Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

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

    Quality by Design Training in Zimbabwe equips pharmaceutical professionals to build quality into a product from the design stage rather than testing it in at the end. Quality by Design (QbD) is a systematic, science-based approach to drug product and process development, set out in the ICH Q8, Q9, Q10 and Q11 guidelines and increasingly expected under the WHO-aligned GMP standards enforced by the Medicines Control Authority of Zimbabwe (MCAZ). Over one practical day, you learn to apply the core QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space and the control strategy. Each concept is reinforced with realistic development scenarios drawn from small molecule and biologic products. The programme suits formulation scientists, process development engineers, analytical chemists, quality assurance teams and regulatory affairs specialists across Zimbabwe's manufacturers, CDMOs and API sites. As local production and export ambitions grow, professionals who can design robust processes and defend them in submissions are in real demand. Start your QbD journey with Invensis Learning.

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

    Quality by Design Training in Zimbabwe equips pharmaceutical professionals to build quality into a product from the design stage rather than testing it in at the end. Quality by Design (QbD) is a systematic, science-based approach to drug product and process development, set out in the ICH Q8, Q9, Q10 and Q11 guidelines and increasingly expected under the WHO-aligned GMP standards enforced by the Medicines Control Authority of Zimbabwe (MCAZ).

    Over one practical day, you learn to apply the core QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space and the control strategy. Each concept is reinforced with realistic development scenarios drawn from small molecule and biologic products.

    The programme suits formulation scientists, process development engineers, analytical chemists, quality assurance teams and regulatory affairs specialists across Zimbabwe's manufacturers, CDMOs and API sites. As local production and export ambitions grow, professionals who can design robust processes and defend them in submissions are in real demand. Start your QbD journey with Invensis Learning.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Zimbabwe 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 Zimbabwe 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 Zimbabwe

    • Instructor-led training formats available for individual learners and corporate teams across the Zimbabwe
    • 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 Zimbabwe
    • 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 Zimbabwe 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 ZimbabweWho 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

    The Value You Gain from QbD TrainingSkills You Can Apply from Day One

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical professionals replace trial-and-error development with a structured, science-based method. You learn to link what a product must achieve to the material attributes and process parameters that control it, and to prove that understanding with data. Whether you work in formulation, process development, analytical science, quality assurance or regulatory affairs, the tools transfer directly to live development and manufacturing projects.

    If you want to strengthen your standing in Zimbabwe's pharmaceutical sector, QbD capability is a clear differentiator. You leave able to run a QTPP workshop, lead a CQA and risk assessment, plan a DoE and shape a control strategy for submission.

    • Design quality into products from the start instead of relying on end-product testing
    • Apply the full QbD toolkit: QTPP, CQAs, risk assessment, DoE, design space and control strategy
    • Build stronger, more defensible pharmaceutical development and process understanding
    • Prepare QbD evidence that stands up in MCAZ and international regulatory submissions
    • Reduce manufacturing deviations, rework and out-of-specification batches
    • Make yourself more valuable to Zimbabwe's growing local manufacturing sector
    • Move confidently between small molecule and biologic development work
    • Gain a practical, immediately usable skill set with no exam to sit
    For Organizations

    For Organizations

    Quality by Design group training helps pharmaceutical organisations embed a consistent, science-based development approach across their teams. When formulation, process, analytical, quality and regulatory colleagues share the same QbD framework, development becomes faster, more predictable and easier to defend. The training can be delivered for a single site, a quality function or a full cross-functional development team.

    For Zimbabwean manufacturers, CDMOs and API producers under pressure to raise compliance and expand into regional markets, QbD group training builds the in-house capability to design robust processes and submit stronger regulatory dossiers.

    • Build a shared QbD language across formulation, process, quality and regulatory teams
    • Strengthen GMP compliance and readiness for MCAZ and WHO-aligned inspections
    • Reduce batch failures, deviations and costly post-approval changes
    • Improve process robustness during scale-up and technology transfer
    • Support local production and export ambitions with regulatory-grade development
    • Standardise how development data is generated, documented and defended
    • Upskill whole cross-functional teams together on live projects
    • Deliver training onsite, live virtual or blended to fit production schedules

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

    Quality by Design skills open doors across Zimbabwe's pharmaceutical sector, from local generic manufacturers and CDMOs to quality assurance and regulatory affairs functions. As the country pushes to expand local production, cut import dependence and meet tougher MCAZ and WHO-aligned standards, employers increasingly value people who can design robust processes and defend them with data, the very capability our Quality by Design training develops. Demand runs from formulation and process roles up to quality and development leadership, and here is what the market signals today.

