Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It MattersUntitledA Science-Led Approach to Pharma Development

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This Quality by Design training in Hong Kong gives scientists, engineers, quality and regulatory professionals the practical tools to apply QbD across product and process development. Aligned to the ICH Q8(R2), Q9, Q10 and Q11 guidelines that the FDA and EMA now expect, the programme walks you through the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space, Process Analytical Technology and the control strategy. With Hong Kong standing up its own Centre for Medical Products Regulation and moving towards primary evaluation, these are exactly the capabilities the local life sciences sector is building. Learn QbD with Invensis Learning and design quality in from the start.

    What Is Quality by Design and Why It MattersA Science-Led Approach to Pharma Development

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This Quality by Design training in Hong Kong gives scientists, engineers, quality and regulatory professionals the practical tools to apply QbD across product and process development.

    Aligned to the ICH Q8(R2), Q9, Q10 and Q11 guidelines that the FDA and EMA now expect, the programme walks you through the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space, Process Analytical Technology and the control strategy.

    With Hong Kong standing up its own Centre for Medical Products Regulation and moving towards primary evaluation, these are exactly the capabilities the local life sciences sector is building. Learn QbD with Invensis Learning and design quality in from the start.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Hong Kong 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 Hong Kong 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 Hong Kong

    • Instructor-led training formats available for individual learners and corporate teams across the Hong Kong
    • 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 Hong Kong
    • 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 Hong Kong 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 Hong KongWho 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 QbD TrainingSkills You Can Apply from Day One

    For Individuals

    For Individuals

    Quality by Design training equips pharmaceutical and biopharma professionals in Hong Kong with practical QbD tools they can apply to live development projects. It suits formulation scientists, process development engineers, analytical scientists, QA specialists and regulatory affairs professionals. Whether you are moving from trial-and-error development to a systematic, science-based approach or preparing QbD evidence for regulatory submissions, the programme builds capability aligned to the ICH Q8 to Q11 guidelines.

    If you want to design quality into products from the start and strengthen your position in Hong Kong's growing life sciences sector, QbD is a clear and practical step forward. You leave able to run the full QbD workflow, from QTPP to control strategy.

    • Apply a systematic, science-based method to product and process development
    • Build quality in from the design stage and cut costly late-stage deviations
    • Construct a Quality Target Product Profile and identify Critical Quality Attributes
    • Lead risk assessments using Ishikawa diagrams and FMEA with RPN prioritisation
    • Plan and interpret Design of Experiments and define a design space
    • Develop a control strategy and prepare QbD evidence for regulatory submissions
    • Strengthen your standing across Hong Kong's pharma and biotech employers
    • Gain skills you can use immediately, with no exam to sit
    For Organizations

    For Organizations

    Quality by Design group training helps pharmaceutical and biopharma organisations in Hong Kong build development capability by equipping cross-functional teams with a common, science-based method. The training can be delivered for formulation, process, analytical, quality and regulatory groups together. For organisations that want to connect development to consistent product quality and stronger submissions, this training provides a scalable, flexible solution.

    If your teams still rely on end-product testing to catch quality problems, QbD group training creates a shared approach to designing quality in. Teams gain a common language for QTPP, risk assessment, design space and control strategy.

    • Build a shared QbD language across development, quality and regulatory teams
    • Reduce manufacturing deviations and post-approval changes
    • Strengthen regulatory submissions with robust, data-backed QbD evidence
    • Apply QbD tools to your own live development projects during training
    • Standardise development practice across sites and functions
    • Prepare teams for Hong Kong's move towards primary evaluation
    • Choose flexible onsite, online or hybrid delivery for teams
    • Scale training across Hong Kong and the Greater Bay Area

    Where QbD Skills Take You in Hong KongWhy the Skill Is in Demand

    Quality by Design capability is increasingly valued across Hong Kong's pharmaceutical and biopharma sector, from generic and biologics manufacturers to CDMOs, regulatory teams and the growing biotech cluster around Hong Kong Science Park. As the city stands up its own Centre for Medical Products Regulation and moves towards primary evaluation, employers want scientists and quality professionals who can design quality in and back it with data. Roles range from QA specialist to formulation and process scientist, QA manager and head of quality.

