Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What QbD Delivers for Pharmaceutical TeamsUntitledA Science-Led Route to Consistent Quality

    Quality by Design Training in Zambia introduces Quality by Design (QbD), a systematic, science-based approach to pharmaceutical product and process development in which quality is built into the product from the design stage rather than tested in at the end. Grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, this instructor-led programme moves teams from a test-and-fix habit to genuine process understanding. The course suits formulation and analytical scientists, process development engineers, quality assurance officers and regulatory affairs professionals in Zambia's pharmaceutical, biopharmaceutical and API organisations. You learn to define a Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run risk assessments and Design of Experiments (DoE), and set a robust Control Strategy that regulators such as ZAMRA, the FDA and the EMA increasingly expect. As Zambia expands local medicine manufacturing under its national plan, employers need people who can raise processes towards international GMP and QbD standards. Build that capability with Invensis Learning and apply it to live development projects straight away.

    What QbD Delivers for Pharmaceutical TeamsA Science-Led Route to Consistent Quality

    Quality by Design Training in Zambia introduces Quality by Design (QbD), a systematic, science-based approach to pharmaceutical product and process development in which quality is built into the product from the design stage rather than tested in at the end. Grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, this instructor-led programme moves teams from a test-and-fix habit to genuine process understanding.

    The course suits formulation and analytical scientists, process development engineers, quality assurance officers and regulatory affairs professionals in Zambia's pharmaceutical, biopharmaceutical and API organisations. You learn to define a Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run risk assessments and Design of Experiments (DoE), and set a robust Control Strategy that regulators such as ZAMRA, the FDA and the EMA increasingly expect.

    As Zambia expands local medicine manufacturing under its national plan, employers need people who can raise processes towards international GMP and QbD standards. Build that capability with Invensis Learning and apply it to live development projects straight away.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Zambia 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 Zambia 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 Zambia

    • Instructor-led training formats available for individual learners and corporate teams across the Zambia
    • 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 Zambia
    • 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 Zambia 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 ZambiaWho 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

    What You Gain from QbD TrainingPractical Value for Every Development Role

    For Individuals

    For Individuals

    QbD training helps pharmaceutical professionals build practical, science-based development skills they can use the very next day. The course suits formulation scientists, analytical chemists, process engineers, QA officers and regulatory specialists who want a structured way to design quality in. Whether you are developing tablets, injectables or biologics, or preparing a dossier for ZAMRA, you gain a toolkit that turns trial and error into controlled, defensible process understanding.

    If you want to stand out in Zambia's expanding pharmaceutical sector, QbD capability is a clear differentiator. You leave able to construct a QTPP, identify CQAs, run risk assessments and DoE, define a design space, and build a Control Strategy that regulators recognise.

    • Build quality into products from the design stage instead of relying on end-product testing
    • Apply QTPP and Critical Quality Attribute thinking to real formulation and process decisions
    • Lead structured risk assessments using Ishikawa diagrams and FMEA with RPN prioritisation
    • Plan and interpret Design of Experiments to define a defensible design space
    • Develop a Control Strategy and PAT approach that stands up to regulatory scrutiny
    • Speak the ICH Q8 to Q11 language expected by ZAMRA, the FDA and the EMA
    • Strengthen your value to Zambia's growing pharmaceutical and biopharmaceutical employers
    • Move confidently from test-and-fix habits to science-based process understanding
    For Organizations

    For Organizations

    QbD group training helps pharmaceutical organisations in Zambia build development capability across an entire cross-functional team. The training can be delivered for formulation, analytical, process, quality and regulatory groups together. For manufacturers working to reach international GMP, reduce batch failures and strengthen ZAMRA submissions, this training provides a scalable, practical foundation.

    If your organisation struggles to link development decisions to consistent product quality, QbD training creates a shared, science-based language. Teams gain a standardised approach to QTPP, risk assessment, design space and Control Strategy that scales across projects.

