Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design and Why It Matters in Pharma

    A Practical, Regulator-Ready Skill Set

    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 Kazakhstan

    Who Can Enrol?

    Why QbD Skills Pay off at Work

    Practical Value from Day One

    Who Should Take Quality by Design Training in Kazakhstan?

    • 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 Kazakhstan

    Roles and Rising Demand

    Quality by Design skills are increasingly sought across Kazakhstan's pharmaceutical sector as domestic production expands and new GMP-compliant plants open in Almaty, Shymkent and Karaganda. Formulation scientists, process engineers, analytical scientists, and quality and regulatory professionals who can apply QbD are well placed as manufacturers move toward regulator-ready, ICH-aligned development. Here is what the market looks like now.

    What Is Driving Demand for QbD Skills in Kazakhstan

    Quality by Design is a practical skill that Kazakhstan's modernising pharmaceutical sector increasingly needs. Build it with instructor-led training and apply it from day one.

    Your Kazakhstan Skills Transformation

    Where Your Development Skills Stand Today

    The Upgrade QbD Delivers

    Kazakhstan's pharmaceutical sector is modernising fast, with new GMP plants and rising regulator expectations, and employers increasingly separate teams that design quality in from those that still test it in. Here is the shift QbD training helps you make.

    Sources: TV BRICS, Astana Times, EY Kazakhstan 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 Kazakhstan 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 Skills You Will Build

    Tools You Apply on Live Projects

    In Quality by Design training you learn to apply the full QbD toolkit to pharmaceutical development, from defining a Quality Target Product Profile through to a documented control strategy. Each skill is practised on realistic small molecule and biologic scenarios so you can use it at work immediately.

    Quality Target Product Profile (QTPP)

    Define what a product must achieve for quality, safety and efficacy, and use the QTPP as the design specification that drives the whole development programme.

    Critical Quality Attributes (CQAs)

    Identify and classify the physical, chemical and biological attributes critical to product quality, and link them to material attributes and process parameters.

    Risk Assessment with FMEA and Ishikawa

    Map sources of variation with fishbone diagrams and rank them with FMEA and Risk Priority Numbers, focusing development effort on the highest-impact variables.

    Design of Experiments and the Design Space

    Plan and interpret DoE studies that quantify how material attributes and process parameters affect CQAs, then define a design space with proven acceptable ranges.

    Process Analytical Technology (PAT)

    Use in-process measurement tools such as NIR and Raman spectroscopy to monitor critical attributes in real time and support real-time release testing.

    Control Strategy and Regulatory Submission

    Build a risk-proportionate control strategy from your QbD outputs and structure the evidence for ICH-aligned CTD pharmaceutical development submissions.

    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

    USD 325

    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 Kazakhstan

    Expert-Led and Flexible

    Invensis Learning delivers practical Quality by Design training for individual professionals and pharmaceutical teams that want to build quality into products from development. Our instructor-led sessions are led by experienced quality management practitioners and combine clear explanation of the ICH framework with hands-on QbD tool exercises. As an ISO 9001:2015 and ISO 27001:2022 certified global training provider with a presence in Kazakhstan and more than 100 countries, we offer flexible live online, classroom and on-site delivery designed around real-world application and measurable outcomes.

    • Experienced quality management trainers with real pharmaceutical development exposure
    • Hands-on QbD exercises using realistic small molecule and biologic scenarios
    • Flexible live online, classroom and on-site delivery across Kazakhstan
    • Content aligned to the ICH Q8, Q9, Q10 and Q11 guidelines
    • Customised corporate training for cross-functional development teams
    • ISO 9001:2015 quality management and ISO 27001:2022 information security certified
    • Dedicated learner support before, during and after training
    • Course completion certificate on finishing the programme

    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 Kazakhstan

    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 Kazakhstan

    Rixos President Astana, 7, Konaev street, Esil district, Astana, Z05P1P0, Kazakhstan

    Quality by Design Training Location in Kazakhstan

    Inter Continental Almaty Hotel, Nauryzbai Batyr str., Kerem, Spring, Bostandyk district, Almaty, 050013, Kazakhstan

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    QbD Training for Your Teams

    Build Department-Wide Capability

    • Customised QbD training for R&D, quality and regulatory teams
    • Flexible on-site, live virtual or hybrid delivery to suit your schedule
    • Role-based examples drawn from your own product development projects
    • Experienced trainers with pharmaceutical quality expertise
    • Progress tracking, assessments and learner feedback
    • Dedicated coordination and support for group programmes
    • Scalable delivery for teams in Almaty, Astana, Shymkent and beyond

    Trusted by Leading Enterprises in Kazakhstan

    SANTONobel Almaty Pharmaceutical FactoryAbdi Ibrahim Global PharmKelun-KazpharmKaraganda Pharmaceutical ComplexAltINFARM

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    Frequently Asked Questions

    Here's everything you may ask...

    Quality by Design training is a one-day, non-certification course that teaches the QbD approach to pharmaceutical development. You learn to apply tools such as the QTPP, CQAs, risk assessment, Design of Experiments, the design space and the control strategy, aligned to the ICH Q8, Q9, Q10 and Q11 guidelines.