Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training?UntitledBuilding Quality in, Not Testing It In

    Quality by Design Training in Singapore is a practical, one-day course that teaches the Quality by Design (QbD) approach to pharmaceutical and biopharmaceutical product and process development. Instead of testing quality in at the end, you learn to build it in from the design stage, based on a thorough understanding of the product and its manufacturing process. The programme is grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH Q9, Q10 and Q11 framework that governs modern QbD practice. You work through the full toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT) and the control strategy, all applied to realistic development scenarios. It suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals and CMC regulatory affairs specialists across Singapore's pharma and biopharma sector. Start building QbD capability with Invensis Learning and apply it to your own projects straight away.

    What Is Quality by Design Training?Building Quality in, Not Testing It In

    Quality by Design Training in Singapore is a practical, one-day course that teaches the Quality by Design (QbD) approach to pharmaceutical and biopharmaceutical product and process development. Instead of testing quality in at the end, you learn to build it in from the design stage, based on a thorough understanding of the product and its manufacturing process.

    The programme is grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH Q9, Q10 and Q11 framework that governs modern QbD practice. You work through the full toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT) and the control strategy, all applied to realistic development scenarios.

    It suits formulation scientists, process development engineers, analytical scientists, quality assurance professionals and CMC regulatory affairs specialists across Singapore's pharma and biopharma sector. Start building QbD capability with Invensis Learning and apply it to your own projects straight away.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Singapore 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 Singapore 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 Singapore

    • Instructor-led training formats available for individual learners and corporate teams across the Singapore
    • 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 Singapore
    • 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 Singapore 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 SingaporeWho 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 Quality by Design TrainingSkills You Can Apply from Day One

    For Individuals

    For Individuals

    Quality by Design Training helps you move from empirical, test-and-fix development to a proactive approach that designs quality into the product from the outset. You gain practical command of the QbD tools that pharmaceutical and biopharmaceutical employers now expect. Whether you work in formulation, process development, analytical science, quality assurance or CMC regulatory affairs, the skills apply directly to your projects across small molecules and biologics.

    If you want to contribute to robust products, smoother scale-up and stronger regulatory submissions, QbD is a capability worth building. You leave able to run QTPP and CQA workshops, facilitate risk assessments, plan DoE studies and shape a control strategy for real development programmes.

    • Replace trial-and-error development with a systematic, science-based QbD approach
    • Construct a Quality Target Product Profile and identify Critical Quality Attributes with confidence
    • Lead risk assessments using Ishikawa diagrams and FMEA to prioritise development effort
    • Plan and interpret Design of Experiments and define a defensible design space
    • Develop a control strategy and apply PAT to assure consistent product quality
    • Speak the language of ICH Q8, Q9, Q10 and Q11 across development, quality and regulatory teams
    • Structure QbD evidence for CTD submissions to the HSA, FDA, EMA and other authorities
    • Stand out in Singapore's competitive pharma and biopharma talent market
    For Organizations

    For Organizations

    Group Quality by Design Training equips a cross-functional development team with a common, science-based method for building quality into products. The session can be delivered for R&D, process development, quality and regulatory groups together. For organisations scaling biologics and complex products, a shared QbD approach connects development decisions to consistent, regulator-ready outcomes.

    If your teams still rely on end-product testing to catch problems, QbD training gives them the tools to understand and control quality upstream. They gain a standardised approach to QTPP, CQAs, risk assessment, DoE and control strategy that scales across projects and sites.