    US$214m

    Zimbabwe pharmaceutical market, 2026

    Mordor Intelligence 2026

    4.3% CAGR

    Projected market growth to 2031

    reaching about US$263m

    9 firms

    Local pharmaceutical manufacturers

    supplying around 12% of medicines used

    US$24k/yr

    Average quality manager pay

    formal-sector estimate, verify

    SECTORS HIRING

    • —Local Pharmaceutical Manufacturing
    • —Generic and Essential Medicines Producers
    • —Contract Development and Manufacturing (CDMOs)
    • —Regulatory Affairs and Quality Assurance
    • —Active Pharmaceutical Ingredient (API) Sites
    • —Veterinary Pharmaceuticals and Health Products

    DEMAND DRIVERS

    • —National drive to expand local medicine production and cut import reliance
    • —MCAZ tightening WHO-aligned GMP enforcement and traceability
    • —Export ambitions into regional and AfCFTA markets
    • —Scarcity of QbD-skilled development and quality professionals
    • —Retooling and equipment upgrades at local plants
    • —Growing regulatory expectation for QbD evidence in submissions

    Sources: Mordor Intelligence, Introspective Market Research (Zimbabwe pharmaceutical market 2026); MCAZ; WorldSalaries, Paylab, Africarrieres (Zimbabwe) 2026.

    Why QbD Skills Are in Demand Across Zimbabwe's Pharma Sector

    Import Dependence and Local Supply Gaps

    Local firms make only about 12% of the medicines Zimbabwe uses, mostly generics from imported APIs. QbD-grade development capability is central to producing more medicines reliably at home.

    QbD builds local development capability

    Tightening GMP Enforcement

    MCAZ runs WHO-aligned GMP audits and is sharpening traceability and enforcement. Manufacturers need robust, science-based process understanding to pass inspections and stay compliant.

    QbD supports inspection readiness

    Quality Built in, Not Tested In

    Trial-and-error development still causes deviations, rework and out-of-specification batches. QbD replaces end-product testing with designed-in quality and a data-backed control strategy.

    QbD replaces trial and error

    Regulatory Submissions Under Pressure

    Regulators increasingly expect QTPP, design space and control strategy evidence in dossiers. Teams that can document QbD are essential to faster, stronger MCAZ and export submissions.

    QbD strengthens dossiers

    Scarce Development and Quality Talent

    Zimbabwe has skilled pharmacists but few professionals trained in DoE, design space and formal risk assessment. QbD capability is a genuine differentiator in a thin talent pool.

    QbD makes you stand out

    Export and Regional Market Ambitions

    As firms target regional and AfCFTA markets, products must meet stricter quality expectations. QbD gives the process robustness and regulatory evidence those markets demand.

    QbD meets export quality bars

    Sources: Mordor Intelligence, Introspective Market Research (Zimbabwe pharmaceutical market 2026); MCAZ; Herald (Zimbabwe) 2026.

    QbD is a practical skill that pays off on the plant floor and in the dossier. Join Zimbabwe's pharmaceutical professionals building quality into every product from the design stage. Start today.

    Your Zimbabwe QbD Transformation

    Where You Stand Today

    The Shift QbD Skills Deliver

    Zimbabwe's pharmaceutical sector is under pressure to make more medicines locally, meet tighter GMP standards and reach new export markets. Employers increasingly separate teams that can design quality in from those still testing it in. Here is the shift QbD skills make.

    Today

    Seen as a delivery specialist, not a development leader

    After QbD

    Recognised for the science-based development the sector is short of

    Today

    Deviations and rework eat into batch reliability

    After QbD

    Fewer deviations and out-of-specification results through designed-in quality

    Today

    Limited mobility beyond your current employer

    After QbD

    Skills that transfer across Zimbabwe's manufacturers, CDMOs and API sites

    You Apply QbD at Work

    Before

    Development runs on trial and error and end-product testing

    Now you have

    You design quality into products using QTPP, CQAs and a control strategy

    Before

    Risk decisions rely on opinion and past habit

    Now you have

    You lead structured risk assessment with Ishikawa diagrams and FMEA

    Before

    One factor changed at a time, missing key interactions

    Now you have

    You plan DoE that reveals how factors interact and define a design space

    Before

    Submissions are hard to defend under MCAZ scrutiny

    Now you have

    You document QbD evidence that stands up in regulatory review

    "In pharma, quality is either designed in from the start or chased at the end, and the teams that design it in are the ones regulators trust."

