Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Quality by Design Training in Mauritius DeliversUntitledA Practical, Science-Based Approach

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical product and process development that builds quality into a product from the design stage rather than testing it in at the end. Quality by Design Training in Mauritius gives pharmaceutical, biopharma and API professionals the practical skills to apply this approach on real development projects. The programme is grounded in the ICH Q8(R2) Pharmaceutical Development guideline, with ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, the framework the FDA and EMA increasingly expect. You learn to define the Quality Target Product Profile, identify Critical Quality Attributes, run risk assessment, use Design of Experiments to map the design space, and build a robust control strategy. Mauritius is growing into a trusted pharmaceutical manufacturing and export hub for Africa, where employers compete on quality and GMP compliance. Whether you work in formulation, analytical or process development, quality assurance or regulatory affairs, QbD skills help you design quality in from the outset. Start your QbD journey with Invensis Learning.

    What Quality by Design Training in Mauritius DeliversA Practical, Science-Based Approach

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical product and process development that builds quality into a product from the design stage rather than testing it in at the end. Quality by Design Training in Mauritius gives pharmaceutical, biopharma and API professionals the practical skills to apply this approach on real development projects.

    The programme is grounded in the ICH Q8(R2) Pharmaceutical Development guideline, with ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, the framework the FDA and EMA increasingly expect. You learn to define the Quality Target Product Profile, identify Critical Quality Attributes, run risk assessment, use Design of Experiments to map the design space, and build a robust control strategy.

    Mauritius is growing into a trusted pharmaceutical manufacturing and export hub for Africa, where employers compete on quality and GMP compliance. Whether you work in formulation, analytical or process development, quality assurance or regulatory affairs, QbD skills help you design quality in from the outset. 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 Mauritius 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 Mauritius 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 Mauritius

    • Instructor-led training formats available for individual learners and corporate teams across the Mauritius
    • 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 Mauritius
    • 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 Mauritius 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 MauritiusWho 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

    Why QbD Skills Pay off in Pharmaceutical DevelopmentDesign Quality in, Not Test It In

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical professionals move from empirical, test-and-fix development to a structured approach that designs quality into the product. The course suits formulation scientists, analytical and process development scientists, QA professionals and regulatory affairs specialists. Whether you are formalising your QbD practice, supporting a first regulatory submission, or leading development in a Mauritius pharma or API organisation, this training builds capability aligned to what employers and regulators expect.

    If you want to apply QbD tools with confidence and connect development work to consistent product quality, this programme is a practical next step. You gain hands-on experience with the QTPP, CQA identification, risk assessment, DoE and control strategy that you can use immediately at work.

    • Apply a systematic QbD approach that replaces trial and error with science-based decisions
    • Build the QTPP and identify Critical Quality Attributes with confidence on real products
    • Lead risk assessments using Ishikawa diagrams and FMEA to focus development effort where it matters
    • Plan and interpret Design of Experiments to define a defensible design space
    • Develop control strategies and apply PAT thinking that stand up to regulatory scrutiny
    • Speak the ICH Q8 to Q11 language that FDA and EMA reviewers expect in submissions
    • Strengthen your standing in Mauritius pharma and biopharma teams that compete on quality
    • Contribute to the CTD pharmaceutical development section from day one
    For Organizations

    For Organizations

    QbD group training helps pharmaceutical and biopharma organisations build quality into products by equipping cross-functional teams with a common, science-based method. The training can be delivered for development teams, QA functions or whole sites. For organisations that want fewer deviations, smoother submissions and stronger process understanding, this training provides a scalable, flexible solution.

    If your teams still rely on end-product testing to catch quality problems, QbD group training creates a shared approach to the QTPP, risk assessment, DoE and control strategy. Your people gain a standardised way to design quality in and defend it to regulators.