    HK$540K

    QA Manager salary, Hong Kong

    average per year, PayScale/Jobsdb 2026

    300+

    Biotech and healthcare firms in Hong Kong

    HKTDC Research 2026

    10.8%

    Medical and healthcare exports growth

    early 2026, HKTDC

    66

    Drugs cleared via GBA connect scheme

    by early 2026, Hong Kong DH

    Sectors Hiring

    • —Pharmaceutical Manufacturing and Generics
    • —Biopharmaceuticals and Biologics
    • —Contract Development and Manufacturing (CDMOs)
    • —Regulatory Affairs and CMC
    • —Traditional Chinese Medicine Producers
    • —Academic and Research Institutes

    Growth Trends

    • —CMPR primary evaluation raising development-data expectations
    • —Greater Bay Area drug and device connect scheme
    • —300+ biotech firms clustered around Hong Kong Science Park
    • —PIC/S manufacturing standards mandated for advanced therapies
    • —Rising medical and healthcare product exports
    • —Scarce QbD-trained talent versus a deep manufacturing base

    Sources: PayScale, Jobsdb, Glassdoor (Hong Kong) 2026; HKTDC, HKSTP, Hong Kong DH / CMPR.

    Market Forces Making QbD Skills Essential in Hong Kong

    Hong Kong's Move to Primary Evaluation

    With the Centre for Medical Products Regulation launching and primary evaluation rolling out from 2026, firms need QbD-grade development data to support direct drug approvals.

    QbD builds the development evidence regulators expect

    Greater Bay Area Drug Connect Scheme

    The GBA connect scheme lets Hong Kong-registered drugs reach designated mainland hospitals, raising the bar for robust, well-documented development behind each product.

    QbD strengthens product and process understanding

    PIC/S Manufacturing Standards

    Since 2020, advanced therapy trials and manufacturing must meet PIC/S standards. QbD provides the science-based process understanding that consistent, compliant production relies on.

    QbD underpins compliant process design

    A Fast-Growing Biotech Cluster

    Hong Kong hosts 300-plus biotech and healthcare firms around Hong Kong Science Park. As they scale from research to manufacturing, QbD capability becomes a real differentiator.

    QbD helps scaling firms industrialise quality

    Rising Regulatory Submission Expectations

    The FDA and EMA expect QbD evidence in CTD Section 3.2.P.2. Hong Kong exporters submitting globally need teams who can present QTPP, design space and control strategy clearly.

    QbD structures evidence for CTD submissions

    Scarce QbD-Trained Talent

    Hong Kong has a deep manufacturing and testing base but few scientists trained in the full QbD method, making the capability rare and sought-after by local employers.

    QbD skills make development professionals stand out

    Sources: Hong Kong DH / CMPR, RAPS, HKTDC, HKSTP 2025-2026.

    Quality by Design is a practical capability, not a credential. Build the skills Hong Kong's pharma and biotech employers need to design quality in from the start. Start your journey today.

    Your Hong Kong Career Transformation

    From Testing Quality in to Designing It In

    Your QbD Career Shift in Hong Kong

    Hong Kong's pharmaceutical and biopharma sector is scaling fast, and employers increasingly separate professionals who can design quality in from those who only test it. Here is the shift QbD training helps you make.

    Today

    Quality checked mainly by end-product testing, with costly deviations

    After QbD

    Quality designed in from the start, reducing deviations and rework

    Today

    Limited leverage when moving between pharma and biotech employers

    After QbD

    Portable skills valued from QA specialist to head of quality, senior roles reaching well into six figures in HK$

    Today

    Regulatory submissions built on empirical, hard-to-defend specifications

    After QbD

    Confident preparing QTPP, design space and control strategy evidence for CTD submissions

    You master QbD

    Before

    Development driven mainly by trial and error

    Now you have

    A structured, science-based QbD workflow you can apply immediately

    Before

    Quality proven only through final end-product testing

    Now you have

    The tools to build quality in using QTPP, CQAs and a control strategy

    Before

    Risk handled informally and late in development

    Now you have

    Formal risk assessment with Ishikawa diagrams and FMEA to focus effort

    Before

    Recognition limited to your current employer

    Now you have

    Capability aligned to ICH Q8 to Q11 that travels across the sector

    "In modern pharmaceutical development, quality is designed in, not tested in, and the professionals who can do it are the ones employers compete for."

    Build QbD capability with Invensis Learning and lead development the way regulators now expect.

    Sources: PayScale, Jobsdb, Glassdoor (Hong Kong) 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 Hong Kong 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 Tools You Will MasterPractical Skills Across the QbD Workflow

    This programme moves you through the full Quality by Design workflow, from defining the product to controlling the process. By the end, you can apply each QbD tool to realistic pharmaceutical development scenarios and connect them into one coherent approach.

    Build a Quality Target Product Profile

    Construct a QTPP from clinical and patient needs, defining the dosage form, route, strength, pharmacokinetic targets and quality standards that guide the whole QbD programme.

    Identify and Classify Critical Quality Attributes

    Use the QTPP and prior knowledge to identify CQAs for small molecules and biologics, and classify which product characteristics are truly critical to quality, safety and efficacy.

