Quality by Design Training in South Korea

Build Quality into Every Batch

Master the ICH-aligned QbD approach that South Korea's world-leading biopharma and CDMO sector runs on. This instructor-led programme, delivered by a specialist Quality by Design training company, equips formulation, process, analytical, quality and regulatory professionals to design quality into pharmaceutical products from the start, applying QTPP, critical quality attributes, risk assessment, DoE and control strategy to real development scenarios.

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Master Quality by Design and Lead Excellence in South Korea

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What Is Quality by Design and Why It Matters in South KoreaDesign Quality in, Not Test It In

Quality by Design (QbD) Training in South Korea is a practical, one-day skills programme that teaches teams to build quality into pharmaceutical and biopharmaceutical products from the design stage rather than testing it in at the end. It is grounded in the ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 guidelines that the Ministry of Food and Drug Safety and global regulators such as the FDA and EMA now expect in modern development and manufacturing submissions.

Over a single focused day you learn to apply the full QbD toolkit: the Quality Target Product Profile, critical quality attributes, risk assessment with Ishikawa diagrams and FMEA, Design of Experiments, the design space, Process Analytical Technology and the control strategy. Every tool is practised on realistic development scenarios so the learning transfers straight to work.

The course suits formulation and analytical scientists, process development engineers, quality assurance professionals and regulatory affairs specialists across South Korea's fast-growing biologics, biosimilar and CDMO industry. As Korean manufacturers scale for global markets, QbD fluency has become a practical, in-demand capability rather than a nice-to-have.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the South Korea 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 South Korea 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 South Korea

Instructor-led training formats available for individual learners and corporate teams across the South Korea
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 South Korea
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 South Korea 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 South KoreaWho 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

How QbD Skills Pay off at WorkCapability You Can Apply from Day One

For Individuals

QbD training helps pharmaceutical professionals turn modern development theory into everyday capability. You learn to construct a Quality Target Product Profile, identify critical quality attributes, run structured risk assessments, and use DoE to understand and control your process. Whether you work in formulation, process development, analytical science, quality assurance or regulatory affairs, the programme builds the practical toolkit that South Korea's biopharma employers increasingly expect.

If you want to move from reacting to quality problems to preventing them, QbD gives you a clear, structured way of working. You leave able to lead a QbD programme end to end, from the QTPP through to a documented control strategy.

Design quality into products from the QTPP stage instead of chasing failures at the end
Replace trial-and-error development with a science-based, defensible approach
Lead CQA identification and risk assessments using Ishikawa diagrams and FMEA
Plan and interpret Design of Experiments to define a robust design space
Build control strategies and apply PAT for consistent, right-first-time output
Structure QbD evidence for MFDS, FDA and EMA regulatory submissions
Become the go-to QbD practitioner your development team relies on
Gain skills that transfer across small molecules and biologics alike

For Organizations

QbD group training equips a whole development team to design quality into products together. Delivered for cross-functional groups, it aligns formulation, process, analytical, quality and regulatory colleagues around one ICH-based way of working. For organisations manufacturing for regulated global markets, this shared capability reduces risk, shortens development and strengthens every submission.

If your teams still rely on end-product testing to catch problems, QbD training creates a common, science-based approach to prevention. Colleagues can apply QTPP, CQA identification, risk assessment and DoE directly to your own live product development projects during the session.

Builds a shared QbD language across formulation, process, quality and regulatory teams
Cuts batch failures and deviations through designed-in process understanding
Strengthens FDA, EMA and MFDS submissions with robust QbD evidence
Reduces costly post-approval changes through a defined design space
Speeds development by focusing experiments on the highest-risk variables
Supports CDMO competitiveness with regulator-ready development capability
Standardises pharmaceutical development practice across sites
Delivered flexibly for cross-functional teams and live projects

Where QbD Skills Take Your CareerIn South Korea's Biopharma Boom

Quality by Design fluency is in sharp demand across South Korea's biopharmaceutical sector, home to the world's largest biologics CDMO and a booming biosimilar industry. As Samsung Biologics, Celltrion, SK bioscience and Lotte Biologics scale manufacturing for FDA and EMA markets, employers need professionals who can apply QbD to development and CMC submissions. That practical capability is exactly what Quality by Design training builds. The roles span formulation and process development scientists, analytical and QA specialists, and regulatory affairs and manufacturing technical leads, and here is what the market is telling us right now.

