Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters for Brazilian PharmaUntitledA Science-Led Route to Better Medicines

    Quality by Design Training in Brazil equips pharmaceutical and biopharmaceutical 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 mandated by the ICH Q8(R2), Q9, Q10 and Q11 guidelines and increasingly expected by ANVISA, the FDA and the EMA as the foundation of modern development submissions. Across Brazil, from national leaders such as EMS and Eurofarma to biosimilar developers and contract manufacturers, employers want scientists who can apply QbD tools including the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), quality risk management, Design of Experiments (DoE) and the control strategy. This one-day programme introduces the full framework with hands-on exercises built on realistic development scenarios. Whether you work in formulation, process development, analytical science, regulatory affairs or quality assurance, QbD skills help you reduce deviations, strengthen dossiers and connect development to consistent manufacturing. Start your QbD journey with Invensis Learning.

    What Is Quality by Design and Why It Matters for Brazilian PharmaA Science-Led Route to Better Medicines

    Quality by Design Training in Brazil equips pharmaceutical and biopharmaceutical 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 mandated by the ICH Q8(R2), Q9, Q10 and Q11 guidelines and increasingly expected by ANVISA, the FDA and the EMA as the foundation of modern development submissions.

    Across Brazil, from national leaders such as EMS and Eurofarma to biosimilar developers and contract manufacturers, employers want scientists who can apply QbD tools including the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), quality risk management, Design of Experiments (DoE) and the control strategy. This one-day programme introduces the full framework with hands-on exercises built on realistic development scenarios.

    Whether you work in formulation, process development, analytical science, regulatory affairs or quality assurance, QbD skills help you reduce deviations, strengthen dossiers and connect development to consistent manufacturing. Start your QbD journey with Invensis Learning.

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    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Brazil 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 Brazil 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 Brazil

    • Instructor-led training formats available for individual learners and corporate teams across the Brazil
    • 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 Brazil
    • 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 Brazil 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 BrazilWho Can Enroll?

    • No formal prerequisites are required to enroll in the Quality by Design training program

    • Basic familiarity with quality assurance concepts is helpful but not mandatory for enrollment

    • Professionals from pharmaceutical, biotechnology, healthcare, and manufacturing industries are well-suited for this training

    • Individuals and corporate teams seeking to build QbD knowledge and apply regulatory-aligned product development principles are eligible to enroll

    • Learners with backgrounds in quality, regulatory affairs, process engineering, and production management will find the content directly applicable to their roles

    What You Gain from Applying QbD at WorkReal Capability, Not Just Theory

    For Individuals

    For Individuals

    QbD training helps pharmaceutical professionals move from empirical development to a science-based approach that regulators and employers increasingly expect. The programme suits formulation scientists, process development engineers, analytical scientists, QA professionals and regulatory affairs specialists. Whether you are entering pharmaceutical development, moving into a submission-facing role, or leading product transfers in generics, biosimilars or CDMO work, this training builds capability you can use immediately.

    If you want to prove you can design quality in and defend it in an ANVISA, FDA or EMA dossier, QbD is a practical, high-value skill set. You leave able to construct a QTPP, identify CQAs, plan a DoE, interpret a design space and shape a control strategy.

    • Apply a proven, ICH-aligned method to design quality into products from the outset
    • Replace trial-and-error formulation with structured Design of Experiments
    • Lead QTPP and CQA workshops that focus development on what matters to patients
    • Run quality risk assessments using FMEA and Ishikawa diagrams with confidence
    • Define a design space and a control strategy that hold up in regulatory review
    • Reduce deviations and reworks through deeper process understanding
    • Strengthen your value to formulation, RA, CMC and QA teams in Brazil
    • Gain a course completion record from Invensis Learning to evidence your learning
    For Organizations

    For Organizations

    QbD group training helps pharmaceutical organisations in Brazil build development capability by equipping cross-functional teams with a consistent, ICH-aligned method. The training can be delivered for R&D groups, quality units or whole development teams. For companies looking to strengthen submissions and improve manufacturing consistency, this training offers a scalable, practical solution.

