Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters for New Zealand PharmaUntitledA Science-Based Route to Built-In Quality

    Quality by Design Training in New Zealand is a one-day, non-certification skills course that teaches the Quality by Design (QbD) approach to pharmaceutical product and process development. You learn to design quality into a product from the outset, based on a thorough understanding of the product and its manufacturing process, rather than relying on end-product testing to catch problems late. The course is grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider quality trilogy of ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. Across the day you work through the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT) and the control strategy, using realistic development scenarios. For scientists, engineers and quality professionals in Auckland, Wellington and Christchurch, QbD skills are increasingly expected as New Zealand manufacturers export to regulated markets. This is a practical programme with immediate on-the-job value, so you finish able to lead QbD work rather than just describe it. Start your QbD journey with Invensis Learning.

    What Is Quality by Design and Why It Matters for New Zealand PharmaA Science-Based Route to Built-In Quality

    Quality by Design Training in New Zealand is a one-day, non-certification skills course that teaches the Quality by Design (QbD) approach to pharmaceutical product and process development. You learn to design quality into a product from the outset, based on a thorough understanding of the product and its manufacturing process, rather than relying on end-product testing to catch problems late.

    The course is grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider quality trilogy of ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. Across the day you work through the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa diagrams and FMEA, Design of Experiments (DoE), the design space, Process Analytical Technology (PAT) and the control strategy, using realistic development scenarios.

    For scientists, engineers and quality professionals in Auckland, Wellington and Christchurch, QbD skills are increasingly expected as New Zealand manufacturers export to regulated markets. This is a practical programme with immediate on-the-job value, so you finish able to lead QbD work rather than just describe it. Start your QbD journey 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 New Zealand 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 New Zealand 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 New Zealand

    • Instructor-led training formats available for individual learners and corporate teams across the New Zealand
    • 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 New Zealand
    • 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 New Zealand 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 New ZealandWho 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

    What You Gain from This ProgrammeOf Learning QbD the Practical Way

    For Individuals

    For Individuals

    This QbD training helps New Zealand pharmaceutical professionals move from trial-and-error development to a structured, regulator-aligned approach. It suits formulation and analytical scientists, process development engineers, quality assurance staff and regulatory affairs specialists who want to apply Quality by Design in practice. Whether you develop small molecules, biologics or pharmaceutical-grade products for export, the course builds capability you can use on your next project, not just theory for a shelf.

    You leave able to construct a QTPP, lead a CQA workshop, facilitate a risk assessment, plan a DoE study and draft a control strategy. These are the practical skills that separate confident QbD practitioners from those who have only heard the terms.

    • Apply a systematic, science-based method to design quality into products from day one
    • Build a Quality Target Product Profile and identify critical quality attributes with confidence
    • Run risk assessments with Ishikawa diagrams and FMEA to focus development effort
    • Plan and interpret Design of Experiments and define a defensible design space
    • Develop a control strategy that regulators and export markets expect
    • Speak the ICH Q8 to Q11 language shared across pharma, biopharma and CDMO teams
    • Add an in-demand capability that strengthens your value on development projects
    • Use QbD tools immediately on real work back in your own organisation
    For Organizations

    For Organizations

    QbD group training helps organisations build cross-functional development capability by equipping teams with a common, science-based methodology. It can be delivered for a single development team, a quality function or a whole R&D group. For manufacturers connecting product development to regulatory and commercial outcomes, this training provides a scalable, flexible way to embed QbD across the organisation.

    If your teams still rely on empirical development and end-product testing, corporate QbD training creates a consistent approach to QTPP, risk assessment, design space and control strategy, so quality is built in and defended on paper for every submission.

    • Builds a shared QbD language across formulation, analytical, process, quality and regulatory teams
    • Reduces manufacturing deviations and out-of-specification results through better process understanding
    • Strengthens export submissions with QbD evidence regulators increasingly expect
    • Supports right-first-time manufacturing and fewer post-approval changes
    • Aligns your development practice with ICH Q8, Q9, Q10 and Q11
    • Can be tailored to your live product and process development projects
    • Scales across sites in Auckland, Wellington, Christchurch and beyond
    • Delivered onsite, live virtual or blended to fit team schedules

    Where QbD Skills Take You in New ZealandRoles, Sectors and Demand

    QbD capability, built through Quality by Design training, has become a practical marker of a strong pharmaceutical development professional across New Zealand, valued by manufacturers, biopharma firms, API producers, CDMOs and medicinal cannabis companies that export into regulated markets. As Medsafe holds the country's Code of GMP in line with the PIC/S standard and exporters target FDA, EMA and TGA submissions, teams that can build quality in by design are increasingly sought after. The roles span formulation and analytical science, process development, quality assurance and regulatory affairs, and here is what the New Zealand market is telling us now.

