Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters in PharmaUntitledA Practical, Regulator-Ready Skill Set

    Quality by Design Training in Kazakhstan equips pharmaceutical and biopharmaceutical professionals to build quality into products from the development stage rather than inspecting it in at the end. Quality by Design (QbD) is a systematic, science-based approach mandated by the ICH Q8, Q9, Q10 and Q11 guidelines and increasingly expected by regulators such as the FDA and EMA. Over one intensive day you learn to apply the core QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. Hands-on exercises use realistic scenarios drawn from both small molecule and biologic products. As Kazakhstan raises domestic medicine production and new GMP-compliant plants come online in Almaty, Shymkent and Karaganda, employers increasingly value staff who can develop products the modern, regulator-ready way. The training gives formulation, process, analytical, quality and regulatory professionals a practical skill set they can use straight away.

    What Is Quality by Design and Why It Matters in PharmaA Practical, Regulator-Ready Skill Set

    Quality by Design Training in Kazakhstan equips pharmaceutical and biopharmaceutical professionals to build quality into products from the development stage rather than inspecting it in at the end. Quality by Design (QbD) is a systematic, science-based approach mandated by the ICH Q8, Q9, Q10 and Q11 guidelines and increasingly expected by regulators such as the FDA and EMA.

    Over one intensive day you learn to apply the core QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. Hands-on exercises use realistic scenarios drawn from both small molecule and biologic products.

    As Kazakhstan raises domestic medicine production and new GMP-compliant plants come online in Almaty, Shymkent and Karaganda, employers increasingly value staff who can develop products the modern, regulator-ready way. The training gives formulation, process, analytical, quality and regulatory professionals a practical skill set they can use straight away.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Kazakhstan 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 Kazakhstan 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 Kazakhstan

    • Instructor-led training formats available for individual learners and corporate teams across the Kazakhstan
    • 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 Kazakhstan
    • 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 Kazakhstan 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 KazakhstanWho Can Enroll?

    • No formal prerequisites are required to enroll in the Quality by Design training program

    • Basic familiarity with quality assurance concepts is helpful but not mandatory for enrollment

    • Professionals from pharmaceutical, biotechnology, healthcare, and manufacturing industries are well-suited for this training

    • Individuals and corporate teams seeking to build QbD knowledge and apply regulatory-aligned product development principles are eligible to enroll

    • Learners with backgrounds in quality, regulatory affairs, process engineering, and production management will find the content directly applicable to their roles

    Why QbD Skills Pay off at WorkPractical Value from Day One

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical professionals turn product development into a controlled, predictable process. You learn to define what a product must achieve, identify what is critical to its quality, and design experiments that prove how to make it consistently. Whether you work in formulation, analytical development, process engineering, quality assurance or regulatory affairs, the tools transfer directly to your daily work and to the submissions your organisation files.

    If you want a practical, regulator-ready skill that raises your standing on any pharmaceutical development team, this training is a clear step forward. You leave able to lead CQA workshops, facilitate risk assessments and interpret a design space with confidence.

    • Apply QbD tools like the QTPP and CQAs to real development projects
    • Replace trial-and-error development with a structured, science-based method
    • Build risk assessment skills using Ishikawa diagrams and FMEA
    • Plan and interpret Design of Experiments to define a robust design space
    • Develop control strategies that stand up to regulatory review
    • Speak the ICH Q8 to Q11 language that global employers expect
    • Strengthen your value across formulation, quality and regulatory roles
    • Gain skills that are immediately useful, with no exam to prepare for
    For Organizations

    For Organizations

    Quality by Design group training equips whole development teams to build quality into products from the outset. Delivered for R&D, quality and regulatory functions together, it creates a common approach to the QTPP, CQA identification, risk assessment and control strategy. For Kazakhstan's growing pharmaceutical manufacturers, a team that shares QbD discipline files stronger submissions and runs more predictable processes.

    If your organisation is scaling production or moving toward international GMP standards, QbD training gives your people a structured, science-based development method. Teams leave able to apply the same tools to live product projects.