    • Builds a shared QbD language across formulation, analytical, process and quality teams
    • Strengthens ICH Q8 to Q11 alignment across development and manufacturing
    • Reduces manufacturing deviations by designing robust processes from the start
    • Improves regulatory submission quality and lowers post-approval change burden
    • Supports GMP compliance and export readiness for regional and international markets
    • Enables customised training mapped to your product pipeline and live projects
    • Standardises risk assessment and design space practice across the organisation
    • Builds stronger in-house QbD and CMC capability

    Where QbD Skills Lead Careers in MauritiusRoles, Demand and Sectors

    Quality by Design skills are increasingly valued across Mauritius as the island grows into a quality-focused pharmaceutical and export hub for Africa. Employers in pharma manufacturing, biopharma, API and CDMOs need professionals who can design quality in and align development to ICH Q8 to Q11. Demand spans formulation, analytical and process development, quality assurance and regulatory affairs, and here is what the market is telling us right now.

    Rs 900k

    Quality Assurance Manager pay, Mauritius

    per year, market estimate 2026

    Rs 641,900

    QA Supervisor average, Mauritius

    per year, worldsalaries 2025-2026

    Rs 1 billion

    PSIP pharma investment

    vaccines and pharma, PSIP 2025/26

    63%

    African biopharma import growth

    2010-2020, trade data

    SECTORS HIRING

    • —Pharmaceutical Manufacturing and Formulation
    • —Biopharmaceutical and Biotechnology
    • —Active Pharmaceutical Ingredient (API) Production
    • —Contract Development and Manufacturing (CDMOs)
    • —Regulatory Affairs and CMC
    • —Quality Assurance and Quality Control Laboratories

    GROWTH TRENDS

    • —Rs 1 billion PSIP investment in vaccine and pharma production
    • —New National Laboratory strengthening testing and quality assurance
    • —Mauritius positioning as a quality-led pharma export hub for Africa
    • —GMP and cold-chain investment raising quality expectations
    • —African biopharma imports up 63% over the last decade
    • —Regulators increasingly expecting QbD evidence in submissions

    Sources: Paylab, worldsalaries, jobs.mu (Mauritius) 2025-2026; trade.gov Mauritius Pharmaceuticals; PSIP 2025/26 to 2029/30.

    Market Pressures Making QbD Skills Essential in Mauritius

    Quality-First Export Ambitions

    Mauritius is growing as a pharma export hub for Africa, and export markets demand consistent, GMP-grade quality that is designed into products, not tested in afterwards.

    QbD builds design-in quality skills

    Rising Regulatory Expectations

    The FDA, EMA and regional regulators increasingly expect QbD evidence in submissions, so teams need people fluent in the QTPP, design space and control strategy.

    QbD aligns you to ICH Q8 to Q11

    Test-And-Fix Development Still Common

    Many teams still rely on end-product testing to catch problems, causing deviations and rework that a science-based QbD approach is built to prevent.

    QbD replaces trial and error

    Scarce QbD and CMC Talent

    Mauritius has capable QA and laboratory professionals but few with structured QbD and Design of Experiments skills, making trained practitioners genuinely sought-after.

    QbD makes your profile stand out

    New National Laboratory Capacity

    A new National Laboratory and Rs 1 billion PSIP investment expand testing and quality capacity, raising demand for staff who understand quality by design end to end.

    QbD supports testing and QA scale-up

    Pressure to Cut Deviations and Cost

    Margin and compliance pressure push manufacturers to design robust processes and control strategies that reduce batch failures and costly post-approval changes.

    QbD builds robust, efficient processes

    Sources: trade.gov Mauritius Pharmaceuticals; PSIP 2025/26 to 2029/30; ICH Q8 to Q11; indian-ocean.com pharma hub overview 2026.

    QbD is more than a method. It is how modern pharmaceutical teams design quality in and win regulatory confidence. Build the skills Mauritius employers are hiring for and start your QbD journey today.

