Quality by Design Training in Indonesia

Build Quality into Every Product

Designed for pharmaceutical and biopharmaceutical professionals in Indonesia, this instructor-led programme shows you how to design quality into products from the outset using the QbD approach set out in the ICH Q8, Q9, Q10 and Q11 guidelines. Learn to apply QTPP, critical quality attributes, risk assessment, Design of Experiments and control strategy to real development work.

Flexible

Duration

Live

Mode

Hours

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Master Quality by Design and Lead Excellence in Indonesia

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What Quality by Design Training in Indonesia CoversA Practical Route to Built-In Quality

Quality by Design Training in Indonesia is a practical, one-day programme that teaches the Quality by Design (QbD) approach to pharmaceutical product and process development, where quality is built into the product from the design stage rather than tested in at the end. Grounded in the ICH Q8, Q9, Q10 and Q11 guidelines that regulators such as BPOM, the FDA and the EMA expect, the course shows you how to define a Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), run risk assessments, design experiments and build a robust control strategy.

Indonesia's pharmaceutical sector is growing at a 7 to 9 per cent annual pace, and BPOM's CPOB requirements now push manufacturers towards the science-based development that QbD provides. Whether you work in formulation, analytical science, process development, quality assurance or regulatory affairs, this training helps you replace trial-and-error development with a systematic, evidence-led method.

Delivered in live virtual, classroom and corporate formats, the programme turns QbD theory into workplace skill through hands-on exercises using realistic development scenarios. Start building quality into your products with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Indonesia 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 Indonesia 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 Indonesia

Instructor-led training formats available for individual learners and corporate teams across the Indonesia
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 Indonesia
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 Indonesia 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 IndonesiaWho 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

The On-The-Job Payoff of Learning QbDSkills You Can Use Immediately

For Individuals

This QbD training helps pharmaceutical professionals turn regulatory theory into practical capability. You learn to apply the QbD toolkit, from QTPP and CQA identification through risk assessment, DoE and control strategy, to your own development work. Whether you are a formulation scientist, analytical scientist, process engineer, quality assurance professional or regulatory affairs specialist, the course builds skills that Indonesia's pharmaceutical and biopharmaceutical employers increasingly expect.

If you want to develop products with confidence and prepare submissions that clear review faster, QbD is a clear route forward. You gain a systematic method, hands-on practice and a skill set that travels across pharma, biotech, API and CDMO organisations.

Learn to build quality into pharmaceutical products from the design stage, not test it in at the end
Apply QTPP and Critical Quality Attributes to define what your product must achieve
Run structured risk assessments using Ishikawa diagrams and FMEA to focus development effort
Use Design of Experiments to map the design space and set robust operating ranges
Develop control strategies and PAT approaches that keep processes within the design space
Prepare QbD evidence for CPOB and CTD submissions expected by BPOM, the FDA and the EMA
Stand out to Indonesia's pharmaceutical employers with a modern, in-demand development skill set
Move confidently from trial-and-error development to a systematic, science-based method

For Organizations

QbD group training helps pharmaceutical organisations build development capability by equipping cross-functional teams with a shared, science-based method. The training can be delivered for R&D, quality, manufacturing or regulatory groups. For organisations moving from testing quality in to designing it in, this training provides a scalable, flexible solution that aligns teams around the ICH framework.

If your teams struggle to document development evidence for BPOM or export submissions, QbD group training creates a common language for QTPP, risk assessment, design space and control strategy, improving consistency and audit readiness across business units.

Standardise QbD practice across formulation, analytical, process and quality teams
Reduce manufacturing deviations and out-of-specification batches through better process understanding
Strengthen regulatory submissions and speed up approvals with robust QbD documentation
Build cross-functional development teams that share one QbD language
Lower post-approval change burden by defining a well-justified design space
Improve product consistency and patient safety across your portfolio
Train whole teams together on live product development projects for immediate impact
Available onsite, live virtual or blended across Indonesia to fit team schedules

Where QbD Skills Take Your CareerDemand in Indonesia's Pharma Sector

Quality by Design skills are increasingly valued across Indonesia's pharmaceutical and biopharmaceutical sector, where regulators and manufacturers are moving from testing quality in to designing it in. As BPOM tightens CPOB expectations and companies invest in biosimilars, APIs and exports, professionals who can apply QTPP, risk assessment, DoE and control strategy are sought after across formulation, quality, process and regulatory roles, which makes practical Quality by Design training a worthwhile career investment. Here is what the market is showing.

