Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design and Why It Matters for New Zealand Pharma

    A Science-Based Route to Built-In Quality

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    What's Included in Your Quality by Design Training

    • One-day course spanning ten structured modules

    • 8 PDUs on completion of the training

    • Copy of course material and SME-prepared study guide

    • Case studies and practical applications module

    • Course completion certificate from Invensis Learning

    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the New Zealand

    Who Can Enrol?

    What You Gain from This Programme

    Of Learning QbD the Practical Way

    Who Should Take Quality by Design Training in New Zealand?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Where QbD Skills Take You in New Zealand

    Roles, 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.

    What Is Driving Demand for QbD Skills in New Zealand

    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.

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

    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 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.

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    The QbD Tools You Will Apply on the Job

    Practical 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.

    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

    NZD 670

    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 Training in New Zealand

    Expert-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

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    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 Zealand

    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 New Zealand

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

    Quality by Design Training Location in New Zealand

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

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    Corporate QbD Training for New Zealand Teams

    Upskill Your Team

    • 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

    Trusted by Leading Enterprises in New Zealand

    Douglas PharmaceuticalsAFT PharmaceuticalsNew Zealand PharmaceuticalsHelius TherapeuticsRua BioscienceFonterra

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    What Our Learners Say About Us

    "It was a pleasur working and learning from Pritesh Shah. He managed to pick up where I was standing and helped me understand from the ground on. I am very greatful he managed to help me in that way. It is absolutely worth the money."

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    ""Despite being the sole participant on the day of the course, I was thoroughly impressed by the quality of the experience. The instructor conducted the session in a remarkably friendly and professional manner, ensuring that the content was perfectly tailored to my individual needs and learning style. The personalized attention I received made the course feel like a one-on-one coaching session, which greatly enhanced my overall learning experience. I would highly recommend this course to anyone looking for a flexible and attentive learning environment."

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    "I had a 1:1 course with PD Saha. It was very interactive and helped me a lot in the preparation of the Lean SixSigma exam."

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    We also deliver Quality by Design Training across multiple cities in New Zealand

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

    Quality by Design Training Course in AucklandQuality by Design Training Course in ChristchurchQuality by Design Training Course in HamiltonQuality by Design Training Course in Wellington

    Frequently Asked Questions

    Here'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.