    • Builds a shared QbD language across formulation, process, analytical, quality and regulatory teams
    • Reduces manufacturing deviations and out-of-specification results through better process understanding
    • Supports smoother technology transfer and scale-up from development to commercial manufacturing
    • Strengthens QbD-based CTD submissions and regulatory relationships
    • Enables a design space that lowers the post-approval change burden
    • Aligns cross-functional teams to ICH Q8, Q9, Q10 and Q11 expectations
    • Can be tailored to your own live product development projects
    • Delivered flexibly for teams across your Singapore and regional sites

    Quality by Design Careers in SingaporeIn-Demand Roles and Sectors

    Quality by Design training builds skills that open doors across Singapore's fast-growing pharmaceutical and biopharmaceutical sector, where eight of the world's top ten biopharma firms run manufacturing sites. Professionals who can build quality into products using the QTPP, CQAs, risk assessment and Design of Experiments are valued in formulation, process development, quality assurance and CMC regulatory roles. As biologics capacity and continuous manufacturing expand, demand for QbD-literate talent keeps rising, and here is what the market is telling us right now.

    ~S$38bn

    Pharma manufacturing output, Singapore

    2023, JTC and EDB Singapore

    8 of 10

    Top 10 biopharma firms with local sites

    EDB Singapore

    32.9%

    Biologics and biosimilars market share

    2026, market research

    S$120,000

    Average QA manager salary, Singapore

    per year, SalaryExpert 2026

    SECTORS HIRING

    • —Pharmaceutical and Biopharmaceutical Manufacturing
    • —Biologics, Vaccines and Cell Therapies
    • —Contract Development and Manufacturing (CDMOs)
    • —Active Pharmaceutical Ingredient (API) Production
    • —CMC Regulatory Affairs and Consulting
    • —Medical Devices and Diagnostics

    GROWTH TRENDS

    • —Eight of the world's top ten biopharma firms run local manufacturing sites
    • —Major biologics capacity coming online at Tuas Biomedical Park
    • —Shift from batch to continuous manufacturing raising process-understanding needs
    • —Regulators increasingly expecting QbD evidence in submissions
    • —Skilled talent gap in QbD, DoE and process characterisation
    • —Right-first-time and cost pressure pushing built-in quality

    Sources: EDB Singapore, JTC, SalaryExpert, PayScale, Morgan McKinley (Singapore) 2026; industry market research.

    Why Quality by Design Skills Are in Demand in Singapore

    Rising Regulatory Expectations

    Authorities including the FDA, EMA and HSA increasingly expect QbD evidence in submissions. Teams that cannot show QTPP, design space and control strategy reasoning face review delays and deficiencies.

    QbD builds submission-ready development skills

    The Biologics Manufacturing Boom

    Large biologics investments at Tuas demand deep process understanding for complex, process-defined products. QbD gives scientists the tools to characterise and control biologic quality attributes.

    QbD builds process-understanding skills

    Shift to Continuous Manufacturing

    As sites move from batch to continuous lines, real-time control becomes essential. QbD and PAT skills let teams design robust processes and monitor quality attributes as products are made.

    QbD builds design-space and PAT skills

    A Persistent QbD Talent Gap

    Singapore has a deep pharma workforce but comparatively few professionals fluent in QbD, DoE and process characterisation. Building these skills makes you visibly more valuable to employers.

    QbD makes your profile stand out

    Right-First-Time Cost Pressure

    Deviations, reworks and out-of-specification batches are costly. QbD reduces them by designing quality in, giving manufacturers more consistent output and fewer late-stage surprises.

    QbD builds robust, low-deviation processes

    Technology Transfer and Scale-Up

    Moving products from development to commercial scale often exposes weak process understanding. A QbD design space and control strategy make transfer and scale-up far more predictable.

    QbD builds scale-up and control-strategy skills

    Sources: EDB Singapore, JTC, biopharmaAPAC, CDMO market research (Singapore) 2026; ICH Q8, Q9, Q10 and Q11 guidelines.

    Quality by Design is a practical capability that pays off at work. Join pharmaceutical professionals in Singapore who build quality into products from the design stage and lead development with confidence. Start your learning journey today.

    Your Singapore QbD Skills Journey

    From Testing Quality in to Designing It In

    Your QbD Skills Transformation

    Singapore's pharma and biopharma sector is expanding with biologics investment and advanced manufacturing, and employers increasingly separate professionals who can design quality in from those who only test it. Here is which side of that line you want to be on.