220+

Licensed pharma manufacturers, Indonesia

registered with BPOM, 2024

7-9%

Pharmaceutical market growth

annual CAGR, 2024-2026

Rp456M

QA Manager average salary

per year, SalaryExpert 2026

Rp548M

Regulatory Affairs Manager salary

per year, SalaryExpert 2026

SECTORS HIRING

—Pharmaceutical Manufacturing and Formulation
—Biopharmaceuticals and Biosimilars
—Active Pharmaceutical Ingredient (API) Production
—Contract Development and Manufacturing (CDMOs)
—Regulatory Affairs and CMC
—Generics, OTC and Herbal Medicine

GROWTH TRENDS

—BPOM CPOB requirements aligning with PIC/S and ICH standards
—National drive for API self-sufficiency and local content (TKDN)
—Biosimilar and biologics investment by Bio Farma and Kalbe
—BPJS universal healthcare expanding drug demand
—Export ambitions raising submission and quality standards
—Shortage of professionals skilled in QbD and DoE

Sources: BPOM, Skylight Strategic, Ken Research (Indonesia pharma) 2024-2026; SalaryExpert, PayScale, Glassdoor, Jobstreet (Indonesia) 2026.

Designation

Quality by Design Professionals in Indonesia : Salary Insights and Trends

Hiring Companies in Indonesia

Rp72000K

Min

Rp108000K

Average

Rp180000K

Max

Glassdoor · SalaryExpert · Jobstreet (Indonesia) 2026

Kimia FarmaSanbe FarmaPhapros

Source: Kimia Farma · Sanbe Farma · Phapros

What Is Driving Demand for QbD Skills in Indonesia

From Quality by Testing to Quality by Design

Many Indonesian manufacturers still rely on end-product testing. BPOM's CPOB, now aligned with PIC/S and ICH, expects quality to be built in through process understanding.

QbD training closes this gap

Rising Regulatory Expectations

BPOM, the FDA and the EMA increasingly expect QbD evidence in submissions. Teams that can document QTPP, design space and control strategy clear reviews more smoothly.

QbD builds submission-ready evidence

API and Local Content Push

Indonesia's drive for API self-sufficiency and TKDN local content demands the science-based process development that QbD delivers for new domestic products.

QbD supports robust process development

Biosimilar and Biologics Complexity

Investment by Bio Farma and Kalbe in biosimilars and biologics brings complex, process-defined products where QbD tools are essential to control critical quality attributes.

QbD controls critical quality attributes

Scarce QbD and DoE Talent

Indonesia's pharma workforce is strong in production but thin in professionals who can run Design of Experiments and define a design space, making QbD skills a differentiator.

QbD skills make you stand out

Cost and Consistency Pressure

Margin pressure and BPJS pricing push manufacturers to cut deviations and rework. QbD reduces out-of-specification batches by understanding what really drives quality.

QbD reduces deviations and rework

Sources: BPOM, Skylight Strategic, Ken Research, IBEF (Indonesia pharma) 2024-2026.

Quality by Design is more than a framework. It is a practical skill that helps pharmaceutical teams build quality into products and clear reviews faster. Start applying QbD to your development work today.

Your Indonesia QbD Transformation

From Testing Quality in to Designing It In

The Shift QbD Skills Make

Indonesia's pharmaceutical sector is shifting from testing quality in to designing it in, and employers increasingly separate professionals who can apply QbD from those who cannot. Here is which side of that line you want to be on.

Today

Limited visibility of what drives product quality

After QbD training

You know which CMAs and CPPs control each CQA

Today

Limited visibility of what drives product quality

Today

Overlooked for QbD-focused roles as employers screen for the skill

After QbD training

Ready for formulation, quality and regulatory roles that value QbD

Today

Overlooked for QbD-focused roles as employers screen for the skill

Today

Reworking out-of-specification batches

After QbD training

Fewer deviations through a robust, well-understood control strategy

Today

Reworking out-of-specification batches

You build QbD capability

Before

You test quality in through end-product checks

Now you have

You design quality in from the QTPP onwards

Before

You test quality in through end-product checks

Before

Development runs on trial and error

Now you have

Development follows a systematic, science-based method

Before

Development runs on trial and error

Before

Experiments vary one factor at a time

Now you have

You use DoE to map the design space efficiently

Before

Experiments vary one factor at a time

Before

Submissions lack structured development evidence

Now you have

You present QbD evidence in the CTD format regulators expect

Before

Submissions lack structured development evidence

"The gap between testing quality and designing it in is now a defined skill set, and the pharmaceutical employers that matter already screen for it."

