Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training in Thailand?A Science-Based Route to Product Quality

    Quality by Design (QbD) Training in Thailand is a one-day, non-certification course that shows pharmaceutical and biopharmaceutical teams how to build quality into a product from the design stage rather than test it in at the end. You learn the QbD approach exactly as the ICH Q8(R2), Q9, Q10 and Q11 guidelines define it. The training is built around the tools regulators now expect: 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. Every concept is practised on realistic development scenarios. For scientists, engineers, and QA and regulatory affairs professionals working under Thai FDA and PIC/S GMP expectations, QbD turns trial-and-error development into a predictable, science-based process, and gives you skills you can apply the very next day.

    What Is Quality by Design Training in Thailand?A Science-Based Route to Product Quality

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    Key Highlightsof the Quality by Design Training Course

    Quality by Design Training Eligibility in the ThailandWho Can Enroll?

    The Practical Payoff of QbD SkillsValue for Individuals and Teams

    Your QbD Career Outlook in ThailandWhere Quality Skills Take You

    QbD skills are increasingly sought after across Thailand's pharmaceutical and biopharmaceutical sector as the country pursues its Medical Hub and Thailand 4.0 ambitions. Employers running generics, biologics, API and contract manufacturing operations need professionals who can apply science-based development and meet PIC/S GMP and Thai FDA expectations. Demand runs from QA and analytical roles up to process development, CMC regulatory and quality management leadership, and here is what the market shows.

    Why QbD Skills Are in Demand Across Thai Pharma

    QbD is a practical skill that pays off from day one. Join pharmaceutical professionals in Thailand who build quality into their products by design. Start your QbD journey today.

    Your Thailand Career Transformation

    From Testing Quality in to Designing It In,

    Your QbD Transformation

    Thailand's pharmaceutical and biopharmaceutical sector is investing in advanced, science-based manufacturing, and employers increasingly value professionals who can design quality in rather than test it in. Here is how QbD skills move you from where you stand today to where the market is heading.

    Sources: JobsDB and Glassdoor Thailand 2026; Thailand BOI biopharmaceutical report.

    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 Thailand 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.

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    Skills You Will Build in This CourseThe Full QbD Toolkit

    This QbD programme gives you a complete, practical toolkit for pharmaceutical development. By the end, you can design quality into a product from the QTPP through to the control strategy, and defend that work in a regulatory submission.

    Set the Quality Target Product Profile

    The skills covered in QbD Training start here: build a Quality Target Product Profile (QTPP) that defines what your product must achieve for quality, safety and efficacy, drawn from clinical and patient needs.

    Identify Critical Quality Attributes

    Work from the QTPP to identify and classify the Critical Quality Attributes (CQAs) that must stay within limits, and link them to the critical material attributes and process parameters that influence them.

    Run Risk Assessments with FMEA and Ishikawa

    Use Ishikawa (fishbone) diagrams and FMEA with Risk Priority Numbers to find and prioritise the material attributes and process parameters that most affect product quality, focusing effort where it matters.

    Design Experiments to Map the Design Space

    Plan Design of Experiments (DoE) that replace one-factor-at-a-time work, then interpret the results to define the design space, Normal Operating Ranges and Proven Acceptable Ranges.

    Apply Process Analytical Technology

    Understand how PAT tools such as NIR and Raman spectroscopy monitor critical attributes in real time, enabling real-time release testing and tighter, in-process control of manufacturing.

    Build a Control Strategy for Submission

    Pull the QbD outputs together into a risk-proportionate control strategy, and structure the evidence for CTD regulatory submissions to Thai FDA and other health authorities.

    Who Should TakeQuality by Design Training in Thailand?

    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

    THB 14030

    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.

    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

    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.

    Best For: Learners who prefer in-person interaction, structured schedules, and collaborative learning experiences.

    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

    Designed for organizations that want to build capabilities at scale, standardize knowledge, and support workforce development through customized team learning initiatives.

    Best For: Organizations looking to upskill employees, address capability gaps, and deliver consistent training across teams.

    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

    Receive personalized instruction tailored to your goals, pace, and learning requirements through dedicated sessions from our trusted Quality by Design training company.

    Best For: Professionals seeking personalized guidance, accelerated learning, or focused support to achieve specific outcomes.

