Quality by Design Training in China

Build Quality into Every Molecule

Master the ICH-aligned Quality by Design approach that China's fast-growing pharmaceutical and biopharma sector now expects. This instructor-led programme equips formulation, process, analytical, quality and regulatory professionals to design quality into products from the outset using QTPP, risk assessment, Design of Experiments and control strategy.

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Master Quality by Design and Lead Excellence in China

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CNY 2980

What Is Quality by Design and Why China's Pharma Sector Relies on ItA Science-Led Route to Consistent Quality

Quality by Design (QbD) Training in China is a practical, non-certification programme that teaches pharmaceutical and biopharmaceutical professionals to build quality into a product from the design stage rather than testing it in at the end. It is grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines that China's National Medical Products Administration adopted after the country joined the ICH in 2017.

Over an intensive one-day programme you work through the full QbD workflow: defining the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes, running Ishikawa and FMEA risk assessment, using Design of Experiments to map the design space, applying Process Analytical Technology, and building a control strategy for regulatory submission. Hands-on exercises use realistic development scenarios.

The training suits formulation, process, analytical, quality and CMC regulatory professionals across China's drug makers, CDMOs and biotech clusters. As reviewers increasingly expect QbD evidence and Chinese innovators expand globally, these skills are a clear advantage. Start building right-first-time development capability with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the China 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 China 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 China

Instructor-led training formats available for individual learners and corporate teams across the China
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 China
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 China 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 ChinaWho 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 This Training Delivers for You and Your TeamPractical QbD Capability, Not Just Theory

For Individuals

QbD training helps pharmaceutical professionals move from empirical, trial-and-error development to a systematic, science-led approach. You gain tools you can apply immediately to formulation, process and analytical work. Whether you develop small molecules or biologics, the programme builds capability aligned with what modern regulators and employers in China expect.

If you want to develop products that are consistent, compliant and right first time, QbD gives you a proven framework. You leave able to lead QTPP workshops, risk assessments and design-space studies on live projects.

Build quality into products from the design stage and cut costly late-stage failures
Construct a Quality Target Product Profile and identify Critical Quality Attributes
Facilitate risk assessments using Ishikawa diagrams and FMEA with confidence
Plan and interpret Design of Experiments to define a robust design space
Apply Process Analytical Technology and control strategy to keep processes in control
Prepare QbD evidence that meets NMPA, FDA and EMA submission expectations
Strengthen your value across pharma, biopharma, CDMO and regulatory roles in China

For Organizations

QbD group training equips cross-functional development teams with a shared, science-based approach to pharmaceutical quality. Sessions can be tailored for R&D, manufacturing, quality and regulatory groups. For organisations scaling innovative pipelines, this builds the process understanding that reduces risk and supports faster, more flexible submissions.

If your teams still rely on end-product testing to catch quality problems, QbD training creates a common framework for designing quality in. Groups gain a consistent approach to QTPP, risk assessment, DoE and control strategy.

Standardise QbD practice across formulation, process, analytical and QA teams
Reduce manufacturing deviations and post-approval changes through process understanding
Strengthen NMPA and global submissions with design-space and control-strategy evidence
Speed up development by focusing experiments on the highest-risk variables
Build cross-functional QbD capability with tailored on-site or live virtual delivery
Support biologics and continuous-manufacturing readiness across sites
Embed a shared quality language from R&D through to commercial manufacturing

Where QbD Takes Your Pharma Career in ChinaRoles, Demand and Hiring

Quality by Design skills are increasingly sought across China's pharmaceutical and biopharma sector, where the NMPA has adopted the ICH quality guidelines and reviewers now expect QbD evidence in submissions. Formulation scientists, process development engineers, analytical and QA professionals, and CMC regulatory specialists who can apply QTPP, risk assessment, DoE and control strategy are in demand across drug makers, CDMOs and biotech clusters. Quality by Design training helps professionals develop exactly these capabilities. Here is what the market is telling us.

Innovative Drugs Approved in China, 2025

NMPA, up from 48 in 2024

8,500+

Biotech and Biopharma Firms in China's Clusters

Yangtze River, Bohai Rim and others

¥646,600

Pharma R&D Scientist Salary, China

average per year, worldsalaries 2026

105 days

NMPA New-Drug Review Time

down from 663 days in 2017

SECTORS HIRING

—Pharmaceutical Manufacturing and Development
—Biopharmaceuticals and Biosimilars
—Contract Development and Manufacturing (CDMOs)
—Active Pharmaceutical Ingredient (API) Makers
—CMC Regulatory Affairs and Consulting
—Medical Devices and Combination Products

GROWTH TRENDS

—NMPA adoption of ICH quality guidelines raising QbD expectations
—Biologics and biosimilars the fastest-growing pharma segment
—Innovative drug approvals rising sharply year on year
—Record outbound licensing pushing products into FDA and EMA markets
—Dense biotech clusters in Shanghai, Suzhou, Beijing and Shenzhen
—Shortage of practitioners fluent in QTPP, DoE and design space

Sources: NMPA, ITIF, Grand View Research, worldsalaries, SalaryExpert (China) 2026; ICH.