    Today

    Progress limited to testing and inspection roles with narrow scope

    After Training

    QbD-literate roles in Singapore span QA, process development and CMC bands that reward built-in quality

    Today

    Passed over for roles that list QbD, DoE or process characterisation

    After Training

    Eligible for QbD-focused roles across pharma, biopharma, API and CDMO employers

    Today

    Strong on lab technique, but light on end-to-end process understanding

    After Training

    Fluent in linking development decisions to consistent, regulator-ready quality

    You build QbD capability

    Before

    Development driven by trial and error and end-product testing

    Now you have

    A systematic, ICH-aligned method for building quality into every product

    Before

    Familiar with the terms but unsure how to apply the QbD tools

    Now you have

    Command of QTPP, CQAs, risk assessment, DoE and the design space

    Before

    Reliant on others to structure the pharmaceutical development story

    Now you have

    Confidence to shape control strategies and QbD evidence for submissions

    Before

    Skills siloed to one function with limited portfolio reach

    Now you have

    A cross-functional skill valued across pharma, biopharma and CDMOs

    "The gap between testing quality in and designing it in is now a recognised skill set, and the pharma teams that matter already know it."

    Join the professionals and teams who upskilled with Invensis Learning and made the shift.

    Sources: SalaryExpert, PayScale, Morgan McKinley (Singapore) 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 Singapore 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 CourseThe QbD Toolkit, Applied

    In Quality by Design Training you will learn to apply the full QbD toolkit, from defining the Quality Target Product Profile to building a control strategy, so you can design quality into pharmaceutical products rather than test for it afterwards. Each skill is practised on realistic development scenarios.

    Define the Quality Target Product Profile

    In Quality by Design Training you will learn to construct a QTPP from clinical and patient needs, setting out the quality, safety and efficacy characteristics that a product must achieve as the design specification for the whole programme.

    Identify and Classify Critical Quality Attributes

    Learn to identify CQAs for small molecules and biologics, distinguish critical from non-critical attributes, and link each CQA to Critical Material Attributes and Critical Process Parameters using Ishikawa diagrams.

    Run QbD Risk Assessments with Ishikawa and FMEA

    Apply structured risk assessment to prioritise the material attributes and process parameters that most affect quality, using fishbone diagrams and FMEA with Severity, Occurrence and Detectability to rank risk.

    Apply Design of Experiments and the Design Space

    Learn how DoE quantifies the relationships between inputs and quality attributes, how to choose screening and response-surface designs, and how the design space, NOR and PAR are defined from the results.

    Build a Control Strategy and Use PAT

    Develop a risk-proportionate control strategy from your QbD outputs and understand how Process Analytical Technology tools such as NIR and Raman enable real-time monitoring and real-time release testing.

    Structure QbD Evidence for Submissions

    Learn how QbD outputs populate Section 3.2.P.2 of the CTD, how the design space supports post-approval change flexibility, and how QbD applies to continuous manufacturing and lifecycle management.

    Who Should TakeQuality by Design Training in Singapore?

    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

    SGD 510

    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

    SGD 510

    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 for Quality by DesignHands-On Training for Singapore Teams

    Invensis Learning delivers structured Quality by Design training for professionals and teams who want to build practical, science-based quality capability. Our sessions combine experienced trainers, hands-on exercises and content aligned to the ICH QbD framework. Whether you enrol as an individual or plan group training for a development team in Singapore, we focus on real-world application, so you can put QTPP, CQA, risk assessment, DoE and control-strategy skills to work straight away. Our operations are backed by ISO 9001:2015 and ISO 27001:2022 standards.

