Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Who Is It For?UntitledA Practical Grounding in ICH-Aligned Development

    The Quality by Design (QbD) Training in the Philippines is a focused, non-certification skills course that teaches a systematic, science-based way 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 that regulators such as the FDA and EMA now expect to see behind modern development submissions. Across the programme you learn to apply the core QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. Realistic pharmaceutical scenarios turn each concept into something you can use the next working day. The course suits formulation and process development scientists, analytical scientists, quality assurance professionals and regulatory affairs (CMC) specialists across the Philippines who want to lead development the way ICH guidelines and local regulators increasingly require. Build the capability with Invensis Learning.

    What Is Quality by Design and Who Is It For?A Practical Grounding in ICH-Aligned Development

    The Quality by Design (QbD) Training in the Philippines is a focused, non-certification skills course that teaches a systematic, science-based way 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 that regulators such as the FDA and EMA now expect to see behind modern development submissions.

    Across the programme you learn to apply the core QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy. Realistic pharmaceutical scenarios turn each concept into something you can use the next working day.

    The course suits formulation and process development scientists, analytical scientists, quality assurance professionals and regulatory affairs (CMC) specialists across the Philippines who want to lead development the way ICH guidelines and local regulators increasingly require. Build the capability with Invensis Learning.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Philippines 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 Philippines 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 Philippines

    • Instructor-led training formats available for individual learners and corporate teams across the Philippines
    • 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 Philippines
    • 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 Philippines 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 PhilippinesWho 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 Quality by Design Skills Strengthen Your WorkValue for Professionals and Teams

    For Individuals

    For Individuals

    Quality by Design training helps pharmaceutical professionals move from empirical, trial-and-error development to a structured, science-based approach. You leave able to apply QbD tools to your own product and process work straight away. Whether you are a formulation scientist, process development engineer, analytical scientist, QA professional or CMC regulatory specialist, the training builds capability that maps directly to how modern development is expected to run.

    If you want to lead development that regulators and employers recognise, QbD skills are a clear step forward. You gain a practical toolkit, hands-on exercises and a way of working that connects product understanding to consistent quality.

    • Build quality into products from the design stage instead of relying on end-product testing
    • Lead QTPP construction and CQA identification workshops with confidence
    • Facilitate risk assessments using Ishikawa diagrams and FMEA with RPN prioritisation
    • Plan and interpret Design of Experiments to define a robust design space
    • Develop control strategies ready for CTD regulatory submissions
    • Speak the ICH Q8 to Q11 language your regulators and auditors expect
    • Apply the skills immediately, with nothing to sit and no renewal to track
    • Stand out as PIC/S-era quality expectations rise across Philippine pharma
    For Organizations

    For Organizations

    QbD group training helps pharmaceutical organisations build development capability by equipping cross-functional teams with a shared, structured methodology. Sessions can be run for formulation, process, analytical, QA and regulatory groups together. For manufacturers scaling local production and tightening quality systems, the training provides a scalable, practical foundation.

    If your teams work in silos or lean on end-product testing, QbD training creates a common language for building quality in. Teams gain a standardised approach to QTPP, risk assessment, DoE and control strategy that supports stronger, more consistent submissions.

    • Standardise QbD practice across formulation, process, analytical and QA teams
    • Reduce manufacturing deviations through stronger process understanding
    • Strengthen CMC submissions to the FDA and other health authorities
    • Lower the post-approval change burden by working within a defined design space
    • Build cross-functional development teams that share one QbD language
    • Support PIC/S-aligned GMP and pharmaceutical quality system maturity
    • Deliver onsite or live virtual, tailored around production schedules
    • Grow in-house development capability instead of relying on external consultants

    Where QbD Takes You in Philippine PharmaRoles, Sectors and Demand

    Quality by Design skills are moving from nice-to-have to expected across Philippine pharmaceutical and biopharmaceutical employers, especially now the country has joined PIC/S and regulators tighten what they expect behind development submissions. Professionals who can run QTPP, risk assessment, DoE and control-strategy work are sought for formulation, process development, analytical, QA and CMC regulatory roles, from local leaders such as Unilab and Pascual Laboratories to multinationals investing in local capability. Quality by Design training gives you the practical tools these roles demand. Here is what the market is telling us right now.