Join the professionals and teams who built new capability with Invensis Learning.

Sources: BPOM CPOB; SalaryExpert, PayScale, Glassdoor (Indonesia) 2026.

Module 1: Introduction to QbD

Background and key drivers that led to the adoption of Quality by Design in pharmaceutical development
Regulatory guidance documents including ICH Q8, Q9, and Q10 that define the QbD framework
QbD development process flow from concept and design through to manufacturing and regulatory submission

Module 2: QbD Tools and Techniques

Risk management principles and tools used to identify, assess, and control quality risks in product development
Design of Experiments (DoE): fundamentals, design types, and how DoE is used to understand process variability
Design Space definition and control strategies: how boundaries are established and maintained throughout the product lifecycle

Module 3: Industry and Regulatory Perspective

Regulatory framework for QbD including agency expectations from the FDA, EMA, and ICH guidelines
Implementation challenges organizations face when transitioning from traditional to QbD-based development approaches
Real-world industry examples demonstrating how pharmaceutical and biotechnology organizations have adopted QbD

Module 4: Quality Target Product Profile (QTPP)

Definition of the Quality Target Product Profile and its role in guiding QbD-based product development decisions
How QTPP links patient needs and regulatory requirements to specific product quality attributes and design objectives
Practical steps for defining a QTPP for pharmaceutical and biotechnology products

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

Identifying Critical Quality Attributes (CQAs): what they are, how to define them, and why they are central to QbD
Critical Material Attributes (CMAs): how raw material properties influence product quality and must be controlled
Critical Process Parameters (CPPs): identifying process parameters that impact CQAs and require monitoring and control

Module 6: Statistical Design of Experiments

Fundamentals of statistical DoE including full factorial, fractional factorial, and response surface methodologies
Applications of DoE in pharmaceutical process development and optimization
Interpreting DoE results to establish design space boundaries and process understanding

Module 7: Design Space and Process Control

Design Space concept: defining the multidimensional combination of input variables and process parameters that provide quality assurance
Implementation of Design Space within regulatory submissions and manufacturing control strategies
Continuous process verification and how Design Space supports process control across the product lifecycle

Module 8: Risk Assessment and Management

Risk assessment methodologies used in QbD including FMEA, Ishikawa diagrams, and risk ranking tools
Applying risk management principles to product development decisions, process design, and control strategy development
Linking risk assessment outcomes to Design Space boundaries and CQA control strategies

Module 9: Real-time Release Testing (RTRT)

RTRT concept: replacing end-product testing with in-process monitoring and real-time quality assurance
Regulatory requirements and industry expectations for RTRT implementation in pharmaceutical manufacturing
Practical considerations for implementing RTRT as part of a QbD-based control strategy

Module 10: Case Studies and Practical Applications

Pharmaceutical and biotechnology case studies demonstrating end-to-end QbD implementation from QTPP to RTRT
Practical group exercises and scenario analysis applying QbD tools including QTPP definition, CQA identification, DoE, and risk assessment
Lessons learned and best practices from real QbD projects in pharmaceutical, biotechnology, and manufacturing environments

Course Curriculumof the Quality by Design Training

The online Quality by Design training course curriculum in the Indonesia 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 Tools You Will Be Able to ApplyFrom QTPP to Control Strategy

In this Quality by Design training you will learn to apply the full QbD toolkit to pharmaceutical product and process development. By the end you can build quality into a product from the design stage using methods aligned to the ICH Q8, Q9, Q10 and Q11 guidelines.

Define the Quality Target Product Profile

Translate patient and clinical needs into a QTPP that sets the design targets for the whole development programme, covering dosage form, strength, delivery and quality standards.

Identify Critical Quality Attributes

Determine which physical, chemical, biological and microbiological properties are critical to product quality, safety and efficacy, for both small molecules and biologics.

Run QbD Risk Assessments

Use Ishikawa diagrams and FMEA with Risk Priority Numbers to link material attributes and process parameters to CQAs and focus your experiments where they matter.

Design Experiments and Define the Design Space

Plan screening and response surface DoE studies, interpret the statistical model, and set the design space with Normal Operating and Proven Acceptable Ranges.