    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

    THB 14030

    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 LearningFor Your QbD Training in Thailand

    Invensis Learning delivers practical Quality by Design training for pharmaceutical and biopharmaceutical professionals and teams in Thailand who want to build quality into their products by design. Our programmes combine experienced trainers, hands-on tool exercises, and structured, science-based courseware grounded in the ICH Q8 to Q11 framework. Whether you enrol as an individual or arrange corporate training for your team, you gain a professional learning experience focused on real-world application, so you can put QbD to work from the very next day.

    • Experienced trainers with real pharmaceutical quality and development expertise
    • Hands-on exercises in QTPP, CQA, risk assessment, DoE and control strategy
    • Courseware grounded in the ICH Q8 to Q11 framework and PIC/S GMP expectations
    • Flexible live virtual, classroom and corporate onsite delivery
    • Content tailored to both small molecule and biologics development
    • Dedicated learner support before, during and after training
    • ISO 9001:2015 quality and ISO 27001:2022 information security certified
    • Scalable delivery for teams across Thailand and worldwide

    500+

    Corporate Clients

    15+

    Years of Training Excellence

    24/7

    Learner Support

    50+

    Industries Served

    ISO 9001:2015 Certified

    ISO 9001:2015 Certified

    ISO 27001:2022 Certified

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    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 ThailandAll our classroom training is now available online at your convenience

    Quality by Design in Thailand

    Four Seasons Resort Koh Samui, 219 Moo 5 Surat Thani Angthong, 84140, Thailand

    Quality by Design in Thailand

    Silavadee Resort, 208/66 Ko Samui District, Surat Thani 84310, Thailand

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    QbD Corporate Training for Thai Pharma TeamsFor Your Teams

    • Tailored QbD training for R&D, process development and QA teams
    • Flexible onsite, live virtual or hybrid delivery in Thailand
    • Schedules aligned to your team's availability
    • Case studies matched to your products and sector
    • Apply QbD tools to your own live development projects
    • Dedicated coordination and learner support
    • Scalable delivery across Thai and global sites

    Trusted by Leading Pharmaceutical Organisations

    GPOSiam BioscienceMega LifesciencesBerlin PharmaceuticalOlic ThailandBiolab

    What Our Learners Say

    Applied the Design Space Straight Away

    "The QbD training finally connected the QTPP, CQAs and DoE for me. I used the design space approach on a tablet reformulation the week after and cut two rounds of trial batches."

    Somchai Wattana

    Formulation Scientist

    0/0

    My CMC Sections Are Much Stronger

    "The way the trainer linked ICH Q8 to Q11 to what the Thai FDA and PIC/S expect made the whole submission side click. My pharmaceutical development sections are far stronger now."

    Nattaya Phromma

    Regulatory Affairs Pharmacist

    0/0

    Practical Risk Assessment Skills

    "Clear, practical and full of real examples. The FMEA and Ishikawa exercises were the most useful part for prioritising what actually affects product quality."

    Kittipong Sae-lim

    Quality Assurance Officer

    0/0

    A Shared QbD Language for Our Team

    "We ran this as an onsite programme for our development and QA teams. Everyone now shares the same QbD language from the QTPP to the control strategy, and our technology transfers run more smoothly."

    Suwanna Rojana

    Quality Assurance Manager, Pharmaceutical Manufacturer

    0/0

    Tailored to Our Biologics Work

    "Invensis tailored the case studies to biologics, which is exactly what our client work needs. Strong facilitation and immediately applicable for our process development group."

    Pornchai Thanapong

    Head of Technical Operations, Contract Manufacturer

    0/0



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    We also deliver Quality by Design Training across multiple cities

    Invensis Learning delivers industry-leading Quality by Design training solutions tailored for individuals and organizations.

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

    Quality by Design Training is a one-day, non-certification course on the QbD approach to pharmaceutical development. It teaches you to build quality into products from the design stage using the ICH Q8, Q9, Q10 and Q11 framework, including the QTPP, CQAs, risk assessment, DoE and control strategy.

    General

    What is Quality by Design (QbD) Training?

    Quality by Design Training is a one-day, non-certification course on the QbD approach to pharmaceutical development. It teaches you to build quality into products from the design stage using the ICH Q8, Q9, Q10 and Q11 framework, including the QTPP, CQAs, risk assessment, DoE and control strategy.

    Is QbD Training worth it for pharma professionals in Thailand?

    Yes. As Thailand grows its biopharma sector and works to PIC/S GMP standards, employers increasingly want science-based development skills. QbD helps you develop products more predictably, strengthen dossiers and stand out for QA, CMC and process development roles.

