Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters in PharmaUntitledA Science-Based Route to Built-In Quality

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical product and process development that builds quality into a product from the design stage rather than testing it in at the end. This Quality by Design training in Namibia gives formulation scientists, process engineers, analytical scientists and quality professionals the practical tools to apply QbD on real development projects. The course is grounded in the ICH quality framework: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, the guidelines that regulators such as the FDA and EMA now expect behind modern submissions. You learn to define the Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run risk assessment, design experiments (DoE), map the design space and build a control strategy. For Namibia's growing pharmaceutical, biopharmaceutical and regulated manufacturing base, QbD skills help teams meet NMRC and GMP expectations and reduce costly batch failures. Start your QbD journey with Invensis Learning.

    What Is Quality by Design and Why It Matters in PharmaA Science-Based Route to Built-In Quality

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    Key Highlightsof the Quality by Design Training Course

    Quality by Design Training Eligibility in the NamibiaWho Can Enroll?

    What This QbD Training Builds for YouSkills You Can Apply from Day One

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

    Quality by Design skills, built through structured Quality by Design training, are valued across Namibia's pharmaceutical, wholesale, regulatory and regulated manufacturing employers, where teams increasingly need to build quality in rather than test it at the end. As the country works to grow local manufacturing, meet NMRC and GMP expectations and reduce reliance on imports, professionals who can apply QbD tools stand out. Demand spans quality control, quality assurance, regulatory affairs and formulation roles, and here is what the market is telling us right now.

    Market Pressures Making QbD Skills Valuable in Namibia

    QbD is a practical capability, not just theory. Join professionals across Namibia who design quality into pharmaceutical products and reduce costly failures. Start your journey today.

    Your Namibia QbD Career Shift

    From Testing Quality in to Building It In

    The Career Shift QbD Delivers

    Namibia's pharmaceutical and regulated manufacturing sector is under growing pressure to build quality in, meet GMP and NMRC expectations and reduce costly failures. Employers increasingly separate teams who can apply QbD from those who cannot. Here is which side of that line you want to be on.

    Sources: SalaryExplorer, PayScale (Namibia) 2024-2026.

    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 Namibia 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 MasterApplying ICH QbD Tools in Practice

    You will learn how to apply Quality by Design end to end, from defining the Quality Target Product Profile through risk assessment, design of experiments, the design space and control strategy. By the end of the programme you can run QbD tool exercises on realistic pharmaceutical development scenarios.

    Build a Quality Target Product Profile

    You will learn to construct a QTPP from clinical and patient needs, setting out dosage form, strength, delivery and quality standards as the design specification that drives the whole QbD programme.

    Identify and Classify Critical Quality Attributes

    Learn to identify CQAs such as assay, dissolution, impurities and, for biologics, glycosylation and aggregation, then link them to critical material attributes and critical process parameters.

    Run Risk Assessment with Ishikawa and FMEA

    Apply Ishikawa (fishbone) diagrams and FMEA with Severity, Occurrence and Detectability scoring to prioritise the material and process variables that most affect quality, focusing effort where it counts.

    Design Experiments and Define the Design Space

    Use design of experiments, from screening to response surface designs, to quantify how factors affect quality, then define the design space, Normal Operating Ranges and Proven Acceptable Ranges.

    Apply PAT and a Robust Control Strategy

    Learn how Process Analytical Technology tools such as NIR and Raman enable real-time monitoring, and how to build a control strategy that assures quality within the design space.

    Structure QbD Evidence for Submissions

    Understand how QTPP, CQAs, risk assessment, design space and control strategy come together in Section 3.2.P.2 of a CTD submission, and how QbD supports lifecycle change management.

    Who Should TakeQuality by Design Training in Namibia?

    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

    NAD 5780

    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

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    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

    NAD 5780

    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 NamibiaTrusted, Expert-Led and Flexible

    Invensis Learning delivers structured Quality by Design training for pharmaceutical professionals and organisations that want to build quality in from the development stage. Our programmes combine experienced trainers, hands-on QbD tool exercises, organised courseware aligned to the ICH framework, and learner-focused support. Whether you are enrolling as an individual or planning group training for your team, Invensis Learning, a trusted Quality by Design training company in Namibia, provides a professional training experience built around practical understanding, real-world application and measurable outcomes.

