Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and What Will You Gain?

    Build Quality in from the Design Stage

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    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the Kenya

    Who Can Enrol?

    What You Gain from QbD Training

    Skills You Can Apply from Day One

    Where QbD Skills Take You in Kenya

    Roles, Sectors and Market Demand

    Kenya is East Africa's most advanced pharmaceutical producer and one of the continent's largest drug exporters, with more than 37 licensed manufacturers. As the country pushes to raise local production, meet WHO and Pharmacy and Poisons Board GMP standards, and win export markets, employers need people who can build quality in by design, the practical capability that Quality by Design training develops. Demand is strongest in formulation, quality assurance, quality control, process development and regulatory affairs, and here is what the market shows.

    Market Forces Driving Demand for QbD Skills in Kenya

    QbD is fast becoming the language of modern pharmaceutical quality. Build the skills Kenyan manufacturers and regulators now expect, and help your organisation produce quality by design. Start today.

    Your Kenya QbD Transformation

    Where Your Quality Practice Stands Today

    The Shift QbD Delivers

    Kenya's pharmaceutical sector is scaling up and raising its quality bar to meet WHO and PPB expectations. Employers increasingly separate teams that can design quality in from those that still test it in. Here is the shift this training delivers.

    Sources: Business Daily, Pharmacy and Poisons Board, WHO GMP guidelines (Kenya) 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 Kenya 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 Will Apply at Work

    In this Quality by Design Training you will learn to apply the full QbD toolkit, from QTPP and CQA identification through risk assessment, DoE and the design space to PAT and the control strategy. Every tool is practised on realistic pharmaceutical development scenarios so you can use it at work immediately.

    Define the Quality Target Product Profile

    Translate patient and clinical needs into a QTPP that sets the design targets for the whole development programme and anchors every later QbD decision.

    Identify Critical Quality Attributes

    Determine which physical, chemical and biological attributes are critical to safety and efficacy, and classify them with confidence for small molecules and biologics.

    Run Risk Assessment with Ishikawa and FMEA

    Map material and process risks to each CQA, then prioritise them by severity, occurrence and detectability using RPN scoring to focus your development effort.

    Design Experiments and Map the Design Space

    Plan screening and response-surface DoE studies, interpret the models, and define the design space with Normal Operating Ranges and Proven Acceptable Ranges.

    Apply Process Analytical Technology

    Use PAT tools such as NIR and Raman to monitor critical attributes in real time and support real-time release testing during manufacturing.

    Build a Robust Control Strategy

    Turn risk and DoE findings into a control strategy of material, process and in-process controls, ready to present in ICH-aligned regulatory submissions.

    Who Should Take

    Quality by Design Training in Kenya?

    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 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

    KES 42090

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

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

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    Why Choose Invensis Learning for Quality by Design Training in Kenya

    Practical, Expert-Led Learning

    Invensis Learning delivers practical Quality by Design Training for pharmaceutical professionals and organisations across Kenya. Our programmes combine experienced trainers, hands-on QbD tool exercises, and content grounded in the ICH Q8 to Q11 framework, so learning connects directly to real development and manufacturing work. As a trusted Quality by Design training company in Kenya, Invensis Learning supports professionals and organisations alike. Whether you enrol as an individual or arrange corporate training for your team, you gain a professional learning experience built around practical understanding, real-world application and measurable outcomes.

    • ISO 9001:2015 certified training provider with rigorous quality management
    • ISO 27001:2022 certified for information security you can trust
    • Experienced trainers with real pharmaceutical and quality management expertise
    • Live virtual, classroom and onsite delivery to suit teams across Kenya
    • Practical, exercise-led sessions using realistic development scenarios
    • Content grounded in the ICH Q8 to Q11 QbD framework
    • Dedicated learner support before, during and after the training
    • Scalable corporate delivery for local and regional pharmaceutical teams

    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

    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 Kenya

    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 Kenya

    Villa Rosa Kempinski, Waiyaki Way, Highridge sublocation, Highridge location, Highridge division, Westlands, Nairobi, Zimmerman, Soko ya Mawe, Nairobi, 97104, Kenya

    Quality by Design Training Location in Kenya

    Radisson Blu Hotel & Residence, Nairobi Arboretum, Aboretum Drive, Kilimani location, Kilimani ward, Kilimani division, Westlands, Nairobi, Zimmerman, Soko ya Mawe, Nairobi, 00400, Kenya

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    Onsite QbD Training for Teams

    Built for Kenya's Pharma

    • Tailored QbD training for your formulation, quality and regulatory teams
    • Onsite, live virtual or blended delivery to fit your schedule
    • Sessions built around your own live development projects
    • Experienced trainers with pharmaceutical quality expertise
    • Consistent QbD practice across sites and business units
    • Progress tracking and dedicated coordination for group training
    • Scalable delivery for teams across Kenya and the region

    Pharmaceutical Employers in Kenya

    Cosmos LimitedUniversal CorporationDawa LimitedBeta HealthcareElys Chemical IndustriesRegal Pharmaceuticals

    What Our Learners Say

    From Trial and Error to a Structured Method

    "The QbD training finally connected the ICH guidelines to what I do at the bench. I now build a QTPP and run risk assessment before touching a formulation, and my development work is far more structured."

    Wanjiru Kamau

    Formulation Scientist

    DoE Made Practical and Clear

    "The sessions on DoE and the design space were the most useful training I have done. I can now plan a screening study and read the model instead of testing one factor at a time. Very practical and hands-on."

    Brian Otieno

    Quality Control Analyst

    Stronger, Submission-Ready Dossiers

    "As a regulatory professional, learning to structure QTPP, design space and control strategy evidence has made our submission dossiers noticeably stronger. The ICH context was explained clearly throughout."

    Achieng Odhiambo

    Regulatory Affairs Officer

    A Shared QbD Language for Our Teams

    "We ran the training onsite for our development and quality teams and it gave everyone a shared QbD language. Risk assessment and control strategy discussions are now much sharper across the site."

    Daniel Mwangi

    Quality Manager, Generics Manufacturer

    Tailored, Practical Corporate Training

    "Invensis Learning tailored the programme to our live projects and delivery schedule. The trainers understood pharmaceutical quality deeply, and our team left able to apply QbD tools straight away."

    Grace Wambui

    Head of Learning and Development, Pharma Group

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    Trustpilot

    4.6

    Ratings

    100K+

    Happy Learners

    100+

    Locations Worldwide

    99%

    Training Satisfaction

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    We also deliver Quality by Design Training across multiple cities

    Invensis Learning delivers industry-leading Quality by Design training solutions tailored for individuals and organizations.

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    Frequently Asked Questions

    Here's everything you may ask...

    Quality by Design is a systematic, science-based approach to pharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. It is defined by the ICH Q8(R2), Q9, Q10 and Q11 guidelines and uses tools such as the QTPP, CQAs, risk assessment, DoE and the control strategy.