Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters in PharmaUntitledA Skill Built for Modern Drug Development

    The Quality by Design Training in Bulgaria is a practical, one-day programme that teaches the Quality by Design (QbD) approach to pharmaceutical product and process development, where quality is built into the product from the design stage rather than tested in at the end. You learn to work the way modern regulators now expect, using science and structured tools instead of trial and error. The course is grounded in the ICH guidelines that define QbD: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. It follows the QbD workflow end to end, from the Quality Target Product Profile (QTPP) and critical quality attributes through risk assessment, Design of Experiments, the design space, Process Analytical Technology and the control strategy that the FDA and EMA look for in CTD submissions. It suits formulation, process development, analytical, quality assurance and regulatory affairs professionals across Bulgaria's pharmaceutical base, from generics leaders such as Sopharma and the Balkanpharma (Teva and Actavis) plants to biopharma and CDMO teams. No prior QbD knowledge is assumed. Build the skills your development projects need and start applying them with Invensis Learning.

    What Is Quality by Design and Why It Matters in PharmaA Skill Built for Modern Drug Development

    The Quality by Design Training in Bulgaria is a practical, one-day programme that teaches the Quality by Design (QbD) approach to pharmaceutical product and process development, where quality is built into the product from the design stage rather than tested in at the end. You learn to work the way modern regulators now expect, using science and structured tools instead of trial and error.

    The course is grounded in the ICH guidelines that define QbD: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. It follows the QbD workflow end to end, from the Quality Target Product Profile (QTPP) and critical quality attributes through risk assessment, Design of Experiments, the design space, Process Analytical Technology and the control strategy that the FDA and EMA look for in CTD submissions.

    It suits formulation, process development, analytical, quality assurance and regulatory affairs professionals across Bulgaria's pharmaceutical base, from generics leaders such as Sopharma and the Balkanpharma (Teva and Actavis) plants to biopharma and CDMO teams. No prior QbD knowledge is assumed. Build the skills your development projects need and start applying them with Invensis Learning.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Bulgaria 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 Bulgaria 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 Bulgaria

    • Instructor-led training formats available for individual learners and corporate teams across the Bulgaria
    • 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 Bulgaria
    • 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 Bulgaria 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 BulgariaWho 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 You Gain from QbD TrainingSkills You Can Apply on Monday Morning

    For Individuals

    For Individuals

    Quality by Design training gives you a systematic, science-based way to develop pharmaceutical products that meet their quality targets first time. You move from empirical, test-and-fix development to designing quality in, which reduces deviations, rework and out-of-specification results. Whether you work in formulation, process development, analytical science, quality assurance or CMC regulatory affairs, the QbD toolkit is directly transferable to your daily projects and to the submissions your organisation files with the EMA and other authorities.

    If you want to strengthen your standing in Bulgaria's growing pharmaceutical sector, QbD fluency is a practical, in-demand capability. You leave able to run a QbD programme end to end, from QTPP to control strategy, and to contribute with confidence to regulatory submissions.

    • Design quality into products from the outset and cut costly rework and deviations
    • Master the full QbD toolkit: QTPP, CQAs, risk assessment, DoE, design space and control strategy
    • Apply the ICH Q8, Q9, Q10 and Q11 framework that the FDA and EMA now expect
    • Contribute confidently to CTD Section 3.2.P.2 pharmaceutical development submissions
    • Replace trial-and-error development with structured, defensible process understanding
    • Strengthen your value across formulation, process, analytical, QA and regulatory roles
    • Gain skills that transfer directly to work in Bulgaria's generics and biopharma sector
    For Organizations

    For Organizations

    Quality by Design group training helps pharmaceutical organisations build a shared, science-based approach to product and process development across their formulation, process, analytical, quality and regulatory teams. QbD reduces manufacturing deviations, strengthens regulatory submissions and supports a more flexible relationship with authorities through a well-justified design space. Delivered onsite or live virtual for your team, the programme can use your own development scenarios so learning transfers straight to live projects.

