Quality by Design Training in Spain

Build Quality into Every Product

Delivered by a trusted Quality by Design training company and designed for pharmaceutical and biopharma professionals in Spain, this instructor-led QbD training shows you how to design quality into products from the start, using the ICH Q8 to Q11 framework, the QTPP, critical quality attributes, risk assessment, Design of Experiments and the control strategy.

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Hours

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Master Quality by Design and Lead Excellence in Spain

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What Is Quality by Design and Why Do Pharma Teams Need It?Building Quality in, Not Testing It In

Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This Quality by Design Training in Spain shows pharmaceutical professionals how to apply that approach in practice, using the ICH Q8(R2), Q9, Q10 and Q11 guidelines that regulators such as the EMA and FDA now expect behind every development and manufacturing submission.

The programme is built around the tools that make QbD work on the job: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. You learn to link material attributes and process parameters to product quality, so you can predict and control quality instead of inspecting for it after the fact.

It suits formulation, analytical and process development scientists, QA professionals and CMC regulatory specialists across Spain's pharma clusters in Catalonia, Madrid and Valencia. Delivered in live virtual, classroom and corporate formats, the training turns ICH theory into skills you can apply to real product development from day one.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Spain 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 Spain 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 Spain

Instructor-led training formats available for individual learners and corporate teams across the Spain
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 Spain
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 Spain 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 SpainWho 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

How QbD Skills Pay off at WorkFrom ICH Theory to Everyday Practice

For Individuals

Quality by Design training gives pharmaceutical professionals a practical, job-ready command of the QbD approach. You leave able to build quality into products, satisfy ICH and regulatory expectations, and reduce the deviations and rework that slow development. Whether you work in formulation, analytical development, process engineering, QA or CMC regulatory affairs, the tools transfer straight to live projects in Spain's pharma and biopharma organisations.

If you want to move from empirical trial and error to a systematic, science-based way of working, QbD is the capability employers increasingly look for. You gain structured methods, real case examples and skills you can apply from day one.

Design quality into products from the start, cutting costly late-stage failures and rework
Apply the ICH Q8 to Q11 principles that EMA and FDA reviewers expect in submissions
Build a Quality Target Product Profile and identify Critical Quality Attributes with confidence
Lead risk assessments using Ishikawa diagrams and FMEA to focus development effort
Plan and interpret Design of Experiments to define a robust design space
Develop control strategies and use PAT for real-time process assurance
Strengthen your value to Spain's pharma, biopharma and CDMO employers
Speak the same QbD language as formulation, analytical, process and regulatory teams

For Organizations

QbD group training helps pharmaceutical and biopharmaceutical organisations embed a consistent, science-based development approach across their teams. Training can be delivered for R&D groups, QA functions, CMC teams or whole development organisations. For companies looking to reduce deviations, strengthen submissions and speed technology transfer, this training builds the shared QbD capability that modern regulators expect.

If your teams still rely on empirical development and end-product testing, QbD group training creates a common language for the QTPP, risk assessment, design space and control strategy, so quality is designed in and defended consistently across every project.

Standardise QbD practice across formulation, analytical, process and regulatory teams
Reduce manufacturing deviations, out-of-specification results and post-approval changes
Strengthen EMA and FDA submissions with robust QTPP, design space and control strategy evidence
Speed up scale-up and technology transfer through deeper process understanding
Build cross-functional QbD capability for live product development projects
Improve investment decisions by focusing experiments on the highest-risk variables
Tailor training to your own molecules, dosage forms and pipelines
Upskill whole teams together with flexible on-site or live virtual delivery

Pharma Careers QbD Opens in SpainDemand 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.

€65,000

Pharma QA Manager salary, Spain

average per year, SalaryExpert 2026

€52,000

Scientist salary, Spain

average per year, ERI 2026

56,000+

Direct pharma jobs, Spain

Farmaindustria 2025

7.1% CAGR

Sector growth rate

2025-2030 market forecast

SECTORS HIRING

—Pharmaceutical Manufacturing and Development
—Biopharmaceuticals and Biosimilars
—Contract Development and Manufacturing (CDMOs)
—Active Pharmaceutical Ingredient (API) Producers
—Regulatory Affairs and CMC Consulting
—Medical Devices and Advanced Therapies

GROWTH TRENDS

—Pharma manufacturing output near 23 billion euros, up 40% in three years
—About 56,000 direct pharma jobs, 96% on permanent contracts
—Biologics and biosimilars are the fastest-growing segment through 2030
—Catalonia's BioRegion hosts around 70% of Spanish biotech companies
—ICH-aligned QbD increasingly expected in EMA and FDA submissions
—Record pharma exports near 26.8 billion euros lifting quality demand

Sources: SalaryExpert, ERI, PayScale, Glassdoor (Spain) 2026; Farmaindustria, Statista, CaixaBank Research 2025-2026.

