Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    Quality by Design Training in Vietnam ExplainedUntitledBuilding Quality in, Not Testing It In

    Quality by Design Training in Vietnam gives pharmaceutical and biopharmaceutical professionals a systematic, science-based way to build quality into a product from the design stage rather than testing it in at the end. Quality by Design (QbD) is the approach set out in the ICH Q8(R2), Q9, Q10 and Q11 guidelines and increasingly expected by regulators such as the US FDA and the EMA. Over one focused day you learn to apply the core QbD tools: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. For formulation scientists, process engineers, analytical scientists, QA teams and regulatory affairs specialists across Vietnam's fast-growing pharma sector, these are fast becoming day-to-day skills. As local manufacturers move from WHO-GMP to EU-GMP and PIC/S standards to win hospital tenders and export generics, the ability to design robust processes and defend them in a CTD submission is a real advantage. Delivered live virtual, in the classroom and onsite by Invensis Learning, the training turns ICH theory into workplace capability. Start building quality by design into your work with Invensis Learning.

    Quality by Design Training in Vietnam ExplainedBuilding Quality in, Not Testing It In

    Quality by Design Training in Vietnam gives pharmaceutical and biopharmaceutical professionals a systematic, science-based way to build quality into a product from the design stage rather than testing it in at the end. Quality by Design (QbD) is the approach set out in the ICH Q8(R2), Q9, Q10 and Q11 guidelines and increasingly expected by regulators such as the US FDA and the EMA.

    Over one focused day you learn to apply the core QbD tools: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. For formulation scientists, process engineers, analytical scientists, QA teams and regulatory affairs specialists across Vietnam's fast-growing pharma sector, these are fast becoming day-to-day skills.

    As local manufacturers move from WHO-GMP to EU-GMP and PIC/S standards to win hospital tenders and export generics, the ability to design robust processes and defend them in a CTD submission is a real advantage. Delivered live virtual, in the classroom and onsite by Invensis Learning, the training turns ICH theory into workplace capability. Start building quality by design into your work 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 Vietnam 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 Vietnam 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 Vietnam

    • Instructor-led training formats available for individual learners and corporate teams across the Vietnam
    • 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 Vietnam
    • 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 Vietnam 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 VietnamWho 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 Payoff of Building Quality by DesignFor Professionals and Teams

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical professionals move from reactive quality control to proactive, design-stage quality. You learn to apply QTPP, CQA identification, risk assessment, DoE and control strategy on real formulation and process work. Whether you are a formulation scientist, process engineer, analytical chemist, QA specialist or regulatory affairs professional in Vietnam, these are the QbD skills EU-GMP and export-focused employers increasingly look for.

    If you want to stand out as your organisation upgrades to EU-GMP and PIC/S, QbD fluency is a clear advantage. You gain a practical toolkit, real-world exercises and a course completion record from Invensis Learning.

    • Design quality into products from the start instead of testing it in later
    • Apply the ICH Q8 to Q11 QbD framework used across modern pharma development
    • Build QTPPs and identify Critical Quality Attributes with confidence
    • Lead risk assessments using Ishikawa diagrams and FMEA
    • Plan and interpret Design of Experiments to understand the design space
    • Develop control strategies and support CTD regulatory submissions
    • Stand out as Vietnam's manufacturers move to EU-GMP and PIC/S standards
    • Gain skills that transfer across small molecules and biologics
    For Organizations

    For Organizations

    Quality by Design group training helps pharmaceutical and biopharmaceutical organisations build design-stage quality capability across development, manufacturing and regulatory teams. It can be delivered for formulation, process, analytical, QA and CMC groups together. For manufacturers upgrading to EU-GMP and PIC/S or preparing export submissions, QbD training creates a shared, ICH-aligned way of working.

    If your teams still rely on end-product testing and trial-and-error scale-up, QbD training gives them a common language for QTPP, risk assessment, DoE and control strategy, reducing deviations and strengthening submissions.