    For Bulgarian manufacturers competing on quality and export readiness, a QbD-fluent team means fewer batch failures, smoother EMA submissions and stronger process understanding. Invensis Learning tailors delivery to your products and your quality system.

    • Builds a common QbD language across development, quality and regulatory teams
    • Reduces deviations, batch failures and out-of-specification results
    • Strengthens CTD submissions to the EMA and other regulatory authorities
    • Applies QbD directly to your own products and development projects
    • Supports design space flexibility and a lower post-approval change burden
    • Improves process understanding, scale-up and technology transfer
    • Scalable onsite or live virtual delivery for cross-functional teams

    Where QbD Skills Take Your Career in BulgariaIn-Demand Pharma Roles

    Quality by Design skills open doors across Bulgaria's fast-growing pharmaceutical sector, one of the fastest-expanding parts of the economy and home to generics leaders and multinational affiliates. QbD-fluent professionals are valued in formulation, process development, analytical science, quality assurance and CMC regulatory affairs, where employers increasingly expect ICH-aligned, science-based development. Demand runs from QC and formulation scientists up to QA and manufacturing managers, and here is what the market shows.

    2.2%

    Pharma share of Bulgaria's GDP

    trade.gov / IQVIA

    4.39%

    Bulgarian pharma market growth

    CAGR 2025-2029, Statista

    10bn+

    Tablets produced in Bulgaria yearly

    IQVIA

    ~EUR 40k

    Pharma research scientist pay

    average per year, worldsalaries 2026

    SECTORS HIRING

    • —Generic Medicines Manufacturing
    • —Biopharmaceuticals and Biosimilars
    • —Active Pharmaceutical Ingredient (API) Production
    • —Contract Development and Manufacturing (CDMO)
    • —Regulatory Affairs and CMC Consulting
    • —Medical Devices and Food Supplements

    GROWTH TRENDS

    • —Pharma among Bulgaria's fastest-growing sectors
    • —Ageing population driving around 10% yearly drug-sales growth
    • —Generics account for two-thirds of the local market
    • —EMA and FDA raising QbD expectations for submissions
    • —Export-focused plants investing in GMP modernisation
    • —Scarcity of professionals fluent in QbD tools

    Sources: trade.gov, Statista, IQVIA, InvestBulgaria (Bulgaria pharmaceutical market) 2025-2026; worldsalaries, PayScale, SalaryExpert, Zaplatomer (Bulgaria) 2026.

    Why QbD Skills Are in Demand in Bulgaria

    A Generics-Heavy Production Base

    Sopharma and the Teva and Actavis (Balkanpharma) plants produce most of Bulgaria's medicines. QbD cuts the deviations and batch failures that erode margins in high-volume generics manufacturing.

    QbD reduces deviations and batch failures

    Rising EMA and FDA Expectations

    Regulators now expect QbD evidence in CTD Section 3.2.P.2. Teams that can build a QTPP, define a design space and justify a control strategy file stronger, faster submissions.

    QbD builds submission-ready evidence

    Ageing Population, Growing Volumes

    Drug sales are rising around 10% a year as the population ages. Meeting that demand without quality slips needs real process understanding, not end-product testing alone.

    QbD builds process understanding at scale

    Cost and Price Pressure

    With euro adoption and tight generic pricing, right-first-time manufacturing matters. QbD reduces rework, waste and out-of-specification results across the process.

    QbD builds right-first-time skills

    Export and GMP Modernisation

    Bulgarian plants export across the EU and are upgrading GMP capability. A well-justified design space supports flexibility and smoother post-approval changes.

    QbD supports design space flexibility

    A Shortage of QbD Talent

    Bulgaria has deep manufacturing experience but few professionals fluent in QTPP, DoE and control strategy. That scarcity makes QbD skills stand out to employers.

    QbD skills make you stand out

    Sources: trade.gov, IQVIA, Statista, InvestBulgaria (Bulgaria pharmaceutical market) 2025-2026.

    QbD is a practical skill that pays off on every development project. Join pharmaceutical professionals across Bulgaria building quality in from the design stage. Start your QbD journey today.

