Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design in Pharmaceutical Development?UntitledA Science-Based Route to Consistent Quality

    The Quality by Design (QbD) Training in Malaysia is a practical, one-day skills course that teaches pharmaceutical and biopharmaceutical teams how to build quality into products from the design stage rather than testing it in at the end. Grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, it introduces QbD from first principles and applies it to real development work. You learn the full QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT) and the control strategy. These are the same tools that regulators such as the FDA and EMA now expect to see in modern development and manufacturing submissions. As Malaysia grows into a trusted ASEAN pharmaceutical and halal manufacturing hub, formulation scientists, process engineers, analytical chemists, QA specialists and regulatory professionals who can apply QbD are increasingly in demand. On completion you receive a course completion record from Invensis Learning and can put the methodology to work straight away.

    What Is Quality by Design in Pharmaceutical Development?A Science-Based Route to Consistent Quality

    The Quality by Design (QbD) Training in Malaysia is a practical, one-day skills course that teaches pharmaceutical and biopharmaceutical teams how to build quality into products from the design stage rather than testing it in at the end. Grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines, it introduces QbD from first principles and applies it to real development work.

    You learn the full QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT) and the control strategy. These are the same tools that regulators such as the FDA and EMA now expect to see in modern development and manufacturing submissions.

    As Malaysia grows into a trusted ASEAN pharmaceutical and halal manufacturing hub, formulation scientists, process engineers, analytical chemists, QA specialists and regulatory professionals who can apply QbD are increasingly in demand. On completion you receive a course completion record from Invensis Learning and can put the methodology to work straight away.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Malaysia 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 Malaysia 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 Malaysia

    • Instructor-led training formats available for individual learners and corporate teams across the Malaysia
    • 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 Malaysia
    • 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 Malaysia 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 MalaysiaWho 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 QbD Training Delivers for Your CareerPractical Skills You Can Apply at Work

    For Individuals

    For Individuals

    QbD training helps pharmaceutical professionals replace empirical, trial-and-error development with a systematic, science-based approach. The programme suits formulation scientists, process development engineers, analytical scientists, QA professionals and regulatory affairs specialists who want to apply QbD in product development and manufacturing. Whether you are formalising development practice, moving from QC into product design, or preparing evidence for regulatory submissions, this training builds capabilities aligned with what modern pharmaceutical employers expect.

    If you want to lead development work with confidence and a globally recognised methodology, QbD is a clear step forward. You gain the tools, hands-on practice and framework knowledge employers value across Malaysia's pharmaceutical, biopharmaceutical and halal manufacturing sectors.

    • Design quality into products from the QTPP and CQAs rather than testing it in later
    • Lead structured risk assessments using Ishikawa diagrams and FMEA
    • Plan and interpret DoE studies and define a robust design space
    • Build ICH-aligned control strategies that regulators expect to see
    • Move into formulation, process, QA and CMC regulatory roles valued in Malaysia
    • Apply a transferable methodology across pharma, biopharma and CDMO employers
    • Reduce costly deviations and reworked batches through process understanding
    • Gain confidence to lead QbD workshops on your own live projects
    For Organizations

    For Organizations

    QbD group training helps organisations build development capability by equipping cross-functional teams with structured knowledge and practical skills. The training can be delivered for formulation, process, analytical, quality and regulatory groups together. For organisations aiming to connect development to consistent quality and meet rising regulatory expectations, this training provides a scalable, flexible solution.

    If your teams still rely on end-product testing and trial-and-error scale-up, QbD group training creates a shared, science-based approach. Cross-functional teams gain a common method for QTPP, CQA identification, risk assessment, DoE and control strategy.

    • Builds a shared, science-based development language across teams
    • Connects formulation, process, analytical and regulatory work under one framework
    • Reduces manufacturing deviations and post-approval change burden
    • Strengthens regulatory submissions with QbD evidence regulators expect
    • Enables customised training aligned with your products and pipeline
    • Standardises QbD practice across development and manufacturing sites
    • Provides flexible delivery for cross-functional teams
    • Builds stronger in-house QbD and quality risk capability

    Your QbD Career Outlook in MalaysiaRoles, Sectors and Rising Demand

    Quality by Design skills are becoming a practical differentiator across Malaysia's pharmaceutical and biopharmaceutical sector. As the country grows into a trusted ASEAN manufacturing and halal pharma hub and regulators align to ICH expectations, employers increasingly value professionals who can apply QbD to formulation, process, analytical and regulatory work. Demand spans formulation scientists, process development engineers, analytical and QA specialists, and CMC regulatory professionals, and here is what the market is telling us.