    Your Mauritius QbD Career Shift

    From Testing Quality in to Designing It In

    What Changes After QbD Training

    Mauritius pharma is moving from catching quality problems late to building quality in from the design stage, and employers increasingly separate teams that can do this from those that cannot. Here is the shift QbD training helps you make.

    Today

    Limited leverage for senior QA and development roles

    After QbD

    Positioned for QA manager and development roles where quality is valued, with QA supervisor bands around Rs 641,900 a year

    Today

    Shortlisted less often for QbD and CMC-focused roles

    After QbD

    Considered across pharma, biopharma, API and CDMO employers in Mauritius

    Today

    Confident in the laboratory, but not in design space thinking

    After QbD

    Fluent in the QTPP, DoE, control strategy and the ICH Q8 to Q11 framework

    You build QbD capability

    Before

    Quality is checked by end-product testing after manufacture

    Now you have

    Quality is designed into the product from the QTPP onward

    Before

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

    Now you have

    Development is science-based, using DoE and a defined design space

    Before

    Risk is handled informally with limited documentation

    Now you have

    Risk is assessed with FMEA and mapped to CQAs, CMAs and CPPs

    Before

    Submissions struggle to show real process understanding

    Now you have

    You can structure QbD evidence for the ICH Q8 pharmaceutical development report

    "The gap between running tests and designing quality in is increasingly a defined skill set, and the pharma organisations that matter already know it."

    Join 50,000+ professionals who trained with Invensis Learning and built new skills.

    Sources: Paylab, worldsalaries, PayScale (Mauritius) 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 Mauritius 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 MasterApplied QbD Tools and Techniques

    This Quality by Design training builds practical, hands-on capability across the full QbD toolkit. By the end of the programme you can define a QTPP, identify CQAs, run risk assessment, plan DoE, define a design space and develop a control strategy for real pharmaceutical products.

    Quality Target Product Profile (QTPP)

    Construct a QTPP from clinical and patient needs, defining dosage form, strength, pharmacokinetics and quality standards as the design specification for the whole development programme.

    Critical Quality Attribute Identification

    Identify and classify the physical, chemical and biological CQAs that must stay within limits to assure product quality, safety and efficacy, for both small molecules and biologics.

    Risk Assessment with FMEA and Ishikawa

    Use fishbone diagrams and FMEA with Severity, Occurrence and Detectability to link material attributes and process parameters to each CQA and prioritise what needs formal study.

    Design of Experiments and Design Space

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

    PAT and Control Strategy

    Apply Process Analytical Technology thinking and build a control strategy of material, process and in-process controls that keeps production within the design space.

    QbD in Regulatory Submissions

    Structure QbD evidence for the CTD Section 3.2.P.2 pharmaceutical development report and manage lifecycle changes in line with ICH Q12.

    Who Should TakeQuality by Design Training in Mauritius?

    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

    MUR 16390

    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

    MUR 16390

    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 Train with Invensis Learning for QbD in MauritiusExpert-Led, Practical and Flexible

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and organisations that want to build quality into their products. Our programmes combine experienced instructors, hands-on QbD exercises, structured courseware and flexible delivery. Whether you enrol as an individual or arrange corporate training for a development team, Invensis Learning, a trusted Quality by Design training company in Mauritius, provides an expert-led experience focused on real-world application and measurable learning outcomes, backed by ISO 9001:2015 and ISO 27001:2022 certification.

    • Instructor-led training delivered by experienced quality and pharmaceutical practitioners
    • Flexible formats: online (live virtual), classroom and onsite corporate delivery
    • ISO 9001:2015 certified quality management and ISO 27001:2022 information security
    • Hands-on QbD exercises using realistic pharmaceutical development scenarios
    • Structured courseware covering the QTPP, CQAs, DoE, design space and control strategy
    • Global training provider with regional support across Mauritius and worldwide
    • Dedicated learner support before, during and after training
    • Course completion record from Invensis Learning on finishing the programme

