Quality by Design Training in Japan

Design Quality in from Day One

This instructor-led programme from a trusted Quality by Design training company helps pharmaceutical and biopharmaceutical professionals across Japan build quality into products from the design stage. Learn to apply the ICH Q8 to Q11 QbD framework, from the QTPP and critical quality attributes to risk assessment, Design of Experiments and the control strategy, with hands-on exercises throughout.

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Master Quality by Design and Lead Excellence in Japan

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What Is Quality by Design and Why It Matters in JapanA Science-Based Route to Built-In Quality

Quality by Design (QbD) training in Japan gives pharmaceutical and biopharmaceutical professionals a systematic, science-based way to build quality into a product from the design stage rather than testing it in at the end. QbD is the approach defined by the ICH Q8(R2) guideline and reinforced by ICH Q9, Q10 and Q11, and it is now expected by regulators including Japan's PMDA, the FDA and the EMA.

This one-day programme walks you through the full QbD workflow: defining the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), linking them to material attributes and process parameters through risk assessment, exploring the design space with Design of Experiments (DoE), and building a robust control strategy. Hands-on exercises use realistic development scenarios so you can apply each tool with confidence.

It suits formulation scientists, analytical scientists, process development engineers, quality assurance teams and CMC regulatory professionals in Japan's drug and biologics sector. With QbD adoption in Japanese submissions now above 70 per cent, these are skills employers actively look for. Start building them with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Japan 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 Japan 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 Japan

Instructor-led training formats available for individual learners and corporate teams across the Japan
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 Japan
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 Japan 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 JapanWho 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 Quality by Design Skills Do for YouValue for Professionals and Teams

For Individuals

Quality by Design training helps pharmaceutical and biopharmaceutical professionals turn empirical, trial-and-error development into a structured, science-based practice. You learn to design quality into the product using the same QbD tools that regulators now expect. Whether you are a formulation scientist, process engineer, analytical scientist or QA professional, the training builds capabilities you can apply to live development projects straight away.

If you work in Japan's drug or biologics sector, QbD fluency is fast becoming a baseline expectation. This programme gives you the QTPP, CQA, risk assessment, DoE and control strategy skills that development and CMC teams rely on.

Build quality into products from the design stage instead of testing it in at the end
Apply the ICH Q8 to Q11 framework with confidence in day-to-day development work
Construct a Quality Target Product Profile and identify Critical Quality Attributes for real products
Lead risk assessments using Ishikawa diagrams and FMEA to prioritise development effort
Plan and interpret Design of Experiments to define a defensible design space
Develop control strategies and structure QbD evidence for regulatory submissions
Gain skills that transfer across both small molecules and biologics
Strengthen your standing with employers as QbD adoption rises across Japan

For Organizations

Quality by Design group training helps organisations embed a consistent, science-based approach to product and process development. Delivered for cross-functional teams, it aligns formulation, analytical, process and quality staff around one QbD method. For pharmaceutical and biopharmaceutical firms in Japan, this shared approach connects development decisions to product quality and regulatory expectations.

If your teams still rely on trial-and-error development, QbD training creates a common framework for defining quality up front, assessing risk, and controlling processes. The result is stronger submissions and more predictable manufacturing.

Builds a shared QbD language across formulation, analytical, process and quality teams
Improves first-time-right development and reduces manufacturing deviations
Strengthens submissions with clearer design space and control strategy evidence
Reduces costly late-stage changes by building understanding in early development
Supports ICH-aligned pharmaceutical quality systems across sites and business units
Enables customised training mapped to your own products and processes
Scales across development, manufacturing and regulatory functions
Prepares teams for QbD expectations from PMDA, the FDA and the EMA

Where QbD Skills Take Your Career in JapanRoles, Demand and Earnings

Quality by Design capability has become a sought-after skill across Japan's pharmaceutical and biopharmaceutical sector, valued by drug makers, biologics developers, CDMOs and regulatory teams that must meet ICH and PMDA expectations. Demand spans formulation, analytical, process development, quality assurance and CMC roles. As QbD adoption in Japanese submissions climbs above 70 per cent, professionals who can apply these tools stand out. Quality by Design training is how they build that capability. Here is what the market looks like now.