    NZD 120,637

    Formulation scientist salary, NZ

    average, SalaryExpert 2026

    NZD 150,726

    Regulatory affairs manager, NZ

    average, SalaryExpert 2026

    41

    Licensed medicinal cannabis firms

    Medsafe, NZ 2026

    700+

    Douglas Pharmaceuticals team

    Auckland, 2026

    SECTORS HIRING

    • —Pharmaceutical Manufacturing and Development
    • —Biopharmaceutical and Biotechnology
    • —Active Pharmaceutical Ingredient (API) Producers
    • —Contract Development and Manufacturing (CDMOs)
    • —Medicinal Cannabis and Natural Health Products
    • —Regulatory Affairs and CMC Consulting

    DEMAND DRIVERS

    • —NZ Code of GMP aligned to the PIC/S standard raising process-understanding expectations
    • —Export growth pushing manufacturers toward FDA, EMA and TGA-grade dossiers
    • —Pharmaceutical-grade medicinal cannabis scaling fast for export
    • —Biopharma and targeted-therapy investment expanding
    • —Rising generic-drug demand needing right-first-time manufacturing
    • —Scarcity of professionals trained in QTPP, DoE and design space methods

    Sources: SalaryExpert, PayScale, Paylab (New Zealand) 2026; Medsafe; NZTE; company reports (Douglas Pharmaceuticals, AFT Pharmaceuticals).

    What Is Driving Demand for QbD Skills in New Zealand

    PIC/S-Aligned GMP Expectations

    New Zealand holds its Code of GMP in line with the PIC/S standard, so regulators expect science-based process understanding and control, not reliance on end-product testing. QbD is built to close that gap.

    QbD builds the process understanding GMP now expects

    Export Dossiers Need QbD Evidence

    Manufacturers exporting to FDA, EMA and TGA markets increasingly need QbD evidence, from QTPP to design space and control strategy, in their submissions. Teams that can produce it are in demand.

    QbD builds submission-ready development evidence

    Scaling Pharmaceutical-Grade Cannabis

    With 41 licensed medicinal cannabis firms and exports surging, producers must deliver consistent pharmaceutical-grade quality batch after batch, which demands the process control QbD provides.

    QbD builds consistent process control at scale

    Biopharma and Targeted Therapies

    As biopharmaceutical and targeted-therapy investment grows, the molecular complexity of biologics makes CQA identification and design space thinking essential to reliable development.

    QbD builds CQA and design space capability for biologics

    Generics Consistency Pressure

    Rising demand for generic medicines pushes manufacturers to deliver right-first-time production. QbD's mechanistic understanding of process and material attributes reduces deviations and rework.

    QbD builds right-first-time manufacturing

    QbD Talent Scarcity

    New Zealand has a capable pharmaceutical workforce but relatively few professionals trained in QTPP, DoE and design space methods, so structured QbD skills set candidates and teams apart.

    QbD makes trained practitioners stand out

    Sources: Medsafe (NZ Code of GMP, PIC/S alignment); NZTE; Beehive.govt.nz; industry market reports (New Zealand) 2026.

    QbD is more than a framework. It is the capability New Zealand pharma teams need to develop, manufacture and export with confidence. Join the professionals building quality in by design. Start your journey today.

    Your New Zealand QbD Transformation

    From Testing Quality in to Designing It In

    Your QbD Skills, Before and After

    New Zealand's pharmaceutical and biopharma sector is growing on the back of export demand and a GMP regime aligned to the PIC/S standard, and employers increasingly separate teams that design quality in from those that test it in. Here is which side of that line you want to be on.

    Today

    Limited leverage without an in-demand development methodology on your CV

    After QbD

    Formulation and QA roles in NZ average around NZ$120,000 to NZ$130,000, with senior bands well above

    Today

    Passed over for development roles that expect QbD process understanding

    After QbD

    Ready for roles across pharma, biopharma, API, CDMO and medicinal cannabis firms

    Today

    Confident in the lab, but export dossiers want documented process understanding

    After QbD

    Fluent in linking material and process attributes to product quality with evidence

    You apply QbD at work

    Before

    Development runs on trial and error, with quality checked at the end

    Now you have

    A structured, ICH-aligned method to build quality in from the design stage

    Before

    You know the QbD terms but have not applied the tools yourself

    Now you have

    Confidence to lead QTPP, CQA and risk-assessment workshops on live projects

    Before

    Design space and control strategy feel abstract and hard to defend

    Now you have

    The skills to plan a DoE, define a design space and draft a control strategy

    Before

    A strong science background but no formal QbD methodology to show

    Now you have

    A capability employers across NZ pharma, biopharma and CDMOs actively seek

    "The difference between testing quality in and designing it in is a way of working, and the manufacturers that export already know it."