$30.4bn

Korea bio-health exports, 2026

forecast, KHIDI

11.9%

Biopharma export growth

per year, KHIDI

₩86.5m

Process engineer salary

average per year, ERI 2026

3rd

Samsung Biologics global rank

biotech market cap, 2026

SECTORS HIRING

—Biopharmaceutical CDMO and CMO manufacturing
—Biosimilar and biologics development
—Vaccine and cell therapy manufacturing
—Active pharmaceutical ingredient (API) production
—Generic and small-molecule pharma
—Regulatory affairs (CMC) and quality assurance

GROWTH TRENDS

—Bio-health exports forecast at USD 30.4bn in 2026
—Biopharmaceutical exports growing about 11.9% a year
—Samsung Biologics scaling as the world's largest biologics CDMO
—Biosimilar third wave driving global submissions
—MFDS shortening review timelines to speed approvals
—Songdo bio-cluster expansion pulling in global CDMO work

Sources: KHIDI, AJU Press, BioSpectrum Asia (2025-2026); Paylab, SalaryExplorer, ERI (South Korea) salary data.

Designation

Quality by Design Professionals in South Korea : Salary Insights and Trends

Hiring Companies in South Korea

₩38000K

Min

₩52000K

Average

₩75000K

Max

Paylab · SalaryExplorer (South Korea)

Samsung BiologicsCelltrionSK bioscienceGC Biopharma

Source: Samsung Biologics · Celltrion · SK bioscience · GC Biopharma

Why QbD Capability Is in Demand Across Korean Pharma

Regulatory Expectation Gap

MFDS, the FDA and the EMA now expect QbD evidence in development submissions. Korean exporters need teams who can produce the QTPP, design space and control strategy that dossiers require.

QbD builds regulator-ready development skills

The Biosimilar Third Wave

As Korea's biosimilar sector enters a higher-stakes phase, robust process understanding is what wins global approvals. QbD gives developers the tools to prove and defend consistent quality.

QbD builds design space and control strategy skills

CDMO Client Requirements

Global clients of Korean CDMOs such as Samsung Biologics and Lotte Biologics demand QbD-based development. Teams that speak QbD fluently help win and retain international contracts.

QbD builds CMC and development capability

Biologics Complexity

Monoclonal antibodies and other biologics are process-defined and sensitive to conditions. Identifying critical quality attributes and running DoE is essential to control quality reliably.

QbD builds CQA and risk assessment skills

Pressure for Faster Approvals

MFDS is shortening biosimilar review times, and a strong QbD dossier helps developers move faster. Designed-in quality and clear evidence reduce queries and rework during assessment.

QbD builds stronger submission evidence

QbD Talent Scarcity

Korea has a deep pharmaceutical manufacturing base but far fewer scientists fluent in the full QbD toolkit. Practical QbD skills make professionals rare and highly sought after.

QbD makes skilled practitioners stand out

Sources: KHIDI, AJU Press, BioSpectrum Asia, Seoulz (South Korea) 2025-2026; ICH Q8-Q11 guidelines.

QbD is more than a method. It is the capability that lets Korean pharma compete for global markets. Join professionals who design quality in from the start and lead development with confidence. Begin your QbD journey today.

Your South Korea QbD Transformation

From Trial and Error to Designed-In Quality

The Shift QbD Delivers

South Korea's pharmaceutical sector is scaling fast for regulated global markets, and employers increasingly separate teams that can design quality in from those still testing it in. Here is the gap QbD training closes for you.