    • Builds a shared QbD language across formulation, quality and regulatory teams
    • Reduces manufacturing deviations through deeper process understanding
    • Supports GMP-compliant, regulator-ready development and submissions
    • Cuts costly late-stage failures by designing quality in early
    • Aligns product development to ICH Q8, Q9, Q10 and Q11 expectations
    • Enables customised, on-site delivery for cross-functional teams
    • Strengthens in-house capability as new GMP plants scale up
    • Improves consistency and value realisation across the product lifecycle

    Where QbD Skills Take Your Career in KazakhstanRoles 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.

    39.8%

    Domestic medicine production share

    of the market, 2026

    173bn tenge

    State-backed investment in new pharma plants

    four GMP plants, 2026

    385,851 tenge

    Average pharmaceutical industry salary

    per month, Paylab

    12.6M tenge

    Chemical and process engineer salary

    average per year, SalaryExpert

    SECTORS HIRING

    • —Domestic Pharmaceutical Manufacturing
    • —Biopharmaceutical and Vaccine Production
    • —Generic and Active Ingredient Manufacturing
    • —Regulatory Affairs and CMC Submissions
    • —Contract Development and Manufacturing (CDMOs)
    • —Quality Assurance and GMP Compliance

    GROWTH TRENDS

    • —Domestic medicine production raised to 39.8% of the market
    • —173 billion tenge approved for four new GMP-compliant plants
    • —China and Turkey launching major pharma hubs in Kazakhstan
    • —New Nobel, Abdi Ibrahim and AltINFARM complexes scaling up
    • —Rising regulator expectations for ICH-aligned development
    • —Shift from imports toward regulator-ready local production

    Sources: TV BRICS, Astana Times, EY Kazakhstan, Paylab and SalaryExpert (Kazakhstan) 2025-2026.

    What Is Driving Demand for QbD Skills in Kazakhstan

    Rapid Localisation of Production

    Domestic medicine output has risen to 39.8% of the market, and new plants must develop products to modern, regulator-ready standards, which is exactly what QbD delivers.

    QbD builds regulator-ready development skills

    New GMP Plants Scaling Up

    With 173 billion tenge approved for four new GMP-compliant plants, manufacturers need staff who can design quality into products and processes from the outset.

    QbD builds design and process understanding

    Rising Regulator Expectations

    Regulators increasingly expect ICH-aligned development evidence, so teams that can build a QTPP, define a design space and document a control strategy are in demand.

    QbD builds submission-ready documentation skills

    Shortage of QbD-Skilled Staff

    Kazakhstan has a growing pharma workforce but few people trained in structured, science-based development, making QbD tool skills a clear differentiator.

    QbD skills make professionals stand out

    Foreign Investment and Tech Transfer

    China and Turkey are launching major pharma hubs locally, and technology transfer runs more smoothly when both sides share the QbD language of QTPP, CQAs and DoE.

    QbD smooths technology transfer

    Pressure to Reduce Failures and Waste

    Late-stage failures and manufacturing deviations are costly, and designing quality in early through risk assessment and DoE reduces both across the product lifecycle.

    QbD builds risk assessment and DoE skills

    Sources: TV BRICS, Astana Times, EY Kazakhstan, Kursiv (Kazakhstan) 2026.

    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.

    Today

    Seen mainly as a hands-on contributor on development projects

    After QbD

    Able to lead CQA workshops and facilitate QbD risk assessments

    Today

    Limited visibility of how ICH guidelines shape submissions

    After QbD

    Fluent in the ICH Q8 to Q11 language employers and regulators expect

    Today

    Pay tracks the pharma industry average of around 385,851 tenge a month

    After QbD

    Positioned for specialist and management roles that pay well above the average

    You master QbD

    Before

    Product development runs on trial and error and end-product testing

    Now you have

    A structured, science-based method that designs quality in from the start

    Before

    Quality problems surface late, often at scale-up or in manufacturing

    Now you have

    Risk assessment and DoE that predict and control quality early

    Before

    Development decisions are hard to justify to regulators

    Now you have

    A design space and control strategy that stand up to ICH-aligned review

    Before

    Your skills are tied to one product or one process

    Now you have

    A transferable QbD toolkit valued across pharma and biopharma employers

    "As Kazakhstan builds regulator-ready plants, the difference between testing quality in and designing it in is exactly what employers are hiring for."

