Quality by Design Training in the Slovak Republic

Build Quality in by Design

Give pharmaceutical and biopharmaceutical teams in the Slovak Republic the practical QbD skills to design quality into products from the start. This instructor-led programme applies the ICH Q8, Q9, Q10 and Q11 framework and hands-on tools like QTPP, CQAs, risk assessment and the design space to real development work.

Flexible

Duration

Live

Mode

Hours

13.3K+ already enrolled

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Want to Train Your Team?

Master Quality by Design and Lead Excellence in Slovak Republic

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EUR 400

What Is Quality by Design and Why It Matters NowA Science-Led Route to Consistent Quality

Quality by Design (QbD) Training in the Slovak Republic is a practical, one-day programme that teaches pharmaceutical and biopharmaceutical professionals how to build quality into a product from the design stage rather than inspecting it in at the end. It is grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines that the EMA and FDA now expect behind modern development and manufacturing submissions.

You learn to work the full QbD chain: define the Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run structured risk assessment, use Design of Experiments (DoE) to map the design space, and set a robust Control Strategy. The course suits formulation, analytical and process development scientists, quality assurance staff and regulatory affairs professionals across Slovakia's growing life sciences base, from API makers in Hlohovec to biotech scale-up in Slovenska Lupca.

With hands-on exercises on realistic development scenarios, you leave able to apply QbD on live projects the next day. Start building science-led quality capability with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Slovak Republic 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 Slovak Republic 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 Slovak Republic

Instructor-led training formats available for individual learners and corporate teams across the Slovak Republic
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 Slovak Republic
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 Slovak Republic 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 Slovak RepublicWho 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 QbD Training DeliversFor You and Your Team

For Individuals

This QbD training helps scientists and quality professionals turn a thorough understanding of product and process into consistent, controllable quality. You learn to apply the tools that modern pharmaceutical development is built on, from the QTPP through to the Control Strategy. Whether you work in formulation, analytical development, process engineering, quality assurance or CMC regulatory affairs, the programme builds capability you can use on live projects across Slovakia's life sciences sector.

If you want to stop testing quality in and start designing it in, this course gives you the QbD workflow, the hands-on practice, and the confidence to lead it at work.

Learn to design quality into products from the start and cut late-stage failures
Apply QTPP and CQA identification to real formulation and process work
Facilitate risk assessments using Ishikawa diagrams and FMEA with confidence
Plan and interpret Design of Experiments to define a robust design space
Build a Control Strategy that stands up to EMA and FDA expectations
Strengthen your value in Slovakia's pharmaceutical and biotech job market
Speak the shared QbD language of formulation, analytical, quality and regulatory teams
Move from trial-and-error development to science-led decision making

For Organizations

QbD group training helps organisations build science-based development capability across formulation, analytical, process, quality and regulatory functions. The training can be delivered for a single team or a whole development pipeline. For pharmaceutical and biotech employers that want fewer deviations, smoother submissions and more consistent products, this programme creates a shared QbD approach the whole team can apply.

If your teams still manage quality through end-product testing, QbD training gives them one language for QTPP, risk assessment, design space and control strategy, and a repeatable way to design quality in.

Standardise QbD practice across development, quality and regulatory teams
Reduce manufacturing deviations and post-approval changes
Strengthen CMC submissions with clear QTPP, design space and control strategy evidence
Build cross-functional QbD teams that work from one framework
Train staff on live product development projects during the session
Improve product consistency and regulatory relationships
Deliver flexibly onsite or live online across your Slovak sites

Where QbD Skills Take Your Career in SlovakiaRoles, Sectors and Demand

Quality by Design skills open doors across Slovakia's pharmaceutical and biotech sector, where employers increasingly expect development, quality and regulatory teams to design quality in, not test it in. Demand spans formulation and analytical scientists, process development engineers, QA specialists and CMC regulatory professionals at API makers, generics producers and biopharma CDMOs. As investment such as Evonik's biotech expansion scales up, professionals who can run QTPP, DoE and control strategy work stand out, and here is what the market shows.

EUR 27,600

Average QA specialist salary, Slovakia

per year, SalaryExpert 2026

EUR 35,060

Senior scientist salary, Slovakia

per year, ERI SalaryExpert 2026

EUR 1,204-2,875

Pharma sector gross pay band

per month, Platy.sk 2026

EUR 80m

Evonik biotech investment

Slovenska Lupca CDMO expansion

SECTORS HIRING

—Pharmaceutical Manufacturing and API Production
—Biopharmaceutical and Biotech CDMOs
—Generics and Formulation Development
—Regulatory Affairs and CMC Consulting
—Medical Devices and Life Sciences
—Contract Development and Manufacturing

GROWTH TRENDS

—Evonik's EUR 80m biopharma expansion in Slovenska Lupca adding capacity and jobs
—Slovakia positioned as a central European life sciences hub in the Eurozone
—Rising CDMO outsourcing lifting demand for QbD-literate scientists
—EMA and ICH alignment making QbD evidence expected in submissions
—Established API base needing design-stage quality skills
—Skilled science workforce drawing complex-molecule manufacturing investment

Sources: SalaryExpert, ERI SalaryExpert, Platy.sk (Slovakia) 2026; SARIO, Evonik, European Biotechnology (life sciences investment).