    Run Structured Risk Assessments

    Map critical material attributes and critical process parameters to each CQA using Ishikawa diagrams, then rank them with FMEA and Risk Priority Numbers to focus your experiments.

    Design and Interpret DoE Studies

    Select screening, response surface and mixture designs, interpret the statistical model, and use the results to understand how process parameters and materials drive quality.

    Define the Design Space and Control Strategy

    Derive a design space from DoE results, set Normal Operating and Proven Acceptable Ranges, and build a risk-proportionate control strategy across materials, process and testing.

    Apply PAT and Prepare Regulatory Evidence

    Use Process Analytical Technology for real-time control and structure your QbD evidence for the CTD Section 3.2.P.2, supporting lifecycle management and post-approval change.

    Who Should TakeQuality by Design Training in Hong Kong?

    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

    HKD 3400

    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

    Untitled

    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

    HKD 3400

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

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

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    Why Choose Invensis Learning in Hong KongPractical and Instructor-Led

    Invensis Learning delivers practical Quality by Design training in Hong Kong for individual professionals and pharmaceutical and biopharma teams. Our programmes combine experienced practitioner trainers, ICH-aligned courseware, hands-on tool exercises and flexible delivery, so you leave able to apply QbD on live product and process development work. As an ISO 9001:2015 and ISO 27001:2022 certified Quality by Design training company serving learners across more than 100 countries, we focus on real-world application, clear learning outcomes and dependable support before, during and after training.

    • Trainers are practising quality and pharmaceutical development experts
    • Courseware aligned to the ICH Q8, Q9, Q10 and Q11 guidelines
    • Hands-on QbD exercises using realistic development scenarios
    • Flexible formats: online (live virtual), classroom, onsite and corporate
    • ISO 9001:2015 and ISO 27001:2022 certified training provider
    • Local delivery and support for learners across Hong Kong
    • A practical focus on applying QbD at work, not just theory
    • Dedicated learner support before, during and after training

    ISO 9001

    Quality Management

    200K+

    Professionals Trained

    12M+

    Hours of Training Delivered

    4

    Flexible Learning Modes

    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 Hong KongAll our classroom training is now available online at your convenience

    Quality by Design in Hong Kong

    Grand Hyatt Hong Kong, Convention Avenue, Wan Chai North, Wan Chai District, Wan Chai District, Hong Kong Island Hong Kong Island, Hong Kong, China

    Quality by Design in Hong Kong

    JW Marriott Hotel Hong Kong, Justice Drive, Tamar, Admiralty, Central and Western District, Hong Kong Island Hong Kong Island, Hong Kong, China

    corporate banner

    Corporate QbD Training for Hong KongUpskill Your Whole Team

    Untitled

    • Customised QbD training for pharma and biotech teams
    • Delivered onsite, online (live virtual) or in hybrid formats
    • Schedules aligned to your team's availability
    • Teams apply QbD tools to your own live development projects
    • Experienced trainers with pharmaceutical development expertise
    • Scalable delivery across Hong Kong and the Greater Bay Area

    Trusted by Life Sciences Teams

    Jacobson PharmaLee'S PharmaceuticalSino BiopharmaceuticalWuXi BiologicsAstraZenecaNovartis

    What Our Learners Say

    Untitled

    The Full QbD Workflow Finally Clicked

    "The training finally connected the QbD tools for me. I now build a QTPP, run an FMEA and plan a DoE as one flow, and I have already used it on a tablet reformulation project."

    Wai-Kit Cheung

    Formulation Scientist

    Untitled

    0/0

    Practical and Submission-Focused

    "Very practical sessions on the design space and control strategy. The link to CTD Section 3.2.P.2 was exactly what I needed for our submissions, and the ICH Q8 to Q11 context was clear."

    Karen Lau

    Regulatory Affairs Specialist

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    Hands-On and Well Paced

    "Good balance of theory and hands-on exercises. Working through risk assessment and DoE on realistic scenarios helped me understand where to focus experiments rather than testing everything."

    Anil Sharma

    Process Development Engineer

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    A Shared QbD Language Across Our Teams

    "We ran this as an in-house programme for our development and quality teams. Everyone now shares one QbD language, and our risk assessments and control strategies are far more consistent."

    Vivian Wong

    Head of Quality, Biopharma

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    Flexible Corporate Training That Fit Our Team

    "The corporate delivery was flexible and well organised, and the trainer tailored examples to our own products. A practical way to prepare our team for Hong Kong's changing regulatory landscape."

