Quality by Design Training in Australia

Design Quality in, Not Test It In

Invensis Learning is a trusted Quality by Design training company. Built for formulation, analytical, process, quality and regulatory professionals in Australia's pharmaceutical and biopharmaceutical sector, this instructor-led programme shows you how to apply the QbD approach and the ICH Q8 to Q11 guidelines, from QTPP and critical quality attributes to design space and control strategy, so you can build quality into products from the start.

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What Is the Quality by Design Approach?Science-Based Pharmaceutical Development

Quality by Design Training in Australia is a practical, one-day programme that teaches the Quality by Design (QbD) approach to pharmaceutical and biopharmaceutical product and process development. QbD is a systematic, science-based way to build quality into a product from the design stage, rather than testing it in at the end.

The training is grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the Q9, Q10 and Q11 guidelines that the TGA, FDA and EMA expect in modern submissions. It walks you through the full QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), the design space and the control strategy.

It suits formulation, analytical and process development scientists, QA professionals and CMC regulatory specialists across Australia's growing medicines-manufacturing sector who want to apply QbD on live development projects. Delivered by Invensis Learning, you finish ready to put these tools to work straight away.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Australia 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 Australia 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 Australia

Instructor-led training formats available for individual learners and corporate teams across the Australia
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 Australia
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 Australia 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 AustraliaWho 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

The Value QbD Training Adds to Your WorkPractical Skills with Real Development Impact

For Individuals

QbD training helps pharmaceutical professionals move from testing quality in at the end to designing it in from the start. You learn to construct a QTPP, identify Critical Quality Attributes, run risk assessments, plan DoE studies and define a design space, then tie it together in a control strategy. Whether you work in formulation, analytical development, process development, quality assurance or CMC regulatory affairs, these tools apply directly to your day-to-day projects in Australia's pharmaceutical and biopharmaceutical organisations.

Because this is a skills programme, there is no exam and no credential to renew. You leave able to apply QbD tools to live product and process development work straight away, and to contribute to ICH-aligned submissions that regulators increasingly expect.

Apply the full QbD toolkit, from QTPP and CQAs to design space and control strategy, on real projects
Replace trial-and-error development with structured, science-based process understanding
Lead risk assessments using Ishikawa diagrams and FMEA with RPN prioritisation
Plan and interpret Design of Experiments to define a defensible design space
Build QbD evidence that supports TGA, FDA and EMA regulatory submissions
Speak the shared language of formulation, analytical, process, QA and regulatory teams
Stand out with Australian pharmaceutical and biopharmaceutical employers hiring QbD skills
Put your learning to work immediately, with no exam to sit and no renewal to maintain

For Organizations

QbD group training helps pharmaceutical and biopharmaceutical organisations build a consistent, science-based development capability. Cross-functional teams learn the same QTPP, CQA, risk assessment, DoE, design space and control strategy tools and apply them together. For organisations scaling local manufacturing or preparing ICH-aligned submissions, this training creates a common QbD approach that connects development, quality and regulatory work.

Delivered onsite or live virtual for your team, corporate QbD training is most effective when participants apply the tools to their own live development projects, turning a one-day programme into immediate, project-specific value.

Build a shared QbD language across formulation, process, QA and regulatory teams
Reduce manufacturing deviations, rework and out-of-specification batches
Strengthen ICH Q8 to Q11 aligned submissions and TGA inspection readiness
Apply QbD tools to your own live development projects during the session
Standardise QTPP, risk assessment and control strategy practice across sites
Support faster, more predictable scale-up and technology transfer
Develop in-house QbD capability without sending teams offshore
Improve product consistency and patient outcomes through better process understanding

What QbD Skills Open Across AustraliaCareers in a Growing Pharma Sector

Quality by Design skills are increasingly valued across Australia's pharmaceutical and biopharmaceutical sector, where sovereign manufacturing investment, the new Moderna mRNA facility and CSL's expansion are driving demand for people who can build quality into products. Professionals who apply QbD move into formulation, process development, quality assurance and CMC regulatory roles that TGA-regulated employers are actively hiring for. Quality by Design training builds exactly this capability. Here is what the market looks like right now.