    Join 50,000+ professionals who trained with Invensis Learning and built the skills that matter.

    Sources: WorldSalaries, Paylab, Africarrieres (Zimbabwe) 2026; MCAZ.

    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 Zimbabwe 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 Toolkit You Will MasterQTPP, DoE and Control Strategy in Practice

    This training turns the QbD framework into hands-on capability. Working through realistic pharmaceutical scenarios, you learn to apply each QbD tool and connect them into a single, defensible development story from product profile to control strategy.

    Build a Quality Target Product Profile (QTPP)

    Translate patient and clinical needs into a prospective summary of the quality, safety and efficacy characteristics a product must achieve. The QTPP becomes the design specification that anchors the whole QbD programme.

    Identify and Classify Critical Quality Attributes

    Determine which physical, chemical, biological and microbiological properties are critical to quality, safety and efficacy, for both small molecules and biologics, and separate true CQAs from non-critical attributes.

    Run Structured Risk Assessment

    Use Ishikawa (fishbone) diagrams and FMEA to link critical material attributes and process parameters to each CQA, then prioritise them by risk priority number so development effort goes where it matters most.

    Design and Interpret Experiments (DoE)

    Move beyond one-factor-at-a-time testing to plan screening and response surface designs, read the resulting models, and understand how material attributes and process parameters interact to affect quality.

    Define the Design Space

    Derive the multidimensional design space from DoE results, set Normal Operating Ranges and Proven Acceptable Ranges, and understand the edge of failure and the regulatory flexibility a design space provides.

    Develop a Control Strategy and Apply PAT

    Build a risk-proportionate control strategy from material controls, process controls, in-process checks and Process Analytical Technology such as NIR and Raman, and document it for regulatory submission.

    Who Should TakeQuality by Design Training in Zimbabwe?

    Process Engineers

    QC Analysts

    Engineering Teams

    Technical Staff

    Production Managers

    Distribution Managers

    Regulatory Affairs Specialists

    Quality Assurance Professionals

    Who Can Take This Certification Training

    Quality by Design Training Modesfor Professionals and Teams

    We offer flexible training formats designed to suit different learning preferences, schedules, and professional goals. Whether you prefer self-paced learning or a structured, corporate, instructor-led experience, choose the option that best supports your skill development journey with the best Quality by Design online training options.

    Quality by Design Live Virtual Training

    • Live online instructor-led sessions

    • Interactive discussions and virtual activities

    • Expert guidance from experienced trainers

    • Practice assessments and revision support

    • Dedicated Q&A sessions for concept clarification

    • Fixed schedules for accountability and momentum

    • Small batch sizes for personalized attention

    • Access from any location with internet connectivity

    USD 345

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

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

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    Quality by Design Classroom Training

    • Instructor-led classroom sessions

    • Interactive discussions and group activities

    • Real-world examples and practical exercises

    • Structured learning with fixed schedules

    • Opportunities for peer networking and collaboration

    • Practice assessments and knowledge checks

    • Dedicated Q&A and concept clarification

    • Immediate trainer feedback and support

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    Learn through face-to-face sessions led by experienced instructors in a collaborative classroom environment. This classroom Quality by Design training combines expert guidance, peer interaction, and hands-on activities to create an engaging learning experience.

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    Best For: Learners who prefer in-person interaction, structured schedules, and collaborative learning experiences.

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    Quality by Design Corporate Group Training

    • Customized training aligned to organizational goals

    • Flexible delivery: onsite, virtual, hybrid, or blended

    • Scheduling tailored to business availability

    • Role-based examples and industry-relevant discussions

    • Progress tracking and learner assessments where applicable

    • Dedicated coordination and administrative support

    • Consistent learning experiences across teams

    • Scalable delivery for local, regional, or global workforces

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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

    USD 345

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

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

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    Why Choose Invensis Learning for QbD Training in ZimbabweExpert-Led and Flexible

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and organisations across Zimbabwe. As an ISO 9001:2015 certified provider with a global network of accredited, industry-experienced trainers, we combine clear instruction, real development scenarios and flexible delivery to turn QbD theory into workplace capability. As an established Quality by Design training company in Zimbabwe, we tailor delivery to how you prefer to learn. Whether you enrol as an individual or arrange training for a cross-functional team, you get expert-led sessions, structured courseware aligned to the ICH QbD guidelines, and support focused on real-world application rather than rote learning.