    • Build a shared, ICH-aligned QbD approach across cross-functional teams
    • Support your upgrade to EU-GMP and PIC/S manufacturing standards
    • Reduce manufacturing deviations through better process understanding
    • Strengthen CTD submissions with defensible design-space evidence
    • Standardise QTPP, risk assessment and DoE practice across sites
    • Prepare development teams for export and hospital-tender requirements
    • Deliver flexible training onsite, live virtual or blended for teams
    • Develop in-house QbD expertise that lasts beyond the programme

    Where Quality by Design Leads in VietnamPharma Roles, Demand and Pay

    Vietnam's pharmaceutical sector is one of Asia's fastest growing, forecast to reach around 10 billion USD in 2026, and its shift to EU-GMP and PIC/S is creating strong demand for professionals who can design quality in. QbD skills, built through structured Quality by Design training, open roles across quality assurance, formulation, process development and regulatory affairs, from QC officer to QA manager and head of quality. Here is what the market is telling us right now.

    $10bn

    Vietnam pharma market, 2026

    forecast, VietnamPlus / Trade.gov

    17

    EU-GMP certified plants

    Vietnam pharma sector data 2026

    â‚«258M

    Reg. affairs specialist pay, HCMC

    per year, WorldSalaries 2026

    238+

    WHO-GMP certified facilities

    Vietnam pharma sector data 2026

    SECTORS HIRING

    • —Generic and Branded Generic Manufacturing
    • —Biopharmaceuticals and Vaccines
    • —Contract Development and Manufacturing (CDMOs)
    • —Multinational Pharma and Technology Transfer
    • —Regulatory Affairs and CMC
    • —API and Excipient Manufacturing

    GROWTH TRENDS

    • —WHO-GMP to EU-GMP and PIC/S upgrade wave across manufacturers
    • —National pharma strategy to 2030, with a vision to 2045
    • —Import-substitution drive and tier-1 hospital-tender access
    • —Export ambitions across Asia-Pacific markets
    • —Foreign investment and vaccine or biologics technology transfer
    • —Rising demand for QbD and DoE-literate quality talent

    Sources: Trade.gov, VietnamPlus, The Investor, WorldSalaries, Paylab, ERI (Vietnam) 2026; Vietnam national pharmaceutical strategy to 2030.

    Industry Forces Making QbD Skills Valuable in Vietnam

    The EU-GMP and PIC/S Upgrade Race

    Vietnamese manufacturers are moving from WHO-GMP to EU-GMP and PIC/S to win tenders and export. That shift demands the design-stage process understanding QbD delivers.

    QbD builds design-stage process understanding

    Pressure to Replace Imported Medicines

    Vietnam's national pharma strategy to 2030 aims to make medicines a spearhead industry and cut import reliance, raising the bar for local product and process development.

    QbD strengthens local development capability

    Winning Tier-1 Hospital Tenders

    EU-GMP quality is now central to hospital bidding channels. Teams that can design and defend robust quality stand out in a competitive procurement market.

    QbD helps you design and defend quality

    Export and Global Submission Readiness

    Selling generics into regulated markets requires QbD evidence in CTD submissions. Design space and control strategy skills make those dossiers defensible.

    QbD builds design space and control skills

    Scarce QbD and DoE Capability

    Vietnam has a deep GMP-compliance base but a thin pool of professionals fluent in QbD, DoE and the design space, making these skills genuinely sought after.

    QbD makes design-stage talent stand out

    Biologics and Technology Transfer

    Biologics leaders and multinational technology-transfer partners need design-stage quality for complex products, from monoclonal antibodies to recombinant therapies.

    QbD supports complex product development

    Sources: Trade.gov, VietnamPlus, The Investor, B-Company; Vietnam national pharmaceutical strategy to 2030 (2026).

    Vietnam's move to EU-GMP and export markets is reshaping pharmaceutical quality. Build the QbD skills employers now look for and lead quality from the design stage.

