Quality by Design Training in Iceland

Build Quality in from the Start

Built for Iceland's pharmaceutical, biosimilar and medical device professionals, this practical Quality by Design course shows you how to design quality into products from the outset using the ICH Q8(R2) framework, the QTPP, risk assessment, Design of Experiments and the control strategy, with expert-led guidance from Invensis Learning, a trusted Quality by Design training company.

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Master Quality by Design and Lead Excellence in Iceland

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What Is Quality by Design and Why It Matters for Icelandic PharmaA Science-Based Route to Consistent Quality

The Quality by Design Training in Iceland is a practical, one-day skills programme that teaches the Quality by Design (QbD) approach to pharmaceutical product and process development. QbD is a systematic, science-based way to build quality into a medicine from the design stage rather than testing it in at the end, and it is defined by the ICH Q8(R2) Pharmaceutical Development guideline alongside ICH Q9, Q10 and Q11.

For professionals across Iceland's biosimilar, generic and medical device sector, from Alvotech and Coripharma to smaller CDMOs, this approach is now the expected foundation of modern development and of regulatory submissions to the EMA and FDA. The course shows you how to apply the core tools, the Quality Target Product Profile (QTPP), Critical Quality Attributes, risk assessment, Design of Experiments and the control strategy, to your own work.

Delivered in live virtual and onsite formats by Invensis Learning, the training suits formulation scientists, process engineers, analytical scientists, and quality and regulatory professionals. You leave able to design quality in, reduce manufacturing risk and support stronger submissions, with skills you can use immediately.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Iceland 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 Iceland 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 Iceland

Instructor-led training formats available for individual learners and corporate teams across the Iceland
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 Iceland
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 Iceland 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 IcelandWho 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

The On-The-Job Payoff of Learning Quality by DesignSkills You Can Apply from Day One

For Individuals

This Quality by Design course gives pharmaceutical and biopharmaceutical professionals a practical command of the QbD framework and its tools. You learn to move from empirical, trial-and-error development to a systematic, science-based approach that regulators now expect. Whether you work in biosimilars, generics, APIs or medical devices, the skills transfer directly to formulation, process development, analytical and regulatory work.

If you want to design quality in, cut manufacturing risk and support cleaner submissions, QbD is a capability worth building. You gain tools you can apply to live development projects straight after the training.

Design quality into products from the outset instead of relying on end-product testing
Apply the QTPP and Critical Quality Attributes to define what a product must achieve
Run risk assessments with Ishikawa diagrams and FMEA to focus development effort
Plan and interpret Design of Experiments to map the design space with confidence
Build robust control strategies that hold quality within the design space
Strengthen regulatory submissions to the EMA and FDA with clear QbD evidence
Add a science-based, in-demand skill valued across Iceland's pharma cluster
Reduce manufacturing deviations and rework by truly understanding your process

For Organizations

Quality by Design group training helps pharmaceutical and medical device organisations in Iceland build development capability across whole teams. Delivered onsite or live virtual, it equips cross-functional groups with a common, structured approach to designing quality in. For companies moving from testing quality in to building it in, this training creates a shared foundation for prioritisation, experimentation and control.

If your development, quality and regulatory teams work in silos, QbD group training gives them one science-based language for the QTPP, Critical Quality Attributes, risk assessment and the design space, so quality decisions stay consistent from bench to commercial manufacture.

Build a shared QbD language across formulation, process, quality and regulatory teams
Design quality into products to reduce deviations, rework and batch failures
Strengthen EMA and FDA submissions with consistent, science-based QbD evidence
Apply QbD tools to live development projects during onsite team sessions
Standardise risk assessment and design-space practice across sites and units
Develop cross-functional capability that supports faster, more reliable scale-up
Flexible delivery for teams in Reykjavik, Hafnarfjordur and across Iceland

Where QbD Skills Take Your Career in IcelandRoles and Pharma Demand

Quality by Design skills are increasingly sought across Iceland's compact but R&D-intensive pharmaceutical cluster, and focused Quality by Design training is a direct route to building them. Employers such as Alvotech in biosimilars and Coripharma in generics and contract development want QbD-literate scientists and engineers who can build quality into products and support EMA and FDA submissions. Demand sits with formulation and process development scientists, analytical and QC scientists, and quality and regulatory professionals, and here is what the market is telling us right now.