    • Embed a consistent QbD approach across formulation, analytical, process and quality teams
    • Reduce manufacturing deviations and out-of-specification batches through process understanding
    • Strengthen regulatory submissions with QTPP, design space and Control Strategy evidence
    • Raise local processes towards international GMP and ICH standards
    • Cut the post-approval change burden by working within a justified design space
    • Build cross-functional capability that supports import-substitution and export ambitions
    • Standardise pharmaceutical development practice across sites and business units
    • Train a whole development team together on live, real-world projects

    Where QbD Skills Take You in ZambiaWhy QbD Capability Is in Demand

    Quality by Design skills are becoming a real differentiator across Zambia's pharmaceutical sector, valued by local manufacturers, CDMOs and regulatory teams working to reach international GMP and ICH standards. As the country scales domestic medicine production and reduces import dependence, employers increasingly seek professionals who can design quality into products and defend it to regulators. Quality by Design training equips professionals to do exactly that. Demand spans formulation and analytical scientists, QA and regulatory officers, and process and quality managers, and here is what the market is showing.

    13-14%

    Zambia pharma market growth

    projected annual growth to 2026, market reports

    US$300M+

    Projected market size by 2030

    6W Research, Mobility Foresights

    7

    Licensed local manufacturers

    ZAM sector review, 2026

    K101,000

    Regulatory Affairs Manager pay

    average per year, WorldSalaries 2026

    SECTORS HIRING

    • —Pharmaceutical Manufacturing and Formulation
    • —Biopharmaceutical and Vaccine Development
    • —Active Pharmaceutical Ingredient (API) Production
    • —Contract Development and Manufacturing (CDMOs)
    • —Regulatory Affairs and Quality Compliance
    • —Medical Devices and Diagnostics

    GROWTH TRENDS

    • —Local medicine manufacturing scaling under the national plan to 2028
    • —Import substitution reducing reliance on foreign generics
    • —ZAMRA tightening GMP, registration and pharmacovigilance expectations
    • —IDC and private investment expanding manufacturing capacity
    • —Rising demand for chronic-disease and preventive medicines
    • —A skills gap in GMP compliance and QbD process understanding

    Sources: 6W Research, Mobility Foresights, Lusaka Times, ZAM, ZAMRA 2022-2026 Strategic Plan, MOTS Pharmaceutical Manufacturing Implementation Plan 2024-2028; WorldSalaries, SalaryExplorer, Paylab (Zambia) 2025-2026.

    Market Pressures Making QbD Skills Valuable in Zambia

    GMP and Quality Standards Gap

    Many local manufacturers still need to lift production to international GMP levels. QbD gives teams the process understanding that turns compliance into consistent, designed-in quality.

    QbD builds process understanding for GMP

    Heavy Reliance on Imports

    Imported generics still dominate Zambian shelves. Import substitution depends on local plants that can develop and control products reliably, exactly what QbD is built to enable.

    QbD supports credible local production

    Rising Regulatory Expectations

    ZAMRA is tightening registration, GMP and pharmacovigilance requirements. QbD evidence such as QTPP, design space and Control Strategy makes dossiers stronger and easier to defend.

    QbD strengthens ZAMRA submissions

    Scarce Process-Development Skills

    Zambia has a solid pharmacist base but thin capability in DoE and design-space thinking. Professionals who can apply QbD tools are rare and increasingly sought after.

    QbD makes capable developers stand out

    Batch Failures and Deviations

    Test-and-fix development leads to costly deviations and out-of-specification batches. Building quality in through QbD reduces rework and improves supply reliability.

    QbD reduces out-of-specification batches

    Scaling Manufacturing Capacity

    Investment from IDC and private players is expanding capacity. New and growing lines need a justified design space and Control Strategy to scale up without losing quality.

    QbD supports robust scale-up

    Sources: Lusaka Times, ZAM, M&J Zambia, MOTS Pharmaceutical Manufacturing Implementation Plan 2024-2028, ZAMRA 2022-2026 Strategic Plan (Zambia) 2025-2026.

    QbD is more than a concept. It is the skill set Zambia's pharmaceutical sector needs to raise quality, cut batch failures and reach international standards. Build that capability and lead the shift. Start your journey today.