    If your teams still rely on end-product testing and case-by-case development, QbD group training creates a common framework for QTPP, risk assessment, DoE and control strategy. Teams gain a structured, defensible approach to designing quality in.

    • Builds a shared QbD language across formulation, analytical, process and quality teams
    • Improves right-first-time development and reduces costly manufacturing deviations
    • Strengthens CMC dossiers as ANVISA aligns with ICH expectations
    • Supports faster, more predictable scale-up and technology transfer
    • Enables customised training tied to your own live development projects
    • Standardises risk assessment and design space practice across sites
    • Provides flexible onsite, live online and blended delivery for teams
    • Builds in-house QbD expertise that reduces reliance on external consultants

    Where QbD Takes Pharma Careers in BrazilWhy QbD Skills Are in Demand

    Quality by Design skills are becoming a marker of strong development professionals across Brazil, valued by generics leaders, biosimilar developers, CDMOs and API producers as ANVISA aligns its expectations with ICH. As the sector modernises, employers increasingly want scientists who can design quality in and defend it in a dossier. Demand spans formulation, process development, analytical science, quality assurance and CMC regulatory roles, and here is what the market is telling us right now.

    US$36B

    Brazil pharmaceutical market, 2026

    Market Research Future / industry 2026

    20-40%

    Regulated-sector pay premium

    above general QA average, EDTI 2026

    R$4,100/mo

    QC analyst average, Brazil

    salario.com.br 2026

    up to R$30k/mo

    Quality manager range

    Glassdoor Brazil 2026

    SECTORS HIRING

    • —Generics and Branded Pharmaceutical Manufacturers
    • —Biopharmaceutical and Biosimilar Developers
    • —Contract Development and Manufacturing Organisations
    • —Active Pharmaceutical Ingredient (API) Producers
    • —Regulatory Affairs and CMC Teams
    • —Medical Devices and Veterinary Pharmaceuticals

    GROWTH TRENDS

    • —ANVISA aligning its regulatory agenda with ICH guidelines and global standards
    • —Biosimilar competition rising under RDC 875/2024 reference rules
    • —Strong national generics base, with local firms around 80% of pharmacy sales
    • —QbD and PAT adoption generating richer development datasets
    • —Chronic-disease demand expanding advanced and complex therapies
    • —Government investment strengthening domestic drug production

    Sources: salario.com.br, Glassdoor, EDTI, Market Research Future, Fortune Business Insights (Brazil) 2026.

    Market Forces Driving Demand for QbD Skills in Brazil

    Alignment with ICH Expectations

    ANVISA is modernising toward ICH standards, and QbD evidence is increasingly expected in submissions. Teams need scientists who can build and defend QbD dossiers.

    QbD builds ICH-aligned development skills

    Rising Biosimilar Competition

    RDC 875/2024 opens the biosimilar market to international comparators, so developers must prove consistent, well-understood processes that only a QbD approach delivers.

    QbD builds process understanding skills

    From Testing in to Designing In

    Many firms still rely on end-product testing to catch problems. QbD shifts the effort upstream, building quality in through QTPP, risk assessment and design space work.

    QbD replaces test-and-fix development

    Cost Pressure in Generics

    National firms dominate pharmacy sales and compete hard on price. Right-first-time development and fewer deviations make QbD-skilled scientists valuable to the bottom line.

    QbD builds right-first-time capability

    The QbD and PAT Data Gap

    Adoption of QbD and Process Analytical Technology generates richer datasets, but few teams can design the experiments and read the results. That skills gap is widening.

    QbD builds DoE and PAT interpretation skills

    Formulation Science Talent Scarcity

    Brazil has deep analytical and QC talent but fewer scientists fluent in QTPP, DoE and control strategy. QbD skills make development professionals rare and sought-after.

    QbD makes development scientists stand out

    Sources: DrugPatentWatch, OpenPR, Market Research Future, Panorama Farmaceutico (Brazil) 2026.