    Your Vietnam Career Shift

    Where You Stand Today,

    And Where Quality by Design Takes You

    Vietnam's pharma sector is moving fast from basic compliance to EU-GMP and export-grade quality, and employers increasingly separate professionals who can design quality in from those who only test for it. Here is which side of that line QbD skills put you on.

    Today

    You rely on end-product testing to catch quality problems

    With QbD

    You build quality in from the design stage using QTPP, CQAs and DoE

    Today

    Strong on GMP compliance but light on QbD and design-space skills

    With QbD

    Fluent in the QbD toolkit Vietnam's EU-GMP transition now rewards

    Today

    Pay capped in a role focused on routine QC checks

    With QbD

    Reg. affairs and QA manager roles in Vietnam reach â‚«480M to â‚«620M a year

    You build QbD capability

    Before

    Quality assured mainly by testing finished batches

    Now you have

    A science-based way to design quality into the product

    Before

    Process understanding built by trial and error

    Now you have

    DoE-driven understanding of how inputs drive your CQAs

    Before

    Submissions that struggle to defend process choices

    Now you have

    CTD-ready QTPP, design space and control strategy evidence

    Before

    Skills tied to one employer or a single product line

    Now you have

    ICH-aligned QbD skills that transfer across pharma and biopharma

    "As Vietnam's manufacturers move to EU-GMP and export markets, the people who can design quality in, not test it in, are the ones who move up."

    Join the professionals who trained with Invensis Learning and made the shift.

    Sources: WorldSalaries, Paylab, ERI (Vietnam) 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 Vietnam 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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    100% Secure and Safe download

    The QbD Skills You Will Build and ApplyFrom QTPP to Control Strategy

    Skills covered in Quality by Design training span the full ICH-aligned QbD workflow. By the end of the programme you can build quality into a pharmaceutical product from the design stage and defend it with data.

    Define the QTPP and Critical Quality Attributes

    Construct a Quality Target Product Profile from clinical and patient needs, then identify and classify the CQAs that determine product safety, quality and efficacy.

    Run QbD Risk Assessments

    Map material attributes and process parameters to each CQA using Ishikawa diagrams and FMEA, and prioritise the high-risk relationships that need experimental study.

    Design and Analyse DoE Studies

    Plan screening and response-surface experiments, interpret the statistical model, and replace slow one-factor-at-a-time work with structured Design of Experiments.

    Establish and Justify the Design Space

    Turn DoE results into a defined design space with Normal Operating and Proven Acceptable Ranges, and understand the edge of failure and the regulatory flexibility it unlocks.

    Apply PAT and Build a Control Strategy

    Use Process Analytical Technology such as NIR and Raman for real-time monitoring, and assemble a risk-proportionate control strategy across materials, process and testing.

    Present QbD in Regulatory Submissions

    Structure QTPP, risk assessment, design space and control strategy evidence for Section 3.2.P.2 of the CTD, aligned to FDA and EMA expectations.

    Who Should TakeQuality by Design Training in Vietnam?

    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 395

    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 395

    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 LearningFor Your QbD Training in Vietnam?

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and organisations across Vietnam, built on the ICH Q8, Q9, Q10 and Q11 guidelines. Our programmes combine experienced quality-management practitioners, flexible delivery and hands-on QbD tool exercises. Whether you enrol as an individual or arrange corporate training for a development team, we focus on real-world application, so you leave able to use QTPP, CQAs, DoE and the control strategy at work.

    • ISO 9001:2015 certified provider with ISO 27001:2022 information security
    • Experienced practitioner trainers in quality management and pharma development
    • Hands-on QbD exercises using realistic pharmaceutical development scenarios
    • Flexible formats: live online, classroom, onsite and corporate delivery
    • Courseware built on the ICH Q8, Q9, Q10 and Q11 quality guidelines
    • Dedicated learner support before, during and after the training
    • Scalable delivery for teams across Vietnam and the wider region
    • Course completion record from Invensis Learning on finishing the programme

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    Corporate Clients

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    Years of Training Excellence

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    Learner Support

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    Over 5000 five star reviews