    RM113k

    Average formulation scientist pay

    per year, ERI SalaryExpert 2026

    RM180k

    Regulatory affairs manager pay

    average, SalaryExpert 2026

    RM99k

    QA executive pay, Malaysia

    average, SalaryExpert 2026

    Rising

    ASEAN pharma hub demand

    halal and export-led growth

    SECTORS HIRING

    • —Generic and Branded Pharmaceutical Manufacturing
    • —Biopharmaceuticals and Biosimilars
    • —Contract Development and Manufacturing (CDMO)
    • —Active Pharmaceutical Ingredient (API) Production
    • —Halal Pharmaceutical and Nutraceutical Production
    • —Regulatory Affairs and CMC Consulting

    GROWTH TRENDS

    • —Malaysia positioning as an ASEAN pharma and halal manufacturing hub
    • —Regulators aligning submission expectations to the ICH QbD guidelines
    • —Rising biosimilar and nutraceutical development for an ageing population
    • —Export-led growth requiring FDA and EMA-grade quality evidence
    • —Investment in continuous manufacturing and PAT-enabled control
    • —Shortage of professionals skilled in QbD versus a deep QC talent pool

    Sources: ERI SalaryExpert, PayScale, Paylab, Michael Page Malaysia Salary Guide 2026; industry reports on Malaysia's pharmaceutical and halal manufacturing sector.

    What Is Driving QbD Demand in Malaysia's Pharma Sector

    Rising Regulatory Expectations

    Malaysian and export regulators increasingly expect ICH Q8 to Q11 QbD evidence in submissions, so teams who can build design space and control strategy documentation are in demand.

    QbD builds ICH-aligned submission skills

    Costly Test-And-Fix Development

    Many manufacturers still rely on end-product testing to catch quality problems. QbD replaces costly trial-and-error with mechanistic process understanding that prevents deviations.

    QbD builds process-understanding skills

    Halal and Export Ambitions

    As Malaysia scales as an ASEAN and halal pharma hub, products must meet FDA and EMA-grade quality standards, raising demand for QbD-literate formulation and regulatory professionals.

    QbD builds quality-by-design capability

    Biosimilar and Biologics Complexity

    Growth in biosimilars and nutraceuticals brings complex, process-defined products where QbD tools such as CQA identification and Design of Experiments are essential to consistent quality.

    QbD builds CQA and DoE skills

    QbD Talent Scarcity

    Malaysia has a deep pool of QC and production staff but few professionals trained in QTPP, risk assessment, DoE and control strategy, making QbD skills a genuine differentiator.

    QbD makes skilled developers stand out

    Continuous Manufacturing and PAT

    Investment in modern continuous lines and Process Analytical Technology demands the QbD process understanding needed to design and control quality in real time.

    QbD builds real-time control skills

    Sources: NPRA and ICH guideline references; industry reports on Malaysia's pharmaceutical, biosimilar and halal manufacturing sector, 2026.

    QbD is fast becoming a baseline skill for pharmaceutical development in Malaysia. Build the capability employers now expect and apply it to your own products. Start your QbD journey today.

    Your Malaysia QbD Career Shift

    From Testing Quality in to Designing It Out

    Your QbD Transformation

    Malaysia's pharmaceutical sector is shifting from reactive, test-and-fix quality control to proactive, science-based development, and employers increasingly separate professionals who can design quality in from those who cannot. Here is the shift QbD skills deliver.

    Today

    Seen as a capable QC or production contributor with limited development influence

    After QbD

    Positioned for formulation, process, QA and CMC roles that value QbD, which in Malaysia reach senior pay bands

    Today

    Confident in testing, but less involved in early product and process design

    After QbD

    Able to lead QTPP, CQA and design-space work that shapes products from the start

    Today

    Skills tied to one company's way of working

    After QbD

    Fluent in the ICH QbD framework that transfers across pharma, biopharma and CDMO employers

    You master QbD

    Before

    Quality is checked by end-product testing after batches are made

    Now you have

    You design quality into the product from the QTPP and CQAs onward

    Before

    Development runs on trial-and-error and one-factor-at-a-time testing

    Now you have

    You use structured DoE and a defined design space to understand the process

    Before

    Risk is managed informally, without documented rationale

    Now you have

    You lead formal risk assessments using Ishikawa diagrams and FMEA

    Before

    Submissions rely on fixed specifications regulators increasingly question

    Now you have

    You build ICH-aligned control strategies that FDA and EMA reviewers expect

    "The gap between checking quality and designing it in is now a skill employers name, and the pharmaceutical organisations that matter already know it."