    Your Bulgaria Career Transformation

    Your Career Before and After QbD

    A Practical, Science-Based Shift

    Bulgaria's pharmaceutical sector is growing and modernising, and employers increasingly separate teams that can design quality in from those that still test it in. Here is what QbD skills change for you.

    Today

    Development leans on empirical trial and error and end-product testing

    After QbD

    You build quality in from the QTPP stage using structured, science-based tools

    Today

    Submissions to the EMA take longer and draw more regulator questions

    After QbD

    You produce clear QbD evidence for CTD Section 3.2.P.2 that reviewers expect

    Today

    Career options limited by a manufacturing-experience-only profile

    After QbD

    You qualify for QbD-focused roles across Bulgaria's generics and biopharma employers

    You Master QbD

    Before

    QbD felt like a regulatory buzzword with no practical toolkit

    Now you have

    A working command of QTPP, CQAs, risk assessment, DoE and control strategy

    Before

    Risk assessments were informal and hard to defend

    Now you have

    Structured Ishikawa and FMEA methods that prioritise the right variables

    Before

    Design decisions relied on one-factor-at-a-time experiments

    Now you have

    DoE and design-space thinking that reveals interactions and safe operating ranges

    Before

    Quality understanding stayed locked in a few experts' heads

    Now you have

    A shared method your whole development team can apply and reuse

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

    Join 50,000+ professionals who trained with Invensis Learning and built new capability.

    Sources: worldsalaries, PayScale, SalaryExpert, Zaplatomer (Bulgaria) 2026; ICH Q8 to Q11.

    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 Bulgaria 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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    Practical QbD Tools You Will MasterApplied Across Every Project

    In this Quality by Design course you learn to run a QbD programme end to end, from defining what a product must achieve to controlling how it is made. Each tool is taught with pharmaceutical examples and hands-on exercises you can take back to work.

    Build a Quality Target Product Profile

    Translate patient and clinical needs into a QTPP that defines the dosage form, performance and quality standards your whole QbD programme is designed to achieve.

    Identify Critical Quality Attributes

    Determine which physical, chemical and biological attributes are critical to safety and efficacy, and link each CQA to the material attributes and process parameters that affect it.

    Run Risk Assessments with Ishikawa and FMEA

    Use fishbone diagrams and Failure Mode and Effects Analysis to rank risks by severity, occurrence and detectability, and focus experiments on the highest-impact variables.

    Design and Interpret DoE Studies

    Plan screening and response-surface experiments, read the models, and define a design space with normal operating and proven acceptable ranges instead of one-factor-at-a-time testing.

    Apply Process Analytical Technology

    Use PAT tools such as NIR and Raman to monitor critical attributes in real time, and understand how real-time release testing supports consistent quality.

    Develop a Control Strategy for Submission

    Turn your risk assessment and DoE results into a control strategy, and structure the QbD evidence for CTD Section 3.2.P.2 pharmaceutical development submissions.

    Who Should TakeQuality by Design Training in Bulgaria?

    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

    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.

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    Why Choose Invensis Learning for Quality by Design Training in BulgariaA Trusted Global Training Partner

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and organisations that want to design quality into their products from the start. Our sessions combine experienced, industry-aligned trainers, ICH-grounded courseware and hands-on exercises that map directly to real development work. Whether you enrol as an individual or arrange group training for a cross-functional team in Bulgaria, you get a professional, supportive learning experience focused on skills you can apply immediately. As a trusted Quality by Design training company in Bulgaria and an ISO 9001:2015 and ISO 27001:2022 certified provider, we deliver training you can trust.