    • Experienced trainers with real pharmaceutical quality and QbD expertise
    • Flexible delivery through live virtual, classroom and onsite formats
    • Practical, exercise-led sessions using real pharma development scenarios
    • Content grounded in the ICH Q8, Q9, Q10 and Q11 QbD framework
    • Support for both individual learners and cross-functional corporate teams
    • Backed by ISO 9001:2015 quality and ISO 27001:2022 information security standards
    • Dedicated learner support before, during and after the training
    • Trusted by professionals and organisations across many industries

    4

    Flexible Learning Modes

    98%

    First-Attempt Pass Rate

    5000+

    Accredited Trainers Globally

    4.7/5

    Rated by Learners Worldwide

    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 SingaporeAll our classroom training is now available online at your convenience

    Quality by Design in Singapore

    Marina Bay Sands Singapore, 10 Bayfront Ave, Singapore 018956

    Quality by Design in Singapore

    The Ritz-Carlton, Millenia Singapore, Marina Bay 7, Raffles Ave., Singapore 039799

    corporate banner

    Corporate Quality by Design TrainingFor Your Teams

    Untitled

    • Tailored QbD training for development, quality and regulatory teams
    • Flexible delivery through onsite, live virtual, hybrid or blended formats
    • Schedules aligned with your team's availability across Singapore sites
    • Exercises mapped to your own live product development projects
    • Experienced trainers with pharmaceutical and biopharmaceutical expertise
    • A shared QbD language that connects functions and reduces deviations
    • Scalable delivery for local, regional and global teams

    Pharma and Biopharma Employers in Singapore

    GSKPfizerSanofiNovartisMSDRoche

    What Our Learners Say

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    QbD Tools I Could Use the Next Week

    "The QTPP and CQA exercises finally made Quality by Design click for me. I went back to my formulation team and ran our first proper risk assessment using the Ishikawa and FMEA approach from the course."

    Wei Ling Tan

    Formulation Scientist

    Untitled

    0/0

    Made the ICH Framework Practical

    "As a CMC regulatory specialist I needed to understand how the design space and control strategy fit the CTD. The trainer connected ICH Q8 to real submission sections clearly, and the biologics examples were spot on."

    Arjun Menon

    Regulatory Affairs Specialist (CMC)

    Untitled

    0/0

    Confident with DoE Concepts Now

    "Good pace for a one-day programme. The Design of Experiments and design space sections gave me the vocabulary and confidence to work more closely with our process development scientists."

    Siti Rahayu

    Quality Assurance Specialist

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    Aligned Our Whole Development Team

    "We ran this as an in-house session for our development and quality teams. Everyone left speaking the same QbD language, and our risk assessments are noticeably more structured. The trainer tailored the examples to our products."

    Daniel Koh

    Head of Manufacturing Quality

    Biopharmaceutical Manufacturer

    0/0

    Smooth, Practical Corporate Delivery

    "Invensis coordinated a corporate cohort across two of our sites with minimal disruption. The practical, scenario-based format suited our scientists far better than theory-heavy training, and the feedback was excellent."

    Priya Nair

    Learning and Development Manager

    Pharmaceutical Company

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

    Quality by Design Training is a practical, one-day skills course on the QbD approach to pharmaceutical and biopharmaceutical development, where quality is built into the product from the design stage. It is worth it because QbD skills are increasingly expected by employers and regulators across Singapore's pharma sector, and they apply directly to your work.

    General

    What is Quality by Design Training and is it worth it?

    Quality by Design Training is a practical, one-day skills course on the QbD approach to pharmaceutical and biopharmaceutical development, where quality is built into the product from the design stage. It is worth it because QbD skills are increasingly expected by employers and regulators across Singapore's pharma sector, and they apply directly to your work.

    What is the QbD approach based on?

    QbD is a systematic, science-based approach defined by the ICH Q8(R2), Q9, Q10 and Q11 guidelines. It uses tools such as the Quality Target Product Profile, Critical Quality Attributes, risk assessment, Design of Experiments, the design space and the control strategy to design quality into pharmaceutical products.

    Who should attend this course?

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

    Do I need prior QbD experience 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.

    Is QbD relevant for both small molecules and biologics?

    Yes. The course covers QbD principles for small molecule drug products such as tablets and injectables and for biopharmaceutical products such as monoclonal antibodies and biosimilars, with case study examples from both. This is especially relevant to Singapore's growing biologics sector.