Build the Control Strategy and Apply PAT

Develop a risk-proportionate control strategy and use Process Analytical Technology such as NIR and Raman for real-time monitoring and release.

Structure QbD Evidence for Submissions

Present QTPP, risk assessment, design space and control strategy in the CTD format expected by BPOM, the FDA and the EMA, and manage the QbD lifecycle.

Who Should TakeQuality by Design Training in Indonesia?

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 395

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 Learn Quality by Design with Invensis LearningTrusted Training for Pharma Professionals

Invensis Learning delivers structured Quality by Design training for pharmaceutical professionals and teams who want to build practical, science-based development capability. Our programmes combine experienced trainers, hands-on QbD tool exercises, organised courseware and learner-focused support. Whether you enrol as an individual or plan corporate training for your team, Invensis Learning provides a professional learning experience built around real-world application and measurable outcomes, backed by ISO 9001:2015 and ISO 27001:2022 certification. As a Quality by Design training company in Indonesia with global reach, we combine international standards with local support you can rely on.

Experienced trainers with real pharmaceutical development and quality experience
Hands-on QbD exercises using realistic small molecule and biologic scenarios
Content aligned to the ICH Q8, Q9, Q10 and Q11 guidelines
Flexible delivery: live virtual, classroom, onsite and corporate formats
ISO 9001:2015 certified quality management for a consistent learning experience
ISO 27001:2022 certified information security you can trust
Global training provider with local support across Indonesia
Course completion certificate and post-training learner support

50+

Industries Served

1-to-1

Doubt-Clearing Sessions

60+

Global Course Portfolio

100+

Countries Served

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 IndonesiaAll our classroom training is now available online at your convenience

Quality by Design in Indonesia

Hotel Indonesia Kempinski, Jalan Haji Mohammad Saleh Ishak, RW 05, Menteng, Jakarta Pusat, Daerah Khusus Ibukota Jakarta, Jawa, 10310, Indonesia

Quality by Design in Indonesia

Grand Hyatt Jakarta, Jalan Haji Mohammad Saleh Ishak, RW 05, Gondangdia, Menteng, Jakarta Pusat, Daerah Khusus Ibukota Jakarta, Jawa, 10350, Indonesia

Quality by Design in Indonesia

Hotel Indonesia Kempinski, Jalan Haji Mohammad Saleh Ishak, RW 05, Menteng, Jakarta Pusat, Daerah Khusus Ibukota Jakarta, Jawa, 10310, Indonesia

Quality by Design in Indonesia

Grand Hyatt Jakarta, Jalan Haji Mohammad Saleh Ishak, RW 05, Gondangdia, Menteng, Jakarta Pusat, Daerah Khusus Ibukota Jakarta, Jawa, 10350, Indonesia

Corporate QbD Training for TeamsFor Your Pharma Workforce

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Upskill formulation, analytical, process and quality teams together
Customised to your own products and live development projects
Flexible onsite, live virtual, hybrid or blended delivery across Indonesia
Trainers with real pharmaceutical and QbD industry experience
Standardise QbD practice and documentation across business units
Progress tracking, assessments and dedicated coordination
Scalable delivery for local and multi-site pharmaceutical teams

What Our Learners Say

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A New Way to Approach Formulation

"The QbD training completely changed how I approach formulation. I now start every project with a QTPP and use risk assessment to focus my experiments instead of testing everything. The DoE and design space exercises were the most useful part."

Rina Wijaya

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Stronger, Clearer Submissions

"I finally understand how to present QbD evidence in a submission. Mapping CQAs to the control strategy made our BPOM documentation far stronger, and the trainer explained the ICH guidelines clearly and practically."

Andi Pratama

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Practical Tools I Use Weekly

"A practical, well-paced course. The Ishikawa and FMEA sessions gave me tools I use every week, and the biologic case study helped me see how QbD applies well beyond tablets."

Siti Nurhaliza

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One Shared QbD Language

"We trained our development and quality teams together. They now share one QbD language, and our design reports are more consistent and audit-ready. The onsite delivery fit our schedule well."

Budi Santoso

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Tailored to Our Biosimilar Work

"Invensis Learning tailored the QbD programme to our biosimilar projects. The hands-on approach meant our scientists applied the tools to real work during the sessions. Strong facilitation and support throughout."

Maya Kusuma

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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 practical course that teaches a systematic, science-based approach to pharmaceutical product and process development, where quality is built into the product from the design stage. It is grounded in the ICH Q8, Q9, Q10 and Q11 guidelines and covers QTPP, CQAs, risk assessment, DoE and control strategy.