    Your Zambia QbD Career Shift

    The Shift QbD Training Delivers

    A Clear Before and After Picture

    Zambia is scaling local medicine manufacturing and raising quality expectations, and employers increasingly separate teams that design quality in from those that still test it in. Here is which side of that line QbD training puts you on.

    Today

    Deviations and failed batches are common and costly

    After QbD

    Process understanding reduces deviations, rework and out-of-specification batches

    Today

    Your profile shows delivery, not modern pharmaceutical development

    After QbD

    You demonstrate ICH-aligned QbD capability that pharmaceutical employers seek

    Today

    Progression is capped without specialist quality and development skills

    After QbD

    QbD-capable roles such as QA Manager command stronger pay bands in Zambia

    You master QbD

    Before

    Quality is checked only by end-product testing after manufacture

    Now you have

    Quality is designed into the product from the QTPP onwards

    Before

    Development relies on one-factor-at-a-time trial and error

    Now you have

    Design of Experiments reveals how factors interact and drive quality

    Before

    Process limits are set empirically and are hard to defend

    Now you have

    A justified design space with normal operating and proven acceptable ranges

    Before

    Regulatory dossiers lack structured development evidence

    Now you have

    QTPP, risk assessment and a Control Strategy strengthen every submission

    "The gap between testing quality in and designing it in is exactly what employers now reward, and the organisations raising local manufacturing already know it."

    Join professionals across Zambia who trained with Invensis Learning and raised their quality game.

    Sources: WorldSalaries, SalaryExplorer, Paylab (Zambia) 2025-2026.

    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 Zambia 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.

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    The QbD Tools You Will MasterSkills Covered in This Programme

    This QbD training builds hands-on skill with the tools that turn pharmaceutical development into a controlled, science-based process. By the end you can carry a product from a Quality Target Product Profile through risk assessment, Design of Experiments and design space to a robust Control Strategy.

    Quality Target Product Profile (QTPP)

    Construct a QTPP from clinical and patient needs so the whole development programme has a clear, agreed design brief to work towards.

    Critical Quality Attribute Identification

    Identify and classify CQAs, then link them to critical material attributes and process parameters that must be understood and controlled.

    Risk Assessment with Ishikawa and FMEA

    Map sources of variation with fishbone diagrams and prioritise them by severity, occurrence and detectability using RPN to focus your effort.

    Design of Experiments (DoE)

    Plan screening and response-surface studies that quantify how material attributes and process parameters affect each Critical Quality Attribute.

    Design Space, NOR and PAR

    Interpret DoE models to define a defensible design space, with normal operating ranges and proven acceptable ranges that give real flexibility.

    Process Analytical Technology (PAT)

    Apply in-process monitoring tools such as NIR and Raman spectroscopy to measure and control quality attributes in real time during manufacture.

    Control Strategy Development

    Build a risk-proportionate Control Strategy spanning material controls, process parameters, in-process controls and testing.

    QbD in Regulatory Submissions

    Structure QTPP, risk assessment, design space and Control Strategy evidence for the pharmaceutical development section of a CTD dossier.

    Who Should TakeQuality by Design Training in Zambia?

    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

    ZMW 6210

    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

    ZMW 6210

    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 in ZambiaYour Pharma Quality Training Partner

    As a Quality by Design training company in Zambia, Invensis Learning delivers structured, practical QbD training for pharmaceutical professionals and organisations that want to build quality into products from the design stage. Our programmes combine experienced, ICH-aligned trainers, flexible delivery formats, organised courseware and learner-focused support. Whether you enrol as an individual or plan corporate training for your team, you get a professional learning experience built around real-world application and measurable outcomes. As an ISO 9001:2015 and ISO 27001:2022 certified provider with a presence across Zambia and worldwide, Invensis Learning is a partner you can rely on.