Designation

Quality by Design Professionals in Slovak Republic : Salary Insights and Trends

Hiring Companies in Slovak Republic

€20K

Min

€28K

Average

€35K

Max

SalaryExpert · Platy.sk (Slovakia) 2026

Saneca PharmaceuticalsIMUNA PHARMHBM Pharma

Source: Saneca Pharmaceuticals · IMUNA PHARM · HBM Pharma

Industry Challenges Driving QbD Demand in Slovakia

Design-Stage Quality Gap

Many development teams still confirm quality through end-product testing. QbD replaces that with a mechanistic understanding of how materials and process parameters drive quality, exactly the gap it is built to close.

QbD builds design-in quality skills

Rising Regulatory Expectations

The EMA and FDA now expect QbD evidence, such as QTPP, design space and control strategy, in development submissions. Teams need people who can produce and defend that evidence in the CTD.

QbD builds submission-ready evidence skills

CDMO Scale-Up Pressure

As Slovak CDMOs like Evonik expand biofermentation and downstream capacity, scale-up demands design space understanding and a control strategy that holds quality steady across larger batches.

QbD builds design space and control skills

API and Generics Consistency

Slovakia's established API and generics base needs mechanistic process understanding to cut deviations and out-of-specification results. QbD gives scientists the tools to predict and control quality, not chase it.

QbD builds process understanding skills

QbD Talent Scarcity

The Slovak workforce is deep in GMP experience but thinner in scientists fluent in DoE, design space and control strategy. Professionals who can apply QbD are rare and increasingly sought after.

QbD makes science-led scientists stand out

Biologics Complexity

Biopharmaceutical products bring complex CQAs such as glycosylation, charge variants and aggregation. QbD provides the structured risk and DoE approach needed to identify and control them reliably.

QbD builds biologic CQA control skills

Sources: SARIO, Evonik, European Biotechnology, Manufacturing Chemist (Slovakia life sciences) 2026; ICH Q8-Q11 regulatory context.

QbD is more than a method. It is the way Slovakia's pharmaceutical and biotech employers now expect quality to be built. Join professionals who design quality in from the start and lead science-led development. Start your journey today.

Your Slovak Republic Skills Transformation

Where You Stand Today

And Where QbD Skills Take You

Slovakia's pharmaceutical and biotech market is expanding with CDMO investment and rising regulatory expectations, and employers increasingly separate scientists who can design quality in from those who only test it. Here is which side of that line you want to be on.

Today

Seen as a lab or process specialist with limited strategic input

After Training

Valued as a science-led quality thinker across the development chain

Today

Seen as a lab or process specialist with limited strategic input

Today

Fewer options as Slovak biotech and CDMO roles ask for QbD skills

After Training

Eligible for QbD-led roles at API, generics and biopharma employers

Today

Fewer options as Slovak biotech and CDMO roles ask for QbD skills

Today

Pay tied mostly to routine execution work

After Training

Positioned for senior scientist and quality manager bands in Slovakia

Today

Pay tied mostly to routine execution work

You master QbD

Before

Quality is checked by end-product testing after the batch is made

Now you have

You design quality in from the QTPP and CQAs at the very start

Before

Quality is checked by end-product testing after the batch is made

Before

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

Now you have

You plan DoE studies and read a design space to control quality

Before

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

Before

Risk is judged informally with no structured method

Now you have

You run FMEA and Ishikawa risk assessments that guide decisions

Before

Risk is judged informally with no structured method

Before

Submissions lean on empirically set specifications

Now you have

You build a control strategy that meets EMA and FDA expectations

Before

Submissions lean on empirically set specifications

"The gap between running tests and designing quality in is now a career divide, and Slovak employers already know which side they are hiring."

Join 50,000+ professionals who trained with Invensis Learning and applied it at work.

Sources: SalaryExpert, ERI SalaryExpert, Platy.sk (Slovakia) 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 Slovak Republic 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

Skills You Will Build in This QbD CourseApplied on Real Development Scenarios

In this Quality by Design course you will learn to run the full QbD workflow, from defining a Quality Target Product Profile to setting a Control Strategy for regulatory submission. By the end you can apply the ICH-aligned tools to your own pharmaceutical development work.

