Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design in Pharmaceutical Development?UntitledA Science-Based Route to Consistent Quality

    Quality by Design (QbD) Training in Greece 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 testing it in at the end. Grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, the course shows you how to define a Quality Target Product Profile, identify Critical Quality Attributes, run structured risk assessments, apply Design of Experiments and set a robust Control Strategy. This training suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals and CMC regulatory specialists across Greece's growing generics, biosimilar and CDMO sector. You gain tools you can apply immediately to development projects and to EMA and EU GMP submissions. Delivered in live virtual, classroom and corporate formats by Invensis Learning, the programme moves you from the older quality by testing mindset to a science-based, regulator-expected way of working. Start building design quality into your products with Invensis Learning.

    What Is Quality by Design in Pharmaceutical Development?A Science-Based Route to Consistent Quality

    Quality by Design (QbD) Training in Greece 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 testing it in at the end. Grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, the course shows you how to define a Quality Target Product Profile, identify Critical Quality Attributes, run structured risk assessments, apply Design of Experiments and set a robust Control Strategy.

    This training suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals and CMC regulatory specialists across Greece's growing generics, biosimilar and CDMO sector. You gain tools you can apply immediately to development projects and to EMA and EU GMP submissions.

    Delivered in live virtual, classroom and corporate formats by Invensis Learning, the programme moves you from the older quality by testing mindset to a science-based, regulator-expected way of working. Start building design quality into your products with Invensis Learning.

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    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Greece 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 Greece 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 Greece

    • Instructor-led training formats available for individual learners and corporate teams across the Greece
    • 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 Greece
    • 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 Greece 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 GreeceWho 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

    Why QbD Skills Pay off on the JobFor Pharmaceutical Professionals and Teams

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical professionals replace trial-and-error development with a structured, science-based method. The programme suits formulation scientists, process and analytical scientists, quality assurance staff and CMC regulatory specialists who want to apply QbD on real projects. Whether you are formalising how you develop products, moving into a quality or regulatory role, or working in Greece's generics, biosimilar or CDMO sector, this training builds capability you can use straight away.

    If you want to design quality in rather than test it in, QbD gives you a clear, practical toolkit. You leave able to build a QTPP, identify CQAs, run risk assessment and DoE, and set a Control Strategy that stands up to EMA and EU GMP scrutiny.

    • Design quality into pharmaceutical products from the earliest development stage
    • Apply the ICH Q8, Q9, Q10 and Q11 framework with confidence at work
    • Lead QTPP and Critical Quality Attribute workshops on live projects
    • Run risk assessments and Design of Experiments that focus development effort
    • Define a design space and Control Strategy ready for EMA submission
    • Cut deviations, reworks and out-of-specification results in manufacturing
    • Strengthen your standing in Greece's generics, biosimilar and CDMO sector
    • Gain skills that transfer across small molecule and biologic development
    For Organizations

    For Organizations

    Quality by Design group training helps pharmaceutical organisations build development and quality capability by equipping cross-functional teams with a common method. The training can be delivered for development groups, quality units, or regulatory and CMC teams. For organisations that want to connect development to consistent, submission-ready quality, this training provides a scalable, flexible solution.

    If your teams know the science but lack a structured QbD approach, group training creates a shared language for QTPP, risk assessment, design space and Control Strategy. Teams gain a consistent, regulator-aligned way of working across products and sites.

    • Build a shared QbD language across development, quality and regulatory teams
    • Reduce post-approval changes and manufacturing deviations
    • Strengthen EMA and EU GMP submission quality with design-led evidence
    • Standardise how teams define CQAs, design space and Control Strategy
    • Speed up development by focusing experiments on the highest-risk variables
    • Develop in-house capability instead of relying on external consultants
    • Deliver training onsite or live virtual to suit your production schedule
    • Support continuous improvement across the product lifecycle

    What QbD Skills Unlock in Greek PharmaRoles, Demand and Sector Growth

    Quality by Design training builds capability that is increasingly valued across Greece's pharmaceutical sector, from generics and branded manufacturers to CDMOs, biosimilar developers and API producers that must meet strict EMA and EU GMP standards. As Greek production grows and vertically integrated CDMOs develop products for the wider European market, employers look for professionals who can build quality in rather than test it in. Demand spans formulation, process, analytical, quality and regulatory roles, and here is what the market is telling us right now.