    Join the professionals who trained with Invensis Learning and now build quality in by design.

    Sources: SalaryExpert, PayScale (New Zealand) 2026; Medsafe.

    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 New Zealand 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.

    image

    100% Secure and Safe download

    The QbD Tools You Will Apply on the JobPractical Tools You Can Use Immediately

    Skills covered in Quality by Design training span the full QbD toolkit, from the QTPP and CQA identification through risk assessment, DoE, the design space, PAT and the control strategy. By the end of the day you can apply each tool to a realistic pharmaceutical development scenario.

    Build a Quality Target Product Profile

    Construct a QTPP from clinical and patient needs, defining the dosage form, delivery, quality standards and performance targets that set the direction for the whole development programme.

    Identify and Classify Critical Quality Attributes

    Identify the CQAs that drive product quality, safety and efficacy, and classify them for small molecules and biologics using prior knowledge and structured risk-based reasoning.

    Run Risk Assessments with Ishikawa and FMEA

    Map potential material and process sources of variation with Ishikawa diagrams, then prioritise them using FMEA and Risk Priority Numbers to focus development on the highest-impact variables.

    Plan a DoE and Define the Design Space

    Select the right Design of Experiments approach, interpret the model output, and define a design space with Normal Operating Ranges and Proven Acceptable Ranges you can justify to regulators.

    Apply PAT and Build a Control Strategy

    Use Process Analytical Technology concepts such as NIR and Raman for real-time monitoring, and develop a risk-proportionate control strategy that assures quality within the design space.

    Structure QbD Evidence for Submissions

    Organise QbD outputs for the CTD Pharmaceutical Development section and understand how a strong control strategy supports smoother post-approval change management across export markets.

    Who Should TakeQuality by Design Training in New Zealand?

    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

    NZD 740

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

    Untitled

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

    Untitled

    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

    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.

    Untitled

    Best For: Learners who prefer in-person interaction, structured schedules, and collaborative learning experiences.

    Untitled

    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

    Untitled

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

    Untitled

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

    Untitled

    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

    Untitled

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

    Untitled

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

    Untitled

    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

    NZD 740

    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.

    Loading schedules…

    Why Choose Invensis Learning for QbD Training in New ZealandExpert-Led and ISO-Certified

    As a Quality by Design training company in New Zealand, Invensis Learning delivers structured, practical QbD training for pharmaceutical and biopharma professionals and teams who want to build quality into products by design. Our programmes combine experienced instructors, hands-on tool exercises, organised courseware and flexible delivery, all backed by ISO 9001:2015 and ISO 27001:2022 certification. Whether you enrol as an individual or plan group training for a development team, Invensis Learning provides a professional learning experience built around real understanding and on-the-job application across New Zealand.

    • Experienced trainers with real pharmaceutical quality and development expertise
    • Practical, hands-on QbD exercises using realistic development scenarios
    • Flexible formats: live virtual instructor-led, classroom and onsite for teams
    • Courseware grounded in the ICH Q8, Q9, Q10 and Q11 framework
    • Customised corporate delivery aligned to your live projects
    • ISO 9001:2015 quality and ISO 27001:2022 information-security certified
    • Dedicated learner support before, during and after training
    • Local support for teams across Auckland, Wellington and Christchurch

    24/7

    Learner Support

    50+

    Industries Served

    1-to-1

    Doubt-Clearing Sessions

    60+

    Global Course Portfolio

    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 New ZealandAll our classroom training is now available online at your convenience

    Quality by Design in New Zealand

    Blanket Bay, 4191 Glenorchy-Queenstown Road, Glenorchy 9372, New Zealand

    Quality by Design in New Zealand

    Rosewood Matakauri, 569 Glenorchy-Queenstown Road, Closeburn 9371, New Zealand

    corporate banner

    Corporate QbD Training for New Zealand TeamsUpskill Your Team

    Untitled

    • Tailored to your live product and process development projects
    • Delivered onsite, live virtual or blended to fit team schedules
    • Builds a shared QbD language across science, quality and regulatory roles
    • Experienced trainers with pharmaceutical development expertise
    • Role-based examples relevant to small molecules, biologics and export products
    • Dedicated coordination and support for group programmes
    • Scalable across sites in Auckland, Wellington and Christchurch