    Pricing

    How much does Quality by Design Training cost in Singapore?

    Pricing varies by delivery mode, group size and whether you join a scheduled session or an in-house corporate programme. Fees are available on request, so contact us for a current quote tailored to your needs in Singapore. Request a quote or speak with a learning advisor.

    What is included in the course fee?

    The fee typically includes instructor-led training across all QbD modules, hands-on tool exercises, learning materials and learner support. Corporate sessions can include tailoring to your own products and projects. Ask about the inclusions for your chosen format.

    Do you offer group or corporate pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for development, quality and regulatory teams. Ask about corporate or group pricing for your Singapore or regional sites.

    What payment options are available?

    We accept major credit and debit cards and bank transfers, and can arrange corporate invoicing for group bookings. Speak with a learning advisor to choose the option that suits you.

    Is this course a good investment for my team?

    Yes. A shared QbD method reduces deviations, smooths scale-up and strengthens submissions, which pays back quickly in a regulated environment. Delivered to a whole team, it aligns functions to one approach. Ask about corporate pricing for your organisation.

    Assessment

    Is there a test at the end of the course?

    No. This is a non-certification skills course with no formal assessment. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and group discussion during the one-day programme.

    Do I receive proof of completion?

    Yes. Participants receive a course completion record from Invensis Learning. No formal credential is awarded by an external body, as QbD is a skills discipline rather than a credentialled scheme; the value is in the practical capability you build.

    How will my learning be reinforced without a test?

    Through applied practice. You work through QTPP construction, CQA identification, Ishikawa risk mapping, a DoE design exercise and design space interpretation on realistic scenarios, so you leave able to apply the tools rather than recall theory.

    Will I be able to apply QbD at work afterwards?

    Yes. After the course you can construct a QTPP, identify and classify CQAs, facilitate risk assessments with Ishikawa diagrams and FMEA, plan a DoE strategy, interpret a design space and help develop a control strategy for regulatory submissions.

    Course Content

    What topics does the QbD syllabus cover?

    The one-day programme covers QbD principles and the ICH regulatory framework, the QTPP and CQAs, risk assessment with Ishikawa and FMEA, DoE and the design space, PAT and the control strategy, and QbD in practice through case studies, CTD submissions and lifecycle management.

    How long is the training and how is it delivered?

    The course runs for one day (about eight hours), and can also be arranged as two half-days. It is delivered in live virtual (online), classroom and corporate onsite formats, so you can choose the option that fits your schedule in Singapore.

    Does the course include hands-on exercises?

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

    Which ICH guidelines does the course reference?

    The course is grounded in ICH Q8(R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances, along with FDA PAT guidance and CTD submission expectations.

    Can beginners follow the material?

    Yes. The course introduces QbD from first principles, so professionals new to it can follow along, while those with development or GMP experience can connect the tools to their own work. No prior QbD knowledge is assumed.

    Enrollment

    How do I enrol in Quality by Design Training?

    You can enrol through the Invensis Learning website. Choose your preferred format, complete your booking, and you will receive access to the schedule, joining details and learning materials. See upcoming schedules or talk to a learning advisor.

    What training formats are available?

    We offer live virtual (online) instructor-led training, classroom sessions and customised corporate onsite training for teams, so you can pick the delivery mode that best fits your schedule and location in Singapore.

    How soon can I start?

    Scheduled sessions run regularly, and corporate cohorts can be arranged around your team's availability. See upcoming schedules or contact a learning advisor to find the next suitable date.

    Can you deliver the course in-house for our team?

    Yes. The course is available as a corporate onsite or live virtual programme for a cross-functional team, and it is especially effective when participants apply the QbD tools to their own live development projects. Ask about corporate training for your team.

    Can I reschedule my booking?

    Yes. Rescheduling is handled per our published policy, and we can transfer your place to another suitable session where needed. Contact our support team to arrange this.