Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Who Is It For?

    A Practical Grounding in ICH-Aligned Development

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    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the Philippines

    Who Can Enrol?

    How Quality by Design Skills Strengthen Your Work

    Value for Professionals and Teams

    Where QbD Takes You in Philippine Pharma

    Roles, 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.

    Why Philippine Pharma Now Needs QbD Skills

    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.

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

    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 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.

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    Skills You Will Build in This Programme

    From 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 Take

    Quality 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 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

    PHP 21020

    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 Philippines

    Skills 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

    12+

    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 Philippines

    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 Philippines

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

    Quality by Design Training Location in Philippines

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

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    Corporate QbD Training for Teams

    Upskill Your Whole Team

    • 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

    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

    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

    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

    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

    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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    Trustpilot

    4.6

    Ratings

    100K+

    Happy Learners

    100+

    Locations Worldwide

    99%

    Training Satisfaction

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    We also deliver Quality by Design Training across multiple cities

    Invensis Learning delivers industry-leading Quality by Design training solutions tailored for individuals and organizations.

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    Frequently Asked Questions

    Here'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.