    • Experienced trainers with real pharmaceutical quality and process-development expertise
    • Live virtual, classroom and onsite delivery to suit teams across Zambia
    • Structured, ICH-aligned courseware built around QbD tools and case studies
    • Hands-on exercises using realistic pharmaceutical development scenarios
    • ISO 9001:2015 quality management and ISO 27001:2022 information security certified
    • Flexible scheduling for individual learners and corporate groups
    • Course completion certificate from Invensis Learning
    • Dedicated learner support before, during and after the training

    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 ZambiaAll our classroom training is now available online at your convenience

    Quality by Design in Zambia

    Radisson Blu, 19029, Great East Road, Kalundu, Lusaka, Lusaka District, Lusaka Province, Zambia

    Quality by Design in Zambia

    Taj Pamodzi Hotel Lusaka, Zambia

    corporate banner

    Corporate Training for Your TeamsBuilt for Zambia Pharma Teams

    Untitled

    • Train formulation, analytical, process and quality teams together
    • Customised delivery via onsite, live virtual or hybrid formats
    • Sessions scheduled around your production and project calendar
    • Real examples applied to your own live development projects
    • Experienced, ICH-aligned trainers with pharmaceutical expertise
    • Progress tracking and dedicated support for group programmes
    • Scalable delivery across Zambian sites and regional operations

    Pharmaceutical Organisations

    PharmanovaIDCLKaribu PharmaAshtons PharmaceuticalsPhilips PharmaceuticalsArtemis Life

    What Our Learners Say

    Untitled

    QbD I Could Use the Next Day

    "The training finally made QbD practical for me. Building a QTPP and running an FMEA on our own tablet formulation changed how I approach development. I now design experiments instead of guessing."

    Chanda Mwape

    Formulation Scientist

    Untitled

    0/0

    Design Space Finally Clicked

    "The DoE and design space sessions were exactly what our analytical team needed. I understand how material attributes and process parameters connect to Critical Quality Attributes, and how to defend our ranges."

    Mercy Tembo

    Analytical Chemist

    Untitled

    0/0

    Stronger on ICH and Submissions

    "As a regulatory professional, the ICH Q8 to Q11 grounding was invaluable. I can now review a Control Strategy and pharmaceutical development section with real confidence when preparing dossiers."

    Mulenga Phiri

    Regulatory Affairs Officer

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    A Shared Language for Quality

    "We trained our quality and process teams together and it standardised how we think about risk and control. Deviations discussions are more structured, and our GMP improvement work has a clearer direction."

    Bwalya Sakala

    Quality Manager, Pharmaceutical Manufacturer

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    Relevant, Well-Run Corporate Training

    "Invensis Learning tailored the corporate programme to our live projects and scheduling. Our cross-functional team came away able to apply QbD tools consistently, which is exactly the capability we needed."

    Natasha Banda

    Head of Learning and Development, Pharmaceutical Group

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

    Quality by Design training is a practical, non-certification skills course on the QbD approach to pharmaceutical product and process development. It teaches ICH Q8(R2), Q9, Q10 and Q11 aligned tools, from the QTPP and Critical Quality Attributes through risk assessment, Design of Experiments, design space and Control Strategy, so quality is built in from the design stage.

    General

    What is Quality by Design (QbD) training?

    Quality by Design training is a practical, non-certification skills course on the QbD approach to pharmaceutical product and process development. It teaches ICH Q8(R2), Q9, Q10 and Q11 aligned tools, from the QTPP and Critical Quality Attributes through risk assessment, Design of Experiments, design space and Control Strategy, so quality is built in from the design stage.

    Who should attend QbD training in Zambia?

    The course suits formulation and analytical scientists, process development engineers, quality assurance officers, and regulatory affairs professionals in Zambia's pharmaceutical, biopharmaceutical and API organisations. It is ideal for anyone who wants to apply QbD in development, manufacturing or regulatory work.

    Is QbD training worth it for pharmaceutical professionals?

    Yes. QbD is increasingly expected by regulators such as ZAMRA, the FDA and the EMA, and Zambia's push to grow local manufacturing has created real demand for people who can design quality in. The practical skills apply immediately to formulation, process and regulatory work.

    Do I need prior QbD experience to join?

    No. The course has no formal prerequisites and introduces QbD from first principles. Familiarity with pharmaceutical development or GMP is helpful but not required, making it accessible to professionals new to the approach.

    Does the course apply to both small molecules and biologics?