    • ISO 9001:2015 certified training provider with globally consistent quality standards
    • Experienced, industry-practitioner trainers who have applied QbD in real development
    • Instructor-led delivery online, in classroom or onsite to fit your schedule
    • Hands-on QbD exercises using realistic pharmaceutical development scenarios
    • Courseware grounded in the ICH Q8, Q9, Q10 and Q11 guidelines and current GMP
    • Flexible options for individual learners and corporate cross-functional teams
    • Dedicated learner support before, during and after the programme
    • Course completion record on finishing the one-day programme

    50+

    Industries Served

    1-to-1

    Doubt-Clearing Sessions

    60+

    Global Course Portfolio

    100+

    Countries Served

    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 ZimbabweAll our classroom training is now available online at your convenience

    Quality by Design in Zimbabwe

    Hyatt Regency Harare The Meikles, Patrice Lumumba Street, Braeside, Harare, Harare Province, Zimbabwe

    Quality by Design in Zimbabwe

    The Rainbow Towers, Robert Mugabe Road, Milton Park, Harare, Harare Province, Zimbabwe

    corporate banner

    Corporate QbD TrainingFor Your Pharmaceutical Teams

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    • Train whole cross-functional development and quality teams together
    • Customised content built around your products and live projects
    • Flexible onsite, live virtual or blended delivery for Zimbabwe teams
    • Strengthen GMP readiness for MCAZ and WHO-aligned inspections
    • Standardise QbD practice across formulation, process, quality and regulatory
    • Experienced trainers with real pharmaceutical development expertise
    • Scalable delivery for single sites or multi-site operations

    Trusted by Leading Organisations

    CAPS PharmaceuticalsVarichem PharmaceuticalsDatlabsPharmanovaPlus Five PharmaceuticalsZimPharm

    What Our Learners Say

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    A Clear, Structured Way to Develop Products

    "The QbD training changed how I approach formulation. I now start every project with a clear QTPP and CQA list instead of jumping straight to trials, and my development work is far more structured and defensible."

    Tendai Moyo

    Formulation Scientist

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    Risk Assessment Finally Clicked

    "The risk assessment session was the highlight for me. Learning to use Ishikawa diagrams and FMEA to link process parameters to quality attributes has made our investigations much sharper and easier to justify."

    Rutendo Chikwava

    QA Analyst

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    Stronger Submissions, Clearer Evidence

    "Very practical and well paced. Understanding the design space and control strategy has helped me prepare stronger, clearer development sections for our regulatory submissions."

    Farai Ncube

    Regulatory Affairs Officer

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    One Shared QbD Language Across Teams

    "We ran this as an onsite programme for our development and quality teams. Everyone now shares the same QbD language, and our scale-up and inspection readiness have both improved noticeably."

    Nyasha Dube

    Quality Manager, Pharmaceutical Manufacturer

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    Tailored, High-Value Team Training

    "The trainers tailored the case studies to our own products, which made the learning stick. It was a practical, high-value investment for building in-house development capability for our site."

    Chipo Mangwiro

    Learning and Development Lead, Generics Producer

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

    Quality by Design training is a practical, non-certification course that teaches a systematic, science-based approach to pharmaceutical product and process development. You learn to build quality into a product from the design stage using the ICH Q8, Q9, Q10 and Q11 framework and tools such as QTPP, CQAs, DoE and the control strategy.

    General

    What is Quality by Design (QbD) training?

    Quality by Design training is a practical, non-certification course that teaches a systematic, science-based approach to pharmaceutical product and process development. You learn to build quality into a product from the design stage using the ICH Q8, Q9, Q10 and Q11 framework and tools such as QTPP, CQAs, DoE and the control strategy.

    Who should attend QbD training in Zimbabwe?

    The programme suits formulation scientists, process development engineers, analytical chemists, quality assurance professionals and regulatory affairs specialists in Zimbabwe's pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations who want to understand and apply QbD in development and manufacturing.

    Is Quality by Design worth it for pharmaceutical professionals?

    Yes. QbD is increasingly expected by regulators and gives you a skill that reduces deviations, strengthens submissions and supports local production and export goals. As Zimbabwe's manufacturers raise compliance and target regional markets, professionals who can design quality in are in real demand.

