Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

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

    Quality by Design Training in Georgia is a one-day, non-certification skills programme that teaches pharmaceutical and biopharmaceutical professionals how to build quality into a product from the design stage rather than test it in at the end. You learn the Quality by Design (QbD) approach exactly as the ICH guidelines set it out, so you can develop products that meet regulatory expectations first time. The course is grounded in the current ICH framework: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. You work through the full QbD toolkit, from the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) to risk assessment, Design of Experiments (DoE), the design space and the control strategy that authorities such as the FDA and EMA increasingly expect in submissions. As Georgia adopts state-backed GMP and its manufacturers pursue EU and export markets, QbD is fast becoming a core capability for local formulation scientists, process engineers, QA teams and regulatory affairs specialists. Learn practical, workplace-ready QbD skills with Invensis Learning and apply them to real product development on day one.

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

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    Key Highlightsof the Quality by Design Training Course

    Quality by Design Training Eligibility in the GeorgiaWho Can Enroll?

    What You Gain by Applying QbD in Product DevelopmentPractical Skills You Can Use on Day One

    Where QbD Skills Take Your Career in GeorgiaRoles, Demand and Pay

    Quality by Design capability is becoming a genuine differentiator across Georgia's pharmaceutical sector, valued by domestic manufacturers, biopharmaceutical developers and regulatory teams working towards GMP and export markets. With production concentrated in companies such as Aversi and GM Pharmaceuticals and the market forecast to keep growing, professionals who can apply the ICH QbD framework are increasingly sought after. For those looking to stand out, structured Quality by Design training is one of the clearest ways to build that capability. Demand spans formulation, analytical, process development, quality assurance and regulatory affairs roles, and here is what the market is telling us right now.

    Quality Pressures Driving QbD Demand in Georgia

    Quality by Design is more than a framework. It is a practical capability that helps Georgian pharma teams design robust products and meet regulatory expectations. Build the skills employers now look for. Start your QbD journey today.

    Your Georgia QbD Skills Transformation

    From Where You Are to QbD-Ready

    The Capability Shift This Training Delivers

    Georgia's pharmaceutical sector is modernising as GMP takes hold and manufacturers reach for export markets, and employers increasingly value teams that can design quality into products from the start. Here is the shift this training helps you make.

    Sources: SalaryExpert (ERI), WorldSalaries, Glassdoor (Georgia) 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 Georgia 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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    The QbD Tools You Will MasterHands-On with ICH Q8 to Q11 Techniques

    This programme builds practical command of the full Quality by Design toolkit, from the QTPP and Critical Quality Attributes through risk assessment, Design of Experiments and the control strategy. By the end, you can apply these tools to real pharmaceutical development work.

    Apply the ICH QbD Framework

    Understand Quality by Design as ICH Q8(R2), Q9, Q10 and Q11 define it, and why it replaces the test-and-fix approach. You will be able to explain the regulatory drivers behind QbD and how it shapes modern pharmaceutical development.

    Build the QTPP and Identify CQAs

    Construct a Quality Target Product Profile from clinical and patient needs, then identify and classify Critical Quality Attributes. You will map CQAs to material attributes and process parameters using Ishikawa diagrams.

    Run Risk Assessment in QbD

    Apply FMEA and criticality assessment to rank which material and process variables most affect quality. You will use risk priority scoring to focus development effort where it matters most and reduce unnecessary experimentation.

    Design and Interpret DoE

    Plan Design of Experiments using screening and response surface approaches, then interpret the model to define a design space. You will understand Normal Operating and Proven Acceptable Ranges and the edge of failure.

    Develop PAT and Control Strategy

    Use Process Analytical Technology and real-time release thinking, then build a control strategy from your risk assessment and DoE outputs. You will link material, process and in-process controls into one coherent strategy.

    Translate QbD into Submissions

    Structure QbD evidence for regulatory submissions and manage post-approval changes across the product lifecycle. You will practise with small molecule and biologic case studies drawn from realistic development scenarios.

    Who Should TakeQuality by Design Training in Georgia?

    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

    GEL 950

    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.

    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

    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.

    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

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

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

    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

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

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

    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

    GEL 950

    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 QbD Training in GeorgiaExpert-Led and ICH-Aligned

    Invensis Learning delivers structured Quality by Design training for pharmaceutical professionals and organisations in Georgia who want to build genuine, workplace-ready QbD capability. Our programmes combine experienced trainers, ICH-aligned courseware, hands-on tool exercises and flexible delivery formats. Whether you enrol as an individual or plan group training for a development team, you get a professional learning experience designed around practical understanding, real case studies and skills you can apply immediately to pharmaceutical product and process development.