Designation

Quality by Design Professionals in Spain : Salary Insights and Trends

Hiring Companies in Spain

€26K

Min

€34K

Average

€48K

Max

ERI · PayScale (Spain) 2026

GrifolsReig JofreKern PharmaEsteve

Source: Grifols · Reig Jofre · Kern Pharma · Esteve

Market Forces Making QbD Essential in Spanish Pharma

Rising Regulatory Expectations

The EMA and FDA increasingly expect QbD evidence in development and manufacturing submissions, so Spanish firms need people who can build QTPP, design space and control strategy into every filing.

QbD training builds submission-ready skills

Biologics and Biosimilars Boom

Biologics and biosimilars are Spain's fastest-growing pharma segment, and their process-defined complexity makes QbD-based development and control essential rather than optional.

QbD training covers biologics development

Costly Late-Stage Failures

Empirical, test-and-fix development still causes deviations, out-of-specification batches and rework. QbD reduces this by designing quality in from the QTPP onward.

QbD training reduces deviations and rework

Scale-Up and Technology Transfer

As Spain expands manufacturing and CDMO capacity, weak process understanding slows scale-up and transfer. The design space and control strategy make these transitions smoother.

QbD training builds process understanding

A QbD Skills Shortage

Spain's pharma workforce is deep in traditional development but thin in practitioners who can run DoE, define a design space and document QbD for regulators.

QbD training makes practitioners stand out

Capital and Cost Pressure

Healthcare cost pressure and biosimilar competition push firms to cut waste. QbD focuses experiments on the highest-risk variables and improves right-first-time manufacturing.

QbD training builds portfolio-level efficiency

Sources: Statista, Farmaindustria, CaixaBank Research, Grand View Research (Spain) 2025-2026.

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.

Today

Seen as a delivery specialist, not a development leader

After QbD

Ready for senior QA, CMC and process development roles across Spain

Today

Seen as a delivery specialist, not a development leader

Today

Competing on experience alone in a crowded talent pool

After QbD

Standing out with QbD skills that are scarce in Spain's pharma workforce

Today

Competing on experience alone in a crowded talent pool

Today

Applying methods that regulators are steadily moving away from

After QbD

Working the ICH Q8 to Q11 way that modern pharma expects

Today

Applying methods that regulators are steadily moving away from

You master QbD

Before

Quality checked by end-product testing, with failures found late

Now you have

Quality designed in from the QTPP, predicted and controlled upfront

Before

Quality checked by end-product testing, with failures found late

Before

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

Now you have

Structured Design of Experiments that maps a robust design space efficiently

Before

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

Before

Submissions that lack the QbD evidence EMA and FDA now look for

Now you have

Confident QTPP, design space and control strategy documentation

Before

Submissions that lack the QbD evidence EMA and FDA now look for

Before

Only your own function's narrow view of product quality

Now you have

A shared, cross-functional QbD language across the development team

Before

Only your own function's narrow view of product quality

"In modern pharma, the gap between testing quality in and designing it in is exactly the gap employers now pay to close."

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

Sources: SalaryExpert, ERI, Farmaindustria (Spain) 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 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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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.

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

Shifts your thinking from testing quality in at the end to designing it in from the start.

100% Secure and Safe download

The QbD Tools You Will MasterFrom 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.

Who Should TakeQuality by Design Training in Spain?

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 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 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 430

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 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 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

Untitled

Please Note: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.

Loading schedules…

Why Choose Invensis Learning for Quality by Design Training in SpainExpert-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 27001:2022 Certified

Secure SSL Encryption

Leaders in Training industry for 12+ years

Over 5000 five star reviews

Level AA conformance, W3C WCAG 2.2

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

Quality by Design in Spain

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

Quality by Design in Spain

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

Quality by Design in Spain

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

Quality by Design in Spain

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

Corporate QbD Training in SpainBuild Team Capability at Scale

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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

What Our Learners Say

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From Trial and Error to a Real Design Space

"The QbD training finally connected ICH Q8 to what I do at the bench. Building a QTPP and running a proper Design of Experiments made my formulation work far more predictable."

Marta Serrano

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Confident Leading CQA and Risk Work

"The risk assessment and FMEA sessions were the most useful. I now lead CQA workshops and prioritise the experiments that matter instead of testing everything."

Javier Molina

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Practical and Submission-Ready

"Clear, practical and grounded in real cases. The control strategy and PAT modules helped me structure our CMC documentation for submission with real confidence."

Lucia Fernandez

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One QbD Language Across the Team

"We trained our development team together and now share one QbD language across formulation, analytical and QA. Deviations during technology transfer have dropped noticeably."

Andres Vidal

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Tailored to Our Biosimilar Pipeline

"The on-site programme was tailored to our biosimilar pipeline. Our QA and process teams now design quality in rather than inspect it at the end, and our submissions are stronger for it."

Elena Castro

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4.6

Ratings

100K+

Happy Learners

100+

Locations Worldwide

99%

Training Satisfaction

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Frequently Asked QuestionsHere'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.

General

What is Quality by Design (QbD) training?

Who should attend the QbD training in Spain?