¥12.9M

Pharma QA Manager salary, Tokyo

average per year, SalaryExpert 2026

¥7.0M

Formulation Scientist salary, Japan

average per year, Paylab / SalaryExpert

$89.5B

Japan pharmaceutical market, 2026

Mordor Intelligence 2026

70%+

QbD adoption in Japan

JPMA survey, since 2021

SECTORS HIRING

—Pharmaceutical Manufacturing and R&D
—Biopharmaceuticals and Biologics
—Contract Development and Manufacturing (CDMOs)
—Active Pharmaceutical Ingredient (API) Production
—Regulatory Affairs and CMC
—Medical Devices and Diagnostics

GROWTH TRENDS

—QbD adoption in Japanese submissions now above 70 per cent
—PMDA aligned with ICH Q8 to Q11 as a shared quality language
—Major capital going into biologics, such as Takeda's Fujisawa complex
—AI-assisted and continuous manufacturing raising process-understanding demand
—CDMO expansion at Fujifilm and AGC Biologics driving QbD capability needs
—An ageing population sustaining a large domestic pharma market

Sources: SalaryExpert, Salary.com, Paylab, ERI (Japan) 2026; Mordor Intelligence Japan Pharmaceutical Market 2026; JPMA QbD survey.

Designation

Quality by Design Professionals in Japan : Salary Insights and Trends

Hiring Companies in Japan

¥4500K

Min

¥6000K

Average

¥8500K

Max

SalaryExpert · ERI (Japan) 2026

ShionogiOno PharmaceuticalKyowa KirinSumitomo Pharma

Source: Shionogi · Ono Pharmaceutical · Kyowa Kirin · Sumitomo Pharma

Market Pressures Making QbD Essential in Japan

Regulators Now Expect QbD Evidence

Japan's PMDA, alongside the FDA and EMA, expects ICH Q8 to Q11 QbD evidence in submissions. Teams without design space and control strategy skills struggle to build compliant development files.

QbD training builds design space and control strategy skills

Trial-And-Error Development Is Too Slow

Empirical, test-and-fix development drives rework and late-stage failure. QbD replaces it with mechanistic process understanding that predicts and controls quality up front.

QbD training builds process-understanding skills

Biologics Complexity Is Rising

Investment in biologics, including Takeda's new Fujisawa complex, demands QbD for molecularly complex, process-defined products where quality cannot simply be tested in at the end.

QbD training builds CQA and DoE skills for biologics

CDMO Growth Needs QbD Capability

As Japanese CDMOs such as Fujifilm and AGC Biologics expand, QbD fluency becomes a differentiating capability that clients and regulators increasingly require.

QbD training makes teams stand out to clients

Established Conditions Adoption Lags

QbD use exceeds 70 per cent in Japan, yet Established Conditions in new drug applications remain low, leaving a gap in translating the design space into flexible regulatory strategy.

QbD training bridges design space to strategy

Ageing-Population Pipelines Stay Full

A large domestic market serving an ageing population sustains steady development pipelines, raising demand for professionals who can build quality in efficiently and consistently.

QbD training builds efficient, consistent development

Sources: JPMA QbD and Established Conditions survey; Mordor Intelligence Japan Pharmaceutical Market 2026; company disclosures (Takeda, Fujifilm, AGC Biologics).

QbD is more than a compliance requirement. It is a practical capability that makes development faster, submissions stronger and manufacturing more reliable. Build these skills with Invensis Learning.

Your Japan Career Transformation

From Testing Quality in to Designing It In

Your QbD Transformation

Japan's pharmaceutical and biopharmaceutical sector is moving decisively from testing quality in to designing it in, and employers increasingly separate teams that can apply QbD from those that cannot. Here is the shift this training helps you make.