+12%

Pharma jobs demand growth

year on year, PharmiWeb 2026

A$1.5B

Government medical manufacturing investment

Australian Government, 2025

200+

New CSL manufacturing jobs

Broadmeadows plant, by 2026

A$140K

Regulatory Affairs Manager pay

average, worldsalaries 2026

SECTORS HIRING

—Pharmaceutical and Biopharmaceutical Manufacturing
—Vaccines and mRNA Therapeutics
—Generics and Biosimilars
—Radiopharmaceuticals and Cell Therapy
—Contract Development and Manufacturing (CDMOs)
—Regulatory and CMC Consulting

GROWTH TRENDS

—Sovereign medicines manufacturing capability being built nationally
—Moderna mRNA facility and CSL expansion in Victoria
—TGA and PIC/S GMP raising process-understanding expectations
—ICH Q8 to Q11 QbD evidence increasingly expected in submissions
—Growth in biologics, biosimilars and advanced therapies
—Skills scarce in QbD, CMC and design space compared with demand

Sources: SalaryExpert, worldsalaries, SEEK, Glassdoor (Australia) 2026; CSL, Moderna, Australian Government, IBISWorld, PharmiWeb (2025-2026).

Designation

Quality by Design Professionals in Australia : Salary Insights and Trends

Hiring Companies in Australia

A$70K

Min

A$90K

Average

A$115K

Max

SalaryExpert · SEEK (Australia) 2026

CSLMayne PharmaViatrisSun Pharma

Source: CSL · Mayne Pharma · Viatris · Sun Pharma ANZ

Why QbD Skills Are in Demand Across Australian Pharma

Sovereign Manufacturing Push

With A$1.5 billion in government backing, the Moderna mRNA facility and CSL's expansion, Australia is scaling local production, and it needs processes with quality designed in, not tested in.

QbD builds the process understanding new plants need

TGA and PIC/S Expectations

Regulators increasingly expect QbD evidence in submissions. QbD gives teams the QTPP, risk assessment, design space and control strategy that TGA-aligned files now call for.

QbD builds QTPP, design space and control strategy skills

Biologics and mRNA Complexity

Biologics, biosimilars and mRNA products are process-defined and highly sensitive, so design space and process analytical technology skills are essential to controlling their quality.

QbD builds design space and PAT capability

Right-First-Time Pressure

Cost and margin pressure make deviations, rework and failed batches expensive. QbD builds the process understanding that keeps quality within the design space every time.

QbD reduces deviations and out-of-specification batches

QbD and CMC Talent Scarcity

Australia has deep GMP and QC talent but thinner strength in QbD, DoE and CMC. Professionals who can lead design space and control strategy work are sought after.

QbD skills make you stand out to employers

Move to Continuous Manufacturing

As sites explore continuous manufacturing and real-time release testing, QbD process understanding and PAT integration become the foundation these approaches depend on.

QbD underpins continuous and real-time release

Sources: CSL, Moderna, Australian Government, TGA, IBISWorld, PharmiWeb (Australia) 2025-2026.

QbD is more than theory. It is the skill set Australia's medicines manufacturers need to design quality into products and satisfy regulators. Start building it today.

Your Australian QbD Career Shift

From Bench Scientist to QbD Practitioner

The Shift This Training Delivers

Australia is investing to become a sovereign medicines manufacturer, and employers increasingly separate people who can apply QbD from those who only test at the end. Here is the shift this training helps you make.

