Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Quality by Design Training in Indonesia Covers

    A Practical Route to Built-In Quality

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    What's Included in Your Quality by Design Training

    • One-day course spanning ten structured modules

    • 8 PDUs on completion of the training

    • Copy of course material and SME-prepared study guide

    • Case studies and practical applications module

    • Course completion certificate from Invensis Learning

    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the Indonesia

    Who Can Enrol?

    The On-The-Job Payoff of Learning QbD

    Skills You Can Use Immediately

    Who Should Take Quality by Design Training in Indonesia?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Where QbD Skills Take Your Career

    Demand 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.

    What Is Driving Demand for QbD Skills in Indonesia

    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.

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

    Module 2: QbD Tools and Techniques

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

    Module 3: Industry and Regulatory Perspective

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

    Module 4: Quality Target Product Profile (QTPP)

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

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

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

    Module 6: Statistical Design of Experiments

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

    Module 7: Design Space and Process Control

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

    Module 8: Risk Assessment and Management

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

    Module 9: Real-time Release Testing (RTRT)

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

    Module 10: Case Studies and Practical Applications

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

    Course Curriculum

    of the Quality by Design Training

    The online Quality by Design training course curriculum in the 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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    The QbD Tools You Will Be Able to Apply

    From 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.

    Quality by Design Training Modes

    for Professionals and Teams

    We offer flexible training formats designed to suit different learning preferences, schedules, and professional goals. Whether you prefer self-paced learning or a structured, corporate, instructor-led experience, choose the option that best supports your skill development journey with the best Quality by Design online training options.

    Quality by Design 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

    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.

    Quality by Design Corporate Group Training

    • Customised training aligned to organisational 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

    Designed for organizations that want to build capabilities at scale, standardise knowledge, and support workforce development through customised team learning initiatives.

    Best For: Organizations looking to upskill employees, address capability gaps, and deliver consistent training across teams.

    Quality by Design Focused 1-to-1 Training

    • One-to-one instructor attention

    • Customised 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

    Receive personalized instruction tailored to your goals, pace, and learning requirements through dedicated sessions from our trusted Quality by Design training company.

    Best For: Professionals seeking personalized guidance, accelerated learning, or focused support to achieve specific outcomes.

    Quality by Design Live Virtual Training

    Quality by Design Live Virtual Training

    Live online instructor-led sessions

    Interactive discussions and virtual activities

    Expert guidance from experienced trainers

    Practice assessments and revision support

    Dedicated Q&A sessions for concept clarification

    Fixed schedules for accountability and momentum

    Small batch sizes for personalized attention

    Access from any location with internet connectivity

    Starts from

    USD 345

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

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

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    Why Learn Quality by Design with Invensis Learning

    Trusted 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 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

    Secure SSL Encryption

    Leaders in Training industry for 12+ years

    Leaders in Training industry for 12+ years

    Over 5000 five star reviews

    Over 5000 five star reviews

    Level AA conformance, W3C WCAG 2.2

    Level AA conformance, W3C WCAG 2.2

    Quality by Design Training Locations in Indonesia

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

    Quality by Design Training Location in Indonesia

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

    Quality by Design Training Location in Indonesia

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

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    Corporate QbD Training for Teams

    For Your Pharma Workforce

    • 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

    Trusted by Leading Enterprises in Indonesia

    Kalbe FarmaKimia FarmaBio FarmaDexa MedicaSanbe FarmaCombiphar

    Enquire with us now

    Drop us a query and our learning consultant will reach out to you shortly

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

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

    Quality by Design Training Course in Bali (Denpasar)Quality by Design Training Course in JakartaQuality by Design Training Course in MedanQuality by Design Training Course in SemarangQuality by Design Training Course in Yogyakarta

    Frequently Asked Questions

    Here'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.

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