Designation

Quality by Design Professionals in China : Salary Insights and Trends

Hiring Companies in China

¥150K

Min

¥240K

Average

¥360K

Max

PayScale · SalaryExpert (China) 2026

WuXi AppTecPharmaronAsymchemTigermed

Source: WuXi AppTec · Pharmaron · Asymchem · Tigermed

What Is Fuelling China's Demand for QbD Expertise

ICH-Aligned Submission Expectations

Since joining the ICH in 2017, China's NMPA has adopted the Q8, Q9 and Q10 guidelines, and reviewers increasingly expect QbD evidence such as design space and control strategy in submissions.

QbD training builds regulatory-ready development skills

Biologics and Biosimilar Complexity

Biologics and biosimilars are China's fastest-growing pharma segment. Their process-defined nature demands the QbD-grade understanding of CQAs, CPPs and design space this training builds.

QbD training builds CQA and design-space skills

Innovative Drug Surge

China approved 76 innovative drugs in 2025, up from 48 a year earlier. Faster, higher-quality pipelines need systematic QbD rather than empirical trial and error.

QbD training builds systematic development capability

Going Global with Exports and Licensing

China's outbound biotech licensing surpassed 135 billion USD in 2026. Products headed for FDA and EMA markets must meet the same QbD expectations, making the skill business-critical.

QbD training aligns products to global expectations

Shortage of QbD Practitioners

China has a deep manufacturing base but relatively few professionals fluent in QTPP, DoE and design-space definition, leaving trained QbD practitioners scarce and highly valued.

QbD training makes trained practitioners stand out

Pressure to Cut Deviations and Cost

Margin and quality pressure push manufacturers to reduce deviations and post-approval changes. QbD process understanding and control strategy support leaner, more reliable production.

QbD training builds control-strategy and optimisation skills

Sources: NMPA, ITIF, Oliver Wyman, Vision Lifesciences, Grand View Research (China) 2026; ICH.

QbD is a practical capability that pays off on live development projects. Join pharmaceutical professionals across China who are designing quality in from the start. Begin your QbD journey today.

Your China QbD Transformation

From Test-And-Fix Today to QbD-Led Tomorrow

Your Development Practice, Transformed

China's pharmaceutical and biopharma sector is scaling fast, and employers increasingly separate professionals who can design quality in from those who still test it in. Here is which side of that line QbD training puts you on.

Today

Seen as a capable scientist without a systematic quality framework

After QbD

Recognised as a QbD practitioner who designs quality into products

Today

Seen as a capable scientist without a systematic quality framework

Today

Limited mostly to your own function within development

After QbD

Able to lead cross-functional QTPP, risk and design-space work

Today

Limited mostly to your own function within development

Today

Development experience valued mainly at project level

After QbD

In demand across China's drug makers, CDMOs and biotech clusters

Today

Development experience valued mainly at project level

You master QbD

Before

Quality is checked by testing finished batches, catching problems late

Now you have

Quality is designed in from the QTPP stage, preventing failures early

Before

Quality is checked by testing finished batches, catching problems late

Before

Development relies on slow one-factor-at-a-time trial and error

Now you have

Development uses Design of Experiments to map the design space efficiently

Before

Development relies on slow one-factor-at-a-time trial and error

Before

Submissions describe a fixed process with limited process understanding

Now you have

Submissions show a justified design space and a clear control strategy

Before

Submissions describe a fixed process with limited process understanding

Before

Risk is judged informally, with little structure to guide experiments

Now you have

Risk is prioritised with Ishikawa and FMEA to focus effort where it counts

Before

Risk is judged informally, with little structure to guide experiments

"The gap between testing quality in and designing it in is exactly where modern regulators and employers now focus, and QbD is how you close it."

Join the professionals building right-first-time development capability with Invensis Learning.

Sources: worldsalaries, SalaryExpert, PayScale (China) 2026; NMPA, ICH.