Today

Development relies on trial and error, with quality checked by end-product testing

After QbD

You design quality in up front using the QTPP, CQAs and a defined design space

Today

Development relies on trial and error, with quality checked by end-product testing

Today

Submissions are slower to defend when reviewers probe process understanding

After QbD

You build clear design space and control strategy evidence for ICH-aligned files

Today

Submissions are slower to defend when reviewers probe process understanding

Today

Roles that list QbD experience feel out of reach

After QbD

You qualify for formulation, process, QA and CMC roles where QbD is expected in Japan

Today

Roles that list QbD experience feel out of reach

You build QbD capability

Before

Empirical development that reacts to problems after they appear

Now you have

A systematic, science-based method that predicts and prevents quality issues

Before

Empirical development that reacts to problems after they appear

Before

Risk decisions made on intuition and past habit

Now you have

Structured risk assessment using Ishikawa diagrams and FMEA with RPN prioritisation

Before

Risk decisions made on intuition and past habit

Before

One-factor-at-a-time experiments that miss interactions

Now you have

Design of Experiments skills that map the design space efficiently

Before

One-factor-at-a-time experiments that miss interactions

Before

QbD knowledge that stays theoretical

Now you have

Practical tools you can apply to live small-molecule and biologic projects

Before

QbD knowledge that stays theoretical

"In Japan, building quality into the product by design is no longer optional; it is how modern pharmaceutical development is expected to work."

Join professionals across Japan who train with Invensis Learning to build QbD capability.

Sources: SalaryExpert, Paylab (Japan) 2026; JPMA QbD survey.

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 Japan is structured across ten modules, taking learners from foundational QbD background and regulatory guidance through to real-world case studies and practical applications in pharmaceutical, biotechnology, and manufacturing environments.

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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.

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

The QbD Skills You Will BuildTools You Will Apply at Work

This training builds practical, job-ready QbD capability across the full workflow. By the end of the one-day programme you can define product quality up front, assess risk, design experiments, and build a control strategy that holds up in ICH-aligned submissions.

Define the Quality Target Product Profile

Construct a QTPP from clinical and patient needs, translating the desired quality, safety and efficacy of a product into a clear design specification that guides the whole development programme.

Identify Critical Quality Attributes

Determine the physical, chemical, biological and microbiological attributes that must stay within limits, for both small molecules and biologics, and classify them by criticality.

Run Risk Assessments with FMEA

Use Ishikawa diagrams and Failure Mode and Effects Analysis to link material attributes and process parameters to CQAs, prioritising them by Risk Priority Number to focus development effort.

Design Experiments and the Design Space

Plan screening and response-surface DoE studies, interpret the resulting models, and define the design space with Normal Operating Ranges and Proven Acceptable Ranges.

Apply PAT and Build a Control Strategy

Use Process Analytical Technology such as NIR and Raman for real-time monitoring, then develop a risk-based control strategy that assures quality within the design space.

Structure QbD for Regulatory Submission

Organise QbD evidence for the CTD Section 3.2.P.2, connect it to the risk and DoE outputs, and understand lifecycle management under ICH Q12 for post-approval change.

Who Should TakeQuality by Design Training in Japan?

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 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 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

JPY 63200

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 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 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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Please Note:Learn through face-to-face sessions led by experienced instructors in a collaborative classroom environment. This classroom Quality by Design training combines expert guidance, peer interaction, and hands-on activities to create an engaging learning experience.

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

Loading schedules…

Why Choose Invensis Learning for Quality by Design Training in JapanExpert-Led, Flexible and Practical

Invensis Learning delivers practical Quality by Design training for professionals and teams across Japan who want to build quality into pharmaceutical products by design. Our programmes combine experienced, industry-practitioner trainers, flexible delivery, well-structured courseware and dedicated learner support. As a trusted Quality by Design training company in Japan, we keep the focus on capability you can apply straight away. Whether you enrol as an individual or arrange corporate training for a cross-functional team, we provide an expert-led experience built around real-world application and measurable outcomes. As an ISO 9001:2015 and ISO 27001:2022 certified provider, we hold our own delivery to international standards.