    Join the professionals and teams who built practical, job-ready skills with Invensis Learning.

    Sources: ERI SalaryExpert, PayScale, Paylab (Malaysia) 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 Malaysia 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.

    image

    100% Secure and Safe download

    Skills You Will Build in This QbD CourseTools You Can Apply Straight Away

    This QbD training builds practical, job-ready capability across the full Quality by Design workflow. By the end you can apply the ICH-aligned tools that turn a product concept into a controlled, regulator-ready manufacturing process.

    Define the Quality Target Product Profile

    Skills covered in this QbD course start with building a Quality Target Product Profile (QTPP) from clinical and patient needs, so you can set clear quality, safety and efficacy targets that guide the entire development programme.

    Identify and Classify Critical Quality Attributes

    Learn to identify Critical Quality Attributes (CQAs) for small molecules and biologics, distinguish critical from non-critical characteristics, and link each CQA to material attributes (CMAs) and process parameters (CPPs).

    Run Structured Risk Assessments

    Apply Ishikawa (fishbone) diagrams and Failure Mode and Effects Analysis (FMEA) to rank CMA and CPP risks by severity, occurrence and detectability, and prioritise which relationships need formal experimentation.

    Design and Interpret Experiments (DoE)

    Use Design of Experiments to study multiple factors at once, understand interactions, and define a robust design space with Normal Operating and Proven Acceptable Ranges instead of relying on one-factor-at-a-time testing.

    Apply PAT and Build a Control Strategy

    Understand Process Analytical Technology tools such as NIR and Raman, real-time release testing, and how to develop a risk-proportionate control strategy that keeps production within the approved design space.

    Structure QbD Evidence for Submissions

    Learn how QbD outputs map to the ICH Q8 to Q11 framework and the CTD Module 3 (Section 3.2.P.2), so you can present QTPP, risk assessment, design space and control strategy evidence that regulators expect.

    Who Should TakeQuality by Design Training in Malaysia?

    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

    MYR 1780

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

    Untitled

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

    Untitled

    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

    Untitled

    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.

    Untitled

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

    Untitled

    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.

    Untitled

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

    Untitled

    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

    Untitled

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

    Untitled

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

    Untitled

    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

    MYR 1780

    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 Learning for QbD Training in MalaysiaTrusted by Professionals and Teams

    Invensis Learning delivers structured, instructor-led Quality by Design training for pharmaceutical and biopharmaceutical professionals and teams across Malaysia. Our programmes combine experienced quality practitioners, hands-on QbD tool exercises, and flexible live virtual, classroom and corporate delivery. As an ISO 9001:2015 and ISO 27001:2022 certified Quality by Design training company in Malaysia, we focus on practical understanding, real-world application and measurable learning outcomes, whether you enrol as an individual learner or train a whole development team.

    • Experienced pharmaceutical quality and QbD practitioners as trainers
    • Hands-on exercises in QTPP, CQA identification, risk assessment and DoE
    • Flexible formats: online (live virtual), classroom and corporate onsite
    • Content grounded in the ICH Q8 to Q11 QbD framework
    • Course completion record from Invensis Learning on finishing the programme
    • Dedicated learner support before, during and after training
    • Scalable delivery for local, regional and global pharma teams
    • Competitive pricing for individual and corporate training programmes

    4

    Flexible Learning Modes

    98%

    First-Attempt Pass Rate

    5000+

    Accredited Trainers Globally

    4.7/5

    Rated by Learners Worldwide

    ISO 9001:2015 Certified

    ISO 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

    Secure SSL Encryption

    Leaders in Training industry for 12+ years

    Leaders in Training industry for 12+ years

    Over 5000 five star reviews

    Over 5000 five star reviews

    Level AA conformance, W3C WCAG 2.2

    Level AA conformance, W3C WCAG 2.2

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

    Quality by Design in Malaysia

    Berjaya Times Square Hotel, 1, Jln Imbi, Bukit Bintang, 55100 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia

    Quality by Design in Malaysia

    Pullman Kuala Lumpur City Centre, 4, Jalan Conlay, Kuala Lumpur, 50450 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia

    corporate banner

    Corporate QbD Training in MalaysiaUpskill Your Quality Teams

    Untitled

    • Train formulation, process, QA and regulatory teams on one QbD framework
    • Customised schedules that fit your production and project calendar
    • Delivery onsite, live virtual or blended across Malaysian and global sites
    • Apply QbD tools to your own live products during the sessions
    • Experienced pharmaceutical quality trainers with industry exposure
    • Progress tracking, assessments and dedicated coordination
    • Scalable for single sites or multi-country manufacturing teams

    Pharma Teams We Can Support

    PharmaniagaDuopharma BiotechCCMHovidKotra PharmaB. Braun

    What Our Learners Say

    Untitled

    A Clear, Practical Route into QbD

    "The training finally connected QTPP, CQAs and DoE for me. I now run risk assessments with FMEA and plan experiments properly instead of testing one factor at a time. It changed how I approach formulation work."