Build a Quality Target Product Profile

Construct a QTPP from clinical and patient needs and use it as the design specification that drives the whole QbD programme, from dosage form and strength to quality standards.

Identify and Classify Critical Quality Attributes

Determine the CQAs for small molecule and biologic products, distinguish critical from non-critical attributes, and link each CQA to material attributes and process parameters.

Run Structured Risk Assessments

Apply Ishikawa fishbone diagrams and FMEA with Risk Priority Numbers to prioritise the material attributes and process parameters that most affect quality, and focus your experiments.

Design and Interpret DoE Studies

Select screening and response surface designs, interpret the resulting model, and define the design space along with Normal Operating Ranges and Proven Acceptable Ranges.

Apply Process Analytical Technology

Use PAT tools such as NIR and Raman spectroscopy for real-time monitoring, and understand how real-time release testing supports control within the design space.

Develop a Control Strategy for Submission

Turn your QbD outputs into a risk-proportionate control strategy and structure the evidence for the CTD, connecting material controls, process controls and in-process checks.

Who Should TakeQuality by Design Training in Slovak Republic?

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

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 QbD Training in the Slovak RepublicExpert-Led, Flexible and Trusted

Invensis Learning delivers practical Quality by Design training for individuals and teams who want to build science-led quality capability, not just sit through theory. Our programmes pair experienced pharmaceutical trainers with hands-on QbD tool exercises, flexible delivery and organised courseware aligned to the ICH guidelines. Whether you enrol as an individual scientist or plan corporate training for a development team, we focus on real-world application, so your people can use QTPP, DoE and control strategy methods on live projects across the Slovak Republic.

Instructor-led QbD training from experienced pharmaceutical quality practitioners
Flexible live online, classroom and onsite delivery across the Slovak Republic
ISO 9001:2015 quality-managed and ISO 27001:2022 information-secure training
Hands-on QbD exercises on realistic pharmaceutical development scenarios
Courseware grounded in the ICH Q8, Q9, Q10 and Q11 framework
Corporate and group training tailored to your development pipeline
Dedicated learner support before, during and after the programme
Trusted by professionals and organisations across 100+ countries

500+

Corporate Clients

15+

Years of Training Excellence

24/7

Learner Support

50+

Industries Served

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 Slovak RepublicAll our classroom training is now available online at your convenience

Quality by Design in Slovak Republic

Grand Hotel River Park, Nábrežie arm. gen. Ludvíka Svobodu, Castle Valley, Bôrik Region, Bratislava, Bratislava I District, Bratislava, Borinka, Bratislava Region, 900 32, Slovakia

Quality by Design in Slovak Republic

Sheraton, Pribinova, Bratislavský downtown, Bratislava, okres Bratislava I, Bratislava, Borinka, Bratislavský kraj, 900 32, Slovensko

Quality by Design in Slovak Republic

Grand Hotel River Park, Nábrežie arm. gen. Ludvíka Svobodu, Castle Valley, Bôrik Region, Bratislava, Bratislava I District, Bratislava, Borinka, Bratislava Region, 900 32, Slovakia

Quality by Design in Slovak Republic

Sheraton, Pribinova, Bratislavský downtown, Bratislava, okres Bratislava I, Bratislava, Borinka, Bratislavský kraj, 900 32, Slovensko

Corporate QbD Training for Slovak TeamsFit to Your Pipeline

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Suitable for small, medium and large pharmaceutical and biotech teams
Customised schedules built around your development and manufacturing calendar
Flexible onsite, live virtual or hybrid delivery across Slovak sites
Trainers with real pharmaceutical quality and QbD experience
Apply QbD tools to your own live product development projects
Standardise QTPP, risk assessment and control strategy practice across teams
Dedicated coordination and learner support for group programmes

What Our Learners Say

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The Full QbD Workflow, Made Practical

"The course finally connected the tools I had heard about into one workflow. I now build a QTPP, map CQAs and plan a DoE with real confidence, and I have already used it on a formulation project."

Martina Kovacova

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Risk Assessment That Finally Made Sense

"The risk assessment and design space sessions were the most useful part for me. Working through Ishikawa diagrams and FMEA on realistic scenarios made the theory click straight away."

Peter Horvath

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Clearer View of QbD in Submissions

"As a regulatory professional I needed to understand how QbD evidence fits the CTD. The control strategy module gave me exactly that, and I can now review development reports far more critically."

Lucia Nagyova

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One Shared QbD Language for the Team

"We ran this onsite for our development team and it gave everyone a shared QbD language. Prioritisation, design space and control strategy discussions are much sharper now across formulation and quality."

Tomas Varga

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Tailored Corporate Training That Delivered

"The trainer tailored the exercises to our own biopharma projects, which made the corporate session genuinely valuable. Our scientists left able to apply the QbD tools the next week."