    42,040 euros

    Quality Assurance Manager salary, Greece

    average per year, PayScale 2026

    50,720 euros

    Regulatory Affairs Manager salary, Greece

    average per year, SalaryExpert 2026

    119,000+

    Jobs linked to Greek pharma

    direct and indirect, SFEE 2024

    1.4 billion euros

    Greek pharma production by 2028

    projected, sector outlook

    SECTORS HIRING

    • —Generic and Branded Pharmaceutical Manufacturing
    • —Contract Development and Manufacturing Organisations (CDMOs)
    • —Biopharmaceutical and Biosimilar Development
    • —Active Pharmaceutical Ingredient (API) Manufacturing
    • —Regulatory Affairs and CMC Consulting
    • —Analytical and Quality Control Laboratories

    GROWTH TRENDS

    • —Greek pharma production projected to reach 1.4 billion euros by 2028
    • —Vertically integrated CDMOs developing products for the European market
    • —Complex generics and biosimilars driving demand for QbD tools
    • —EMA and EU GMP compliance raising expectations for design-led evidence
    • —Deep science base but a shortage of structured development skills
    • —Capital-efficiency pressure pushing firms to optimise development

    Sources: SalaryExpert, PayScale, Glassdoor (Greece) 2026; SFEE pharmaceutical market facts 2024; ReportLinker Greece pharma outlook.

    Industry Forces Driving Demand for QbD Skills in Greece

    EMA and EU GMP Compliance Pressure

    Greek manufacturers and CDMOs must meet strict EMA and EU GMP expectations, and regulators increasingly look for QbD evidence in development and submission dossiers.

    QbD builds submission-ready development evidence

    Complex Generics and Biosimilars

    Greece's generics and biosimilar pipeline depends on reproducible formulations, exactly the outcomes QbD tools such as CQAs, DoE and design space are built to deliver.

    QbD builds robust formulation and process skills

    A Growing CDMO Sector Serving Europe

    Vertically integrated Greek CDMOs develop products for clients across Europe, where QbD capability is now a differentiator that helps win and retain contracts.

    QbD is a differentiator that wins contracts

    The Cost of Quality by Testing

    Relying on end-product testing drives deviations, rejects and out-of-specification batches. QbD reduces this by building quality in through process understanding.

    QbD reduces deviations and rejects

    Scarce Structured Development Skills

    Many teams know the science but lack a structured QbD method, leaving strong demand for people who can run QTPP, risk assessment and DoE with confidence.

    QbD makes structured developers stand out

    Capital and Efficiency Pressure

    With margins tight, Greek pharma firms need development that targets high-risk variables and avoids costly post-approval changes, the core promise of QbD.

    QbD focuses effort on high-risk variables

    Sources: SFEE pharmaceutical market facts 2024; ReportLinker Greece pharma outlook; EMA and EU GMP guidance; Medicines for Europe 2026.

    QbD is a practical capability that pharmaceutical teams across Greece increasingly expect. Build the skills to design quality in and lead development with confidence. Start today.

    Your Pharma Career Shift in Greece

    Your Shift from Quality by Testing to Quality by Design

    See the Difference It Makes in Greece

    Greece's pharmaceutical sector is growing with generics, biosimilars and CDMO work for the European market, and employers increasingly separate teams that design quality in from those that still test it in. Here is which side of that line you want to be on.

