Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design Training in Thailand?UntitledA 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

    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.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Thailand 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 Thailand 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 Thailand

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

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

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

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

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

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

    The Practical Payoff of QbD SkillsValue for Individuals and Teams

    For Individuals

    For Individuals

    QbD Training helps pharmaceutical professionals in Thailand move from reactive quality control to proactive quality design. It suits formulation scientists, analytical scientists, process development engineers, and QA and regulatory affairs specialists who want a systematic, science-based way to develop products. Whether you work in generics, biologics, APIs or at a contract development and manufacturing organisation, the tools you learn map directly onto ICH-aligned development and dossier work.

    If you want your development work to be faster, more predictable and easier to defend in a regulatory submission, QbD is a practical, immediately useful skill set. You leave able to construct a QTPP, identify CQAs, plan a DoE and build a control strategy for your own products.

    • Build quality into products from the design stage instead of relying on end-product testing
    • Apply the ICH Q8 to Q11 framework confidently in day-to-day pharmaceutical development
    • Lead QTPP construction and CQA identification workshops for your product teams
    • Run risk assessments using FMEA and Ishikawa diagrams to focus development effort
    • Plan and interpret Design of Experiments to define a robust design space
    • Develop control strategies that stand up to Thai FDA and PIC/S review
    • Strengthen your standing for QA, CMC and process development roles in Thailand
    • Gain practical skills you can put to work at your organisation immediately
    For Organizations

    For Organizations

    QbD group training helps Thai pharmaceutical and biopharmaceutical organisations build quality into products by design rather than by inspection. The programme can be delivered for R&D groups, process development teams, QA functions or cross-functional project teams. For companies scaling biologics, expanding exports or maturing their quality systems, QbD provides a consistent, science-based approach the whole team can share.

    If your development teams work in silos or rely on trial and error, corporate QbD training creates a common framework from the QTPP through to the control strategy. Teams leave able to apply the tools to real projects, supporting stronger submissions and more predictable manufacturing.

    • Build a shared QbD language across formulation, analytical, process and QA teams
    • Reduce manufacturing deviations through stronger process understanding
    • Strengthen dossiers for Thai FDA, PIC/S and regional export markets
    • Speed up scale-up and technology transfer with design-space thinking
    • Cut post-approval changes through robust, risk-proportionate control strategies
    • Standardise development practice across sites and business units
    • Choose flexible onsite or live virtual delivery for your team
    • Apply QbD tools to your own live product projects during training

    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.

    ฿70,000+

    QA manager pay, Thailand

    per month, JobsDB 2026

    ฿30,000-55,000

    Formulation scientist pay, Bangkok

    per month, JobsDB 2026

    ฿27.5bn

    Biopharma market value, Thailand

    projected, Thailand BOI

    100+

    Pharmaceutical roles listed

    Glassdoor Thailand 2026

    SECTORS HIRING

    • —Generic and Branded Pharmaceutical Manufacturing
    • —Biopharmaceuticals and Biosimilars
    • —Active Pharmaceutical Ingredient (API) Production
    • —Contract Development and Manufacturing (CDMOs)
    • —Regulatory Affairs and CMC Consulting
    • —Vaccines and Government Pharmaceutical Bodies

    GROWTH TRENDS

    • —Medical Hub 2025-2034 driving biopharma investment
    • —Siam Bioscience scaling domestic biologics production
    • —PIC/S GMP raising science-based dossier expectations
    • —Thailand 4.0 targeting advanced pharma manufacturing
    • —Rising export focus needing ICH-aligned submissions
    • —QbD and DoE talent scarce versus routine QC skills

    Sources: JobsDB and Glassdoor Thailand 2026; Thailand Board of Investment (BOI) biopharmaceutical report; Thai FDA and PIC/S GMP guidance.

    Why QbD Skills Are in Demand Across Thai Pharma

    End-Product Testing Still Dominates

    Many Thai manufacturers still verify quality by testing finished batches. QbD builds quality in from the design stage, cutting deviations and rejects and giving teams real process understanding.

    QbD builds quality in from the design stage

    PIC/S and Thai FDA Raise the Bar

    As a PIC/S member, Thailand expects science-based dossiers. QbD gives teams the QTPP, CQA and control-strategy evidence that Thai FDA and PIC/S reviewers now look for.

    QbD delivers the evidence regulators expect

    Biologics Scale-Up Is Complex

    Domestic biologics producers work with process-defined products that are sensitive to conditions. QbD design space and control strategy make scale-up and tech transfer far more predictable.

    QbD makes scale-up predictable

    Exports Need ICH-Aligned Dossiers

    Thai exporters compete in regulated ASEAN and global markets. QbD structures development evidence to ICH Q8 to Q11, making submissions stronger and easier to defend.

    QbD structures development evidence

    QbD and DoE Talent Is Scarce

    Thailand's pharma workforce is deep in routine QC but thin in QbD and Design of Experiments skills, making trained practitioners rare and sought-after by employers.

    QbD skills make you stand out

    Trial-And-Error Slows Development

    One-factor-at-a-time work misses interactions and wastes batches. QbD uses DoE to map the design space efficiently, cutting rework and speeding up development.

    QbD speeds up development with DoE

    Sources: Thai FDA and PIC/S GMP guidance; Thailand BOI biopharmaceutical report; ICH Q8 to Q11 guidelines; JobsDB and Glassdoor Thailand 2026.

    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.

    Today

    Seen mainly as a testing or compliance resource

    After QbD

    Positioned for QA, CMC regulatory and process development leadership

    Today

    Fewer options as biopharma roles increasingly ask for QbD skills

    After QbD

    Eligible for QbD-focused roles at biopharma producers and CDMOs

    Today

    Pay tied largely to routine quality control work

    After QbD

    Access to higher-paying QbD and regulatory roles across Bangkok

    You Master QbD

    Before

    Quality checked mainly through end-product testing

    Now You Have

    Quality built in through the QTPP, CQAs and a defined design space

    Before

    Development driven by trial and error and one-factor-at-a-time work

    Now You Have

    Structured Design of Experiments that reveal the design space quickly

    Before

    Dossiers that struggle to meet PIC/S and ICH expectations

    Now You Have

    Science-based submissions aligned with ICH Q8 to Q11 and PIC/S expectations

    Before

    A limited role in cross-functional development decisions

    Now You Have

    Confidence to lead CQA identification and risk-assessment workshops

    "The gap between testing quality in and designing it in is exactly what employers now look for, and QbD is how you cross it."

    Join thousands of professionals who trained with Invensis Learning and put QbD to work.

    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.

    • 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 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.

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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

    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.

    Loading schedules…

    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

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    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

    Untitled

    • 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

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    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

    Untitled

    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

    Untitled

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    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

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    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

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    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

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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.