    Nurul Aina

    Formulation Scientist

    Untitled

    0/0

    Strong on Risk Assessment and PAT

    "The sessions on risk assessment and Process Analytical Technology were exactly what our lab needed. I understand how in-process measurements link to control strategy now, and I can explain the design space to our team with confidence."

    Wei Jian Tan

    Analytical Scientist

    Untitled

    0/0

    Made Our Submissions Easier to Defend

    "Very useful for regulatory work. Mapping QbD outputs to the ICH framework and the CTD pharmaceutical development section made our submissions far easier to structure and defend. The case studies were realistic and relevant."

    Ravindran Kumar

    Regulatory Affairs Executive

    Untitled

    0/0

    One Shared QbD Language for the Team

    "We trained a cross-functional development team together and now share one QbD language across formulation, process and quality. Deviations have dropped and our development reports are far more consistent."

    Siti Rahayu

    Head of Quality, Pharmaceutical Manufacturer

    Untitled

    0/0

    Tailored to Our Pipeline

    "The trainer tailored the exercises to our biosimilar pipeline, so the team could apply QTPP and CQA work to real products. Practical, well organised and genuinely useful for standardising how we develop."

    Andrew Lim

    Learning and Development Manager, Biopharmaceutical Company

    Untitled

    0/0



    Trustpilot

    4.6

    Ratings

    100K+

    Happy Learners

    100+

    Locations Worldwide

    99%

    Training Satisfaction

    Enquire with us now

    Drop us a query and our learning consultant will reach out to you shortly

    Get Course Details & Pricing

    Fill out this form and we will respond quickly.

    We also deliver Quality by Design Trainingacross multiple cities

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

    Johor BahruKuala Lumpur
    City map with location markers

    Explore Our Other Course Categories

    Agile

    Project Management

    ITSM

    Quality Management

    DevOps

    IT Governance

    Other Related Courses

    Foundation

    Poka Yoke

    Foundation

    Lean Six Sigma Yellow Belt

    Foundation

    Business Process Management

    Foundation

    Six Sigma Awareness

    Foundation

    7 QC Tools Training

    Advanced

    Lean Six Sigma Black Belt

    Foundation

    Quality Function Deployment

    Foundation

    Lean IT

    Advanced

    Lean Six Sigma Green Belt

    Foundation

    Minitab Essentials

    Foundation

    Design for Six Sigma

    Foundation

    Lean Fundamentals

    Foundation

    Quality by Design

    Foundation

    Lean Manufacturing

    Foundation

    Value Stream Mapping

    Foundation

    Kaizen

    Foundation

    Root Cause Analysis

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

    Quality by Design (QbD) training is a practical, non-certification course that teaches pharmaceutical and biopharmaceutical teams how to build quality into products from the design stage. It covers the ICH Q8 to Q11 framework, QTPP, CQAs, risk assessment, DoE, PAT and control strategy.

    General

    What is Quality by Design (QbD) training?

    Quality by Design (QbD) training is a practical, non-certification course that teaches pharmaceutical and biopharmaceutical teams how to build quality into products from the design stage. It covers the ICH Q8 to Q11 framework, QTPP, CQAs, risk assessment, DoE, PAT and control strategy.

    Who should attend this QbD course in Malaysia?

    The course suits formulation scientists, process development engineers, analytical scientists, QA professionals and CMC regulatory specialists in pharmaceutical, biopharmaceutical, API and CDMO organisations. Familiarity with pharmaceutical development or GMP helps but is not required.

    Is QbD worth learning for pharma professionals in Malaysia?

    Yes. As Malaysia grows into an ASEAN pharma and halal manufacturing hub and regulators align to ICH expectations, QbD-literate professionals are increasingly valued across formulation, process, quality and regulatory roles. The skills apply immediately to development work.

    What standards and guidelines does the training cover?

    The training is grounded in the ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 Drug Substance guidelines, along with FDA PAT guidance and EMA process validation expectations.

    Do I need prior QbD experience to join?

    No. The course introduces QbD from first principles in a pharmaceutical development context, aligned to the ICH Q8(R2) guideline. Prior exposure to formulation, process development or GMP is helpful but not a prerequisite, so beginners can join too.

