Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design and Why Do Pharma Teams Need It?

    Building Quality in, Not Testing It In

    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 Spain

    Who Can Enrol?

    How QbD Skills Pay off at Work

    From ICH Theory to Everyday Practice

    Who Should Take Quality by Design Training in Spain?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Pharma Careers QbD Opens in Spain

    Demand in Catalonia, Madrid, Valencia

    Quality by Design skills are increasingly sought across Spain's pharmaceutical clusters, from Catalonia's BioRegion to Madrid and Valencia, where manufacturers, biopharma firms and CDMOs run large, regulated development pipelines. As biologics and biosimilars grow and EMA and FDA reviewers expect QbD evidence, professionals who can build quality in are in real demand, making Quality by Design training a practical career investment. Roles span formulation, analytical and process development scientists, QA managers and CMC regulatory specialists, and here is what the market shows right now.

    Market Forces Making QbD Essential in Spanish Pharma

    QbD is fast becoming the standard for modern pharmaceutical development in Spain. Build the skills that employers and regulators now expect, and lead quality from the design stage. Start your QbD journey today.

    Your QbD Skills Transformation in Spain

    From Test-And-Fix to Designed-In Quality

    The Shift QbD Training Delivers

    Spain's pharmaceutical sector is moving from empirical, test-and-fix development toward the science-based Quality by Design approach that regulators increasingly expect. Here is the difference those skills make to how you work and where your career can go.

    Sources: SalaryExpert, ERI, Farmaindustria (Spain) 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 Spain 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 Master

    From QTPP to Control Strategy

    This Quality by Design programme builds hands-on command of the full QbD toolkit, from the QTPP through risk assessment, DoE and the design space to the control strategy. By the end you can apply each tool to real pharmaceutical development scenarios and defend your decisions to regulators.

    Apply the ICH QbD Framework

    Work confidently within ICH Q8(R2), Q9, Q10 and Q11, and explain why QbD has replaced test-and-fix development in the expectations of EMA and FDA reviewers.

    Build the Quality Target Product Profile

    Construct a QTPP from clinical and patient needs and use it as the design specification that drives the whole development programme from the outset.

    Identify Critical Quality Attributes

    Identify and classify CQAs for both small molecules and biologics, and link them to critical material attributes and critical process parameters.

    Run Structured Risk Assessments

    Use Ishikawa diagrams and FMEA with Risk Priority Number scoring to prioritise the variables that most affect quality and focus your experiments.

    Design Experiments and the Design Space

    Plan screening and response-surface DoE, interpret the models, and define the design space with normal operating and proven acceptable ranges.

    Build the Control Strategy and Apply PAT

    Develop a risk-based control strategy, apply Process Analytical Technology for real-time assurance, and document it all for CTD 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 340

    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 Spain

    Expert-Led, Practical and Flexible

    Invensis Learning delivers practical Quality by Design training for pharmaceutical and biopharmaceutical professionals and teams across Spain. Our programmes combine trainers with real QbD and ICH experience, structured courseware, and hands-on exercises that turn the ICH Q8 to Q11 guidelines into skills you can apply immediately. Whether you enrol as an individual or arrange corporate training for a development team, we focus on practical understanding, real-world application and measurable outcomes, backed by ISO-certified training delivery.

    • Experienced trainers with real pharmaceutical QbD and ICH regulatory expertise
    • Practical, scenario-based learning built on real development case studies
    • Flexible formats: live virtual (online), classroom and on-site corporate training
    • Hands-on exercises in QTPP, CQA identification, risk assessment and DoE
    • Course completion certificate from Invensis Learning
    • ISO 9001:2015 quality-certified training delivery
    • Dedicated learner support before, during and after the training
    • Trusted by professionals and organisations across many industries

    5000+

    Accredited Trainers Globally

    4.7/5

    Rated by Learners Worldwide

    500+

    Corporate Clients

    15+

    Years of Training Excellence

    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 Spain

    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 Spain

    Mandarin Oriental Ritz, Madrid Pl. de la Lealtad, 5, Retiro, 28014 Madrid, Spain

    Quality by Design Training Location in Spain

    Cap Rocat, Ctra. d'enderrocat, s/n, 07609 Cala Blava-Llucmajor, Balearic Islands, Spain

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    Corporate QbD Training in Spain

    Build Team Capability at Scale

    • Tailored to your own molecules, dosage forms and development pipeline
    • Delivered on-site, live virtual or blended to suit team schedules
    • Standardises QbD practice across R&D, QA, process and regulatory teams
    • Experienced trainers with pharmaceutical and ICH regulatory expertise
    • Hands-on QbD exercises applied to your live development projects
    • Scalable delivery for teams in Barcelona, Madrid, Valencia and beyond
    • Dedicated coordination and support for corporate programmes

    Trusted by Leading Enterprises in Spain

    GrifolsAlmirallRoviReig JofreEsteveFerrer

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

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

    Quality by Design Training Course in BarcelonaQuality by Design Training Course in MadridQuality by Design Training Course in Valencia

    Frequently Asked Questions

    Here's everything you may ask...

    Quality by Design (QbD) training is a practical, non-certification course that teaches pharmaceutical professionals how to design quality into products from the development stage. It covers the ICH Q8(R2), Q9, Q10 and Q11 framework and QbD tools such as the QTPP, Critical Quality Attributes, risk assessment, DoE, design space and control strategy.

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