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 China 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

Skills You Will Build in This QbD ProgrammeThe QbD Toolkit, End to End

Skills covered in QbD training span the full workflow, from defining a Quality Target Product Profile through to a control strategy ready for submission. By the end of the one-day programme you can apply each tool to realistic pharmaceutical development scenarios.

Build a Quality Target Product Profile

Learn what a self-contained QbD workflow starts with: constructing a QTPP from clinical and patient needs to define what a product must achieve in quality, safety and efficacy.

Identify and Classify Critical Quality Attributes

Determine which physical, chemical, biological and microbiological properties are critical to quality, and link them to material attributes and process parameters.

Run Risk Assessments with Ishikawa and FMEA

Apply fishbone diagrams and Failure Mode and Effects Analysis to prioritise the CMAs and CPPs that most influence quality, focusing experiments where risk is highest.

Design and Interpret DoE and the Design Space

Use Design of Experiments to understand how variables interact, then define and justify a design space with Normal Operating and Proven Acceptable Ranges.

Apply Process Analytical Technology

Explore PAT tools such as NIR and Raman for real-time monitoring, and see how they support in-process control and real-time release testing.

Develop a Control Strategy for Submission

Bring risk assessment and DoE outputs together into a control strategy, and structure QbD evidence for CTD submissions to the NMPA, FDA and EMA.

Who Should TakeQuality by Design Training in China?

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

CNY 2980

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 ChinaExpert-Led, ISO-Certified Training

Invensis Learning delivers Quality by Design training in China for pharmaceutical professionals and organisations that want practical, science-led quality capability. Our programmes combine experienced trainers, ICH-aligned content, hands-on exercises and flexible delivery formats. Whether you enrol as an individual or arrange training for a cross-functional team, you get a structured, learner-focused experience built around real-world application and measurable outcomes.

Experienced pharmaceutical trainers with real QbD and regulatory expertise
Content aligned to the ICH Q8, Q9, Q10 and Q11 quality guidelines
Flexible live virtual, classroom and on-site delivery across China
Hands-on exercises using realistic pharmaceutical development scenarios
ISO 9001:2015 quality-managed and ISO 27001:2022 information-secure delivery
A practical, apply-at-work focus rather than theory alone
Dedicated learner support before, during and after training
Course completion certificate from Invensis Learning

4.7/5

Rated by Learners Worldwide

500+

Corporate Clients

15+

Years of Training Excellence

24/7

Learner Support

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 ChinaAll our classroom training is now available online at your convenience

Quality by Design in China

Mandarin Oriental Wangfujing Beijing, No. 269 Wangfujing Street, Beijing, China, 100006

Quality by Design in China

Atlantis Sanya, 9P5R+4Q6, North Haitang Bei Road, Sanya, China, 572013

Quality by Design in China

Mandarin Oriental Wangfujing Beijing, No. 269 Wangfujing Street, Beijing, China, 100006

Quality by Design in China

Atlantis Sanya, 9P5R+4Q6, North Haitang Bei Road, Sanya, China, 572013

Corporate QbD Training for China Pharma TeamsUpskill Your Team

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Suitable for small, medium and large pharmaceutical teams
Tailored schedules aligned to your team's availability
Delivery through on-site, live virtual or hybrid formats
Trainers with pharma, biopharma and regulatory expertise
Role-based examples for formulation, process, QA and regulatory teams
Dedicated coordination and support for group programmes
Scalable delivery for teams across China and global sites

What Our Learners Say

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One Clear Workflow I Could Apply at Once

"The QbD training finally connected QTPP, CQAs and DoE into one workflow I could use straight away. The design-space exercises were the most useful part for my formulation work."

Li Wei

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PAT and Risk Assessment Finally Clicked

"I now understand how PAT and control strategy fit together and why our risk assessments matter so much. The FMEA session changed how I prioritise my method work."

Zhang Min

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Practical and Aligned to ICH

"Clear, practical and well aligned to the ICH guidelines. I left able to structure QbD evidence for our submissions with far more confidence than before."

Chen Jing

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One Shared QbD Language Across Teams

"We trained a cross-functional team and now share one QbD language from R&D to manufacturing. Deviations and rework have already started to fall."

Wang Hao

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Tailored On-Site Training That Delivered

"The on-site programme was tailored to our products. Our teams now apply QTPP and design-space thinking to live projects, which has strengthened our submissions."

Liu Fang

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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 pharmaceutical and biopharmaceutical professionals to build quality into a product from the design stage. It covers QTPP, Critical Quality Attributes, risk assessment, Design of Experiments, the design space, PAT and control strategy, grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines.

General

What is Quality by Design training?

Is QbD training worth it for professionals in China?