Zuzana Balaz

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4.6

Ratings

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Happy Learners

100+

Locations Worldwide

99%

Training Satisfaction

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

Quality by Design training is a practical course that teaches pharmaceutical and biopharmaceutical professionals how to build quality into a product from the design stage rather than testing it in at the end. It follows the ICH Q8(R2), Q9, Q10 and Q11 framework and covers tools such as QTPP, CQAs, risk assessment, DoE, the design space and the control strategy.

General

What is Quality by Design (QbD) training?

Is QbD training worth it for pharma professionals in Slovakia?

Yes. Slovak pharmaceutical, API and biotech employers increasingly expect development, quality and regulatory teams to apply QbD, and regulators expect QbD evidence in submissions. The skills are immediately usable on live projects, which makes the training a strong practical investment for your career.

Who should attend this QbD course?

The course suits formulation, analytical and process development scientists, quality assurance staff, QC scientists, and CMC regulatory affairs professionals in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations who want to apply QbD in product development.

Do I need prior experience to join?

No formal prerequisites are required. Familiarity with pharmaceutical development or GMP is helpful but not essential, as the course introduces QbD from first principles before moving into the tools and hands-on exercises.

Which ICH guidelines does QbD align with?

QbD is grounded in ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. The course also references the FDA PAT framework and EMA expectations for process understanding.

Pricing

How much does QbD training cost in the Slovak Republic?

Pricing varies by delivery mode, group size and whether you attend a public or corporate session, so the fee is available on request. Contact a learning advisor for a current quote tailored to how you want to train.

What is included in the course fee?

The fee typically includes instructor-led delivery of all six QbD modules, hands-on tool exercises, course materials and learner support, plus a course completion record from Invensis Learning. Request a quote to confirm the inclusions for your chosen format.

Do you offer group or corporate pricing?

Yes. We offer tailored corporate and group pricing for pharmaceutical and biotech teams, with schedules built around your development calendar. Ask about corporate or group pricing for a 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.

Are there any exam or extra fees to pay?

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

Assessment

Is there an exam for this QbD course?

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

Do I receive a certificate after the training?

You receive a course completion record from Invensis Learning after finishing the programme. It confirms you completed the training. There is no external credential or awarding body, as this is a practical skills course rather than a certification.

How is learning assessed during the course?

There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, Ishikawa diagrams and DoE design selection to realistic development scenarios throughout the programme, which reinforces the concepts as you go.

What will I be able to do after completing the training?

You will be able to construct a QTPP, identify and classify CQAs, run FMEA and Ishikawa risk assessments, plan and interpret a DoE, define a design space with NOR and PAR, and develop a control strategy for a CTD submission.

Is this a certification course?

No, it is a practical skills training course. It builds QbD knowledge and workplace capability you can apply immediately, without an examination or a formal credential. You receive a course completion record on finishing.

Course Content

What topics does the QbD training cover?

The training covers QbD principles and the ICH framework, the QTPP and CQAs, risk assessment, Design of Experiments and the design space, Process Analytical Technology and the control strategy, and QbD in practice through case studies and regulatory submission.

What is a Quality Target Product Profile (QTPP)?

The QTPP is a prospective summary of the quality characteristics a product should achieve to ensure the desired quality, safety and efficacy. It defines elements such as dosage form, strength and quality standards, and acts as the design specification for the whole QbD programme.

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

Yes. You learn how DoE replaces one-factor-at-a-time testing, which screening and response surface designs to use, how to interpret the model, and how to define the design space along with Normal Operating Ranges and Proven Acceptable Ranges.

Does it apply to 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, with case study examples drawn from both product types.

What materials and hands-on exercises are provided?

You receive course materials covering all six QbD modules and work through hands-on exercises, including QTPP construction, CQA identification and criticality assessment, Ishikawa risk mapping and DoE design selection, all applied to realistic pharmaceutical development scenarios.

Enrollment

How do I enrol in the QbD course in the Slovak Republic?

You can enrol through the Invensis Learning website. Choose your preferred format, complete payment, and you receive access to schedules, course materials and learning resources. Talk to a learning advisor if you would like help choosing a format.

What training formats are available?

The course is available as live online (live virtual) instructor-led training, classroom training, onsite delivery and customised corporate group training, so you can pick the format that fits your schedule and team.

How long is the training?

The programme runs for one day, a total of eight hours, and can also be delivered as two half-day sessions. It covers all six QbD modules with concept explanations, case examples and hands-on tool exercises.

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

Yes. We deliver QbD training onsite or live online for teams across Slovak sites, with schedules and examples tailored to your development pipeline. Ask about corporate training for a quote for your team.

Can I reschedule my booking?

Yes. Flexible options let you reschedule or transfer to another session where available. Contact our support team to arrange a change to your booking.