    Yes. The training covers QbD principles for both small molecule products, such as tablets, capsules and injectables, and biopharmaceuticals, such as monoclonal antibodies and biosimilars, with case examples drawn from both.

    Pricing

    How much does QbD training cost in Zambia?

    Pricing is available on request and varies by delivery format and group size. Instructor-led, self-paced and corporate options are offered. Speak with a learning advisor for a quote tailored to your needs.

    What is included in the course fee?

    The fee typically includes ICH-aligned courseware, hands-on QbD tool exercises, case studies, learner support and a course completion certificate from Invensis Learning. Confirm the exact inclusions for your chosen format when you enquire.

    Do you offer corporate or group pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for pharmaceutical teams, PMOs and business units. Contact us for a tailored group quote.

    Are flexible payment options available?

    Yes. Selected plans offer flexible and instalment payment options. Talk to a learning advisor to choose the arrangement that suits you or your organisation.

    Is there a separate exam fee?

    No. This is a non-certification skills course with no examination, so there is no separate exam fee. The fee covers the training, materials and learner support only.

    Assessment

    Is there an exam for QbD training?

    No. QbD training is a non-certification course with no examination. Learning is reinforced through hands-on tool exercises, pharmaceutical case studies and team discussion during the programme.

    Will I receive a certificate after the training?

    Yes. You receive a course completion certificate from Invensis Learning once you complete the programme. This recognises your participation and the practical QbD skills you have built.

    How is learning reinforced without an exam?

    Learning is reinforced through applied exercises using realistic development scenarios, such as building a QTPP, identifying CQAs, running an FMEA and interpreting a design space, alongside case studies and trainer-led discussion.

    How long is the QbD training?

    The core programme runs for one day, around eight hours, covering all six QbD modules from principles and the ICH framework through to Control Strategy and case studies. Corporate schedules can be adapted to suit your team.

    What will I be able to do after the training?

    You will be able to construct a QTPP, identify and classify CQAs, run a risk assessment with Ishikawa diagrams and FMEA, plan and interpret Design of Experiments, define a design space with NOR and PAR, and build a Control Strategy for regulatory submission.

    Course Content

    What topics does the QbD course cover?

    The course covers QbD principles and the ICH regulatory context, QTPP and Critical Quality Attributes, risk assessment, Design of Experiments and design space, Process Analytical Technology and Control Strategy, and QbD in practice through case studies and regulatory submissions.

    Which QbD tools will I learn to use?

    You will work with the QTPP, Critical Quality Attribute identification, Ishikawa diagrams and FMEA, Design of Experiments, design space with normal operating and proven acceptable ranges, Process Analytical Technology and Control Strategy development.

    Does the course cover Design of Experiments (DoE)?

    Yes. DoE is a central part of the course. You learn screening and response-surface designs, how to run and analyse a QbD DoE, and how to use the results to define and justify a design space.

    Is the content aligned to current standards?

    Yes. The content is aligned to the ICH Q8(R2) Pharmaceutical Development guideline and to ICH Q9, Q10 and Q11, and reflects the QbD expectations of regulators such as the FDA and the EMA that also inform ZAMRA practice.

    Are there hands-on exercises in the course?

    Yes. Hands-on exercises run throughout, applying QbD tools such as QTPP construction, CQA identification, risk assessment and design space interpretation to realistic pharmaceutical development scenarios.

    Enrollment

    How do I enrol in QbD training in Zambia?

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

    What delivery formats are available?

    The course is available online as live virtual instructor-led training, in the classroom, and as onsite corporate training for teams across Zambia. Choose the format that best fits your schedule and learning preference.

    Can the course be delivered onsite for our team?

    Yes. We deliver customised onsite and live virtual corporate training for pharmaceutical teams, so a whole cross-functional group can learn QbD together on your own projects. Contact us to arrange a session.

    Can I reschedule my enrolment to another batch?

    Yes. Flexible options let you reschedule or transfer to another batch on selected plans. Contact our support team to arrange a change that works for you.

    How soon can I start?

    New batches run regularly across live virtual and classroom formats, and corporate sessions can be scheduled to suit your team. Speak with a learning advisor to see upcoming dates and reserve your place.