    P759B

    Philippine pharma market by 2030

    BMI, BusinessWorld 2026

    14%

    Domestic production growth

    year on year, industry data 2025

    P1.19M

    QA Manager salary, Philippines

    per year, SalaryExpert 2026

    P7B+

    AstraZeneca local investment

    2026-2028, PEZA agreement

    SECTORS HIRING

    • —Pharmaceutical Manufacturing and Generics
    • —Biopharmaceutical and Biotechnology
    • —Active Pharmaceutical Ingredient (API) Production
    • —Contract Development and Manufacturing (CDMOs)
    • —Regulatory Affairs and CMC Consulting
    • —Multinational Pharma and Medical Devices

    GROWTH TRENDS

    • —Philippines joined PIC/S with effect from 1 January 2026
    • —FDA green lane to fast-track local manufacturing facilities
    • —AO 2024-0013 revising product and API registration rules
    • —AstraZeneca committing over PHP 7 billion, 2026 to 2028
    • —Domestic production up around 14% year on year
    • —Local manufacturing push to cut a large import trade deficit

    Sources: BMI, BusinessWorld, IMARC (market size); SalaryExpert, PayScale, Jobstreet (Philippines) 2026; FDA Philippines and PIC/S (PIC/S membership); PEZA and BusinessMirror (AstraZeneca investment).

    Why Philippine Pharma Now Needs QbD Skills

    Import Dependence and the Local Manufacturing Push

    The Philippines runs a large pharmaceutical trade deficit and is pushing to make more medicines locally. Manufacturers scaling production need the science-based development skills that QbD provides.

    QbD builds the development capability behind local production

    PIC/S-Era Quality Expectations

    With the Philippine regulator joining PIC/S from January 2026 and applying the PE 009-17 GMP guide, expectations for process understanding rise, and QbD is the framework that delivers it.

    QbD underpins the process understanding PIC/S GMP expects

    Tighter Registration Rules

    AO 2024-0013 has revised the rules for registering pharmaceutical products and APIs. Strong QTPP, risk and design-space evidence helps development and regulatory teams meet the new bar.

    QbD produces the development evidence submissions need

    Scaling Biopharmaceutical Ambition

    The local biopharmaceutical sector is set to grow substantially, but biologics are complex and process-sensitive. QbD offers the CQA and design-space discipline these products demand.

    QbD gives biologics teams a structured development route

    A Gap in Development Science Talent

    The Philippines has a deep pool of pharmacists but far fewer professionals fluent in QbD tools. Learning QTPP, DoE and control-strategy work makes you scarce and sought-after.

    QbD skills make development scientists stand out

    Fewer Deviations, Better Capital Efficiency

    As domestic output climbs, quality problems get expensive. QbD builds the process understanding that reduces deviations, rework and out-of-specification batches on the line.

    QbD reduces deviations and rework at scale

    Sources: FDA Philippines and PIC/S; Freyr and IMARC (registration and market); BusinessMirror and vocal.media (biopharma investment) 2025-2026.

    QbD is more than a methodology. It is the capability Philippine pharma now needs to compete on quality. Join the professionals building quality in from the design stage. Start your journey today.

    Your Philippines QbD Transformation

    Where You Stand Today,

    And What QbD Skills Change

    The Philippine pharmaceutical market is expanding with local manufacturing investment and tighter, PIC/S-era quality expectations, and employers increasingly separate teams that build quality in from those that still test it in. Here is which side of that line you want to be on.

    Today

    Seen as a capable scientist, but not a QbD lead

    After QbD

    Ready to lead QbD workshops across the development team

    Today

    Local roles increasingly list PIC/S-era skills you lack

    After QbD

    Fluent in the ICH Q8 to Q11 tools employers now look for

    Today

    Focused on your own function, with limited cross-team reach

    After QbD

    Able to connect formulation, process, analytical and QA work

    You master QbD

    Before

    Quality checked mainly through end-product testing

    Now you have

    Quality built in from the design stage using proven QbD tools

    Before

    Development run largely by trial and error

    Now you have

    Development driven by the QTPP, CQAs and a defined design space

    Before

    Risk handled informally, case by case

    Now you have

    Structured risk assessment using Ishikawa diagrams and FMEA

    Before

    Submissions questioned for a weak development rationale

    Now you have

    CMC submissions backed by clear, science-based QbD evidence

    "The line between building quality in and testing it in is increasingly the line between a modern pharma team and the rest, and Philippine regulators already know it."

    Join the professionals who trained with Invensis Learning and made the shift.

    Sources: SalaryExpert, PayScale, Jobstreet (Philippines) 2026; FDA Philippines and PIC/S.

    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 Philippines 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.

    • 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.

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    Skills You Will Build in This ProgrammeFrom QTPP to Control Strategy

    This programme builds a practical, end-to-end QbD toolkit you can apply to real pharmaceutical development, from framing the QTPP through to documenting a control strategy for submission. Each skill maps to the roles that Philippine employers are hiring for.

    Frame the QTPP and Identify CQAs

    Skills covered in this Quality by Design training start with the essentials: construct a Quality Target Product Profile from clinical and patient needs, then identify and classify the Critical Quality Attributes that define product quality, safety and efficacy.