    Is this a certification course?

    No. This is a practical, non-certification skills course. There is no examination or external credential. On completion you receive a course completion record from Invensis Learning and job-ready QbD capability you can apply straight away.

    Pricing

    How much does QbD training cost in Malaysia?

    Pricing varies by delivery format, group size and whether you enrol individually or as a corporate team. Instructor-led and self-paced options are available on request. Contact a learning advisor for a current quote for your requirements.

    What is included in the course fee?

    The fee typically includes instructor-led sessions, QbD courseware and reference materials, hands-on tool exercises, learner support and a course completion record from Invensis Learning. Ask us for the exact inclusions for your chosen format.

    Do you offer corporate or group pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for quality teams, development groups and manufacturing sites. Request a tailored quote for your team.

    What payment options are available?

    We accept major payment methods and can discuss options for individual and corporate enrolments. Speak with a learning advisor to arrange a plan that suits you.

    Are there any additional fees?

    No. Because this is a non-certification course, there is no separate examination or credentialing fee. The quoted training fee covers the programme and its materials. Request a quote to see the full cost for your chosen format.

    Assessment

    How is learning assessed on this course?

    There is no formal assessment. Learning is reinforced through hands-on QbD tool exercises, realistic pharmaceutical case studies and team discussion throughout the programme, so you practise applying the tools rather than sitting a test.

    What do I receive on completing the training?

    You receive a course completion record from Invensis Learning. This is a non-certification programme, so no external credential is awarded, but you gain practical QbD skills you can apply to development and manufacturing work immediately.

    Will I be able to apply QbD at work afterwards?

    Yes. On completion you can construct a QTPP, lead CQA identification, facilitate risk assessments with Ishikawa and FMEA, plan and interpret DoE studies, define a design space and build a control strategy for submissions.

    Does the course prepare me for regulatory submissions?

    Yes. The training shows how QbD outputs map to the ICH Q8 to Q11 framework and the CTD Module 3 (Section 3.2.P.2), so you can structure QTPP, risk assessment, design space and control strategy evidence that regulators such as the FDA and EMA expect.

    Are there prerequisites or eligibility conditions?

    No. The course has no formal prerequisites and is open to all. Familiarity with pharmaceutical development or GMP is beneficial but not required, as QbD is introduced from first principles.

    Course Content

    What topics does the QbD training cover?

    The programme covers QbD principles and the ICH regulatory context, the QTPP and Critical Quality Attributes, risk assessment, Design of Experiments and the design space, Process Analytical Technology and the control strategy, plus QbD case studies and lifecycle management.

    Which QbD tools will I learn to use?

    You learn the core QbD toolkit: QTPP, CQA identification and criticality assessment, Ishikawa diagrams and FMEA, Design of Experiments, Normal Operating and Proven Acceptable Ranges, PAT and the control strategy, all applied to realistic scenarios.

    Does the course cover both small molecules and biologics?

    Yes. The training includes QbD case studies for small molecule drug products such as tablets, and for biologics such as monoclonal antibodies and biosimilars, covering the CQAs and process parameters relevant to each.

    How long is the QbD training?

    The core programme runs as a one-day, eight-hour course covering all QbD modules with concept explanations, ICH context, case studies and hands-on tool exercises. A two half-day format is also available for the same total hours.

    Are practical exercises included?

    Yes. Hands-on exercises run throughout, including QTPP construction, CQA identification, Ishikawa risk mapping and DoE design selection, all applied to realistic pharmaceutical development scenarios so you practise the tools directly.

    Enrollment

    How do I enrol in the QbD course?

    You can enrol through the Invensis Learning website. Choose your preferred format, whether you take the Quality by Design course online or in the classroom, complete your booking, and you will receive access to schedules, courseware and learning resources. Talk to a learning advisor if you need help choosing.

    What training formats are available?

    The course is available as online (live virtual) instructor-led training, classroom training, and customised corporate onsite training for teams, so you can pick the format that fits your schedule and location in Malaysia.

    When can I start?

    New batches run regularly across live virtual and classroom formats, and corporate sessions are scheduled to suit your team. See upcoming schedules or contact an advisor to find the next available date.

    Can this be delivered on-site for my team in Malaysia?

    Yes. We deliver corporate on-site and live virtual QbD training for pharmaceutical and biopharmaceutical teams across Malaysia, tailored to your products and schedule. Request corporate training for a tailored plan.

    Is post-training support available?

    Yes. You receive learner support before, during and after the programme, including post-training guidance so you can apply QbD tools confidently in your own development projects.