    • Experienced, industry-practitioner trainers with pharmaceutical quality expertise
    • Live virtual, classroom and onsite delivery to fit your schedule
    • Hands-on QbD exercises using realistic pharmaceutical development scenarios
    • Structured courseware covering the full ICH Q8 to Q11 framework
    • ISO 9001:2015 quality and ISO 27001:2022 information security certified
    • Dedicated learner support before, during and after training
    • Course completion certificate from Invensis Learning
    • Trusted by professionals and organisations across 100+ countries

    12M+

    Hours of Training Delivered

    4

    Flexible Learning Modes

    98%

    First-Attempt Pass Rate

    5000+

    Accredited Trainers Globally

    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 NamibiaInstructor-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 Namibia

    Hilton Windhoek, Rev. Michael Scott Street, Windhoek Central, Windhoek, Khomas Region, 10005, Namibia

    Quality by Design Training Location in Namibia

    Avani Windhoek Hotel & Casino, 129, Independence Avenue, Windhoek Central, Windhoek, Khomas Region, 10005, Namibia

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    Corporate QbD Training in NamibiaScale Quality Capability

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    • Suitable for small, medium and large pharmaceutical and manufacturing teams
    • Customised schedules aligned with shift patterns and project timelines
    • Onsite, live virtual, hybrid or blended delivery across Namibia
    • Trainers with real pharmaceutical quality and QbD experience
    • Role-based examples for formulation, analytical, QA and regulatory teams
    • Dedicated coordination and learner support throughout
    • Scalable delivery for teams in Windhoek and across the country

    Organisations We Support

    FabupharmNAMPHARMEROGO MedGEKA PharmaceuticalsNamibia Institute Of PathologyNamibia Breweries

    What Our Learners Say

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    QbD Tools I Use Every Week

    "The hands-on QTPP and CQA exercises finally made Quality by Design click for me. I now lead risk assessments on our formulation projects using Ishikawa and FMEA instead of guesswork, and my development reports are far stronger."

    Selma Amukwaya

    Formulation Scientist

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    Practical and Well Structured

    "Clear, practical and grounded in the ICH framework. The design of experiments and design space sessions helped me understand how to reduce batch variability. The trainer used realistic pharmaceutical scenarios throughout."

    Tomas Shikongo

    Quality Assurance Officer

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    Directly Useful for Submissions

    "As a regulatory affairs officer, the module on structuring QbD evidence for CTD submissions was exactly what I needed. I now understand how QTPP, risk assessment and control strategy fit together for a dossier."

    Ndapewa Nghipandulwa

    Regulatory Affairs Officer

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    A Shared QbD Language for Our Teams

    "We ran the QbD training onsite for our development and QA teams. It gave everyone a shared language for QTPP, critical quality attributes and control strategy, and we have already seen fewer deviations on new products."

    Johannes Hamutenya

    Quality Manager, Pharmaceutical Manufacturer

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    Tailored and Business-Relevant

    "Invensis Learning tailored the programme to our GMP and NMRC context. The team came away able to apply risk assessment and design of experiments to live projects, which has improved our development consistency."

    Maria Iyambo

    Operations Director, Regulated Manufacturing

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

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

    Quality by Design (QbD) training is a practical, non-certification course on building quality into pharmaceutical products from the development stage. It teaches the ICH Q8 to Q11 framework and QbD tools such as the QTPP, critical quality attributes, risk assessment, design of experiments and control strategy.

    General

    What is Quality by Design training?

    Quality by Design (QbD) training is a practical, non-certification course on building quality into pharmaceutical products from the development stage. It teaches the ICH Q8 to Q11 framework and QbD tools such as the QTPP, critical quality attributes, risk assessment, design of experiments and control strategy.

    Who should attend QbD training in Namibia?

    The course suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals and regulatory affairs specialists in pharmaceutical, biopharmaceutical, veterinary and regulated manufacturing organisations who want to apply QbD in their work.

    Is Quality by Design training worth it?

    Yes. QbD skills help you design robust products, reduce costly batch failures and support GMP and NMRC-ready submissions. For Namibia's growing pharmaceutical and regulated manufacturing base, professionals who can apply QbD are increasingly valued across QA, regulatory and development roles.