    Run Structured Risk Assessments

    Map potential sources of variation with Ishikawa diagrams and prioritise CMA and CPP risks using FMEA and Risk Priority Numbers, so development effort focuses on the variables that matter most.

    Design and Interpret DoE

    Plan the right Design of Experiments, from screening to response-surface designs, and interpret the models that quantify how material attributes and process parameters affect each CQA.

    Define and Defend a Design Space

    Turn DoE results into a design space, set Normal Operating Ranges and Proven Acceptable Ranges, understand the edge of failure, and justify the boundaries for regulatory review.

    Apply PAT and Build a Control Strategy

    Use Process Analytical Technology such as NIR and Raman for real-time monitoring, and build a control strategy that spans material controls, process controls, in-process checks and testing.

    Position QbD for Regulatory Submission

    Structure QbD evidence for the CTD Section 3.2.P.2, connect it across the submission, and manage the product lifecycle and post-approval changes in line with ICH Q12.

    Who Should TakeQuality by Design Training in Philippines?

    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 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

    PHP 24100

    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 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 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 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

    PHP 24100

    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 Choose Invensis Learning for QbD in the PhilippinesSkills You Apply at Work

    As a trusted Quality by Design training company, Invensis Learning delivers structured, practical QbD training for individual professionals and pharmaceutical organisations that want to build quality into products from the design stage. Our programmes combine experienced practitioner instructors, flexible delivery formats, organised courseware and hands-on tool exercises. Whether you are enrolling as an individual learner or planning group training for a development team, Invensis Learning provides a professional learning experience built around practical understanding, real-world application and measurable outcomes.

    • Instructor-led training from experienced quality and pharmaceutical practitioners
    • Flexible formats: online (live virtual), classroom, onsite and corporate group training
    • ISO 9001:2015 quality management and ISO 27001:2022 information security
    • Structured, practical courseware with hands-on QbD tool exercises
    • A course completion record from Invensis Learning
    • Dedicated learner support before, during and after training
    • Local support across the Philippines with globally consistent delivery
    • Trusted by professionals and organisations across regulated industries

    500+

    Corporate Clients

    15+

    Years of Training Excellence

    24/7

    Learner Support

    50+

    Industries 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 PhilippinesAll our classroom training is now available online at your convenience

    Quality by Design in Philippines

    Makati Shangri-La, Ayala Avenue, San Lorenzo, District I, Makati, Southern Manila District, Metro Manila, 1226, Philippines

    Quality by Design in Philippines

    Conrad Manila, Seaside Boulevard, Barangay 76, Zone 10, District 1, Pasay, Southern Manila District, Metro Manila, 1300, Philippines

    corporate banner

    Corporate QbD Training for TeamsUpskill Your Whole Team

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    • Tailored QbD curriculum mapped to your own products and processes
    • Delivery onsite, live virtual or blended around production schedules
    • Train formulation, process, analytical, QA and regulatory teams together
    • Apply QbD tools to your live development projects during the session
    • Experienced pharmaceutical quality trainers with real-world exposure
    • Volume-based pricing with dedicated coordination and support
    • Progress tracking and post-training support for your teams

    Leading Philippine Pharma Employers

    UnilabPascual LaboratoriesRiteMEDLloyd LaboratoriesNatrapharmAmherst Laboratories

    What Our Learners Say

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    QTPP and CQAs Finally Clicked

    "The training finally made QTPP and CQA identification click for me. I ran my first proper risk assessment with an Ishikawa diagram and FMEA the week after, and it changed how our formulation team scopes a project."

    Maria Santos

    Formulation Scientist

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    Stronger CMC Submissions

    "As a CMC regulatory specialist, the session on structuring QbD evidence for Section 3.2.P.2 was exactly what I needed. Our development narratives are far stronger and better aligned to what reviewers expect."

    Jomar Reyes

    Regulatory Affairs (CMC) Specialist

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    Clear on DoE and PAT

    "Practical and well paced. The DoE and design space content, plus the walk-through of PAT tools, gave me a much clearer picture of how analytical work feeds real process control."

    Katrina Dizon

    Analytical Scientist

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    One Shared Language for the Team

    "We ran this as onsite corporate training for our QA and process teams. It gave everyone one shared QbD language, and we are already seeing better process understanding and fewer avoidable deviations."

    Ramon Cruz

    QA Manager, Generics Manufacturer

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    Tailored to Our Biologics Pipeline

    "The trainer tailored the case studies to biologics, which suited our pipeline. Our development and manufacturing leads now approach CQAs and control strategy in a far more structured, cross-functional way."