    Leading New Zealand Pharma and Biotech Employers

    Douglas PharmaceuticalsAFT PharmaceuticalsNew Zealand PharmaceuticalsHelius TherapeuticsRua BioscienceFonterra

    What Our Learners Say

    Untitled

    QbD Tools That I Could Use Straight Away

    "The course finally made the design space and control strategy click for me. Building a QTPP and running a risk assessment on a realistic scenario was far more useful than any slide deck. I applied the FMEA approach on a live formulation project the following week."

    Anahera Williams

    Formulation Scientist

    Untitled

    0/0

    Clear Link from Lab Work to Control Strategy

    "As an analytical chemist I wanted to understand how our data feeds the control strategy and PAT. The trainer connected CQAs, DoE and real-time release testing in a way that made sense for our Auckland site. Practical, clear and well paced."

    Ben Thompson

    Analytical Chemist

    Untitled

    0/0

    Exactly What I Needed for CMC Reviews

    "Coming from regulatory affairs, I needed to understand QbD to review CMC submissions with confidence. The ICH Q8 to Q11 grounding and the design space justification were exactly what I was missing. I feel much better equipped for export dossiers."

    Priya Naidu

    Regulatory Affairs Specialist

    Untitled

    0/0

    A Shared QbD Language for Our Team

    "We ran this as an onsite session for our cross-functional development team. It gave formulation, analytical and quality staff a shared QbD language and a common approach to risk assessment. Our development discussions are noticeably more structured now."

    Michael Chen

    R&D Manager, Pharmaceutical Manufacturer

    Untitled

    0/0

    Flexible Delivery, Real Capability Uplift

    "As an L&D lead I needed training that would lift QbD capability across several sites without disrupting production. The flexible virtual delivery worked well and the hands-on exercises kept our people engaged. Strong practical value for the investment."

    Sarah O'Connor

    Learning and Development Lead, Biopharma

    Untitled

    0/0



    Trustpilot

    4.6

    Ratings

    100K+

    Happy Learners

    100+

    Locations Worldwide

    99%

    Training Satisfaction

    Enquire with us now

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

    Get Course Details & Pricing

    Fill out this form and we will respond quickly.

    We also deliver Quality by Design Trainingacross multiple cities

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

    HamiltonAucklandWellingtonChristchurch
    City map with location markers

    Explore Our Other Course Categories

    Agile

    Project Management

    ITSM

    Quality Management

    DevOps

    IT Governance

    Other Related Courses

    Foundation

    Poka Yoke

    Foundation

    Lean Six Sigma Yellow Belt

    Foundation

    Business Process Management

    Foundation

    Six Sigma Awareness

    Foundation

    7 QC Tools Training

    Advanced

    Lean Six Sigma Black Belt

    Foundation

    Quality Function Deployment

    Foundation

    Lean IT

    Advanced

    Lean Six Sigma Green Belt

    Foundation

    Minitab Essentials

    Foundation

    Design for Six Sigma

    Foundation

    Lean Fundamentals

    Foundation

    Quality by Design

    Foundation

    Lean Manufacturing

    Foundation

    Value Stream Mapping

    Foundation

    Kaizen

    Foundation

    Root Cause Analysis

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

    QbD training is a one-day, non-certification skills course that teaches a systematic, science-based approach to pharmaceutical product and process development. You learn to build quality into a product from the design stage using tools such as the QTPP, critical quality attributes, risk assessment, Design of Experiments, the design space and the control strategy.

    General

    What is Quality by Design (QbD) training?

    QbD training is a one-day, non-certification skills course that teaches a systematic, science-based approach to pharmaceutical product and process development. You learn to build quality into a product from the design stage using tools such as the QTPP, critical quality attributes, risk assessment, Design of Experiments, the design space and the control strategy.

    Which standard or framework is the QbD course based on?

    The course is grounded in the ICH Q8(R2) Pharmaceutical Development guideline, together with ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 for drug substances. These are the guidelines that regulators such as the FDA and EMA expect QbD submissions to reflect.

    Is QbD training worth it for New Zealand professionals?