kr 11.9M

Average pharmaceutical scientist salary, Iceland

per year, SalaryExpert 2026

kr 11.3M

Regulatory affairs director salary, Iceland

average, SalaryExpert 2026

kr 13.4M

Senior scientist salary, Iceland

8+ years, SalaryExpert 2026

2.8%

Iceland pharma market growth

CAGR 2025-2030, Mordor Intelligence

Sectors Hiring

—Biosimilar and Biologics Manufacturing
—Generic Pharmaceuticals and CDMOs
—Active Pharmaceutical Ingredient (API) Production
—Medical Devices and Health Technology
—Regulatory Affairs and CMC Consulting
—Quality Assurance and Pharmaceutical Quality Systems

Demand Drivers

—Alvotech scaling biosimilar development and manufacturing in Reykjavik
—Coripharma growing as a CDMO after acquiring Actavis R&D operations
—EMA and FDA expecting QbD evidence in modern regulatory submissions
—Deep ex-Actavis talent base concentrated in the capital region
—Biosimilar complexity demanding robust design-space understanding
—Capital and quality pressure pushing science-based development

Sources: SalaryExpert / ERI, Glassdoor, Paylab (Iceland) 2026; Mordor Intelligence Iceland Pharmaceutical Market.

Designation

Quality by Design Professionals in Iceland : Salary Insights and Trends

Hiring Companies in Iceland

kr8000K

Min

kr10500K

Average

kr13500K

Max

SalaryExpert / ERI (Iceland) 2026

CoripharmaAlvotechFlorealisEpiEndo

Source: Coripharma - Alvotech - Florealis - EpiEndo

Market Forces Making QbD Skills Essential in Iceland

Biosimilar Complexity

Alvotech develops and manufactures biosimilars in Reykjavik, and these molecularly complex, process-defined products demand robust QbD understanding of the design space and control strategy.

QbD builds design-space and control-strategy skills

Rising Regulator Expectations

The EMA and FDA now expect QbD evidence in modern submissions. Iceland's EEA membership ties development to EMA standards, so QbD-literate teams are increasingly essential.

QbD prepares you for EMA and FDA submissions

CDMO Differentiation

Coripharma has grown from a contract manufacturer into a CDMO after acquiring Actavis R&D. QbD expertise is a differentiating capability that helps CDMOs win and retain pharma clients.

QbD is a capability CDMOs compete on

Generics and Bioequivalence

Generic development needs consistent quality and bioequivalence. QbD replaces trial-and-error formulation with a systematic route to reliable, right-first-time products.

QbD builds systematic development skills

Concentrated Talent, Rising Demand

Iceland's deep ex-Actavis talent base sits in the capital region, yet demand for structured QbD capability outpaces the pool of formally trained practitioners.

QbD makes trained practitioners stand out

Capital and Quality Pressure

Cost and quality pressure push organisations to design quality in, cutting deviations, rework and post-approval changes through deeper process understanding.

QbD builds process-understanding skills

Sources: Alvotech and Coripharma company disclosures; Mordor Intelligence Iceland Pharmaceutical Market; ICH and EMA guidance, 2026.

Quality by Design is fast becoming the standard for pharmaceutical development in Iceland. Build the skills employers and regulators now expect, and start your QbD journey today.

Your Iceland QbD Transformation

From Testing Quality in to Designing It In

Your QbD Transformation

Iceland's pharmaceutical sector is moving from empirical development to the science-based, QbD-driven design that regulators now expect. Here is how building these skills changes your day-to-day work and your standing.