    QbD is more than a framework. It is the skill set that turns pharmaceutical development into a predictable, submission-ready science. Join professionals across Brazil who design quality in from the start. Begin your QbD journey today.

    Your Brazil QbD Transformation

    Your QbD Skills, Before and After the Training

    A Clear Capability Shift

    Brazil's pharmaceutical sector is modernising as ANVISA aligns with ICH and biosimilar competition grows, and employers increasingly separate scientists who can design quality in from those who only test it. Here is which side of that line you want to be on.

    Today

    Seen as a lab specialist with a narrow remit

    After QbD

    Recognised as a development professional who links science to consistent quality

    Today

    Deviations and reworks slow your projects down

    After QbD

    Fewer deviations and reworks through robust, well-understood processes

    Today

    Pay tied to a general QC band with limited leverage

    After QbD

    Positioned for higher-paying QA, regulatory and development roles

    You master the QbD toolkit

    Before

    Quality checked mainly through end-product testing

    Now you have

    Quality designed in from the QTPP and CQAs onward

    Before

    Formulation choices made by trial and error

    Now you have

    Formulation and process decisions guided by DoE and a defined design space

    Before

    Risk assessments done informally, if at all

    Now you have

    Structured risk assessment skills using FMEA and Ishikawa diagrams

    Before

    Limited input into regulatory submissions

    Now you have

    The ability to shape QbD evidence for ANVISA, FDA and EMA dossiers

    "The gap between running tests and understanding a process is a set of QbD skills, and the organisations that matter in Brazil already know it."

    Join 50,000+ professionals who trained with Invensis Learning and moved their skills forward.

    Sources: salario.com.br, Glassdoor, EDTI (Brazil) 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 Brazil 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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    Skills You Will Build in This QbD ProgrammeTools You Will Use Every Day

    The QbD training helps you build practical development capability across the full framework. By the end of the one-day programme, you can move from a Quality Target Product Profile through risk assessment, DoE and design space to a defensible control strategy.

    Build a Quality Target Product Profile

    This QbD training covers the tools you will use across pharmaceutical development. You will learn to construct a QTPP from clinical and patient needs so the whole programme is anchored to a clear quality specification.

    Identify and Classify Critical Quality Attributes

    Learn to identify CQAs and distinguish them from non-critical attributes, then link each one to critical material attributes and critical process parameters using prior knowledge and risk-based reasoning.

    Run Quality Risk Assessments

    Apply Ishikawa diagrams and FMEA to map and prioritise risks, using severity, occurrence and detectability to focus experimental effort on the relationships that most affect product quality.

    Design Experiments and Define the Design Space

    Use Design of Experiments, from screening to response surface designs, to quantify how parameters affect CQAs, then define a design space with normal operating and proven acceptable ranges.

    Apply Process Analytical Technology

    Understand how PAT tools such as NIR and Raman spectroscopy enable real-time monitoring of critical attributes during manufacturing and support real-time release testing.

    Develop a Control Strategy for Submissions

    Bring risk assessment and DoE outputs together into a control strategy, and learn how QbD evidence is structured for CTD Module 3 pharmaceutical development sections.

    Who Should TakeQuality by Design Training in Brazil?

    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 425

    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 425

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

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

    Loading schedules…

    Why Choose Invensis Learning for Quality by Design Training in BrazilTrusted Training for Pharma Teams

    Invensis Learning delivers structured QbD training for pharmaceutical professionals and organisations in Brazil that want to build quality into development and strengthen submissions. As a trusted Quality by Design training company in Brazil, our programmes combine experienced trainers, ICH-aligned content, hands-on exercises and flexible delivery. Whether you are enrolling as an individual or planning corporate training for your team, Invensis Learning provides a professional learning experience built around practical understanding, real-world application and measurable outcomes. As an ISO 9001:2015 and ISO 27001:2022 certified organisation, we hold our training and information security to international standards.