Today

Limited leverage for roles that ask for QbD and design-space experience

After QbD

Eligible for QbD-led development and CMC roles at Korea's top biopharma firms

Today

Limited leverage for roles that ask for QbD and design-space experience

Today

Contributing to submissions without owning the pharmaceutical development story

After QbD

Able to structure Section 3.2.P.2 QbD evidence for FDA, EMA and MFDS dossiers

Today

Contributing to submissions without owning the pharmaceutical development story

Today

Skills tied to one product, process or way of working

After QbD

A transferable QbD toolkit that travels across small molecules and biologics

Today

Skills tied to one product, process or way of working

You build QbD capability

Before

Quality issues surface late, in end-product testing and failed batches

Now you can

Quality is built in from the QTPP and design stage, before problems appear

Before

Quality issues surface late, in end-product testing and failed batches

Before

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

Now you can

DoE and the design space give you a science-based, predictable process

Before

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

Before

Risk decisions are informal and hard to defend to regulators

Now you can

FMEA and criticality assessment give a documented, ICH-aligned rationale

Before

Risk decisions are informal and hard to defend to regulators

Before

Manufacturing changes trigger costly regulatory rework

Now you can

A defined design space and control strategy give room to flex without resubmission

Before

Manufacturing changes trigger costly regulatory rework

"The gap between testing quality in and designing it in is what separates development teams that win global markets, and the organisations that matter already know it."

Join 50,000+ professionals who trained with Invensis Learning and made the shift.

Sources: Paylab, SalaryExplorer, ERI (South Korea) 2025-2026; KHIDI.

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 South Korea 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 Toolkit You Will MasterFrom QTPP to Control Strategy

Skills covered in Quality by Design training range from building a QTPP through risk assessment, Design of Experiments and the design space to Process Analytical Technology and the control strategy. By the end of the day you can lead a QbD programme end to end on real pharmaceutical development scenarios.

Build a Quality Target Product Profile

Construct a QTPP from clinical and patient needs, defining the dosage form, delivery, quality standards and performance targets that anchor the entire QbD programme.

Identify and Classify Critical Quality Attributes

Use prior knowledge and risk-based thinking to identify CQAs for small molecules and biologics, and distinguish them from non-critical attributes.

Run QbD Risk Assessments

Apply Ishikawa diagrams and FMEA to link material attributes and process parameters to each CQA, then prioritise the highest-risk relationships with Risk Priority Numbers.

Design Experiments and Define the Design Space

Select the right DoE for screening or optimisation, interpret the model output, and define a design space with Normal Operating and Proven Acceptable Ranges.

Apply PAT and Build a Control Strategy

Use Process Analytical Technology for real-time monitoring and develop a risk-proportionate control strategy across materials, process and testing.

Structure QbD Evidence for Submissions

Present QTPP, risk assessment, DoE and control strategy as Section 3.2.P.2 evidence for MFDS, FDA and EMA dossiers, and manage post-approval change under ICH Q12.

Who Should TakeQuality by Design Training in South Korea?

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

USD 425

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

Untitled

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 LearningExpert-Led QbD Training in South Korea

Invensis Learning delivers structured Quality by Design training for pharmaceutical professionals and organisations across South Korea that want to build practical, ICH-aligned development capability. Our programmes combine experienced trainers, hands-on QbD tool exercises, organised courseware and learner-focused support. As an established Quality by Design training company in South Korea, we help you turn QbD principles into everyday practice. Whether you enrol as an individual or plan corporate training for a cross-functional team, we provide a professional learning experience designed around practical understanding, real-world application and measurable outcomes.