    Today

    Quality is checked at the end through final product testing

    After QbD

    Quality is designed in and controlled through process understanding

    Today

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

    After QbD

    Development is guided by risk assessment and Design of Experiments

    Today

    Submissions rely on fixed set points that limit manufacturing flexibility

    After QbD

    A justified design space gives room to operate without post-approval changes

    You master QbD

    Before

    You know QbD is expected but have no structured way to apply it

    Now you have

    A clear method that runs from QTPP through to a documented Control Strategy

    Before

    Risk discussions are informal and hard to defend in submissions

    Now you have

    Ishikawa and FMEA tools that prioritise and document risk for reviewers

    Before

    DoE feels like a statistics problem left only to specialists

    Now you have

    The confidence to plan and interpret DoE and define a design space

    Before

    Your skills are tied to one employer or one product type

    Now you have

    Transferable QbD skills valued across Greek and wider EU pharma

    "The gap between running experiments and designing quality in is a structured method, and the pharmaceutical employers that matter already expect it."

    Join professionals across Greece who trained with Invensis Learning and changed how they develop products.

    Sources: SalaryExpert, PayScale (Greece) 2026; SFEE, ReportLinker pharma outlook.

    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 Greece 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.

    • 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.

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    The Practical QbD Skills You Will BuildApplied Tools for Pharmaceutical Development

    This training builds practical Quality by Design capability, from defining product quality targets to setting a control strategy. By the end, you can apply QbD tools to real pharmaceutical development projects and to EMA and EU GMP submissions.

    Build a Quality Target Product Profile

    Skills covered in Quality by Design training start here: build a Quality Target Product Profile that translates patient and clinical needs into the quality, safety and efficacy targets a product must achieve.

    Identify Critical Quality Attributes

    Identify and classify the physical, chemical and biological attributes that are critical to product quality, and separate them from non-critical characteristics using prior knowledge and risk tools.

    Run Risk Assessments with FMEA

    Apply Ishikawa diagrams and FMEA to link material attributes and process parameters to CQAs, using severity, occurrence and detectability to prioritise what needs formal study.

    Design Experiments and a Design Space

    Plan and interpret Design of Experiments to understand how inputs affect quality, then define a design space with Normal Operating and Proven Acceptable Ranges.

    Apply Process Analytical Technology

    Use PAT tools such as NIR and Raman to monitor critical attributes in real time, supporting real-time release and tighter process control during manufacturing.

    Develop a Robust Control Strategy

    Turn risk assessment and DoE results into a Control Strategy of material, process and in-process controls, documented for CTD regulatory submission.

    Who Should TakeQuality by Design Training in Greece?

    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 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 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

    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 400

    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 GreeceExpert-Led, Flexible and Practical

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and teams across Greece who want to design quality into their products and meet EMA and EU GMP expectations. Our programmes combine experienced pharmaceutical trainers, hands-on QbD tool exercises, flexible delivery and dedicated learner support. Whether you join as an individual scientist or enrol your development team, Invensis Learning provides an expert-led, ISO 9001 certified training experience focused on real workplace application, not just theory. It is this practical, application-first approach that makes Invensis Learning a trusted Quality by Design training company in Greece.

    • Experienced trainers with real pharmaceutical development and quality expertise
    • Hands-on QbD tool exercises using realistic development scenarios
    • Flexible live virtual, classroom and onsite delivery across Greece
    • ISO 9001:2015 certified quality and ISO 27001:2022 information security
    • Practical focus on applying QbD to EMA and EU GMP submissions
    • Customised corporate training for pharmaceutical and CDMO teams
    • Dedicated learner support before, during and after the training
    • Trusted by professionals and organisations in over 100 countries

    ISO 9001

    Quality Management

    200K+

    Professionals Trained

    12M+

    Hours of Training Delivered

    4

    Flexible Learning Modes

    ISO 9001:2015 Certified

    ISO 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

    Secure SSL Encryption

    Leaders in Training industry for 12+ years

    Leaders in Training industry for 12+ years

    Over 5000 five star reviews

    Over 5000 five star reviews

    Level AA conformance, W3C WCAG 2.2

    Level AA conformance, W3C WCAG 2.2

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

    Quality by Design in Greece

    InterContinental Athenaeum Athens, Greece

    Quality by Design in Greece

    Conrad Athens The Ilisian, 46, Vasilissis Sofias, Lykavittos, Kolonaki Quarter, 1st Community of Athens, Athens, Municipality of Athens, Regional Unit of the Central Sector of Athens, Region of Attica, Decentralized Administration of Attica, 115 28, Greece

    corporate banner

    Corporate QbD TrainingFor Your Pharma Organisation

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    • Train your development, quality and regulatory teams together
    • Customised delivery onsite, live virtual or hybrid across Greece
    • Apply QbD tools to your own live product development projects
    • Build in-house capability for EMA and EU GMP submissions
    • Experienced pharmaceutical trainers with real QbD expertise
    • Flexible scheduling around your production and project calendar
    • Scalable delivery for single sites or multi-site organisations