    • Experienced trainers with real pharmaceutical development and quality expertise
    • ICH-aligned courseware covering Q8 to Q11 and the full QbD toolkit
    • Flexible delivery: live online, classroom and corporate on-site formats
    • Hands-on QbD exercises using realistic development case studies
    • Practical focus on applying QTPP, CQAs, DoE and control strategy at work
    • Customised group training for pharmaceutical and biopharma teams
    • Dedicated learner support before, during and after the programme
    • ISO 9001:2015 and ISO 27001:2022 certified training quality and security

    4

    Flexible Learning Modes

    98%

    First-Attempt Pass Rate

    5000+

    Accredited Trainers Globally

    4.7/5

    Rated by Learners Worldwide

    ISO 9001:2015 Certified

    ISO 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

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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 GeorgiaAll our classroom training is now available online at your convenience

    Quality by Design in Georgia

    Sheraton Metekhi Palace, 20, St. Ketevan Dedofli Avenue, Avlabari, Zemo Avlabari, Metromshen, Isni District, Tbilisi, 0144, Georgia

    Quality by Design in Georgia

    Radisson Blu Iveria Hotel, 1, First Republic Square, Mtatsminda, Sololak, Mtatsminda District, Tbilisi, 0108, Georgia

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    Corporate QbD Team Training in GeorgiaUpskill Your Team

    • Suitable for small, medium and large pharmaceutical development teams
    • Customised schedules built around your product types and processes
    • Flexible delivery through on-site, live virtual or blended formats
    • Experienced trainers with pharmaceutical quality and QbD expertise
    • Role-based examples for formulation, process, QA and regulatory staff
    • Dedicated coordination and learner support for group programmes
    • Scalable delivery for teams across Georgia and international sites

    Trusted Across the Pharmaceutical Sector

    AversiGM PharmaceuticalsPSPWelt PharmaNovartisRoche

    What QbD Learners Across Georgia Say

    QbD Tools I Could Use Immediately

    "The training finally made the ICH QbD framework practical for me. I can now build a QTPP and run a proper risk assessment instead of relying on end-product testing. I applied the DoE approach to a formulation project the week after."

    Nino Beridze

    Formulation Scientist

    0/0

    Clear Link from QbD to Submissions

    "As a regulatory affairs specialist, the sessions on design space and control strategy were exactly what I needed. I understand much better how QbD evidence fits into a submission, which matters as we push towards European markets."

    Giorgi Kapanadze

    Regulatory Affairs Specialist

    0/0

    Practical and Well Paced

    "Very well structured and hands-on. The FMEA and criticality exercises helped me focus experiments on the variables that actually drive quality. The trainer used realistic pharma examples throughout, not just theory."

    Tamar Lomidze

    Quality Assurance Officer

    0/0

    Aligned Our Whole Team on QbD

    "We booked group training for our development and quality teams as we prepare for GMP. It gave everyone a shared QbD language, from QTPP to control strategy, and the delivery was flexible around our shift patterns."

    Levan Tsereteli

    Head of Quality, Pharmaceutical Manufacturer

    0/0

    A Capable, Science-Based Upskill

    "As an L&D lead, I needed training that would move our process engineers beyond trial and error. This programme did that, with strong ICH grounding and practical DoE work. Coordination with Invensis Learning was smooth from start to finish."

    Mariam Gelashvili

    Learning and Development Lead, Biopharma

    0/0



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    99%

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

    Quality by Design training is a one-day skills programme that teaches the QbD approach to pharmaceutical product and process development, based on the ICH Q8, Q9, Q10 and Q11 guidelines. It suits formulation scientists, process engineers, analytical scientists, QA professionals and regulatory affairs specialists in Georgia.

    General

    What is Quality by Design training and who is it for?

    Quality by Design training is a one-day skills programme that teaches the QbD approach to pharmaceutical product and process development, based on the ICH Q8, Q9, Q10 and Q11 guidelines. It suits formulation scientists, process engineers, analytical scientists, QA professionals and regulatory affairs specialists in Georgia.

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

    Yes. As Georgian manufacturers adopt GMP and target export and EU markets, professionals who can apply the QbD framework are increasingly in demand. QA and regulatory roles in Tbilisi average around GEL 100,000 or more per year, and QbD skills help you stand out for higher-value development and quality work.

    What standard is Quality by Design based on?

    QbD is defined by the ICH guidelines, principally ICH Q8(R2) Pharmaceutical Development, supported by ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. It is increasingly expected by regulators such as the FDA and EMA in development submissions.