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    Quality by Design Training Locations in VietnamAll our classroom training is now available online at your convenience

    Quality by Design in Vietnam

    Sofitel Legend Metropole Hanoi, 15, Ngo Quyen Street, Hoan Kiem Ward, Hanoi City, 11024, Vietnam

    Quality by Design in Vietnam

    Caravelle Saigon Hotel, Lam Son Square, Quarter 5, Saigon Ward, Thu Duc, Ho Chi Minh City, 71006, Vietnam

    corporate banner

    Corporate Quality by Design TrainingFor Your Vietnam Teams

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    • Train formulation, process, QA and regulatory teams together
    • Flexible onsite, live virtual, hybrid or blended delivery
    • Schedules aligned with your production and project calendar
    • Real pharma scenarios and your own products in the exercises
    • Support your move to EU-GMP and PIC/S standards
    • Dedicated coordination and reporting for group programmes
    • Scalable delivery across sites in Vietnam and the region

    Pharma and Biopharma Organisations

    DHG PharmaImexpharmTraphacoSanofi VietnamNanogenDomesco

    What Our Learners Say

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    QbD Thinking That I Use Every Week

    "The exercises finally made QTPP and CQAs click for me. I came in strong on GMP but weak on design-stage thinking, and now I can map material attributes and process parameters to quality with real confidence."

    Nguyen Thi Mai

    Formulation Scientist

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    Practical from Start to Finish

    "Clear, practical and well paced. The risk-assessment session on Ishikawa and FMEA changed how our lab prioritises studies. I left able to run a proper criticality assessment instead of guessing."

    Tran Van Hung

    QA Specialist

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    Helped Me with CTD Submissions

    "As we prepare export dossiers, understanding how QTPP, design space and control strategy fit into Section 3.2.P.2 was exactly what I needed. The ICH grounding was accurate and easy to follow."

    Le Thi Thanh

    Regulatory Affairs Specialist

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    DoE Made Simple and Usable

    "The DoE and design-space content was the highlight. Replacing one-factor-at-a-time work with structured experiments has already made our scale-up more predictable and easier to defend."

    Pham Minh Quan

    Process Development Engineer

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    A Shared QbD Language for Our Teams

    "We ran this for our development and QA teams as we upgrade to EU-GMP. It gave everyone a shared QbD language, and the trainer tailored the case examples to our own products. Deviations discussions are far more focused now."

    Vu Thi Lan

    QA Manager, Generic Manufacturer

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    Reliable Partner for Team Upskilling

    "As an L&D lead in a biopharma group, I needed training that scaled across formulation, analytical and regulatory staff. Invensis Learning delivered a consistent, practical programme and coordinated the whole cohort smoothly."

    Dang Hoang Nam

    Learning and Development Lead, Biopharma

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

    Quality by Design (QbD) is a systematic, science-based way to build quality into a pharmaceutical product from the design stage rather than testing it in at the end. The training covers the ICH Q8(R2), Q9, Q10 and Q11 framework and tools including QTPP, CQAs, risk assessment, DoE, the design space and control strategy.

    General

    What is Quality by Design and what does the training cover?

    Quality by Design (QbD) is a systematic, science-based way to build quality into a pharmaceutical product from the design stage rather than testing it in at the end. The training covers the ICH Q8(R2), Q9, Q10 and Q11 framework and tools including QTPP, CQAs, risk assessment, DoE, the design space and control strategy.

    Who should attend Quality by Design training in Vietnam?

    It suits formulation scientists, process development engineers, analytical scientists, QA professionals and regulatory affairs specialists in pharmaceutical, biopharmaceutical, API and CDMO organisations. Anyone applying QbD in product development or submissions will benefit.

    Is QbD training worth it for pharma professionals in Vietnam?

    Yes. As Vietnamese manufacturers move from WHO-GMP to EU-GMP and PIC/S and target export markets, employers increasingly expect QbD skills. The ability to design robust processes and defend them in submissions is a genuine career advantage.