Today

Seen as a capable scientist without a systematic development method

After QbD

Recognised as a QbD practitioner who can lead development and support submissions

Today

Seen as a capable scientist without a systematic development method

Today

Limited leverage in a competitive Icelandic pharma job market

After QbD

In demand across biosimilar, generic and medical device employers in Iceland

Today

Limited leverage in a competitive Icelandic pharma job market

Today

Confident at the bench but not across the full development lifecycle

After QbD

Able to link the QTPP, risk assessment, DoE and control strategy end to end

Today

Confident at the bench but not across the full development lifecycle

You master QbD

Before

Quality is checked by end-product testing, so problems surface late

Now you have

Quality is designed in from the start using the QTPP and Critical Quality Attributes

Before

Quality is checked by end-product testing, so problems surface late

Before

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

Now you have

You use Design of Experiments to map the design space efficiently

Before

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

Before

Risk is judged informally, with little structured evidence

Now you have

You run FMEA and Ishikawa-based risk assessment to focus effort where it counts

Before

Risk is judged informally, with little structured evidence

Before

Submissions rely on fixed specifications and empirical limits

Now you have

Submissions carry clear QbD evidence and a justified control strategy

Before

Submissions rely on fixed specifications and empirical limits

"In modern pharma, the gap between testing quality and designing it in is exactly what employers and regulators now look for."

Join professionals across Iceland's pharma cluster who train with Invensis Learning.

Sources: SalaryExpert / ERI (Iceland) 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 Iceland 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 Skills You Will BuildPractical Tools for Real Development

By the end of this Quality by Design course you will be able to apply the full QbD toolkit to pharmaceutical development. You will construct a QTPP, identify Critical Quality Attributes, run risk assessments, plan a Design of Experiments and build a control strategy for regulatory submission.

Quality Target Product Profile (QTPP)

Construct a QTPP from clinical and patient needs to define the quality, safety and efficacy targets that guide the entire development programme.

Critical Quality Attributes (CQAs)

Identify and classify the physical, chemical and biological attributes that must stay within limits, and link them to material attributes and process parameters.

Risk Assessment with FMEA and Ishikawa

Use fishbone diagrams and Failure Mode and Effects Analysis with RPN scoring to prioritise the material attributes and process parameters that most affect quality.

Design of Experiments and the Design Space

Plan screening and response-surface experiments, interpret the model, and define the design space, including Normal Operating and Proven Acceptable Ranges.

Process Analytical Technology and Control Strategy

Apply PAT tools such as NIR and Raman and build a control strategy that keeps quality within the design space across manufacturing.

QbD in Regulatory Submissions

Structure QbD evidence for the CTD Section 3.2.P.2, aligning with ICH Q8(R2) through Q11 for EMA and FDA submissions across small molecules and biologics.

Who Should TakeQuality by Design Training in Iceland?

Process Engineers

QC Analysts

Engineering Teams

Technical Staff

Production Managers

Distribution Managers

Regulatory Affairs Specialists

Quality Assurance Professionals

Who Can Take This Certification Training

Quality by Design Training Modesfor Professionals and Teams

We offer flexible training formats designed to suit different learning preferences, schedules, and professional goals. Whether you prefer self-paced learning or a structured, corporate, instructor-led experience, choose the option that best supports your skill development journey with the best Quality by Design online training options.

Quality by Design Live Virtual Training

Live online instructor-led sessions
Interactive discussions and virtual activities
Expert guidance from experienced trainers
Practice assessments and revision support
Dedicated Q&A sessions for concept clarification
Fixed schedules for accountability and momentum
Small batch sizes for personalized attention
Access from any location with internet connectivity

EUR 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 Classroom Training

Instructor-led classroom sessions
Interactive discussions and group activities
Real-world examples and practical exercises
Structured learning with fixed schedules
Opportunities for peer networking and collaboration
Practice assessments and knowledge checks
Dedicated Q&A and concept clarification
Immediate trainer feedback and support

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Learn through face-to-face sessions led by experienced instructors in a collaborative classroom environment. This classroom Quality by Design training combines expert guidance, peer interaction, and hands-on activities to create an engaging learning experience.

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Best For: Learners who prefer in-person interaction, structured schedules, and collaborative learning experiences.

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Quality by Design Corporate Group Training

Customized training aligned to organizational goals
Flexible delivery: onsite, virtual, hybrid, or blended
Scheduling tailored to business availability
Role-based examples and industry-relevant discussions
Progress tracking and learner assessments where applicable
Dedicated coordination and administrative support
Consistent learning experiences across teams
Scalable delivery for local, regional, or global workforces

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Designed for organizations that want to build capabilities at scale, standardize knowledge, and support workforce development through customized team learning initiatives.