General

What is Quality by Design (QbD) training?

Who should attend QbD training in Indonesia?

The course suits formulation scientists, analytical scientists, process development engineers, quality assurance professionals and regulatory affairs specialists in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations across Indonesia. No prior QbD knowledge is required.

Is Quality by Design worth learning for pharma professionals?

Yes. As BPOM aligns CPOB with PIC/S and ICH and companies invest in biosimilars, APIs and exports, employers increasingly expect QbD skills. The training gives you an in-demand, immediately applicable capability that strengthens development, quality and regulatory work.

Which standards and guidelines does the course follow?

The course is aligned to the ICH guidelines that define QbD: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. It also references FDA and EMA expectations and Indonesia's BPOM CPOB requirements.

Do I need prior experience to join?

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

Pricing

How much does Quality by Design training cost in Indonesia?

Fees vary by delivery format, whether live virtual, classroom or corporate, and by group size. Pricing is available on request. Contact a learning advisor for a quote tailored to your needs.

What is included in the course fee?

The fee typically includes instructor-led training across all QbD modules, hands-on tool exercises, course materials, pharmaceutical case studies, a course completion certificate and post-training support.

Do you offer group or corporate discounts?

Yes. We offer corporate group training with customised schedules and volume-based pricing for pharmaceutical teams. Request a group quote for your team and we will tailor the programme to your projects.

Are there payment or instalment options?

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

Will I need to pay for anything beyond the training fee?

No. Quality by Design is a non-certification skills course, so there is no separate examination fee. Your fee covers the training, materials and support, and any optional add-ons are shared upfront.

Assessment

Is there an exam for Quality by Design training?

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

Do I receive a certificate after the course?

Yes. You receive a course completion certificate from Invensis Learning. The course does not award a formal credential from an external body; it builds practical QbD skills you can apply immediately.

How is my learning assessed?

There is no formal assessment. You apply QbD tools such as QTPP construction, CQA identification, risk assessment and design space interpretation to realistic scenarios throughout the course, so you practise as you learn.

Does the training need renewal?

No. There is no credential to maintain or renew. The QbD skills you learn are immediately applicable to development work and do not expire.

Is this a recognised certification?

It is a professional skills training course, not a certification. QbD itself is defined by the ICH Q8, Q9, Q10 and Q11 guidelines; the course teaches you to apply that framework in practice rather than sit an exam.

Course Content

What topics does the QbD course cover?

The programme covers QbD principles and the ICH regulatory context, QTPP and Critical Quality Attributes, risk assessment with Ishikawa and FMEA, Design of Experiments and the design space, Process Analytical Technology and control strategy, and QbD in regulatory submissions and lifecycle management.

Will I learn Design of Experiments (DoE)?

Yes. The course covers DoE within QbD, including screening and response surface designs, interpreting the statistical model, and using the results to define the design space and set Normal Operating and Proven Acceptable Ranges.

Does the course cover both small molecules and biologics?

Yes. It includes case study examples for small molecule drug products such as tablets and for biopharmaceuticals such as monoclonal antibodies and biosimilars, reflecting Indonesia's growing biologics investment.

Is the training hands-on?

Yes. You work through practical exercises: constructing a QTPP, identifying CQAs, building Ishikawa diagrams, selecting DoE designs and interpreting a design space, all using realistic pharmaceutical development scenarios.

How long is the training?

The programme runs for one day (eight hours), covering all six QbD modules with concept explanations, ICH regulatory context, case studies and hands-on tool exercises.

Enrollment

How do I enrol in QbD training in Indonesia?

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

What delivery formats are available?

You can take the Quality by Design course online or in the classroom, whichever suits you. The course is offered as live virtual (online) instructor-led training, classroom training, onsite sessions and customised corporate group training, so you can choose the format that fits your schedule.

Can training be delivered onsite for our team in Indonesia?

Yes. We deliver onsite and live virtual corporate sessions across Indonesia, and can tailor the content to your own product development projects. Ask about corporate or group pricing for your team.

How soon can I start?

New batches run regularly in live virtual and classroom formats. See upcoming schedules or ask a learning advisor about the next available cohort.

What is the refund or reschedule policy?

Refunds and reschedules are handled per our published policy, and selected plans let you transfer to another batch. Contact support for the details that apply to your enrolment.