    Do I need prior QbD knowledge to join?

    No. The programme introduces QbD from first principles in a pharmaceutical development context. Familiarity with development or GMP concepts helps but is not required.

    Which ICH guidelines does the QbD training align to?

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

    Pricing

    How much does Quality by Design training cost in Vietnam?

    Fees vary by delivery format (live online, classroom or corporate), group size and schedule. Contact us for current pricing in your preferred format. Corporate and group rates are available on request.

    What is included in the course fee?

    The fee typically includes instructor-led training across all QbD modules, hands-on tool exercises, courseware and learning resources, learner support and a course completion record from Invensis Learning.

    Do you offer corporate or group pricing?

    Yes. We offer group and corporate rates for teams, with customised schedules for QA, development and regulatory groups. Ask about corporate pricing for a tailored quote.

    Are there savings for team enrolments?

    Volume-based pricing is available for team and corporate bookings. Talk to a learning advisor about the best option for your group.

    What payment options are available?

    We accept major cards and bank transfers, with instalment options on selected plans. Speak with a learning advisor to choose what suits you.

    Assessment

    Is there a test or assessment at the end of the course?

    No. This is a practical, non-assessment skills programme. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and discussion rather than a formal test.

    What do I receive on completing the training?

    You receive a course completion record from Invensis Learning. This is a non-certification programme, so no external credential is awarded; the value is the practical QbD skills you can apply immediately at work.

    How is my learning reinforced during the course?

    Through practical exercises: constructing a QTPP, identifying CQAs, building an Ishikawa diagram, running an FMEA and interpreting a design space, all applied to realistic pharmaceutical development scenarios.

    Is there a governing body behind this training?

    No single body governs the training itself. QbD is defined by the ICH quality guidelines (Q8 to Q11) and expected by regulators such as the FDA and EMA; the course teaches that framework and its tools.

    What will I be able to do after the training?

    You will be able to construct a QTPP, identify and classify CQAs, run FMEA-based risk assessments, plan and interpret DoE, define a design space with NOR and PAR, and build a control strategy for CTD submissions.

    Course Content

    What topics does the QbD training cover?

    It covers QbD principles and the ICH regulatory context, QTPP and CQAs, risk assessment (Ishikawa and FMEA), Design of Experiments and the design space, Process Analytical Technology and control strategy, and QbD in practice through case studies and submissions.

    Does the course cover Design of Experiments (DoE)?

    Yes. DoE is central to QbD. You learn screening and response-surface designs, how to interpret the statistical model, and how DoE results define the design space and its Normal Operating and Proven Acceptable Ranges.

    Is the training relevant to both small molecules and biologics?

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

    How long is the programme and how is it delivered?

    The programme runs as a focused one-day (8-hour) course. It is available live online, in the classroom and as onsite corporate training, so you can choose the format that fits your schedule.

    Does the course include hands-on practice?

    Yes. Hands-on QbD tool exercises run throughout, so you apply QTPP construction, CQA identification, risk assessment and design-space interpretation to realistic scenarios.

    Enrollment

    How do I enrol in QbD training in Vietnam?

    Enrol through the Invensis Learning website. Choose your format, complete payment, and you receive access to schedules, courseware and learning resources. Talk to a learning advisor if you need help choosing.

    What delivery formats are available?

    You can take the training live online (virtual instructor-led), in a classroom, onsite at your premises, or as customised corporate group training, so you can pick what fits your schedule.

    How soon can I start?

    Public live online sessions run regularly, and corporate sessions are scheduled to suit your team. See upcoming schedules or ask an advisor about the next available cohort.

    Can you deliver the training onsite for our team in Vietnam?

    Yes. We deliver onsite and live virtual corporate training for pharmaceutical and biopharmaceutical teams across Vietnam, tailored to your products and processes. Request a group quote to get started.

    What is the reschedule or cancellation policy?

    Rescheduling and cancellations follow our published policy, and selected plans allow you to transfer to another batch. Contact support for the details that apply to your booking.