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Best For: Organizations looking to upskill employees, address capability gaps, and deliver consistent training across teams.

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Quality by Design Focused 1-to-1 Training

One-to-one instructor attention
Customized learning plans and objectives
Flexible scheduling based on availability
Personalized feedback and coaching
Additional focus on challenging topics
Targeted practice and revision support
Faster clarification of questions and concepts
Learning pace is adapted to individual needs

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Receive personalized instruction tailored to your goals, pace, and learning requirements through dedicated sessions from our trusted Quality by Design training company.

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Best For: Professionals seeking personalized guidance, accelerated learning, or focused support to achieve specific outcomes.

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Quality by Design Live Virtual Training

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 430

Please Note:Attend fully interactive weekday Quality by Design training sessions from anywhere while benefiting from real-time instructor guidance and collaborative learning experiences.

Best For: Professionals seeking the flexibility of online learning without compromising on live instructor interaction.

Loading schedules…

Why Choose Invensis Learning for Quality by Design Training in IcelandPractical, Expert-Led and Flexible

Invensis Learning delivers practical, instructor-led Quality by Design training for individuals and teams across Iceland's pharmaceutical and medical device sector. Our trainers are experienced quality and development practitioners, and our programmes combine clear explanation of the ICH framework with hands-on exercises on real development scenarios, making Invensis Learning a trusted Quality by Design training company in Iceland. As an ISO 9001:2015 and ISO 27001:2022 certified global training provider, we offer flexible live virtual and onsite delivery, structured courseware and dedicated learner support, so you move from concept to confident application.

Experienced trainers with real pharmaceutical quality and development expertise
Practical, hands-on exercises using the QTPP, CQAs, risk assessment and DoE
Aligned to the ICH Q8(R2), Q9, Q10 and Q11 quality guidelines
Flexible live virtual (online) and onsite delivery for Iceland
ISO 9001:2015 certified for quality management
ISO 27001:2022 certified for information security
Structured courseware, case studies and post-training support
Trusted by professionals and organisations across many industries

24/7

Learner Support

50+

Industries Served

1-to-1

Doubt-Clearing Sessions

60+

Global Course Portfolio

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 IcelandAll our classroom training is now available online at your convenience

Quality by Design in Iceland

Hilton Reykjavik Nordica, 2, Suðurlandsbraut, Háaleiti, Háaleiti og Bústaðir, Reykjavíkurborg, Höfuðborgarsvæðið, 108, Ísland

Quality by Design in Iceland

Grand Hotel Reykjavik, 38, Sigtún, Teigar, Laugardalur, Reykjavíkurborg, Höfuðborgarsvæðið, 105, Ísland

Quality by Design in Iceland

Hilton Reykjavik Nordica, 2, Suðurlandsbraut, Háaleiti, Háaleiti og Bústaðir, Reykjavíkurborg, Höfuðborgarsvæðið, 108, Ísland

Quality by Design in Iceland

Grand Hotel Reykjavik, 38, Sigtún, Teigar, Laugardalur, Reykjavíkurborg, Höfuðborgarsvæðið, 105, Ísland

Corporate QbD TrainingUpskill Your Iceland Pharma Teams

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Tailored QbD training for formulation, process, quality and regulatory teams
Onsite, live virtual or blended delivery across Iceland
Apply QbD tools to your own live development projects
Build a shared, science-based development language across sites
Flexible scheduling aligned to team and shift availability
Experienced trainers with pharmaceutical and biopharma expertise
Scalable delivery for local and multinational teams

What Our Learners Say

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A Systematic Way to Design Quality In

"The training finally connected the QTPP and Critical Quality Attributes to how I actually develop formulations. Building the design space with Design of Experiments made our development far more systematic, and I could apply it the week I got back."

Gudrun Jonsdottir

Formulation Scientist

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DoE and Design Space Made Clear

"The Design of Experiments and control strategy sessions were the highlight. I now understand how to set Normal Operating and Proven Acceptable Ranges and defend the design space, which is exactly what our process work needed."

