pharmaceutical development scenarios.

    Quality Target Product Profile (QTPP)

    Construct a QTPP from clinical and patient needs, defining dosage form, route, strength, pharmacokinetic targets and quality standards as the design specification for the whole programme.

    Critical Quality Attributes (CQAs)

    Identify and classify the physical, chemical, biological and microbiological attributes critical to product quality, safety and efficacy, for both small molecules and biologics.

    Risk Assessment with Ishikawa and FMEA

    Map potential Critical Material Attributes and Critical Process Parameters to each CQA, then rank them by severity, occurrence and detectability to focus development effort where it counts.

    Design of Experiments and the Design Space

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

    Process Analytical Technology (PAT)

    Use in-process monitoring tools such as near-infrared and Raman spectroscopy to control critical attributes in real time and enable real-time release testing.

    Control Strategy and Regulatory Submission

    Build a risk-proportionate control strategy from your QbD outputs and structure the evidence for CTD Module 3 (Section 3.2.P.2) regulatory submissions.

    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.

    Loading schedules…

    Why Choose Invensis Learning

    For Your Quality by Design Training in Croatia

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and organisations that want to design quality into their products, not test it in. Our programmes combine experienced quality practitioners, structured courseware and hands-on exercises grounded in the ICH quality framework. Whether you enrol as an individual or plan corporate training for a cross-functional team, we provide a professional learning experience built around real-world application and measurable outcomes, backed by ISO-certified quality and security standards.

    • Experienced trainers with real pharmaceutical quality and QbD practitioner backgrounds
    • Training grounded in the ICH Q8, Q9, Q10 and Q11 quality guidelines
    • Flexible live virtual, classroom and onsite delivery across Croatia
    • Hands-on QbD tool exercises using realistic development scenarios
    • ISO 9001:2015 quality management and ISO 27001:2022 information security certified
    • Course completion certificate from Invensis Learning
    • Dedicated learner support before, during and after training
    • Customised corporate training for pharmaceutical and biopharma teams

    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 Croatia

    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 Croatia

    Hotel Westin, 1, Ulica Isidora Kršnjavoga, Local Board "Mimara", City District Donji grad, Zagreb, City of Zagreb, 10000, Croatia

    Quality by Design Training Location in Croatia

    Sheraton Zagreb, 2, Ulica kneza Borne, Local Board "Knez Mislav", City quarter Donji grad, Zagreb, City of Zagreb, 10000, Croatia

    corporate banner

    Corporate QbD Training

    Upskill a Whole Development Team

    • Onsite, live virtual or hybrid delivery for teams across Croatia
    • Customised to your own live product development projects
    • Builds a shared QbD language across formulation, analytical, quality and regulatory
    • Experienced pharmaceutical quality trainers with hands-on QbD expertise
    • Flexible scheduling arranged around your team's availability
    • Volume-based pricing for group enrolments
    • Progress tracking and dedicated coordination support

    Trusted by Leading Enterprises in Croatia

    PlivaBelupoJGLPharmaSKrkaFidifarm

    Enquire with us now

    Drop us a query and our learning consultant will reach out to you shortly

    Request Training Details

    Fill out this form and we will respond quickly.

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

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

    Quality by Design Training Course in OsijekQuality by Design Training Course in RijekaQuality by Design Training Course in SplitQuality by Design Training Course in ZadarQuality by Design Training Course in Zagreb

    Frequently Asked Questions

    Here's everything you may ask...

    Quality by Design is a systematic, science-based approach that builds quality into pharmaceutical products from the design stage rather than testing it in at the end. It is defined by the ICH Q8(R2) Pharmaceutical Development guideline and is increasingly expected by regulators such as the EMA and FDA.