Quality by Design Training in Croatia

Build Quality into Every Product

Master the ICH-aligned Quality by Design approach used across Croatia's pharmaceutical and biopharmaceutical sector. This instructor-led training equips formulation, analytical, process and quality professionals to apply the QTPP, critical quality attributes, risk assessment, Design of Experiments and control strategy, so quality is engineered into products from the very first design stage.

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Duration

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Hours

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Master Quality by Design and Lead Excellence in Croatia

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What Is Quality by Design and Why It MattersA Science-Led Route to Built-In Quality

The Quality by Design (QbD) Training is a practical, one-day programme that teaches you how to build quality into pharmaceutical products from the design stage instead of testing it in at the end. Delivered across Croatia in live virtual and classroom formats, this Quality by Design training grounds you in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH quality framework (Q9, Q10 and Q11) that regulators such as the EMA and FDA now expect.

You learn to work through the full QbD chain: defining the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), running risk assessment, using Design of Experiments (DoE) to map the design space, and building a robust control strategy. Every concept is applied to realistic development scenarios.

For scientists, engineers and quality professionals in Croatia's growing pharma sector, QbD fluency is fast becoming a core workplace expectation. Start building that capability with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Croatia 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 Croatia 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 Croatia

Instructor-led training formats available for individual learners and corporate teams across the Croatia
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 Croatia
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 Croatia 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 CroatiaWho 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 This Training Does for YouPractical QbD Skills You Can Use at Work

For Individuals

Quality by Design training helps pharmaceutical scientists, engineers and quality professionals move from empirical trial-and-error development to a systematic, ICH-aligned method. You gain the tools to design robust products and processes that consistently meet their intended quality. Whether you work in formulation, analytical development, process development, quality assurance or regulatory affairs, the training builds capability you can apply the very next day.

If you want to strengthen your standing in Croatia's pharmaceutical and biopharmaceutical sector, QbD is a high-value, practical skill set. You leave able to construct a QTPP, run risk assessments, plan DoE studies and shape a control strategy for regulatory submission.

Build quality into pharmaceutical products from the design stage, not through end-product testing
Apply the ICH Q8(R2) enhanced approach with confidence in real development work
Construct a Quality Target Product Profile and identify Critical Quality Attributes for any product
Lead risk assessments using Ishikawa diagrams and FMEA to focus development effort
Plan Design of Experiments studies and interpret a design space and control strategy
Speak the QbD language that CMC, regulatory and manufacturing teams share
Strengthen your value to Croatia's pharma, biopharma and CDMO employers
Put your skills to work immediately after the one-day programme

For Organizations

Quality by Design group training helps pharmaceutical organisations embed a consistent, science-based development approach across their teams. Delivered onsite or live virtual, it equips cross-functional groups to design quality into products and processes. For manufacturers, biopharma developers and CDMOs, this shared capability reduces variability, strengthens regulatory submissions and improves product consistency.

If your development teams still rely on end-product testing to catch quality problems, QbD training gives them a common framework to prevent them. Groups leave able to run QTPP, CQA, risk assessment and design space work on their own projects.

Builds a shared QbD language across formulation, analytical, quality and regulatory teams
Reduces manufacturing deviations and post-approval changes through better process understanding
Aligns development practice with ICH Q8, Q9, Q10 and Q11 and EMA expectations
Strengthens the quality of CMC and CTD Module 3 submissions
Supports faster, more predictable scale-up and technology transfer
Can be delivered onsite for a whole cross-functional development team
Lets teams apply QbD tools to your own live product development projects

Why QbD Fluency Pays off in CroatiaRoles 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.

Croatian pharma companies

employing about 5,000 people, EIZG 2025

842m EUR

Sector export revenue

6.4% of Croatia's export income, EIZG

$2.13bn

Market size, 2026

CAGR 5.5% to 2031, Mordor Intelligence

100m EUR

New Zagreb biotech plant

Pfizer and Sobi investment, 2024 to 2026

SECTORS HIRING

—Generic and Branded Pharmaceutical Manufacturing
—Biopharmaceuticals and Biosimilars
—Active Pharmaceutical Ingredient (API) Production
—Contract Development and Manufacturing (CDMOs)
—Regulatory Affairs and CMC Consulting
—Medical Devices and Veterinary Pharma

GROWTH TRENDS

—Pfizer and Sobi 100 million euro Zagreb biotech plant reaching full output in 2026
—Pliva's expanded Zagreb oral solid dose facility adding 2 billion tablets a year
—EMA-aligned approvals shortening biosimilar and generic launch timelines
—A wave of 2026 to 2027 patent expiries driving fresh generic development
—Rising regulator expectation of QbD evidence in CTD submissions
—Pharma among Croatia's highest-paying manufacturing sectors

Sources: EIZG Pharmaceutical Industry Sector Analysis 2025; Mordor Intelligence and MarkWide Research (Croatia pharma market) 2026; Invest Croatia; company announcements (Pliva, Pfizer, Sobi).