    100+

    Countries Served

    ISO 9001

    Quality Management

    200K+

    Professionals Trained

    12M+

    Hours of Training Delivered

    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 MauritiusAll our classroom training is now available online at your convenience

    Quality by Design in Mauritius

    Sugar Beach Resort Mauritius, Coastal Road, Flic en Flac, Flic en Flac VCA, Black River, 90503, Mauritius / Maurice

    Quality by Design in Mauritius

    Hilton Mauritius Resort & Spa, Coastal Road, Flic en Flac, Flic en Flac VCA, Black River, 90503, Mauritius / Maurice

    corporate banner

    Corporate QbD Training for TeamsEmbed Quality Company-Wide

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    • Customised QbD training mapped to your product pipeline and live projects
    • Flexible delivery: onsite, live virtual, hybrid or blended for teams
    • Schedules aligned to your team and manufacturing availability
    • Experienced trainers with pharmaceutical quality and QbD expertise
    • Role-based examples for formulation, analytical, process and QA teams
    • Dedicated coordination and learner support for group programmes
    • Scalable delivery for teams across Mauritius and global sites

    Pharmaceutical and Life Sciences Employers

    Africure PharmaceuticalsCIDPAjanta PharmaAlliance Global GroupCERNOL ChemicalsPro-Pharma

    What Our Learners Say

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    DoE Finally Made Sense

    "The DoE and design space sessions changed how I approach formulation. I can now plan experiments that actually map the design space instead of guessing, and my risk assessments are far more structured."

    Yashvin Beeharry

    Formulation Scientist

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    Quality Designed in, Not Tested In

    "Coming from a QC background, the QTPP and CQA modules connected everything. I understand now how quality is designed in, not just tested at the end. The trainer used real pharma scenarios throughout."

    Anjali Ramdhony

    Quality Assurance Officer

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    Directly Useful for Submissions

    "Practical and well paced. Mapping the QbD outputs to the CTD pharmaceutical development section was exactly what I needed for our regulatory submissions."

    Kevin Li Ying

    Regulatory Affairs Specialist

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    A Shared QbD Language for Our Site

    "We trained our development and QA teams together. Everyone now shares one language for the QTPP, risk assessment and control strategy, and our deviation reviews have clearly improved."

    Fabrice Laval

    Head of Quality, Pharmaceutical Manufacturer

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    Tailored and Practical Corporate Training

    "The corporate programme was tailored to our product pipeline. Science-based, practical and immediately applicable across our formulation and process teams."

    Sandhya Curpen

    L&D Manager, Life Sciences

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

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical product and process development that builds quality into a product from the design stage rather than testing it in at the end. It uses tools such as the QTPP, Critical Quality Attributes, risk assessment, Design of Experiments, the design space and a control strategy.

    General

    What is Quality by Design (QbD)?

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical product and process development that builds quality into a product from the design stage rather than testing it in at the end. It uses tools such as the QTPP, Critical Quality Attributes, risk assessment, Design of Experiments, the design space and a control strategy.

    Who should attend this QbD training in Mauritius?

    The course suits formulation scientists, analytical and process development scientists, QA and QC professionals, regulatory affairs and CMC specialists, and manufacturing technical managers in pharmaceutical, biopharma, API, CDMO and medical device organisations who want to understand and apply QbD.

    Is QbD training worth it for my career?

    Yes. QbD is increasingly expected by the FDA, EMA and regional regulators, and Mauritius employers competing on quality value people who can design it in. The practical skills apply immediately to development, quality and regulatory work, strengthening your standing across the sector.

    Which regulatory framework does QbD follow?

    QbD is grounded in the ICH Q8(R2) Pharmaceutical Development guideline, supported by ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. These guidelines shape how quality is designed, assessed and controlled.

    Do I need prior QbD knowledge to join?

    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 pharmaceutical development context.

    Pricing

    How much does QbD training cost in Mauritius?

    Fees vary by delivery format (live online, classroom or corporate) and group size, so pricing is available on request. Contact a learning advisor for a quote tailored to your needs.