    Trusted Across Greece's Pharma Sector

    VianexPharmathenElpenDemoGenepharmFamar

    What Our Learners Say

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    A Structured Way to Develop Products

    "The training gave me a structured way to move from trial-and-error formulation to a real QbD method. I now build a QTPP and identify CQAs at the start of every project, and the DoE sessions finally made design space click for me."

    Dimitris Papadopoulos

    Formulation Scientist

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    Directly Useful for CMC Submissions

    "As a regulatory specialist, the clearest value was seeing how QTPP, risk assessment and control strategy map into the pharmaceutical development section of a submission. The ICH Q8 to Q11 grounding was exactly what I needed for EMA dossiers."

    Eleni Georgiou

    Regulatory Affairs Specialist

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    Practical and Hands-On

    "Good balance of concepts and hands-on work. The FMEA and Ishikawa exercises were practical, and the PAT section gave me a much clearer picture of how analytical monitoring supports real-time control on the line."

    Nikos Antoniou

    Analytical Scientist

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    A Shared QbD Language for the Team

    "We trained our quality and development staff together and it created a shared language for CQAs, design space and control strategy. Deviation discussions are now far more structured, and our submission evidence is stronger."

    Maria Konstantinou

    Quality Assurance Manager

    Generic Pharmaceuticals Manufacturer

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    Tailored Corporate Training That Stuck

    "As a CDMO we needed our teams to speak QbD fluently for European clients. The corporate session was tailored to our processes and the trainer used our own scenarios, so people applied it the following week."

    Georgios Dimitriou

    Head of Development

    Contract Development and Manufacturing Organisation

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

    Quality by Design training is a practical, one-day skills course that teaches pharmaceutical professionals how to build quality into a product from the design stage rather than testing it in at the end. It covers the QbD approach grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, including QTPP, CQAs, risk assessment, DoE, design space and control strategy.

    General

    What is Quality by Design training?

    Quality by Design training is a practical, one-day skills course that teaches pharmaceutical professionals how to build quality into a product from the design stage rather than testing it in at the end. It covers the QbD approach grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, including QTPP, CQAs, risk assessment, DoE, design space and control strategy.

    Who should attend QbD training in Greece?

    The course suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals and CMC regulatory specialists in pharmaceutical, biopharmaceutical, API and CDMO organisations. It is well suited to teams across Greece's generics, biosimilar and CDMO sector who want to apply QbD in development and regulatory work.

    Is Quality by Design training worth it?

    Yes. QbD is increasingly expected by regulators such as the EMA and FDA, and by employers who need reproducible, submission-ready development. The training gives you a structured, science-based toolkit you can apply straight away, which is valued across formulation, process, analytical, quality and regulatory roles in Greece.

    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 course introduces QbD from first principles in a pharmaceutical development context. It is designed for professionals who want to understand and apply QbD, whatever their starting point.

    Which framework does the training follow?

    The training is grounded in the ICH guidelines that underpin QbD: ICH Q8(R2) for pharmaceutical development, ICH Q9 for quality risk management, ICH Q10 for the pharmaceutical quality system, and ICH Q11 for drug substances. It also references EU GMP and the FDA PAT framework where relevant.

    Pricing

    How much does QbD training cost in Greece?

    Fees are quoted in euros and vary by delivery mode, group size and whether you join a public session or a corporate booking. Pricing is available on request. Contact a learning advisor for a current quote for individual or team training.

    What is included in the course fee?

    The fee typically includes instructor-led training across all QbD modules, hands-on tool exercises, pharmaceutical case study examples, learning materials, learner support, and a course completion record from Invensis Learning. Ask about the exact inclusions for your chosen format.