    Do I need prior experience to take QbD training?

    No. There are no formal prerequisites. Familiarity with pharmaceutical development or GMP is helpful but not required, as the course introduces Quality by Design from first principles in a development context.

    Which framework is the QbD course based on?

    The course is grounded in the ICH quality framework: ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, the guidelines regulators such as the FDA and EMA expect behind modern submissions.

    Pricing

    How much does QbD training cost in Namibia?

    Pricing is available on request and varies by delivery mode, group size and format. Instructor-led, self-paced and corporate options are offered. Request a quote and a learning advisor will share the current fee for your preferred format.

    What is included in the QbD course fee?

    The fee typically includes structured courseware covering the full ICH Q8 to Q11 framework, hands-on QbD tool exercises, case studies, learner support and a course completion certificate from Invensis Learning.

    Do you offer corporate or group pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for development, quality and regulatory teams. Contact us for a tailored group quote.

    What payment options are available?

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

    Is the completion certificate included in the fee?

    Yes. A course completion certificate from Invensis Learning is included when you complete the programme, at no extra cost.

    Assessment

    How is learning assessed in the QbD course?

    Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and team discussion rather than a formal test. You apply QTPP construction, CQA identification, risk assessment and design space interpretation to realistic scenarios during the programme.

    Do I receive a certificate after the QbD training?

    Yes. You receive a course completion certificate from Invensis Learning after completing the programme. It records the practical QbD skills you have built and is awarded on completion.

    Is Quality by Design a certification?

    No. This is a non-certification skills course. There is no formal credential or governing body; instead you gain practical, immediately applicable QbD capability and a course completion certificate from Invensis Learning.

    What will I be able to do after the training?

    You will be able to construct a QTPP, identify and classify critical quality attributes, run risk assessments with Ishikawa and FMEA, plan design of experiments, interpret a design space, and develop a control strategy for regulatory submissions.

    Does the course cover both small molecule and biologic products?

    Yes. The course covers QbD principles for small molecule drug products such as tablets and injectables, and for biopharmaceuticals such as monoclonal antibodies, with case study examples from both.

    Course Content

    What topics are covered in the QbD training?

    The programme covers QbD principles and the ICH regulatory context, the QTPP and critical quality attributes, risk assessment, design of experiments and the design space, Process Analytical Technology and control strategy, plus QbD case studies and submission structuring.

    Does the course include hands-on DoE practice?

    Yes. The course uses hands-on exercises to help you select and interpret design of experiments, from screening to response surface designs, and to read a design space with Normal Operating Ranges and Proven Acceptable Ranges.

    How long is the QbD training?

    The course is delivered as a one-day, eight-hour programme covering all six QbD modules with concept explanations, ICH context, real-world pharmaceutical case studies and hands-on tool exercises.

    Does the course cover regulatory submissions?

    Yes. You learn how QTPP, CQAs, risk assessment, design space and control strategy come together in Section 3.2.P.2 of a CTD submission, and how a well-documented QbD approach supports lifecycle change management.

    What learning materials are provided?

    You receive structured courseware aligned to the ICH Q8 to Q11 framework, pharmaceutical case studies, and QbD tool exercise materials for QTPP, CQA identification, risk assessment and design space interpretation.

    Enrollment

    How do I enrol in the QbD course in Namibia?

    You can enrol through the Invensis Learning website. Choose your preferred format, complete payment, and you will receive access to schedules, courseware and learning resources. See upcoming batches or talk to a learning advisor to get started.

    What training formats are available?

    We offer online (live virtual) instructor-led training, classroom training, self-paced learning and customised corporate onsite training, so you can choose the format that fits your schedule and team.

    Can the course be delivered onsite for my team?

    Yes. The course is available as a corporate onsite programme for pharmaceutical and manufacturing teams, delivered across Namibia and tailored to your GMP and NMRC context. Ask about corporate or group pricing.

    Can I reschedule or transfer my enrolment?

    Yes. Flexible options let you reschedule or transfer to another batch on selected plans. Contact learner support to arrange this.

    How soon can I start the QbD training?

    You can start with the next available batch or arrange a corporate session at a time that suits your team. See upcoming schedules or speak with a learning advisor to confirm dates in your time zone.