    Aileen Villanueva

    Head of Product Development, Biopharmaceutical Firm

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

    Quality by Design (QbD) training is a practical skills course covering the science-based approach to pharmaceutical product and process development, in which quality is built into the product from the design stage. It teaches the ICH Q8, Q9, Q10 and Q11 framework and tools such as QTPP, CQAs, risk assessment, DoE, design space and control strategy.

    General

    What is Quality by Design training?

    Quality by Design (QbD) training is a practical skills course covering the science-based approach to pharmaceutical product and process development, in which quality is built into the product from the design stage. It teaches the ICH Q8, Q9, Q10 and Q11 framework and tools such as QTPP, CQAs, risk assessment, DoE, design space and control strategy.

    Is Quality by Design training worth it for pharma professionals?

    Yes. QbD skills are increasingly expected across Philippine pharmaceutical and biopharmaceutical employers, especially now the country has joined PIC/S and registration rules have tightened. The training gives you tools you can apply to real development work straight away, making you more valuable in formulation, process, analytical, QA and regulatory roles.

    Who should attend this QbD course?

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

    Do I need prior experience to join?

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

    Which standards does the training follow?

    The training is grounded in the ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 drug substance guidelines. These are the ICH standards that regulators such as the FDA and EMA expect behind modern QbD-based submissions.

    Pricing

    How much does QbD training cost in the Philippines?

    Pricing varies by delivery mode (live virtual, classroom, onsite or corporate group), region and group size, so the fee is available on request. Share your preferred format and team size and we will prepare a tailored quote. Request a quote to see current options.

    What is included in the training fee?

    The fee typically covers instructor-led delivery across all QbD modules, structured courseware, hands-on tool exercises and case studies, learner support and a course completion record. Confirm the exact inclusions for your chosen format with a learning advisor.

    Do you offer corporate or group pricing?

    Yes. We offer corporate group training with customised content and volume-based pricing for development, QA and regulatory teams. It is especially effective when teams apply QbD tools to their own live projects. Ask about corporate or group pricing for a tailored quote.

    What payment options are available?

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

    Is there a separate exam or credential fee?

    No. This is a non-certification skills course, so there is no examination and no separate credential fee. The training fee covers the programme, materials and learner support.

    Assessment

    Is there an exam for the QbD course?

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

    What do I receive on completing the training?

    You receive a course completion record from Invensis Learning. The training builds practical QbD methodology and tool skills that are immediately applicable to pharmaceutical product and process development work.

    How is learning assessed?

    There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, Ishikawa risk mapping and DoE design selection to realistic development scenarios during the programme, so you practise the skills as you learn them.

    Is this a formal qualification?

    No. It is a practical skills training course rather than a formal qualification. It focuses on building QbD capability you can use at work, grounded in the ICH Q8 to Q11 framework.

    Will the skills need renewing over time?

    No. There is nothing to renew or maintain. The QbD tools and methodology you learn are immediately applicable and do not expire, so you can keep applying them across future development projects.

    Course Content

    What will I learn in the QbD training?

    You will learn to construct a QTPP, identify and classify CQAs, run risk assessments with Ishikawa diagrams and FMEA, plan and interpret DoE, define a design space, apply PAT and build a control strategy, and structure QbD evidence for regulatory submission.

    Does it cover both small molecules and biologics?

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

    Are there hands-on exercises?

    Yes. Hands-on QbD tool exercises run throughout, including QTPP construction, CQA identification and criticality assessment, Ishikawa diagrams for risk assessment, and DoE design selection, all applied to realistic pharmaceutical development scenarios.

    How long is the training?

    The programme is delivered as a focused course covering all six QbD modules, from principles and the ICH framework through QTPP, CQAs, risk assessment, DoE, design space, PAT and control strategy, to QbD in practice. Confirm the current schedule with a learning advisor.

    Does it cover regulatory submissions?

    Yes. You learn how QbD outputs form the Pharmaceutical Development section (3.2.P.2) of a CTD submission, how to connect the evidence across the dossier, and how ICH Q12 supports post-approval change and lifecycle management.

    Enrolment

    How do I enrol in the QbD training?

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

    What training formats are available?

    You can take the Quality by Design course online (live virtual), in the classroom, onsite and as customised corporate group training, so you can choose the format that fits your schedule and team.

    Can teams be trained onsite in the Philippines?

    Yes. We deliver onsite corporate training for pharmaceutical organisations across the Philippines, so a cross-functional development team can learn together and apply QbD tools to their own products. Ask about onsite delivery for your team.

    How soon can I start?

    We run regular scheduled sessions alongside corporate dates. See upcoming batches or speak with a learning advisor to find the next start that works for you.

    Can I reschedule my booking?

    Yes. Flexi options let you reschedule or move to another batch on selected plans. Contact our support team to arrange this.