The training suits formulation, analytical and process development scientists, QA and QC professionals, CMC regulatory affairs specialists and manufacturing technical managers in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations across Spain.

Is Quality by Design worth it for pharma professionals?

Yes. QbD is increasingly expected by the EMA and FDA and underpins modern development and manufacturing submissions. Professionals who can apply it are in strong demand across Spain's pharma clusters, making these practical, job-ready skills a worthwhile investment.

Which ICH guidelines does the QbD training cover?

The course is built around the ICH quality guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. You learn how these guidelines shape QbD practice and regulatory expectations.

Is the QbD training relevant to biologics as well as small molecules?

Yes. The training covers QbD for both small-molecule drug products and biologics such as monoclonal antibodies and biosimilars, with case examples from both, reflecting Spain's fast-growing biopharma and biosimilar sector.

How long is the Quality by Design training?

The course runs for one day (about 8 hours) and can also be delivered as two half-day sessions. It covers all QbD topics through concept explanations, ICH regulatory context and hands-on tool exercises.

Pricing

How much does QbD training cost in Spain?

QbD training fees in Spain vary by delivery format (live virtual, classroom or corporate) and group size, so pricing is available on request. Contact a learning advisor for a quote tailored to individual or team training.

What is included in the QbD course fee?

The fee typically includes instructor-led training, structured courseware and learning resources, hands-on QbD exercises, real case studies, dedicated learner support and a course completion certificate from Invensis Learning.

Do you offer group or corporate discounts for QbD training?

Yes. We offer corporate group training with tailored content and volume-based pricing for R&D, QA, process and regulatory teams. Ask about corporate or group pricing for a tailored quote for your organisation.

What payment options are available?

We accept major credit and debit cards and bank transfers, with instalment options on selected plans. Speak with a learning advisor to choose the option that suits you best.

Is there a separate exam fee?

No. Quality by Design training is a non-certification course, so there is no exam and no separate exam fee. The fee covers the training, materials and a course completion certificate only.

Assessment

Is there an exam for the QbD training?

No. This is a non-certification skills course with no exam. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case examples and group discussion throughout the programme.

Do I get a certificate after the QbD training?

Yes. You receive a course completion certificate from Invensis Learning after completing the programme. It recognises the practical QbD skills you have built, which apply immediately to development projects.

Are there any prerequisites for the QbD course?

None. There are no formal prerequisites. Familiarity with pharmaceutical development or GMP is helpful but not required, as the course introduces QbD from first principles in a development context.

How is learning assessed during the course?

Learning is assessed informally through practical exercises such as building a QTPP, identifying CQAs, running a risk assessment and interpreting a design space, applied to realistic scenarios rather than through a formal test.

Will I be able to apply QbD at work afterwards?

Yes. After the course you can construct a QTPP, identify and classify CQAs, run FMEA-based risk assessments, plan and interpret DoE, define a design space, and build a control strategy for regulatory submissions.

Course Content

What topics does the QbD training cover?

The training covers QbD principles and the ICH regulatory context, the QTPP and CQAs, risk assessment with Ishikawa and FMEA, Design of Experiments and the design space, Process Analytical Technology and the control strategy, plus QbD case studies including CTD submissions.

What is the Quality Target Product Profile (QTPP)?

The QTPP is a prospective summary of the quality characteristics a drug product should achieve to ensure its safety and efficacy. It is the design specification that drives the whole QbD programme, and you learn to build one during the course.

Does the course cover Design of Experiments and the design space?

Yes. The course explains screening and response-surface DoE, how to interpret the models, and how to define the design space with normal operating ranges and proven acceptable ranges, so you can characterise processes with confidence.

What learning materials are provided?

You receive structured courseware, real pharmaceutical case examples, QbD tool templates and exercise materials covering the QTPP, CQA identification, risk assessment, DoE and the control strategy.

Is the courseware aligned to current ICH guidelines?

Yes. The courseware is aligned to the current ICH quality guidelines, ICH Q8(R2), Q9, Q10 and Q11, and reflects the QbD expectations of regulators such as the EMA and FDA.

Enrollment

How do I enrol in the QbD training in Spain?

You can enrol through the Invensis Learning website. Choose your preferred format, such as the Quality by Design course online or classroom training, complete payment, and you receive access to schedules, courseware and learning resources. Talk to a learning advisor if you need help choosing.

What training formats are available?

We offer live virtual (online) instructor-led training, classroom training, and customised corporate on-site training, so you can pick the format that fits your schedule and team.

Can the QbD course be delivered on-site for my team?

Yes. The QbD course is available as a corporate on-site or live virtual programme tailored to your pipeline, letting a cross-functional team apply the tools to live projects together. Ask about corporate training for a quote.

How soon can I start?

New live virtual and classroom sessions run regularly, and corporate sessions are scheduled to suit your team. See upcoming batches or contact an advisor for the next available dates in Spain.

What is the refund or reschedule policy?

Selected plans include flexible reschedule options and a money-back guarantee. Contact our support team for the refund or reschedule terms that apply to your enrolment.