    Yes. As New Zealand manufacturers export into markets governed by the FDA, EMA and TGA and Medsafe holds the Code of GMP in line with the PIC/S standard, QbD skills are increasingly expected. Trained professionals stand out in formulation, analytical, process, quality and regulatory roles that command strong salaries locally.

    Who should attend the QbD course?

    The training suits formulation and analytical scientists, process development engineers, quality assurance professionals, regulatory affairs and CMC specialists, and manufacturing technical managers in pharmaceutical, biopharmaceutical, API, CDMO and medicinal cannabis organisations who want to apply QbD in practice.

    Do I need prior QbD 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 before moving into the tools and hands-on exercises.

    Pricing

    How much does the QbD training cost in New Zealand?

    Pricing varies by delivery mode, group size and whether you attend a public session or book corporate training, so a current quote is available on request. Contact a learning advisor for New Zealand pricing and upcoming batches.

    What is included in the course fee?

    The fee typically includes instructor-led delivery of all QbD modules, hands-on tool exercises, course materials and learner support, plus a course completion certificate from Invensis Learning. Ask for a detailed inclusions list when you request your quote.

    Do you offer group or corporate pricing?

    Yes. We offer corporate group training with volume-based pricing and schedules tailored to your team. This is popular with development and quality teams that want a shared QbD approach. Contact us for a group quote for your organisation.

    What payment options are available?

    We accept major credit and debit cards and bank transfers, with invoicing available for corporate bookings. Speak with a learning advisor to arrange the option that suits you or your organisation.

    Is there a discount for booking a whole team?

    Yes. Corporate and group bookings attract tailored pricing based on the number of participants and delivery format. Request a quote and we will put together an option for your team.

    Course Content

    What topics does the QbD training cover?

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

    Are there hands-on exercises in the course?

    Yes. Learning is reinforced through hands-on QbD tool exercises, including QTPP construction, CQA identification, Ishikawa and FMEA risk assessment, and design space interpretation, all applied to realistic pharmaceutical development scenarios rather than theory alone.

    Does the course cover both small molecules and biologics?

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

    How long is the QbD training?

    The course is delivered as a one-day, eight-hour programme covering all QbD modules with concept explanations, the ICH regulatory context, case studies and hands-on tool exercises. An extended two half-day format is also available.

    What will I be able to do after the training?

    You will be able to construct a QTPP, identify and classify CQAs, run a risk assessment using Ishikawa diagrams and FMEA, plan a DoE strategy, interpret a design space with NOR and PAR, and develop a control strategy ready to support regulatory submissions.

    Assessment

    Is there an exam for the QbD course?

    No. This is a non-certification skills course with no examination. Learning is reinforced through hands-on tool exercises, case study examples and team discussion during the programme rather than a formal test.

    Do I receive anything on completion?

    Yes. On completing the programme you receive a course completion certificate from Invensis Learning that recognises your participation. It confirms you have completed the QbD training and can apply the tools at work.

    How is my learning assessed during the day?

    There is no formal assessment. Instead, you apply the QbD tools to realistic development scenarios through guided exercises, so you can check your understanding by doing the work rather than sitting a test.

    Does completion expire or need renewal?

    No. The skills you gain are immediately applicable and do not expire, and there is no renewal requirement. The QbD methodology you learn stays relevant across pharmaceutical development and manufacturing projects.

    Is this course tied to a governing or awarding body?

    No. QbD training is a vendor-neutral skills course with no awarding body or credential. It is grounded in the recognised ICH Q8 to Q11 framework, which is the industry reference for Quality by Design in pharmaceutical development.

    Enrollment

    How do I enrol in the QbD course in New Zealand?

    You can enrol through the Invensis Learning website or by contacting a learning advisor. Choose your preferred format, confirm your place, and you will receive schedule details and course materials. See upcoming batches to get started.

    What delivery formats are available?

    The course is available as online (live virtual) instructor-led training, classroom sessions, and onsite corporate delivery for teams. This lets learners across Auckland, Wellington and Christchurch choose the format that fits their schedule.

    Can the training be delivered onsite for our team?

    Yes. We deliver onsite and live virtual corporate sessions for pharmaceutical and biopharma teams, and these can be tailored to your live development projects. Contact us to arrange a session for your organisation.

    When can I start?

    Public sessions run on a regular schedule and corporate sessions can be arranged to suit your team's availability. Talk to a learning advisor to find the next available date in New Zealand.

    Can I reschedule my booking?

    Yes. Rescheduling options are available depending on your booking. Contact our support team and we will help you move to a suitable batch or format.