    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 context. It is suitable for both newcomers to QbD and experienced professionals.

    Is QbD relevant for both small molecule and biologic products?

    Yes. The training covers QbD principles for small molecule drug products such as tablets and injectables, and for biopharmaceuticals such as monoclonal antibodies and biosimilars. Case study examples from both product types are included so you can apply the tools to your own work.

    Pricing

    How much does Quality by Design training cost in Georgia?

    Pricing depends on the delivery format, whether you join a public session or book group training, and the size of your team. Fees are available on request. Contact a learning advisor for a tailored quote for individual or corporate training in Georgia.

    What is included in the course fee?

    The fee typically includes instructor-led training across all six QbD modules, ICH-aligned courseware, hands-on tool exercises, case study materials, learner support and 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 corporate group training with customised schedules and volume-based pricing for pharmaceutical and biopharma teams. This is ideal for organisations preparing for GMP or export markets. Contact us for a group quote.

    In what currency is training billed in Georgia?

    Training for learners in Georgia can be quoted in Georgian lari (GEL) or another agreed currency depending on your enrolment and delivery format. Speak with a learning advisor to confirm pricing and payment options for your situation.

    Are there payment or instalment options?

    We accept common payment methods and can discuss options for individual and corporate enrolments. Talk to a learning advisor about the arrangement that best suits you or your team.

    Assessment

    Is there an exam for the Quality by Design training?

    No. This is a non-certification course with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and group discussion during the programme, so you build practical skills rather than sit a test.

    Do I receive a certificate after completing the training?

    You receive a course completion record from Invensis Learning. No formal credential is awarded by an external body, as QbD is a skills discipline rather than a certification. The value lies in the practical capability you gain and can apply immediately.

    How am I assessed during the course?

    There is no formal assessment. Instead, you apply the QbD tools through practical exercises, such as constructing a QTPP, identifying CQAs, running an FMEA and interpreting a design space, using realistic development scenarios throughout the programme.

    What will I be able to do after the training?

    You will be able to construct a QTPP, identify and classify CQAs, run risk assessments with Ishikawa diagrams and FMEA, plan and interpret DoE for a design space, and develop a control strategy structured for regulatory submissions.

    How long is the Quality by Design training?

    The programme runs for one day, around eight hours, covering all six QbD modules from principles and the ICH framework through QTPP, CQAs, risk assessment, DoE, PAT and the control strategy, with hands-on exercises throughout.

    Course Content

    What topics does the Quality by Design course cover?

    The course covers QbD principles and the ICH Q8 to Q11 framework, the QTPP and Critical Quality Attributes, risk assessment with FMEA, Design of Experiments and design space, Process Analytical Technology and the control strategy, plus case studies and lifecycle management.

    Does the course include hands-on practice?

    Yes. Practical exercises run throughout, including constructing a QTPP, identifying CQAs, building Ishikawa diagrams, selecting a DoE design and interpreting a design space, all applied to realistic pharmaceutical development scenarios.

    Is the courseware aligned with the current ICH guidelines?

    Yes. The courseware is aligned to the current ICH framework, principally ICH Q8(R2) Pharmaceutical Development, along with ICH Q9, Q10 and Q11. This ensures the tools you learn match what regulators expect in modern development submissions.

    What materials are provided with the training?

    You receive ICH-aligned courseware, worked case study examples for small molecule and biologic products, QbD tool templates and exercise materials, and a course completion record on finishing the programme.

    Can beginners follow the Quality by Design course?

    Yes. The course introduces QbD from first principles, so a beginner in a science or engineering role can follow it, while experienced professionals gain a structured way to formalise and extend their practice.

    Enrollment

    How do I enrol in Quality by Design training in Georgia?

    You can enrol through the Invensis Learning website or by speaking with a learning advisor. Choose your preferred format, complete your booking, and you will receive access to the schedule and learning materials. See upcoming batches to get started.

    What training formats are available?

    We offer live online (live virtual) instructor-led training, classroom sessions and customised corporate on-site delivery, so you can choose the format that best fits your schedule and team. Talk to an advisor about the options in Georgia.

    How soon can I start?

    Public sessions run on a regular schedule, and corporate group training can be arranged around your team's availability. Contact a learning advisor to see upcoming dates and reserve your place.

    Can this be delivered on-site for our organisation?

    Yes. We deliver on-site and live virtual group training for pharmaceutical organisations that want to train a cross-functional team together. This works well when teams can apply the QbD tools to their own live development projects. Ask about corporate training.

    Can I reschedule my enrolment?

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