    Who should attend the QbD Training?

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

    Do I need prior QbD knowledge or specific qualifications?

    No. The course has no formal prerequisites and introduces QbD from first principles. Familiarity with pharmaceutical development or GMP is helpful but not required, so scientists, engineers and quality staff can all follow it.

    Which standards does the QbD Training follow?

    The training is grounded in the ICH guidelines that define QbD: ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. These align with Thai FDA and PIC/S GMP expectations.

    Pricing

    How much does QbD Training cost in Thailand?

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

    What is included in the course fee?

    The fee covers instructor-led training across all six QbD modules, hands-on tool exercises, learning materials and a course completion record from Invensis Learning. Request a quote for full inclusions.

    Do you offer corporate or group pricing?

    Yes. We offer group and corporate onsite pricing for teams in Thailand, with content tailored to your products. Ask about corporate or group pricing for a tailored quote.

    Are there better rates for booking a team?

    Group bookings are quoted on a per-team basis, and larger cohorts typically benefit from better rates. Talk to a learning advisor about training your team for the best available price.

    In what currency is the training billed?

    Training for learners and teams in Thailand can be quoted in Thai baht (THB). Final pricing depends on the format and group size and is available on request.

    Assessment

    How is learning assessed on the QbD course?

    There is no formal assessment. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and group discussion across the one-day programme, so you practise the tools throughout rather than sit a test.

    What do I receive on completing the training?

    You receive a course completion record from Invensis Learning that recognises your participation. QbD is a non-certification skills course, so it awards practical capability that you can apply straight away rather than a formal credential.

    Does the QbD course award a formal credential?

    No. It is a non-certification skills course. There is no governing body or formal credential; instead you gain practical QbD methodology and tool skills, plus a course completion record from Invensis Learning.

    Will the QbD skills expire or need renewing?

    No. The QbD skills you learn do not expire and need no renewal. They are immediately applicable to pharmaceutical development projects and stay useful throughout your career.

    How will I apply what I learn at work?

    You leave able to construct a QTPP, identify and classify CQAs, run FMEA and Ishikawa risk assessments, plan a DoE, define a design space and build a control strategy for your own products, ready to use the next working day.

    Course Content

    What topics does the QbD Training cover?

    The course covers all six QbD modules: QbD principles and the ICH Q8 to Q11 framework; the QTPP and CQAs; risk assessment; Design of Experiments and the design space; Process Analytical Technology and the control strategy; and QbD case studies with lifecycle management.

    How long is the QbD Training?

    The programme runs for one day (8 hours). It can also be delivered as two half-day sessions. The full framework, from QbD principles to the control strategy, is covered with hands-on exercises throughout.

    Does the course cover both small molecules and biologics?

    Yes. QbD principles apply to both small molecule drug products and biologics such as monoclonal antibodies and biosimilars, and the training includes case study examples from both, which is relevant to Thailand's growing biopharma sector.

    Are there hands-on exercises in the QbD course?

    Yes. You practise the tools throughout, including QTPP construction, CQA identification, Ishikawa and FMEA risk assessment, DoE design selection and design-space interpretation, all applied to realistic pharmaceutical development scenarios.

    Is Design of Experiments (DoE) covered in the training?

    Yes. The course explains why DoE replaces one-factor-at-a-time work, the design types used in QbD, and how DoE results define the design space, Normal Operating Ranges and Proven Acceptable Ranges.

    Enrollment

    How do I enrol in the QbD Training in Thailand?

    You can enrol through the Invensis Learning website or by contacting a learning advisor. Choose your preferred format, confirm your place, and you will receive joining details, schedules and learning materials. See upcoming batches to get started.

    What delivery formats are available?

    The course is offered as live virtual (online) instructor-led training, classroom training, and corporate onsite delivery for teams. You can pick the format that best fits your schedule and location in Thailand.

    Can the QbD Training be delivered onsite for our team?

    Yes. We deliver corporate onsite and live virtual programmes for pharmaceutical teams in Thailand, tailored to your products so participants can apply QbD tools to live projects. Ask about corporate or group options.

    When are the next QbD Training sessions?

    New public and corporate sessions are scheduled regularly in live virtual and classroom formats. Contact a learning advisor to see upcoming batches and find a date that suits you.

    Can I reschedule my QbD Training booking?

    Yes. Flexible rescheduling options are available on selected plans. Contact our support team to move to another batch or arrange a suitable date.