Kristjan Olafsson

Process Development Engineer

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Stronger, Clearer Submissions

"As a regulatory professional, the module on structuring QbD evidence for the CTD Section 3.2.P.2 was invaluable. It gave me a much clearer picture of what the EMA and FDA expect in a modern submission."

Sigrun Thorarinsdottir

Regulatory Affairs Specialist

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A Shared QbD Language for Our Team

"We ran this onsite for a cross-functional development team, and it gave everyone one shared language for QbD. Risk assessment and design-space discussions are now far more consistent between our formulation, process and quality people."

Anna Bjarnadottir

Head of Quality, Biosimilar Manufacturer

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Practical Training That Fit Our Business

"The trainer tailored the case studies to our generic and CDMO work, so the exercises felt real. Our scientists left able to lead CQA identification and risk assessments, and the practical focus made it easy to justify the investment."

Petur Gunnarsson

Learning and Development Manager, Generic Pharmaceutical Company

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Frequently Asked QuestionsHere's everything you may ask...

Quality by Design is a systematic, science-based approach to pharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. It is defined by ICH Q8(R2) and supported by ICH Q9, Q10 and Q11, using tools such as the QTPP, Critical Quality Attributes, risk assessment, Design of Experiments and the control strategy.

General

What is Quality by Design (QbD)?

Who should attend the Quality by Design training?

The course is designed for formulation scientists, process development engineers, analytical and QC scientists, and quality assurance and regulatory affairs professionals in pharmaceutical, biopharmaceutical, API and medical device organisations. It suits anyone in Iceland's pharma sector who wants to apply QbD in development and submissions.

Is the Quality by Design training worth it for Icelandic pharma professionals?

Yes. QbD is now the expected foundation of modern pharmaceutical development and of EMA and FDA submissions, and it is a sought-after skill across Iceland's biosimilar, generic and medical device employers such as Alvotech and Coripharma. The training builds capability you can apply to development work immediately.

Which ICH guidelines does Quality by Design follow?

QbD is defined by ICH Q8(R2) Pharmaceutical Development and supported by ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. The course teaches how these guidelines shape the QTPP, risk assessment, the design space and the control strategy.

Do I need prior QbD experience to attend?

No. 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.

Pricing

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

Pricing depends on your chosen delivery format, whether individual or group, and team size, so fees are available on request. The course is offered in live virtual and onsite formats. Request a quote from a learning advisor for current pricing in your preferred format.

What is included in the course fee?

The fee typically includes instructor-led training across all six QbD modules, structured courseware, hands-on tool exercises, pharmaceutical case study examples and a course completion record. Contact us to confirm exactly what is included in your chosen format.

Do you offer group or corporate pricing for teams?

Yes. We offer corporate and group pricing with customised, onsite or live virtual delivery for pharmaceutical and medical device teams across Iceland. Ask about corporate pricing for a tailored quote for your team.

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.

Is the training available for both individuals and teams?

Yes. You can enrol as an individual in a scheduled session or arrange dedicated corporate training for your team. Request a quote to compare individual and group options.

Assessment

How is learning checked during the course?

Learning is reinforced through hands-on QbD tool exercises, realistic pharmaceutical case studies and team discussion rather than a formal assessment. You apply the QTPP, CQA identification, risk assessment and design-space interpretation to development scenarios during the programme.

Does the course award a formal credential?

No. This is a non-certification skills course, so there is no formal credential or awarding body. You receive a course completion record from Invensis Learning, and the QbD skills you gain are immediately applicable to your work.

What do I receive on completing the training?

On completing the one-day programme you receive a course completion record from Invensis Learning that recognises your participation. More importantly, you leave able to apply the full QbD toolkit to pharmaceutical development projects.

Is there any test at the end of the course?

No. There is no examination or test. The training focuses on practical understanding, reinforced through tool exercises and case studies across the QbD framework.

How soon can I apply QbD skills at work?

Straight away. Because the course is practical and non-certification, you can construct QTPPs, lead CQA identification, run risk assessments and plan Design of Experiments on live projects as soon as you return to work.

Course Content

What topics does the Quality by Design course cover?