    Do you offer corporate or group pricing?

    Yes. We offer customised corporate training with volume-based pricing for development, quality and regulatory teams. Group delivery can be onsite or live virtual and tailored to your products. Request a group quote for your team.

    What payment options are available?

    We accept major credit and debit cards and bank transfers, and can arrange invoicing for corporate bookings. Speak with a learning advisor to choose the option that suits you or your organisation.

    Is there a discount for booking a team together?

    Group and corporate bookings are priced on a per-team basis, which is usually more cost-effective than enrolling individuals separately. Contact us with your team size and preferred format for a tailored quote.

    Assessment

    Is there an exam for Quality by Design training?

    No. This is a non-certification skills course with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case study examples and discussion during the one-day programme, so you practise the tools as you learn them.

    Do I receive anything after completing the course?

    Yes. On finishing the programme you receive a course completion record from Invensis Learning. It confirms your attendance and the QbD skills covered, which you can apply immediately to development and quality work.

    How is my learning assessed during the training?

    There is no formal assessment. Instead, you apply QbD tools throughout the day, building a QTPP, identifying CQAs, running risk assessment and interpreting a design space using realistic development scenarios, so you leave able to use the tools in practice.

    Does this course award a formal qualification?

    No. This is a practical skills training programme rather than an accredited qualification, and there is no governing body or examination. The value is in the applied QbD capability you gain, which does not expire and needs no renewal.

    Do I need to renew anything after the training?

    No renewal is required. The QbD knowledge and tools you learn are immediately applicable and do not expire, so there is no cycle to maintain. You can revisit further training, such as DoE or statistical tools, whenever it suits your work.

    Course Content

    What topics does the QbD training cover?

    The programme covers QbD principles and the ICH regulatory context, the Quality Target Product Profile and Critical Quality Attributes, risk assessment with Ishikawa and FMEA, Design of Experiments and design space, Process Analytical Technology, and building a control strategy, plus case studies and lifecycle management.

    Does the course cover DoE and the design space?

    Yes. A dedicated module covers Design of Experiments in QbD and how DoE results define a design space, including Normal Operating Ranges and Proven Acceptable Ranges. You practise selecting a design and interpreting outputs using development scenarios.

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

    Yes. The course covers QbD principles for both small molecule drug products and biopharmaceuticals, with case study examples from tablets and injectables through to monoclonal antibodies and biosimilars, so it is relevant to Greece's growing biosimilar sector.

    What tools will I practise during the course?

    You practise the core QbD toolkit: constructing a QTPP, identifying and classifying CQAs, mapping risks with Ishikawa diagrams, ranking them with FMEA, planning and interpreting DoE, defining a design space, and building a control strategy for submission.

    How long is the QbD training?

    The programme runs for one day, totalling eight hours. It can also be delivered as two half-day sessions of four hours each. Both formats cover all QbD modules with concept explanation, case study examples and hands-on tool exercises.

    Enrollment

    How do I enrol in QbD training in Greece?

    You can enrol through the Invensis Learning website or by contacting a learning advisor. Choose your preferred format, complete the booking, and you receive access to the schedule, materials and learning resources. Talk to an advisor to see upcoming sessions.

    What delivery formats are available?

    The training is available as live virtual (online) instructor-led sessions, in-person classroom training, and customised corporate onsite delivery. Choose the format that fits your schedule and, for teams, your production calendar.

    Can the course be delivered onsite for my team?

    Yes. We deliver corporate onsite and live virtual training for pharmaceutical, biopharmaceutical and CDMO teams across Greece. Sessions can be tailored to your products and processes so participants apply QbD to real projects. Request a group quote to arrange this.

    How soon can I start?

    Public sessions run on a regular schedule, and corporate bookings are arranged around your team's availability. Contact a learning advisor to see upcoming dates and secure a place in the next suitable session.

    Can I reschedule my booking?

    Yes. Rescheduling is handled per our published policy, and we aim to be flexible where schedules change. Reach out to our support team to move your place to another session that suits you.