Quality by Design Training in New Zealand

Build Quality in by Design

Give your pharmaceutical and biopharma teams a science-based way to build quality into products from the design stage instead of testing it in at the end. This instructor-led programme grounds New Zealand professionals in the ICH Q8, Q9, Q10 and Q11 framework, from the Quality Target Product Profile and critical quality attributes through to the design space and control strategy, ready to apply on live development projects.

Flexible

Training Schedules

Instructor-led

Mode

Hours

13.3K+ already enrolled

4.1 (2330+ Reviews)

10 enrolled this week

Want to Train Your Team?

Master Quality by Design and Lead Excellence in New Zealand

Starts from

NZD 740

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.

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

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

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

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).

Designation

Quality by Design Professionals in New Zealand : Salary Insights and Trends

Hiring Companies in New Zealand

NZ$66K

Min

NZ$92K

Average

NZ$113K

Max

SalaryExpert (New Zealand) 2026

Douglas PharmaceuticalsAFT PharmaceuticalsNew Zealand PharmaceuticalsRua Bioscience

Source: Douglas Pharmaceuticals · AFT Pharmaceuticals · NZP · Rua Bioscience

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.

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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

Shifts your thinking from testing quality in at the end to designing it in from the start.

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.

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

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

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

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

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

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 27001:2022 Certified

Secure SSL Encryption

Leaders in Training industry for 12+ years

Over 5000 five star reviews

Level AA conformance, W3C WCAG 2.2

Quality by Design Training Locations in New ZealandInstructor-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

Corporate QbD Training for New Zealand TeamsUpskill 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

What Our Learners Say

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

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

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

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

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

0/0

4.6

Ratings

100K+

Happy Learners

100+

Locations Worldwide

99%

Training Satisfaction

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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?

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.

Quality by Design Training in New Zealand

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

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

Key Highlightsof the Quality by Design Training Course

Quality by Design Training Eligibility in the New ZealandWho Can Enroll?

What You Gain from This ProgrammeOf Learning QbD the Practical Way

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

SECTORS HIRING

DEMAND DRIVERS

What Is Driving Demand for QbD Skills in New Zealand

PIC/S-Aligned GMP Expectations

Export Dossiers Need QbD Evidence

Scaling Pharmaceutical-Grade Cannabis

Biopharma and Targeted Therapies

Generics Consistency Pressure

QbD Talent Scarcity

From Testing Quality in to Designing It In

Your QbD Skills, Before and After

Module 1: Introduction to QbD

Module 2: QbD Tools and Techniques

Module 3: Industry and Regulatory Perspective

Module 4: Quality Target Product Profile (QTPP)

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

Module 6: Statistical Design of Experiments

Module 7: Design Space and Process Control

Module 8: Risk Assessment and Management

Module 9: Real-time Release Testing (RTRT)

Module 10: Case Studies and Practical Applications

Course Curriculumof the Quality by Design Training

Module 1: Introduction to QbD

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

Build a Quality Target Product Profile

Identify and Classify Critical Quality Attributes

Run Risk Assessments with Ishikawa and FMEA

Plan a DoE and Define the Design Space

Apply PAT and Build a Control Strategy

Structure QbD Evidence for Submissions

Who Should TakeQuality by Design Training in New Zealand?

Quality by Design Training Modesfor Professionals and Teams

Quality by Design Live Virtual Training

Quality by Design Classroom Training

Quality by Design Corporate Group Training

Quality by Design Focused 1-to-1 Training

Quality by Design Live Virtual Training

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

Quality by Design Training Locations in New ZealandInstructor-led in-person Classroom training is available for group batches. All other public cohorts are delivered as Instructor-led Live Virtual. See available cohorts.

Corporate QbD Training for New Zealand TeamsUpskill Your Team

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