Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design and Why It Matters for Georgian Pharma

    A Science-Based Route to Consistent Quality

    Quality by Design course badge

    What's Included in Your Quality by Design Training

    • One-day course spanning ten structured modules

    • 8 PDUs on completion of the training

    • Copy of course material and SME-prepared study guide

    • Case studies and practical applications module

    • Course completion certificate from Invensis Learning

    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the Georgia

    Who Can Enrol?

    What You Gain by Applying QbD in Product Development

    Practical Skills You Can Use on Day One

    Who Should Take Quality by Design Training in Georgia?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Where QbD Skills Take Your Career in Georgia

    Roles, 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 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 optimisation
    • 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 Curriculum

    of 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 Master

    Hands-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.

    Quality by Design Training Modes

    for Professionals and Teams

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

    Quality by Design Classroom Training

    • Instructor-led classroom sessions

    • Interactive discussions and group activities

    • Real-world examples and practical exercises

    • Structured learning with fixed schedules

    • Opportunities for peer networking and collaboration

    • Practice assessments and knowledge checks

    • Dedicated Q&A and concept clarification

    • Immediate trainer feedback and support

    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

    • Customised training aligned to organisational 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, standardise knowledge, and support workforce development through customised 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

    • Customised 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 850

    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 Georgia

    Expert-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

    99%

    Training Satisfaction

    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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    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 Georgia

    Instructor-led in-person Classroom training is available for group batches. All other public cohorts are delivered as Instructor-led Live Virtual. See available cohorts.

    Quality by Design Training Location in Georgia

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

    Quality by Design Training Location 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 Georgia

    Upskill 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 by Leading Enterprises in Georgia

    AversiGM PharmaceuticalsPSPWelt PharmaNovartisRoche

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    Frequently Asked Questions

    Here'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.