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.

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.

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.

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.

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.

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.

Quality by Design Training in Malaysia

Build Quality into Every Product

Master the science-based QbD approach that pharmaceutical and biopharmaceutical teams across Malaysia use to design quality into products from the start. Delivered by a trusted Quality by Design training company, this instructor-led programme helps formulation, analytical, process and regulatory professionals apply the ICH Q8 to Q11 framework, QTPP, CQAs, risk assessment, DoE and control strategy to real development work.

Flexible

Training Schedules

Instructor-led

Mode

Hours

PDUs

13.3K+ already enrolled

4.1 (2330+ Reviews)

100% Money-back Guarantee*

Want to Train Your Team?

Master Quality by Design and Lead Excellence in Malaysia

Starts from

MYR 1410

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.

Next: What's Included

What's Included in Your Quality by Design Training

One-day course spanning ten structured modules
8 PDUs on completion of the training
Copy of course material and SME-prepared study guide
Case studies and practical applications module
Course completion certificate from Invensis Learning

Next: Course Highlights

Key Highlights

of 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 programme
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 programme
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 organised 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 customised group training depending on availability and organisational 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 recognised 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.

Next: Eligibility Criteria

Quality by Design Training Eligibility in the Malaysia

Who Can Enrol?

No formal prerequisites are required to enrol in the Quality by Design training programme
Basic familiarity with quality assurance concepts is helpful but not mandatory for enrolment
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 enrol
Learners with backgrounds in quality, regulatory affairs, process engineering, and production management will find the content directly applicable to their roles

Next: Benefits

What QbD Training Delivers for Your Career

Practical Skills You Can Apply at Work

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

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

Next: Who Can Take

Who Should Take Quality by Design Training in Malaysia?

Process Engineers
QC Analysts
Engineering Teams
Technical Staff
Production Managers
Distribution Managers
Regulatory Affairs Specialists
Quality Assurance Professionals

Your QbD Career Outlook in Malaysia

Roles, 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.

Designation

Quality by Design Professionals in Malaysia : Salary Insights and Trends

Hiring Companies in Malaysia

RM71K

Min

RM99K

Average

RM115K

Max

ERI SalaryExpert Â· PayScale (Malaysia) 2026

PharmaniagaDuopharma BiotechHovidCCM

Source: Pharmaniaga Â· Duopharma Biotech Â· Hovid Â· CCM

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 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 optimisation
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 Curriculum

of 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.

100% Secure and Safe download

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

Shifts your thinking from testing quality in at the end to designing it in from the start.

100% Secure and Safe download

Skills You Will Build in This QbD Course

Tools 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.

Quality by Design Training Modes

for 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

Starts from

MYR 1410

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

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

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Why Choose Invensis Learning for QbD Training in Malaysia

Trusted 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

Flexible Learning Modes

99%

Training Satisfaction

5000+

Accredited Trainers Globally

4.7/5

Rated by Learners Worldwide

ISO 9001:2015 Certified

ISO 27001:2022 Certified

Secure SSL Encryption

Leaders in Training industry for 12+ years

Over 5000 five star reviews

Level AA conformance, W3C WCAG 2.2

Quality by Design Training Locations in Malaysia

Instructor-led in-person Classroom training is available for group batches. All other public cohorts are delivered as Instructor-led Live Virtual. See available cohorts.

Quality by Design Training Location in Malaysia

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

Quality by Design Training Location in Malaysia

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

Corporate QbD Training in Malaysia

Upskill Your Quality Teams

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

Enquire with us now

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We also deliver Quality by Design Training across multiple cities in Malaysia

Quality by Design training for individuals and teams. Select a city in Malaysia to view upcoming dates, formats and pricing.

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Frequently Asked Questions

Here'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.

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Quality by Design Training in Malaysia

What Is Quality by Design in Pharmaceutical Development?

What's Included in Your Quality by Design Training

Key Highlights

Quality by Design Training Eligibility in the Malaysia

What QbD Training Delivers for Your Career

Who Should Take Quality by Design Training in Malaysia?

Your QbD Career Outlook in Malaysia

SECTORS HIRING

GROWTH TRENDS

What Is Driving QbD Demand in Malaysia's Pharma Sector

Rising Regulatory Expectations

Costly Test-And-Fix Development

Halal and Export Ambitions

Biosimilar and Biologics Complexity

QbD Talent Scarcity

Continuous Manufacturing and PAT

From Testing Quality in to Designing It Out

Your QbD Transformation

Module 2: QbD Tools and Techniques

Module 3: Industry and Regulatory Perspective

Module 4: Quality Target Product Profile (QTPP)

Module 5: Critical Quality Attributes, Critical Material Attributes, and Critical Process Parameters

Module 6: Statistical Design of Experiments

Module 7: Design Space and Process Control

Module 8: Risk Assessment and Management

Module 9: Real-time Release Testing (RTRT)

Module 10: Case Studies and Practical Applications

Course Curriculum

Module 1: Introduction to QbD

Skills You Will Build in This QbD Course

Define the Quality Target Product Profile

Identify and Classify Critical Quality Attributes

Run Structured Risk Assessments

Design and Interpret Experiments (DoE)

Apply PAT and Build a Control Strategy

Structure QbD Evidence for Submissions

Quality by Design Training Modes

Quality by Design Classroom Training

Quality by Design Corporate Group Training

Quality by Design Focused 1-to-1 Training

Quality by Design Live Virtual Training

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