Experienced trainers with real pharmaceutical and QbD practitioner backgrounds
Instructor-led online (live virtual) and classroom formats to fit your schedule
Hands-on QbD exercises using realistic development scenarios
Courseware aligned to the ICH Q8 to Q11 framework
Flexible corporate and onsite delivery for teams across Japan
Dedicated learner support before, during and after training
ISO 9001:2015 and ISO 27001:2022 certified training organisation
Trusted by professionals and organisations across multiple industries

200K+

Professionals Trained

12M+

Hours of Training Delivered

Flexible Learning Modes

98%

First-Attempt Pass Rate

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 JapanAll our classroom training is now available online at your convenience

Quality by Design in Japan

Halekulani Okinawa,1967-1 Nakama, Onna Kunigami District, Okinawa 904-0401, Japan

Quality by Design in Japan

Aman Tokyo, The Otemachi Tower, 1 Chome-5-6 Ōtemachi, Chiyoda City, Tokyo 100-0004, Japan

Quality by Design in Japan

Halekulani Okinawa,1967-1 Nakama, Onna Kunigami District, Okinawa 904-0401, Japan

Quality by Design in Japan

Aman Tokyo, The Otemachi Tower, 1 Chome-5-6 Ōtemachi, Chiyoda City, Tokyo 100-0004, Japan

Corporate Quality by Design TrainingFor Your Teams in Japan

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Customised QbD training mapped to your own products and processes
Flexible delivery through onsite, live virtual or hybrid formats
Cross-functional sessions for formulation, analytical, process and QA teams
Trainers with real pharmaceutical development and QbD experience
Practical exercises using your live development scenarios
Dedicated coordination and support for group programmes
Scalable delivery for teams across Japan and global sites

What Our Learners Say

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Finally Applied QbD to a Real Project

"The training made the QTPP and CQA workflow click for me. I went back and used the risk assessment and DoE approach on a live tablet formulation, and the design space work was far more structured than our old trial-and-error method."

Kenji Tanaka

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Clear, Practical and Well Paced

"The sessions on PAT and control strategy were exactly what I needed. The trainer used realistic pharmaceutical scenarios, so it never felt theoretical. I now understand how our in-process controls connect to the CQAs."

Yuki Sato

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Strengthened My Submission Work

"Understanding how QbD evidence maps into the CTD Section 3.2.P.2 has changed how I review development reports. The FMEA and design space explanations were clear and immediately useful for my submission work."

Haruto Yamamoto

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Aligned Our Whole Team

"We ran this as a group session for our formulation and QA teams. Everyone came away speaking the same QbD language, which has made our development reviews faster and our risk assessments more consistent."

Aiko Nakamura

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Great Fit for a Cross-Functional Team

"The corporate programme was tailored to our process development context. Our engineers and scientists could apply the DoE and control strategy tools to our own projects during the session, which was excellent value."

Ryo Kobayashi

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4.6

Ratings

100K+

Happy Learners

100+

Locations Worldwide

99%

Training Satisfaction

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

Quality by Design training is a one-day, non-certification course that teaches a systematic, science-based way to build quality into pharmaceutical products from the design stage. It covers the ICH Q8 to Q11 framework and QbD tools such as the QTPP, CQAs, risk assessment, Design of Experiments and control strategy.

General

What is Quality by Design training?

Who should attend QbD training in Japan?

The training suits formulation scientists, analytical scientists, process development engineers, quality assurance professionals and CMC regulatory specialists in pharmaceutical, biopharmaceutical, API and CDMO organisations across Japan who want to understand and apply QbD in development and submissions.

Is Quality by Design training worth it?

Yes. QbD is the approach regulators including PMDA, the FDA and the EMA now expect, and adoption in Japanese submissions exceeds 70 per cent. Professionals who can apply QbD tools are valued across development, quality and regulatory roles, making these practical skills a strong investment.

Do I need prior QbD experience to join?

No. The course has no formal prerequisites and introduces QbD from first principles in a pharmaceutical development context. Familiarity with pharmaceutical development or GMP is helpful but not required.

Which standards does the training follow?

The programme is aligned to the ICH Q8(R2) Pharmaceutical Development guideline and the related ICH Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Q11 (Drug Substances) guidelines that underpin QbD worldwide.