    Samuel Ng

    Learning and Development Manager, Pharma

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

    Quality by Design training is a practical, non-certification course that teaches the QbD approach to pharmaceutical and biopharmaceutical development. You learn to build quality into products from the design stage using the QTPP, critical quality attributes, risk assessment, Design of Experiments, the design space and a control strategy, aligned to the ICH Q8 to Q11 guidelines.

    General

    What is Quality by Design training?

    Quality by Design training is a practical, non-certification course that teaches the QbD approach to pharmaceutical and biopharmaceutical development. You learn to build quality into products from the design stage using the QTPP, critical quality attributes, risk assessment, Design of Experiments, the design space and a control strategy, aligned to the ICH Q8 to Q11 guidelines.

    Who should attend QbD training in Hong Kong?

    The course suits formulation scientists, process development engineers, analytical scientists, QA and QC professionals, and regulatory affairs and CMC specialists in pharmaceutical, biopharma, API and CDMO organisations across Hong Kong. It is ideal for anyone applying QbD in product development or regulatory submissions.

    Is Quality by Design worth learning for my career?

    Yes. As Hong Kong stands up its Centre for Medical Products Regulation and moves towards primary evaluation, employers increasingly want professionals who can design quality in and support it with data. QbD skills apply across QA, development and regulatory roles and travel well between pharma and biotech employers.

    Which ICH guidelines does the QbD course cover?

    The programme is grounded in the ICH quality guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. It also references FDA PAT guidance and the CTD format used for regulatory submissions.

    Do I need prior experience to take this course?

    No formal prerequisites are required. Familiarity with pharmaceutical development or GMP is helpful but not essential, as the course introduces QbD from first principles. It is designed for professionals who want to understand and apply QbD in a development context.

    Pricing

    How much does QbD training cost in Hong Kong?

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

    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 case studies, and a Course Completion Certificate from Invensis Learning. Ask about the exact 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. Request a corporate quote and we will tailor delivery to your organisation.

    Are there payment or instalment options?

    We accept common payment methods and can discuss instalment options on selected plans. Speak with a learning advisor to choose the arrangement that suits you or your team.

    Is there a discount for enrolling a team?

    Team and corporate enrolments are priced on a per-group basis, and volume-based rates are available. Ask about group pricing when you request a quote for your organisation.

    Assessment & Completion

    Is there an exam for the QbD course?

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

    Do I receive a certificate after the training?

    Yes. On completing the programme you receive a Course Completion Certificate from Invensis Learning. This records your attendance and completion; it is not an external credential or accreditation.

    How is my learning assessed?

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

    Is QbD a certification or a skills course?

    It is a practical skills course. There is no awarding body, exam or formal credential. The focus is on building QbD capability you can apply immediately to product and process development work.

    Does the course cover both small molecules and biologics?

    Yes. QbD principles are taught for both small molecule drug products and biologics, with case study examples such as tablet formulation and monoclonal antibody development so you can apply the method across product types.

    Course Content

    What topics does the QbD training cover?

    The course covers QbD principles and the ICH regulatory context, the QTPP and CQAs, risk assessment with Ishikawa diagrams and FMEA, Design of Experiments and design space definition, Process Analytical Technology and the control strategy, plus QbD in regulatory submissions and lifecycle management.

    Are there hands-on exercises in the course?

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

    What QbD tools will I learn to use?

    You will work with the QTPP, CQA and criticality classification, Ishikawa diagrams, FMEA with Risk Priority Numbers, Design of Experiments, the design space with Normal Operating and Proven Acceptable Ranges, PAT and the control strategy.

    How long is the QbD training?

    The programme is delivered as a focused one-day course of around 8 hours, covering all QbD modules with concept explanations, ICH context, case studies and hands-on tool exercises. A half-day format across two sessions is also available.

    Is the courseware aligned with current standards?

    Yes. The courseware follows the current ICH quality guidelines, Q8(R2), Q9, Q10 and Q11, and reflects how the FDA and EMA expect QbD evidence to be presented in CTD submissions.

    Enrollment

    How do I enrol in QbD training in Hong Kong?

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

    What training formats are available?

    The course is available as online (live virtual) instructor-led training, in-person classroom training, and customised corporate on-site training for teams. Choose the format that best fits your schedule and learning preference.

    Can I take the QbD course online in Hong Kong?

    Yes. The course is offered online as live virtual instructor-led training, so professionals in Hong Kong can attend from home or the office with full trainer interaction and the same hands-on exercises as the classroom format.

    When are the upcoming batches?

    New public and corporate sessions are scheduled regularly across virtual and in-person formats. Request the current schedule or speak with a learning advisor to find a batch that suits you or your team.

    Can I reschedule my enrolment?

    Yes. Flexible options let you reschedule or transfer to another batch where available. Contact our support team to arrange a change to your enrolment.