    • Experienced trainers with real pharmaceutical quality and QbD project expertise
    • Practical, exercise-led sessions using real development scenarios
    • Content grounded in the ICH Q8, Q9, Q10 and Q11 QbD framework
    • Flexible formats: live virtual (online), classroom and onsite corporate delivery
    • Course completion certificate from Invensis Learning
    • Dedicated learner support before, during and after training
    • Customised group training for pharmaceutical teams across Bulgaria
    • ISO 9001:2015 and ISO 27001:2022 certified training operations

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    Global Course Portfolio

    100+

    Countries Served

    ISO 9001

    Quality Management

    200K+

    Professionals Trained

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    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 BulgariaAll our classroom training is now available online at your convenience

    Quality by Design in Bulgaria

    Grand Hotel Sofia, 1, Gen. Yosif V. Gurko, Center, Sofia, Sredets, Stolichna, Sofia-city, 1000, Bulgaria

    Quality by Design in Bulgaria

    Sofia Balkan Palace, 5, Sveta Nedelya Square, Center, Sofia, Sredets, Stolichna, Sofia-grad, 1000, Bulgaria

    corporate banner

    Corporate QbD TrainingBuilt Around Your Products and Teams

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    • Tailored QbD training built around your own products and processes
    • Flexible delivery: onsite, live virtual, hybrid or blended for teams
    • Schedules aligned to your production and project timelines
    • Trainers with pharmaceutical quality and regulatory experience
    • Applies QbD to live development projects for fast transfer to work
    • Dedicated coordination and support for group programmes
    • Scalable across sites and cross-functional teams in Bulgaria

    Trusted by Life Sciences Teams

    SopharmaTevaBalkanpharmaAdipharmVassil PharmaChaikapharma

    What Our Learners Say

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    QbD I Could Use the Next Week

    "The QTPP and DoE sessions completely changed how I plan formulation studies. I stopped running one-factor-at-a-time experiments and started defining a proper design space. Everything was practical and grounded in real pharmaceutical examples."

    Georgi Petrov

    Formulation Scientist

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    0/0

    Risk Assessment Finally Made Sense

    "The Ishikawa and FMEA exercises gave me a structured way to prioritise which parameters actually matter for our critical quality attributes. I now lead risk assessments for our analytical methods with far more confidence."

    Elena Dimitrova

    Analytical Scientist

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    Stronger Submissions

    "As a CMC regulatory specialist, understanding how QbD outputs feed CTD Section 3.2.P.2 was invaluable. The control strategy module helped me review development reports far more effectively before they go to the EMA."

    Nikolay Ivanov

    Regulatory Affairs Specialist, CMC

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    Great Fit for Our Development Team

    "We trained a cross-functional group and it created a shared QbD language across formulation, process and quality. We have seen fewer deviations and smoother technology transfer since. The trainer tailored the examples to our generics products."

    Maria Georgieva

    Head of Quality Assurance, Generics Manufacturer

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    Practical and Well Organised

    "Invensis delivered onsite QbD training for our biopharma site and used our own process scenarios. Our scientists and engineers came away able to apply design-space thinking immediately. Coordination and support were excellent throughout."

    Stefan Kolev

    Learning and Development Manager, Biopharmaceuticals

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

    Quality by Design training is a one-day, non-certification course that teaches a systematic, science-based approach to pharmaceutical development, where quality is built into the product from the design stage. It covers the ICH Q8, Q9, Q10 and Q11 framework and tools such as QTPP, CQAs, risk assessment, DoE and control strategy.

    General

    What is Quality by Design (QbD) training?

    Quality by Design training is a one-day, non-certification course that teaches a systematic, science-based approach to pharmaceutical development, where quality is built into the product from the design stage. It covers the ICH Q8, Q9, Q10 and Q11 framework and tools such as QTPP, CQAs, risk assessment, DoE and control strategy.

    Who should attend the QbD course in Bulgaria?

    The course suits formulation, process development, analytical, quality assurance and CMC regulatory affairs professionals in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations. It is aimed at anyone who needs to understand and apply QbD in product development or regulatory submissions.

    Is Quality by Design worth learning?

    Yes. QbD is increasingly expected by regulators such as the FDA and EMA and by employers across Bulgaria's growing pharmaceutical sector. The skills reduce deviations and strengthen submissions, and they transfer directly to formulation, process, quality and regulatory work.

    What is QbD based on?

    QbD is defined by the ICH guidelines: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. The training follows this framework and the FDA and EMA expectations built on it.

    Do I need prior QbD experience?