Designation

Quality by Design Professionals in Croatia : Salary Insights and Trends

Hiring Companies in Croatia

EUR16K

Min

EUR22K

Average

EUR32K

Max

MojaPlaca.hr · PayScale (Croatia) 2026

PlivaBelupoJGLPharmaS

Source: Pliva (Teva) · Belupo · JGL · PharmaS

Why Croatian Pharma Needs QbD Skills Now

End-Product Testing Still Dominates

Many development teams still rely on testing quality in at the end, which misses process understanding. QbD builds quality in from the design stage and cuts costly out-of-specification batches.

QbD builds quality in from the design stage

Rising Regulatory Expectations

The EMA and FDA increasingly expect QbD evidence in CTD Module 3 submissions. Teams without QTPP, design space and control strategy skills risk slower, weaker regulatory approvals.

QbD strengthens CTD Module 3 submissions

Biosimilar and Biologic Complexity

New biotech capacity near Zagreb brings complex, process-defined products. QbD gives scientists the risk assessment and Design of Experiments tools these sensitive molecules demand.

QbD gives the tools biologics demand

Patent-Cliff Generic Development

A wave of 2026 to 2027 patent expiries is driving fast generic development. QbD helps teams characterise products and processes quickly and defensibly ahead of launch.

QbD speeds defensible generic development

Costly Manufacturing Deviations

Weak process understanding causes deviations, rejects and post-approval changes. The QbD design space and control strategy reduce variability and protect reliable supply.

QbD reduces variability and protects supply

Scarce QbD-Ready Talent

Croatia has deep pharmaceutical manufacturing expertise but fewer professionals fluent in the full ICH QbD toolkit, making the skill set a clear career differentiator.

QbD skills set professionals apart

Sources: ICH Q8(R2), Q9, Q10 and Q11 guidelines; EMA and FDA pharmaceutical development guidance; Mordor Intelligence and DrugPatentWatch (Croatia) 2026.

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.

Today

Seen as a lab specialist with a narrow remit

After Training

Valued as a cross-functional QbD contributor across CMC, regulatory and manufacturing

Today

Seen as a lab specialist with a narrow remit

Today

Limited leverage in Croatia's competitive pharmaceutical job market

After Training

A sought-after skill set as biotech and generic capacity expands near Zagreb

Today

Limited leverage in Croatia's competitive pharmaceutical job market

Today

Reacting to deviations after they have already happened

After Training

Preventing deviations through design space and control strategy thinking

Today

Reacting to deviations after they have already happened

You master QbD

Before

Quality checked mainly by testing finished batches

Now you have

Quality designed into the product from the QTPP onward

Before

Quality checked mainly by testing finished batches

Before

Development driven by trial and error and one-factor-at-a-time work

Now you have

Structured DoE that maps the design space and factor interactions

Before

Development driven by trial and error and one-factor-at-a-time work

Before

Risk handled informally and reactively

Now you have

Formal Ishikawa and FMEA risk assessment guiding priorities

Before

Risk handled informally and reactively

Before

Submissions left open to avoidable regulatory questions

Now you have

QbD evidence that strengthens your CTD Module 3 documentation

Before

Submissions left open to avoidable regulatory questions

"The gap between testing quality in and designing it in is exactly what regulators and employers now reward, and QbD is how you cross it."

Join thousands of professionals who trained with Invensis Learning and levelled up their skills.

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

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 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.

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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 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.

Who Should TakeQuality by Design Training in Croatia?

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 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 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

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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 LearningFor 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 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 CroatiaAll our classroom training is now available online at your convenience

Quality by Design in Croatia

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

Quality by Design in Croatia

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

Quality by Design in Croatia

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

Quality by Design in Croatia

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

Corporate QbD TrainingUpskill a Whole Development Team

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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

What Our Learners Say

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A Workflow I Could Use Straight Away

"The training finally connected the QTPP, CQAs and DoE into one workflow I could use straight away. Within a week I was mapping critical parameters for a real tablet project."

Ana Kovacevic

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Risk Assessment That Finally Clicked

"The risk assessment sessions on Ishikawa and FMEA were the most useful part for me. I now understand why we test what we test, not just how, and it has changed how I plan my work."

Marko Horvat

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Practical and Clearly Explained

"Clear, practical and well paced. The design space and control strategy modules made our CTD Module 3 work much easier to prepare and defend during review."

Petra Novak

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A Shared Language for the Whole Team

"We ran the course onsite for our development team. It gave everyone a shared QbD language and noticeably reduced the back-and-forth between formulation and quality."

Ivan Maric

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Sector-Relevant and Immediately Useful

"Our scientists came away able to apply DoE and risk assessment to live biologics projects. A strong, sector-relevant programme that fitted our team's real work."

Marija Babic

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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 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.

General

What is Quality by Design (QbD) and why does it matter?

Is the Quality by Design training worth it for my career in Croatia?