Does QbD apply to both small molecules and biologics?

Yes. The training covers QbD for small-molecule drug products such as tablets and injectables and for biologics such as monoclonal antibodies, with case examples from both product types.

Pricing

How much does QbD training cost in Japan?

Pricing varies by delivery format, group size and schedule, so the fee is available on request. Contact a learning advisor for a quote, and ask about group rates if you are training a team.

What is included in the course fee?

The fee typically includes instructor-led training across all six QbD modules, hands-on tool exercises, structured courseware and learner support, plus a course completion certificate from Invensis Learning. Request a quote for the exact inclusions in your chosen format.

Are there group or corporate rates?

Yes. We offer corporate group training with customised schedules and volume-based pricing for cross-functional teams. Contact us for a tailored quote for your organisation.

Is there a separate examination fee?

No. Quality by Design training is a non-certification skills course, so there is no examination and no separate exam fee. You receive a course completion certificate from Invensis Learning on finishing the programme.

What payment options are available?

We accept major cards and bank transfers, with instalment options on selected plans. Speak with a learning advisor to choose what suits you, and ask about corporate billing for team enrolments.

Assessment

Is there an exam for QbD training?

No. This is a non-certification course with no examination. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case examples and discussion during the one-day programme.

Do I receive a certificate after the training?

You receive a course completion certificate from Invensis Learning after completing the programme. It recognises your participation and the practical QbD skills you have built; it is not an external certification, as QbD training has no awarding body.

How am I assessed during the course?

There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, risk assessment and design space interpretation to realistic development scenarios throughout the day, so you practise each skill hands-on.

How long is the QbD training?

The course runs for one day (about eight hours), covering QbD principles and the ICH framework, the QTPP and CQAs, risk assessment, DoE and the design space, PAT and control strategy, and QbD in practice, with tool exercises throughout.

Will I be able to apply QbD at work afterwards?

Yes. After the training you can construct a QTPP, identify and classify CQAs, run FMEA-based risk assessments, plan and interpret DoE for a design space, and build a control strategy, all skills you can use on live projects straight away.

Course Content

What topics does the QbD course cover?

The programme covers six areas: QbD principles and the ICH regulatory context, the QTPP and CQAs, risk assessment, Design of Experiments and the design space, Process Analytical Technology and control strategy, and QbD in practice including case studies and submissions.

What QbD tools will I learn to use?

You will work with the QTPP, Critical Quality Attributes, Ishikawa diagrams, FMEA with Risk Priority Numbers, Design of Experiments, the design space with NOR and PAR, PAT tools such as NIR and Raman, and the control strategy.

Are there hands-on exercises?

Yes. Hands-on exercises run throughout the day, including QTPP construction, CQA identification and criticality assessment, Ishikawa risk mapping, DoE design selection and design space interpretation, all based on realistic pharmaceutical development scenarios.

Does the course cover regulatory submissions?

Yes. It shows how QbD outputs are structured for the CTD Section 3.2.P.2 Pharmaceutical Development and how a strong control strategy supports lifecycle management and post-approval change under ICH Q12.

Is the content relevant to Japan's regulators?

Yes. QbD is harmonised through ICH, and Japan's PMDA aligns with ICH Q8 to Q11 alongside the FDA and EMA, so the framework and tools taught apply directly to development and submissions in Japan.

Enrollment

How do I enrol in QbD training?

You can enrol through the Invensis Learning website. Choose your preferred format, complete payment, and you will receive access to schedules, courseware and joining details. Contact a learning advisor if you would like guidance first.

What training formats are available?

We offer instructor-led training online (live virtual) and in the classroom, plus customised corporate onsite delivery for teams. You can choose the format that best fits your schedule and location in Japan.

Is online (live virtual) training available in Japan?

Yes. QbD training is available online as live virtual instructor-led sessions, as well as in classroom and corporate onsite formats, so professionals across Japan can join without travel.

Can I arrange training for my whole team?

Yes. Corporate group training can be delivered onsite or live virtual and tailored to your products and processes, so cross-functional teams learn a shared QbD approach. Contact us for a group quote.