    What is included in the course fee?

    The fee typically includes instructor-led training across all QbD modules, structured courseware, hands-on tool exercises, pharmaceutical case studies, learner support and a course completion record from Invensis Learning. Ask a learning advisor for the full list of inclusions.

    Do you offer group or corporate pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for development teams, QA functions and whole sites in Mauritius. Ask about corporate and group pricing for a tailored quote.

    In what currency is the training billed?

    Training for learners in Mauritius is typically quoted in Mauritian rupees (Rs), though pricing can vary by delivery format and group size. Confirm the current amount with a learning advisor when you enquire.

    What payment options are available?

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

    Assessment

    How is learning assessed in this QbD course?

    There is no formal test or assessment. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and group discussion, so you practise QTPP construction, CQA identification, risk assessment and DoE as you learn.

    What do I receive on completing the training?

    You receive a course completion record from Invensis Learning. This is a practical skills programme, so the real outcome is the ability to apply QbD tools and the ICH framework to your own pharmaceutical development projects.

    Does this course award a formal qualification?

    No. This is a practical skills programme, not a formal qualification. It focuses on building workplace capability in QbD methodology and the ICH Q8 to Q11 framework, and the skills you gain are immediately usable on real development projects.

    Will the skills expire or need renewing?

    No. QbD skills do not expire and require no renewal. Once you can build a QTPP, run risk assessment, plan DoE and define a control strategy, those capabilities stay with you and apply across products and projects.

    Can I apply QbD immediately at work?

    Yes. The course is built around realistic pharmaceutical scenarios, so you leave able to construct a QTPP, identify CQAs, facilitate FMEA risk assessments, plan DoE and develop a control strategy for regulatory submissions straight away.

    Course Content

    What topics does the QbD course cover?

    The programme covers QbD principles and the ICH regulatory context, the QTPP and Critical Quality Attributes, risk assessment with Ishikawa and FMEA, Design of Experiments and the design space, Process Analytical Technology and control strategy, and QbD case studies and lifecycle management.

    What will I learn about Design of Experiments?

    You learn why DoE replaces one-factor-at-a-time testing, how to choose screening and response-surface designs, how to interpret the model, and how to define a design space with Normal Operating Ranges and Proven Acceptable Ranges.

    Does the course cover both small molecules and biologics?

    Yes. The training covers QbD for small molecule drug products such as tablets and injectables, and for biologics such as monoclonal antibodies, with case study examples from both, including attributes like glycosylation and aggregation.

    Are there hands-on exercises?

    Yes. You work through practical exercises in QTPP construction, CQA identification and criticality, Ishikawa and FMEA risk assessment, DoE design selection and design space interpretation, all applied to realistic pharmaceutical development scenarios.

    How does QbD fit into regulatory submissions?

    QbD outputs form the pharmaceutical development section, CTD Section 3.2.P.2, of regulatory submissions. The course shows how to structure QTPP, CQA, risk assessment, DoE and control strategy evidence and manage lifecycle changes in line with ICH Q12.

    Enrollment

    How do I enrol in the QbD course?

    You can enrol through the Invensis Learning website. Choose your preferred format, complete payment, and you 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, classroom training, and onsite corporate delivery for teams. Choose the format that fits your schedule and how your team prefers to learn.

    How long is the QbD training?

    The programme runs for one day (eight hours), covering all QbD modules from principles and the ICH framework through the QTPP, CQAs, risk assessment, DoE, design space, PAT and control strategy, with hands-on tool exercises throughout.

    Can you deliver the course onsite in Mauritius?

    Yes. We deliver corporate onsite training for pharmaceutical and biopharma teams across Mauritius, and live virtual sessions for distributed teams. Ask about corporate scheduling for a tailored plan.

    How soon can I start?

    New live online and corporate sessions are scheduled regularly. Contact a learning advisor to see upcoming dates and reserve your place, or to arrange a dedicated session for your team.