Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What QbD Delivers for Pharmaceutical Teams

    A Science-Led Route to Consistent Quality

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    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the Zambia

    Who Can Enroll?

    What You Gain from QbD Training

    Practical Value for Every Development Role

    Where QbD Skills Take You in Zambia

    Why 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.

    Market Pressures Making QbD Skills Valuable in Zambia

    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.

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

    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 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 Curriculum

    of 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.

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    The QbD Tools You Will Master

    Skills 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 Take

    Quality 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 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

    • 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

    Designed for organizations that want to build capabilities at scale, standardize knowledge, and support workforce development through customized 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

    • 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

    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

    ZMW 6110

    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 in Zambia

    Your 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 Zambia

    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 Zambia

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

    Quality by Design Training Location in Zambia

    Taj Pamodzi Hotel Lusaka, Zambia

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    Corporate Training for Your Teams

    Built for Zambia Pharma Teams

    • 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

    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

    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

    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

    0/0

    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

    0/0

    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

    0/0



    Trustpilot

    4.6

    Ratings

    100K+

    Happy Learners

    100+

    Locations Worldwide

    99%

    Training Satisfaction

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    Frequently Asked Questions

    Here'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.