Expert trainers with real pharmaceutical and QbD delivery experience
ICH Q8 to Q11 aligned courseware built around real development scenarios
Flexible live virtual, classroom and onsite formats for Korean teams
Hands-on QTPP, CQA, FMEA and DoE exercises, not slideware
ISO 9001:2015 certified training quality management
ISO 27001:2022 certified information security
Dedicated learner support before, during and after training
Trusted by professionals and organisations across 100+ countries

60+

Global Course Portfolio

100+

Countries Served

ISO 9001

Quality Management

200K+

Professionals Trained

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 South KoreaAll our classroom training is now available online at your convenience

Quality by Design in South Korea

Oakwood Premier, Incheon KR, 165 Convensia-daero, Yeonsu-gu, Incheon, South Korea

Quality by Design in South Korea

Four Seasons Hotel, Seoul 97 Saemunan-ro, Dangju-dong, Jongno District, Seoul, South Korea

Quality by Design in South Korea

Oakwood Premier, Incheon KR, 165 Convensia-daero, Yeonsu-gu, Incheon, South Korea

Quality by Design in South Korea

Four Seasons Hotel, Seoul 97 Saemunan-ro, Dangju-dong, Jongno District, Seoul, South Korea

Corporate QbD Training for PharmaStandardize Across Your Sites

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Tailored QbD curriculum built around your own products and processes
Live virtual, onsite or hybrid delivery across Korea and global sites
Cross-functional training for formulation, process, QA and regulatory teams
Apply QTPP, CQA and DoE tools to your live development projects
Flexible scheduling around your team's availability
Dedicated coordination and progress reporting for group programmes
Scalable delivery for local and multinational teams

What Our Learners Say

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The Tools Finally Clicked into One Method

"The QbD training finally connected the tools I had read about into one flow. I can now build a QTPP, run an FMEA and plan a DoE with confidence. The design-space exercise alone changed how our formulation team approaches development."

Ji-woo Park

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Directly Useful for Process Development

"As a process engineer I found the DoE and design-space sessions directly useful. The trainer used realistic biologics scenarios, so I could see exactly how to define Normal Operating and Proven Acceptable Ranges for our own process."

Min-jun Lee

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Made the Regulatory Link Clear

"The link between QbD outputs and Section 3.2.P.2 of the dossier was the highlight for me. I now understand how the QTPP, risk assessment and control strategy fit together in a submission. Very practical and well paced."

Seo-yeon Kim

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Our Team Now Shares One QbD Language

"We ran this for our quality team ahead of a major CDMO project. Everyone came away speaking the same QbD language, from CQA identification to control strategy. It has already reduced back-and-forth between development and QA."

Hyun-woo Choi

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Credible for Seniors, Accessible for Juniors

"As an L&D lead I needed training that senior scientists would respect and juniors could follow. This delivered on both. The hands-on exercises on our own product types made it stick far better than a generic overview would have."

Eun-ji Jung

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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 skills course that teaches teams to build quality into pharmaceutical and biopharmaceutical products 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 and covers the QTPP, critical quality attributes, risk assessment, DoE, the design space, PAT and the control strategy.

General

What is Quality by Design training?

Who should attend QbD training in South Korea?

The training suits formulation and analytical scientists, process development engineers, quality assurance professionals, and regulatory affairs specialists in pharmaceutical, biopharmaceutical, API and CDMO organisations. It is ideal for anyone in South Korea's biologics and biosimilar sector who wants to apply QbD in product development.

Is QbD training worth it for pharma professionals?

Yes. As South Korea scales manufacturing for FDA and EMA markets, employers increasingly need people who can design quality in and produce QbD evidence for submissions. The skills are immediately applicable to development and CMC work, making QbD fluency a practical career advantage across the sector.

Does QbD apply 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. Case examples from both product types are included so the tools transfer to your work.

What standards does QbD training follow?

The training follows the ICH quality guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. These are the frameworks the Ministry of Food and Drug Safety, the FDA and the EMA expect in modern development submissions.

Pricing

How much does QbD training cost in South Korea?

Pricing varies by delivery mode, group size and schedule, so an exact figure is available on request. The fee covers the full one-day programme, courseware, hands-on QbD exercises and a course completion record. Request a quote for the format that suits you.

What is included in the QbD course fee?