    No. There are no prerequisites. Familiarity with pharmaceutical development or GMP is helpful but not required, as the course introduces QbD from first principles using pharmaceutical examples.

    How long is the training?

    The programme runs for one day (eight hours) and can also be delivered as two half-days. It covers the full QbD workflow with concept explanation, ICH context and hands-on tool exercises throughout.

    Pricing

    How much does the QbD course cost in Bulgaria?

    Fees depend on the delivery format (live virtual, classroom or corporate onsite) and group size, and are quoted in euro following Bulgaria's 2026 euro adoption. Contact us for current pricing, or request a quote from a learning advisor for an exact figure.

    What is included in the course fee?

    The fee typically includes instructor-led training across all six QbD modules, courseware and reference materials, hands-on tool exercises, learner support and a course completion certificate from Invensis Learning. Ask us what is included in your chosen format.

    Do you offer group or corporate pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for pharmaceutical teams. It is ideal for training formulation, process, quality and regulatory colleagues together. Contact us for a tailored group quote.

    Is there an exam or membership fee?

    No. QbD is a non-certification course with no exam and no external body, so there is no exam or membership fee. You pay only the training fee for your chosen delivery format.

    What payment options are available?

    We accept major credit and debit cards and bank transfers, and offer flexible options for corporate bookings. Speak with a learning advisor to arrange payment for your enrolment.

    Assessment

    Is there an exam for the QbD course?

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

    Do I receive a certificate?

    Yes. You receive a course completion certificate from Invensis Learning after completing the one-day programme. It recognises your participation rather than a formal external credential, as QbD has no certifying body.

    Is QbD a certification?

    No. QbD is a skills-based training course, not a certification, and there is no awarding body or credential. It builds practical methodology and tool skills you can apply immediately to pharmaceutical development.

    How is my learning assessed?

    There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, risk assessment and design-space interpretation to realistic scenarios during the session, so you practise the methods as you learn.

    What will I be able to do after the course?

    After the course you can construct a QTPP, identify and classify CQAs, run Ishikawa and FMEA risk assessments, plan and interpret DoE studies, define a design space and develop a control strategy for CTD submissions.

    Course Content

    What topics does the QbD training cover?

    The training covers six areas: QbD principles and the ICH regulatory framework; QTPP and critical quality attributes; risk assessment; Design of Experiments and the design space; Process Analytical Technology and control strategy; and QbD in practice with case studies and submissions.

    Does it cover both small molecules and biologics?

    Yes. The course uses examples from both small-molecule drug products, such as tablets and injectables, and biopharmaceuticals, such as monoclonal antibodies and biosimilars, so the tools apply across product types.

    Are DoE and risk assessment taught hands-on?

    Yes. You work through practical exercises in QTPP construction, CQA identification, Ishikawa and FMEA risk assessment, DoE design selection and design-space interpretation using realistic pharmaceutical development scenarios.

    What materials are provided?

    You receive structured courseware and reference materials aligned to the ICH Q8 to Q11 QbD framework, worked pharmaceutical case examples and tool templates to support your work after the training.

    Does the course cover regulatory submissions?

    Yes. It explains how QbD outputs form CTD Section 3.2.P.2 pharmaceutical development, how the design space and control strategy are justified, and what FDA and EMA reviewers expect from a QbD submission.

    Enrollment

    How do I enrol in the QbD course?

    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 format.

    What training formats are available?

    The course is available online (live virtual instructor-led), in classroom sessions and as customised corporate onsite training for teams. You can pick the format that best fits your schedule and location in Bulgaria.

    When are the next sessions?

    New public sessions and corporate dates are scheduled regularly. Check the upcoming batches on our website, or ask a learning advisor about the next available dates for your preferred format.

    Can you deliver the training onsite in Bulgaria?

    Yes. We deliver corporate onsite and live virtual QbD training for pharmaceutical teams across Bulgaria, tailored to your products and quality system. Contact us to arrange an onsite programme for your team.

    What is the reschedule or cancellation policy?

    Rescheduling and cancellations are handled per our published policy, and corporate bookings can be adjusted with notice. Reach out to our team for the details that apply to your enrolment.