Yes. QbD fluency is a high-value, practical skill across Croatia's pharmaceutical and biopharmaceutical sector, where manufacturers, biosimilar developers, API producers and CDMOs are expanding and modernising. It applies directly to formulation, analytical, process, quality and regulatory work.

Who should attend this training?

The course suits formulation scientists, analytical scientists, process development engineers, quality assurance professionals, regulatory affairs (CMC) specialists and manufacturing technical managers in pharmaceutical, biopharma, API, CDMO and medical device organisations.

Do I need prior experience to take this course?

No formal prerequisites are required. Familiarity with pharmaceutical development or GMP is helpful but not essential, as the training introduces QbD from first principles in a development context.

Which standards and guidelines does the training follow?

The training is grounded in the ICH quality framework: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances, with reference to supporting FDA and EMA guidance.

Is QbD relevant to both small molecules and biologics?

Yes. The course covers QbD for small molecule products such as tablets and injectables and for biopharmaceuticals such as monoclonal antibodies and biosimilars, with case examples drawn from both.

Pricing

How much does the Quality by Design training cost in Croatia?

Fees vary by delivery format (live virtual, classroom or corporate onsite) and group size, so pricing is available on request. Corporate and group rates are also available. Request a quote to see the options that fit you or your team.

What is included in the course fee?

The fee typically includes instructor-led training across all QbD modules, hands-on tool exercises, learning materials and a course completion certificate from Invensis Learning. Confirm the exact inclusions for your chosen format when you enrol.

Do you offer corporate or group discounts?

Yes. We offer volume-based pricing for teams and departments, with customised onsite or live virtual delivery for pharmaceutical and biopharma groups. Ask about corporate pricing for your organisation.

Are there any exam or certification fees?

No. This is a non-certification skills course with no examination, so there are no separate exam or awarding-body fees. You pay only the training fee for your chosen delivery format.

How can I pay for the training?

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

Assessment And Certificate

Is there an exam for this course?

No. Quality by Design training is a non-certification course with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case examples and discussion throughout the one-day programme.

Will I receive a certificate after the training?

Yes. On completing the one-day programme you receive a course completion certificate from Invensis Learning. It recognises your participation and the practical QbD skills you have built.

How is learning assessed during the training?

There is no formal assessment. Instead you apply QbD tools such as QTPP construction, CQA identification, risk assessment and design space interpretation to realistic development scenarios throughout the day.

Is any credential or licence awarded?

No external credential or licence is awarded, as QbD is a skills discipline rather than a certification scheme. The value lies in the practical capability you can apply immediately in your development work.

Do the QbD skills expire or need refreshing?

No. The skills you gain are grounded in established ICH guidelines and are immediately and durably applicable at work. There is nothing to renew, though you may choose further training as guidance such as ICH Q12 evolves.

Course Content

What will I learn in the Quality by Design course?

You learn the full QbD workflow: the Quality Target Product Profile, Critical Quality Attributes, risk assessment with Ishikawa and FMEA, Design of Experiments and the design space, Process Analytical Technology, and building a control strategy for regulatory submission.

What QbD tools are covered in the training?

The course covers the QTPP, CQA identification, CMA and CPP mapping, Ishikawa diagrams, FMEA with Risk Priority Numbers, DoE design types, design space definition, Normal Operating and Proven Acceptable Ranges, PAT and the control strategy.

Does the course include hands-on practice?

Yes. Hands-on exercises run throughout, applying QbD tools to realistic pharmaceutical development scenarios so you can practise QTPP construction, CQA classification, risk assessment and design space interpretation.

How long is the training?

The programme runs for one day (eight hours), covering all six QbD modules from principles and the ICH regulatory context through to case studies, CTD submission and lifecycle management.

Is the content aligned to current regulatory expectations?

Yes. The content follows the current ICH Q8(R2) Pharmaceutical Development guideline and the wider Q9, Q10 and Q11 framework that the EMA and FDA expect to see reflected in modern pharmaceutical submissions.

Enrollment

How do I enrol in the Quality by Design training?

You can enrol through the Invensis Learning website. Choose your preferred format, complete payment and you will receive access to the schedule and learning materials. Talk to a learning advisor if you need help choosing a format.

What training formats are available?

The course is offered as online (live virtual) instructor-led training, in-person classroom sessions and customised corporate onsite delivery, so you can choose the format that fits your schedule and team.

Can the course be delivered onsite for my team in Croatia?

Yes. We deliver corporate onsite and live virtual sessions for pharmaceutical and biopharma teams across Croatia, and can tailor the content to your own live development projects. Ask about corporate training for your team.

How soon can I start?

New live virtual and classroom sessions run regularly, and corporate dates are arranged around your team's availability. See upcoming schedules or contact us to confirm the next available session.

What is your reschedule or refund policy?

Reschedules and refunds are handled under our published policy, and selected plans include flexible options. Reach out to our team for the details that apply to your enrolment.