Yes. China's NMPA has adopted the ICH quality guidelines, and reviewers increasingly expect QbD evidence in submissions, so the skills apply directly to daily work across drug makers, CDMOs and biotech clusters. You gain a systematic approach that reduces late-stage failures and strengthens submissions.

Who should attend this QbD course?

The training suits formulation scientists, process development engineers, analytical scientists, QA professionals, CMC regulatory specialists and manufacturing technical managers in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations who want to understand and apply QbD.

Do I need prior QbD knowledge to join?

No. There are no formal prerequisites. Familiarity with pharmaceutical development or GMP is helpful but not required, as the course introduces QbD from first principles in a pharmaceutical development context.

Which guidelines and framework does the training follow?

The course is grounded in the ICH Q8(R2) Pharmaceutical Development guideline, together with ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. It also references FDA PAT guidance and EMA expectations that shape modern QbD submissions.

Pricing

How much does QbD training cost in China?

Pricing is available on request and varies by delivery mode, group size and format. Speak with a learning advisor for a quote tailored to individual or team training.

What is included in the course fee?

The fee typically includes instructor-led sessions, structured courseware and learning resources, hands-on QbD tool exercises, case studies, learner support and a course completion certificate from Invensis Learning.

Do you offer group or corporate pricing?

Yes. We offer corporate group training with customised schedules and volume-based pricing for R&D, manufacturing, quality and regulatory teams. Contact us for a tailored quote.

Is there a discount for booking a whole team?

Group bookings are priced on a volume basis, so the more colleagues you train together, the better the per-person value. Ask about corporate and group pricing for your organisation.

What payment methods are available?

We accept major credit and debit cards and bank transfers, with instalment options on selected plans. Talk to a learning advisor to choose the option that suits you.

Assessment

Is there an exam for the QbD training?

No. Quality by Design training is a non-certification course with no examination. Learning is reinforced through hands-on tool exercises, pharmaceutical case studies and discussion during the one-day programme.

Do I receive a certificate after the training?

You receive a course completion certificate from Invensis Learning. No external credential is awarded, as this is a practical skills course focused on capability rather than a formal qualification.

How is my learning assessed?

There is no formal assessment. Instead, hands-on QbD tool exercises, such as building a QTPP, identifying CQAs, running risk assessment and interpreting a design space, let you apply each concept to realistic scenarios during the session.

What will I be able to do after the course?

You will be able to construct a QTPP, identify and classify CQAs, facilitate Ishikawa and FMEA risk assessments, plan and interpret DoE, define a design space, and develop a control strategy for regulatory submission.

Is the training relevant to both small molecules and biologics?

Yes. The course covers QbD principles for small molecule drug products such as tablets and injectables, as well as biopharmaceuticals such as monoclonal antibodies and biosimilars, with case examples from both.

Course Content

What topics does the QbD training cover?

The programme covers QbD principles and the ICH framework, QTPP and CQAs, risk assessment, Design of Experiments and design space, Process Analytical Technology and control strategy, and QbD in practice through case studies and submission examples.

What QbD tools will I learn to use?

You will work with the Quality Target Product Profile, Ishikawa diagrams, FMEA, Design of Experiments, the design space with Normal Operating and Proven Acceptable Ranges, PAT tools and the control strategy.

Are there hands-on exercises included?

Yes. Practical exercises run throughout the day, applying QbD tools to realistic pharmaceutical development scenarios so you leave able to use them on your own live projects.

Is the content aligned to the current ICH guidelines?

Yes. The content is aligned to the ICH Q8(R2), Q9, Q10 and Q11 guidelines, which China's NMPA has adopted and which underpin QbD expectations from the FDA and EMA.

What learning materials are provided?

You receive structured courseware, reference material on the ICH framework, worked case studies, and tool templates for QTPP, risk assessment and design-space interpretation to support your work after the course.

Enrollment

How do I enrol in the QbD course?

You can enrol through the Invensis Learning website. Choose your preferred format, 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 on-site programmes, so you can choose the format that fits your schedule and team.

How soon can I start the training?

Public sessions run on a regular schedule, and corporate on-site dates are arranged to suit your team. See upcoming batches or speak with a learning advisor to find the next available date.

Can the course be delivered on-site for our team in China?

Yes. We deliver tailored on-site and live virtual QbD training for cross-functional teams across China, mapped to your own products and development projects. Contact us to arrange a group session.

What is the reschedule or cancellation policy?

Rescheduling and cancellations are handled per our published policy, with flexible options on selected plans. Reach out to our team for the details that apply to your booking.