    Join 50,000+ professionals who trained with Invensis Learning and built future-ready skills.

    Sources: TV BRICS, Astana Times, EY Kazakhstan 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 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.

    • 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.

    image

    100% Secure and Safe download

    The QbD Skills You Will BuildTools 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.

    Who Should TakeQuality by Design Training in Kazakhstan?

    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

    USD 345

    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

    Untitled

    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

    USD 345

    Please Note:Attend fully interactive weekday Quality by Design training sessions from anywhere while benefiting from real-time instructor guidance and collaborative learning experiences.

    Best For: Professionals seeking the flexibility of online learning without compromising on live instructor interaction.

    Loading schedules…

    Why Choose Invensis Learning for QbD Training in KazakhstanExpert-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 KazakhstanAll our classroom training is now available online at your convenience

    Quality by Design in Kazakhstan

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

    Quality by Design in Kazakhstan

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

    corporate banner

    QbD Training for Your TeamsBuild Department-Wide Capability

    Untitled

    • 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 Pharmaceutical Teams

    SANTONobel Almaty Pharmaceutical FactoryAbdi Ibrahim Global PharmKelun-KazpharmKaraganda Pharmaceutical ComplexAltINFARM

    What Our Learners Say

    Untitled

    QbD Tools I Use Every Week

    "The training finally made the QTPP and CQA process click for me. I now start every formulation project by defining what the product must achieve, and the risk assessment exercises translated straight into my daily work."

    Aigerim S.

    Formulation Scientist

    Untitled

    0/0

    DoE and Design Space Made Clear

    "The Design of Experiments and design space sessions were the highlight. I came away able to plan a screening study, read the response surface and set proven acceptable ranges with far more confidence than before."

    Daniyar T.

    Process Development Engineer

    Untitled

    0/0

    Structured and Practical

    "A practical, well-paced day. The FMEA and Ishikawa exercises and the PAT examples gave me a structured way to link our analytical work to the wider control strategy. The instructor clearly knew the pharma context."

    Assel K.

    Analytical Scientist

    Untitled

    0/0

    A Shared Approach Across the Team

    "We ran the training on-site for our development and quality teams. Everyone now shares the same QbD language, and our risk assessments and control strategies are noticeably more consistent across projects."

    Nurlan B.

    Head of Quality Assurance, Pharmaceutical Manufacturer

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    Directly Useful for Our Submissions

    "Booking this for our regulatory and CMC group was a strong decision. The session on structuring QbD evidence for submissions matched the ICH expectations we work to, and the team applied it to a live dossier within weeks."

    Gulnara M.

    Regulatory Affairs Lead, Biopharma Company

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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 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.

    General

    What is Quality by Design training?

    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.

    Is Quality by Design training worth it?

    Yes. QbD is mandated by the ICH guidelines and increasingly expected by regulators such as the FDA and EMA, so the skills are directly useful on any pharmaceutical development team. In Kazakhstan, where domestic production is expanding, employers value staff who can develop products the regulator-ready way.

    Who should attend the training?

    The training suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals, and regulatory affairs and CMC specialists in pharmaceutical, biopharmaceutical, API and medical device organisations who want to understand and apply QbD.

    Do I need prior experience to join?

    No formal prerequisites are required. Familiarity with pharmaceutical development or GMP concepts is helpful, but the course introduces QbD from first principles, so professionals new to the approach can follow it comfortably.

    Which standards does the training follow?

    The training is grounded in the ICH quality guidelines: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, with reference to FDA and EMA expectations for QbD-based submissions.

    Is this a certification course?

    No. This is a practical, non-certification skills course. You receive a course completion certificate from Invensis Learning and gain QbD tools you can apply immediately, rather than a credential from an external body.

    Pricing

    How much does Quality by Design training cost in Kazakhstan?