The one-day course covers the full QbD framework across six modules: QbD principles and the ICH context, the QTPP and Critical Quality Attributes, risk assessment, Design of Experiments and the design space, Process Analytical Technology and the control strategy, and QbD in practice through case studies and CTD submissions.

What will I be able to do after the training?

You will be able to construct a QTPP, identify and classify Critical Quality Attributes, map risks with Ishikawa diagrams and FMEA, plan and interpret a Design of Experiments, define the design space, and build a control strategy for regulatory submission.

Does the course cover both small molecule and biologic products?

Yes. The course covers QbD for small molecule drug products such as tablets and injectables, and for biopharmaceuticals such as monoclonal antibodies and biosimilars, with case study examples from both, which is directly relevant to Iceland's biosimilar sector.

Are there hands-on exercises in the course?

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

Which framework and guidelines is the course based on?

The course is grounded in the ICH quality guidelines, principally ICH Q8(R2) Pharmaceutical Development, together with Q9, Q10 and Q11, and reflects EMA and FDA expectations for QbD evidence in modern regulatory 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 receive access to schedules, courseware and learning resources. Talk to a learning advisor if you need help choosing a session.

What delivery formats are available in Iceland?

The course is available as live virtual (online) instructor-led training and as onsite or classroom training for teams. Choose the format that fits your schedule and location across Iceland.

How long is the Quality by Design programme?

The training runs as a one-day, eight-hour programme covering all six QbD modules, with hands-on tool exercises throughout. It can also be delivered as two half-day sessions to suit team availability.

Can the course be delivered onsite for our team in Iceland?

Yes. We deliver onsite corporate training for pharmaceutical and medical device teams in Reykjavik, Hafnarfjordur and across Iceland, so a cross-functional group can apply QbD to live projects together. Ask about corporate options for your team.

Can I reschedule my enrolment to another session?

Yes. Flexible options let you reschedule or transfer to another session. Contact our support team to arrange this.

Quality by Design Training in Iceland

What Is Quality by Design and Why It Matters for Icelandic PharmaUntitledA Science-Based Route to Consistent Quality

What Is Quality by Design and Why It Matters for Icelandic PharmaA Science-Based Route to Consistent Quality

Key Highlightsof the Quality by Design Training Course

Quality by Design Training Eligibility in the IcelandWho Can Enroll?

The On-The-Job Payoff of Learning Quality by DesignSkills You Can Apply from Day One

Where QbD Skills Take Your Career in IcelandRoles and Pharma Demand

Sectors Hiring

Demand Drivers

Market Forces Making QbD Skills Essential in Iceland

Biosimilar Complexity

Rising Regulator Expectations

CDMO Differentiation

Generics and Bioequivalence

Concentrated Talent, Rising Demand

Capital and Quality Pressure

From Testing Quality in to Designing It In

Your QbD Transformation

Module 1: Introduction to QbD

Module 2: QbD Tools and Techniques

Module 3: Industry and Regulatory Perspective

Module 4: Quality Target Product Profile (QTPP)

Module 5: Critical Quality Attributes, Critical Material Attributes, and Critical Process Parameters

Module 6: Statistical Design of Experiments

Module 7: Design Space and Process Control

Module 8: Risk Assessment and Management

Module 9: Real-time Release Testing (RTRT)

Module 10: Case Studies and Practical Applications

Course Curriculumof the Quality by Design Training

Module 1: Introduction to QbD

The QbD Skills You Will BuildPractical Tools for Real Development

Quality Target Product Profile (QTPP)

Critical Quality Attributes (CQAs)

Risk Assessment with FMEA and Ishikawa

Design of Experiments and the Design Space

Process Analytical Technology and Control Strategy

QbD in Regulatory Submissions

Who Should TakeQuality by Design Training in Iceland?

Quality by Design Training Modesfor Professionals and Teams

Quality by Design Live Virtual Training

Quality by Design Classroom Training

Quality by Design Corporate Group Training

Quality by Design Focused 1-to-1 Training

Quality by Design Live Virtual Training

Why Choose Invensis Learning for Quality by Design Training in IcelandPractical, Expert-Led and Flexible

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

Corporate QbD TrainingUpskill Your Iceland Pharma Teams

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