The fee includes instructor-led training across all six QbD modules, ICH-aligned courseware, hands-on QTPP, CQA, risk assessment and DoE exercises, case study materials, learner support and a course completion record from Invensis Learning.

Do you offer corporate or group pricing?

Yes. We offer tailored corporate and group pricing for pharmaceutical teams, with volume-based rates for cross-functional development groups. Talk to a learning advisor for a quote built around your team size and delivery preference.

Are there payment or instalment options?

We accept major credit and debit cards and bank transfers, and offer instalment options on selected plans. Speak with a learning advisor to choose the option that works best for you or your organisation.

Is there a discount for team enrolments?

Yes. Enrolling a group is usually more cost-effective than booking individually, and corporate rates apply for whole teams. Contact us with your headcount and we will prepare a group quote.

Assessment

Is there an exam for QbD training?

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

Do I receive a certificate after the training?

Yes. On completing the one-day programme you receive a course completion record from Invensis Learning. It recognises that you have covered the full QbD toolkit; it is a record of completion rather than a formal credential from an awarding body.

How is learning assessed during the course?

There is no formal assessment. Instead you apply QbD tools throughout the day, building a QTPP, identifying CQAs, running a risk assessment and interpreting a design space on realistic scenarios, so you practise the skills rather than sit a test.

Are there any prerequisites for QbD training?

None. The course introduces QbD from first principles. Familiarity with pharmaceutical development or GMP is helpful but not required, so scientists, engineers, quality and regulatory professionals at any level can take part.

Will I be able to apply QbD at work afterwards?

Yes. After the training you can construct a QTPP, lead CQA identification, facilitate FMEA-based risk assessments, plan and interpret DoE studies, define a design space and develop a control strategy for regulatory submissions.

Course Content

What topics does QbD training cover?

The course covers QbD principles and the ICH regulatory context, the QTPP and critical quality attributes, risk assessment with Ishikawa diagrams and FMEA, Design of Experiments and the design space, Process Analytical Technology and the control strategy, and QbD in practice through case studies and submissions.

Will I learn Design of Experiments (DoE)?

Yes. The course explains why DoE replaces one-factor-at-a-time testing, covers screening, response surface and mixture designs, and shows how to interpret the model output to define a design space with Normal Operating and Proven Acceptable Ranges.

Does the course cover PAT and the control strategy?

Yes. You learn how Process Analytical Technology enables real-time monitoring and release, and how to build a risk-proportionate control strategy spanning material controls, process parameter ranges, in-process controls, testing and periodic review.

Can a beginner take this course?

Yes. The programme introduces QbD from the ground up in a pharmaceutical development context, so newcomers can follow it while experienced scientists deepen and structure what they already do. Hands-on exercises support learners at every level.

What materials are provided with the training?

You receive ICH-aligned courseware covering all six QbD modules, hands-on exercise worksheets for the QTPP, CQA identification, risk assessment and design space, case study examples for small molecules and biologics, and a course completion record.

Enrollment

How do I enrol in QbD training in South Korea?

You can enrol through the Invensis Learning website. Choose your preferred format, complete payment, and you will receive access to the schedule, courseware and learning resources. Talk to a learning advisor if you would like help choosing a batch.

What training formats are available?

The course is available online as live virtual instructor-led training, in a classroom, and as onsite corporate delivery for teams. Choose the format that best fits your schedule and how your team prefers to learn.

How soon can I start QbD training?

New batches run regularly across live virtual and onsite formats. See upcoming schedules on the website, or speak with a learning advisor to find the next session that fits your calendar in South Korea.

Can I reschedule my enrolment to another batch?

Yes. Flexi options let you move to another batch if your plans change. Contact our support team and we will help you transfer to a session that suits you.

Is onsite corporate delivery available in Korea?

Yes. We deliver QbD training onsite for pharmaceutical and biopharmaceutical teams across South Korea, and via live virtual or hybrid formats for multi-site groups. Contact us to arrange a session tailored to your organisation.