    Pricing depends on the delivery format, whether live online, classroom or corporate on-site, and on group size. Fees are available on request. Contact a learning advisor for a quote tailored to your needs.

    What is included in the course fee?

    The fee typically includes instructor-led sessions, structured courseware, hands-on QbD tool exercises, case studies, learner support and a course completion certificate. Ask us to confirm exactly what your chosen format includes.

    Do you offer corporate or group pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for R&D, quality and regulatory teams. Request a tailored group quote and we will build an option around your team.

    What payment options are available?

    We accept major credit and debit cards and bank transfers, with instalment options on selected plans. Speak with a learning advisor to choose the option that suits you.

    Is the training available online as well as in a classroom?

    Yes. The course is offered as online (live virtual) instructor-led training, in-person classroom sessions, and corporate on-site delivery. Pricing varies by format, so ask for a quote for the option you prefer.

    Assessment

    How is the training assessed?

    The training is hands-on rather than assessed by a test. You apply QbD tools to realistic development scenarios throughout the day, and reinforce your learning through exercises, case studies and group discussion.

    What will I be able to do after completing it?

    You will be able to construct a QTPP, identify and classify CQAs, map risks with Ishikawa diagrams and FMEA, plan and interpret a DoE, define a design space with proven acceptable ranges, and build a control strategy for regulatory submission.

    Do I receive a certificate?

    Yes. On completing the one-day programme you receive a course completion certificate from Invensis Learning. It records your attendance and the QbD skills covered, and is separate from any external credential.

    Does the training cover both small molecule and biologic products?

    Yes. The course applies QbD principles to both small molecule drug products, such as tablets and injectables, and biopharmaceutical products, such as monoclonal antibodies and biosimilars, with case study examples from both.

    Are the tools immediately usable at work?

    Yes. Every tool is practised on realistic scenarios during the session, so you leave able to lead CQA workshops, facilitate risk assessments and interpret a design space on your own product development projects.

    Course Content

    What topics does the training cover?

    The course covers QbD principles and the ICH regulatory framework, the QTPP and CQAs, risk assessment, Design of Experiments and the design space, Process Analytical Technology and the control strategy, plus worked case studies and lifecycle management.

    What QbD tools will I practise?

    You practise building a QTPP, identifying and classifying CQAs, mapping risks with Ishikawa diagrams and FMEA, selecting a DoE design, and interpreting a design space, all applied to realistic pharmaceutical development scenarios.

    How long is the training?

    The programme runs for one day, a total of eight hours, and can also be delivered as two half-day sessions. It covers the full QbD framework with concept explanations, ICH context and hands-on tool exercises throughout.

    Does it cover regulatory submissions?

    Yes. The training shows how QbD outputs form the Pharmaceutical Development section (3.2.P.2) of a CTD submission, linking the QTPP, CQAs, risk assessment, design space and control strategy to what regulators expect under ICH Q8 to Q11.

    What learning materials are provided?

    You receive structured courseware, hands-on QbD exercises, worked pharmaceutical case studies and reference materials that support the QTPP, CQA identification, risk assessment, design space and control strategy topics covered in the programme.

    Enrollment

    How do I enrol in Quality by Design training?

    You can enrol through the Invensis Learning website. Choose your preferred format and complete your booking, and you will receive access to schedules, courseware and learning resources. Talk to a learning advisor if you need help choosing.

    What delivery formats are available?

    The training is available as online (live virtual) instructor-led sessions, in-person classroom training, and customised corporate on-site delivery, so you can choose the format that best fits your schedule and team.

    Is the training available across Kazakhstan?

    Yes. Live online sessions are available nationwide, and on-site corporate delivery can be arranged in Almaty, Astana, Shymkent and other locations. Contact us to confirm availability for your city or team.

    Can I train my whole team together?

    Yes. Corporate on-site delivery is ideal for cross-functional development teams, as participants can apply QbD tools to their own live product projects during the session. Request a group quote to get started.

    Can I reschedule my booking?

    Yes. Flexible options let you reschedule or transfer to another batch where available. Reach out to our support team and we will arrange the details that apply to your enrolment.