    Does the course cover both small molecule and biologic products?

    Yes. The training covers QbD principles for small molecule drug products such as tablets, capsules and injectables, and for biologics such as monoclonal antibodies and biosimilars. Case study examples are drawn from both product types.

    Do I need prior QbD experience to attend?

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

    Pricing

    How much does QbD training cost in Zimbabwe?

    Fees vary by delivery format, group size and whether you enrol as an individual or a corporate team. Pricing is available on request. Contact a learning advisor for a current quote tailored to your needs.

    What is included in the QbD course fee?

    The fee typically includes instructor-led sessions across all QbD modules, structured courseware, hands-on tool exercises, realistic case studies and learner support. A course completion record is provided on finishing the programme.

    Do you offer corporate or group pricing for QbD training?

    Yes. We offer corporate group training with customised content and volume-based pricing for development, quality and regulatory teams. It is a cost-effective way to build shared capability. Ask about corporate and group pricing for your team.

    Are payment options available?

    Yes. We accept major cards and bank transfers, and can discuss options for corporate bookings. Speak with a learning advisor to arrange the approach that suits you.

    Do you provide anything on completion of the training?

    Yes. On completing the one-day programme you receive a course completion record from Invensis Learning, confirming the QbD skills you have built. There is no exam or external credential attached to the course.

    Assessment

    Is there an exam for the QbD course?

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

    How is learning assessed during the programme?

    There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, risk assessment and design space interpretation to realistic development scenarios throughout the day, so you practise the skills as you learn them.

    How long is the QbD training?

    The programme is delivered in one day of about eight hours, covering QbD principles and the ICH framework, QTPP and CQAs, risk assessment, DoE and the design space, PAT and the control strategy, and QbD in practice, with hands-on exercises throughout.

    Which standards and guidelines does the course follow?

    The course is grounded in the ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Q11 (Drug Substances) guidelines, alongside FDA and EMA expectations and WHO-aligned GMP practice.

    Will the skills expire or need renewing?

    No. The QbD knowledge and tools are immediately applicable and do not expire. There is no credential to maintain or renew, so the learning stays useful on every development project you take on.

    Course Content

    What topics does the QbD syllabus cover?

    The syllabus spans QbD principles and the ICH regulatory context, the QTPP and CQAs, risk assessment with Ishikawa diagrams and FMEA, DoE and design space definition, PAT and the control strategy, and QbD in practice including case studies, submissions and lifecycle management.

    What QbD tools will I learn to use?

    You learn to build a QTPP, identify and classify CQAs, run risk assessment with Ishikawa diagrams and FMEA, plan and interpret Design of Experiments, define a design space with NOR and PAR, and develop a control strategy supported by Process Analytical Technology.

    Are there hands-on exercises in the training?

    Yes. Hands-on QbD tool exercises run throughout the day, including QTPP construction, CQA identification and criticality assessment, Ishikawa diagrams for risk assessment, a DoE design selection exercise and design space interpretation, all applied to realistic development scenarios.

    Is the courseware aligned to the current ICH guidelines?

    Yes. The courseware is aligned to the current ICH Q8, Q9, Q10 and Q11 guidelines that define the QbD approach, and reflects current FDA, EMA and WHO-aligned GMP expectations.

    Will the training help with regulatory submissions?

    Yes. You learn how QbD outputs such as the QTPP, CQAs, risk assessment, design space and control strategy form the pharmaceutical development section of a CTD submission, so you can structure and defend QbD evidence for MCAZ and international health authorities.

    Enrollment

    How do I enrol in the QbD course in Zimbabwe?

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

    What training formats are available?

    The course is available as online (live virtual) instructor-led training, in-person classroom training, and customised corporate onsite training for teams, so you can choose the format that fits your schedule and location.

    When can I start the QbD training?

    Public sessions run on a regular schedule, and corporate onsite dates can be arranged around your team's availability. See upcoming schedules or contact a learning advisor to confirm the next available start.

    Can I arrange onsite training for my team in Zimbabwe?

    Yes. We deliver onsite and live virtual group training for pharmaceutical teams across Zimbabwe, with content tailored to your products and processes. Request a group quote to plan a session for your organisation.

    Can I reschedule my enrolment?

    Yes. Flexible options let you reschedule or transfer to another session where needed. Contact our support team and they will help you move to a date that works for you.