    • Experienced trainers with real pharmaceutical development and quality expertise
    • Content aligned to the ICH Q8, Q9, Q10 and Q11 QbD guidelines
    • Flexible formats for individuals, working professionals and corporate teams
    • Hands-on QbD tool exercises on realistic pharmaceutical development scenarios
    • Live online, classroom and onsite delivery to fit your schedule
    • Customised group training that can use your own live development projects
    • Dedicated learner support before, during and after the programme
    • Course completion record from an ISO 9001:2015 certified training organisation

    200K+

    Professionals Trained

    12M+

    Hours of Training Delivered

    4

    Flexible Learning Modes

    98%

    First-Attempt Pass Rate

    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 BrazilAll our classroom training is now available online at your convenience

    Quality by Design in Brazil

    Renaissance São Paulo Hotel, 2233, Alameda Santos, Cerqueira César, Jardim Paulista, São Paulo, Região Sudeste, 01419-002, Brasil

    Quality by Design in Brazil

    Hilton São Paulo Morumbi, 12901, Avenida das Nações Unidas, Brooklin Novo, Itaim Bibi, São Paulo, Região Sudeste, 04571-000, Brasil

    corporate banner

    Corporate QbD Training for TeamsBuilt Around Your Projects

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    • Suitable for small, medium and large development and quality teams
    • Customised schedules built around your team availability
    • Onsite, live virtual, hybrid or blended delivery across Brazil
    • Trainers with pharmaceutical development and QbD expertise
    • Exercises applied to your own live formulation and process projects
    • Dedicated coordination and support for corporate programmes
    • Scalable delivery for teams across single or multiple sites

    Leading Pharmaceutical Organisations

    EMSEurofarmaAcheHypera PharmaCristaliaLibbs

    What Our Learners Say

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    QbD Made Practical at Last

    "The training finally made the ICH framework practical for me. Building a QTPP and mapping CQAs to process parameters in the exercises changed how I approach formulation work at my company."

    Carolina Mendes

    Formulation Scientist

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    DoE That I Can Actually Apply

    "The Design of Experiments and design space sessions were the highlight. I now understand how to plan experiments instead of changing one factor at a time, which has already saved us development runs."

    Rafael Oliveira

    Process Development Analyst

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    Directly Useful for CMC Work

    "As a regulatory affairs professional, the control strategy and CTD sessions helped me see how QbD evidence fits a dossier. Very relevant as ANVISA moves closer to ICH expectations."

    Juliana Costa

    Regulatory Affairs Specialist

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    Great Fit for a Cross-Functional Team

    "We ran this as an onsite session for our development and quality teams. It gave everyone a shared QbD language and the risk assessment exercises mapped straight onto our current projects."

    Marcelo Ferreira

    R&D Team Lead, Generics Manufacturer

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    Tailored and Immediately Applicable

    "The trainer tailored the case studies to biosimilar development, which is exactly our focus. Our team came away able to run structured CQA and risk assessment workshops in-house."

    Patricia Almeida

    Quality Assurance Manager, Biopharma

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

    Yes. QbD training gives you a practical, ICH-aligned method to build quality into products, reduce deviations and strengthen submissions. As ANVISA aligns with ICH and biosimilar competition grows, these skills are increasingly valued across generics, biopharma, API and CDMO employers in Brazil.

    General

    Is Quality by Design training worth it for pharma professionals in Brazil?

    Yes. QbD training gives you a practical, ICH-aligned method to build quality into products, reduce deviations and strengthen submissions. As ANVISA aligns with ICH and biosimilar competition grows, these skills are increasingly valued across generics, biopharma, API and CDMO employers in Brazil.

    What is Quality by Design (QbD)?

    QbD is a systematic, science-based approach to pharmaceutical development in which quality is designed into the product from the start rather than tested in at the end. It is defined by the ICH Q8(R2), Q9, Q10 and Q11 guidelines and uses tools such as the QTPP, CQAs, risk assessment, DoE, the design space and the control strategy.

    Who should attend this QbD training?

    The training suits formulation scientists, process development engineers, analytical scientists, regulatory affairs and CMC specialists, and quality assurance professionals in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations who want to apply QbD in development.

    Do I need prior QbD knowledge to join?

    No. The course has no formal prerequisites and introduces QbD from first principles. Familiarity with pharmaceutical development or GMP is helpful but not required, so professionals new to QbD can follow the full framework comfortably.

    Which standards and guidelines does the course follow?

    The training is grounded in the ICH QbD guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances, with context on FDA, EMA and ANVISA expectations.

    Pricing

    How much does the Quality by Design training cost in Brazil?

    Pricing varies by delivery mode, group size and format, so a current fee is available on request. Public and corporate options are offered in Brazil. Request a quote or talk to a learning advisor for the exact price for your chosen format.

    What is included in the course fee?

    The fee typically includes instructor-led sessions, QbD courseware, hands-on tool exercises and case studies, learner support, and a course completion record from Invensis Learning. Confirm the exact inclusions for your selected format when you enquire.

    Do you offer group or corporate pricing?

    Yes. We offer corporate group training with schedules tailored to your team and volume-based pricing for development and quality units. Ask about corporate or group pricing for a quote suited to your organisation.

    Is there a discount when a whole team enrols together?

    Group enrolments are quoted on a corporate basis, which is usually more cost-effective per learner than individual seats. Share your team size with us and we will prepare a tailored quote.

    What payment methods are available?

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

    Assessment

    What do I receive after completing the training?

    On completing the one-day programme you receive a course completion record from Invensis Learning. This is a skills training course, so it builds practical QbD capability you can apply straight away rather than a formal credential.

    How is learning reinforced during the programme?

    Learning is reinforced through hands-on QbD tool exercises, real pharmaceutical case study examples and group discussion. You apply QTPP construction, CQA identification, risk assessment and design space interpretation to realistic development scenarios.

    Are the QbD exercises practical and hands-on?

    Yes. Throughout the day you work through practical exercises, building a QTPP, mapping CQAs, running an Ishikawa and FMEA risk assessment, and interpreting a design space, so the concepts translate directly into your own projects.

    Will I be able to apply QbD at work straight away?

    Yes. The tools are immediately applicable. After the training you can construct QTPPs, lead CQA identification, facilitate risk assessments, plan and interpret DoE studies, define a design space and help develop a control strategy for submissions.

    Does the training need to be repeated later?

    No. The skills you learn do not expire and there is nothing to maintain afterwards. You can, however, extend your learning with complementary Design for Six Sigma or Minitab Essentials training for DoE and statistical analysis.

    Course Content

    What topics does the QbD training cover?

    The one-day programme covers QbD principles and the ICH framework, the QTPP and CQAs, quality risk assessment, Design of Experiments and the design space, Process Analytical Technology and the control strategy, and QbD in practice through case studies and submissions.

    Does the course cover both small molecules and biologics?

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

    How long is the training?

    The programme runs for one day, totalling 8 hours. It is also available in a half-day format across two sessions. Both cover the complete QbD framework with hands-on tool exercises throughout.

    Does the course include Design of Experiments (DoE)?

    Yes. DoE is a core module. You learn screening and response surface designs, how to run and analyse a QbD experiment, and how DoE results define a design space with normal operating and proven acceptable ranges.

    What learning materials are provided?

    You receive structured QbD courseware, pharmaceutical case study examples and tool exercise materials covering QTPP, CQA identification, risk assessment and design space interpretation to support learning during and after the programme.

    Enrollment

    How do I enrol in the QbD training in Brazil?

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

    What delivery formats are available?

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

    How soon can I start?

    Public sessions run on a scheduled basis and corporate sessions are arranged around your team availability. Check the upcoming schedules or contact us, and we will confirm the next available dates for your chosen format.

    Can this be delivered onsite for our team in Brazil?

    Yes. Corporate onsite delivery is available across Brazil and is especially effective when a cross-functional team applies QbD tools to its own live development projects during the session. Ask about corporate training options for a tailored quote.

    Can I reschedule my enrolment to another session?

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