Today

Seen as a bench specialist rather than a development leader

After QbD

Able to lead QTPP, CQA and design space work across a project

Today

Seen as a bench specialist rather than a development leader

Today

Limited visibility of how material and process parameters drive quality

After QbD

A clear, science-based understanding of what makes quality fail or hold

Today

Limited visibility of how material and process parameters drive quality

Today

Passed over for CMC and QbD roles that employers now prioritise

After QbD

Positioned for formulation, process, QA and CMC roles in demand across Australia

Today

Passed over for CMC and QbD roles that employers now prioritise

You master QbD

Before

Quality checked mainly by end-product testing after manufacture

Now you have

Quality designed into the product from the QTPP onwards

Before

Quality checked mainly by end-product testing after manufacture

Before

Development driven by trial and error and one-factor-at-a-time testing

Now you have

Structured DoE and a design space that explain how the process behaves

Before

Development driven by trial and error and one-factor-at-a-time testing

Before

Risk handled informally with limited documentation

Now you have

Formal Ishikawa and FMEA risk assessments that guide the control strategy

Before

Risk handled informally with limited documentation

Before

Submissions built on empirical specifications set at development scale

Now you have

ICH Q8 to Q11 aligned QbD evidence ready for TGA, FDA and EMA files

Before

Submissions built on empirical specifications set at development scale

"The gap between testing quality in and designing it in is now a recognised skill set, and the manufacturers investing in Australia already know it."

Join the professionals who upskilled with Invensis Learning and moved into QbD and CMC roles.

Sources: SalaryExpert, worldsalaries, SEEK (Australia) 2026.

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 Australia 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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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.

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 MasterHands-On with Every Core Technique

You will learn to apply every core QbD tool to realistic pharmaceutical development scenarios, from building a QTPP and identifying CQAs through risk assessment, DoE, design space and PAT to a complete control strategy. By the end of the one-day programme you can put these tools to work on live projects.

Build a Quality Target Product Profile (QTPP)

Learn to construct a QTPP from clinical and patient needs, defining dosage form, route, strength, pharmacokinetic targets and quality standards as the design specification for the whole QbD programme.

Identify and Classify Critical Quality Attributes

Identify the CQAs that drive product quality, safety and efficacy, then link them to Critical Material Attributes and Critical Process Parameters using prior knowledge and structured criticality assessment.

Run QbD Risk Assessments with FMEA

Apply Ishikawa diagrams and FMEA to map and rank CMA and CPP risks by severity, occurrence and detectability, using the Risk Priority Number to focus experiments on the highest-impact variables.

Design Experiments and Read the Results

Use Design of Experiments, from screening to response surface designs, to quantify how factors affect CQAs, replacing one-factor-at-a-time testing with real, statistical process understanding.

Define and Justify a Design Space

Turn DoE results into a defensible design space, set Normal Operating Ranges and Proven Acceptable Ranges, understand the edge of failure and know why working within the space is not a change.

Develop a Control Strategy with PAT

Build a control strategy from your risk and DoE outputs, apply process analytical technology such as NIR and Raman for real-time control, and structure QbD evidence for CTD regulatory submissions.

Who Should TakeQuality by Design Training in Australia?

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 Classroom Training

Instructor-led classroom sessions
Interactive discussions and group activities
Real-world examples and practical exercises
Structured learning with fixed schedules
Opportunities for peer networking and collaboration
Practice assessments and knowledge checks
Dedicated Q&A and concept clarification
Immediate trainer feedback and support

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Learn through face-to-face sessions led by experienced instructors in a collaborative classroom environment. This classroom Quality by Design training combines expert guidance, peer interaction, and hands-on activities to create an engaging learning experience.

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

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Quality by Design 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

AUD 740

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

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

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Quality by Design Corporate Group Training

Customized training aligned to organizational goals
Flexible delivery: onsite, virtual, hybrid, or blended
Scheduling tailored to business availability
Role-based examples and industry-relevant discussions
Progress tracking and learner assessments where applicable
Dedicated coordination and administrative support
Consistent learning experiences across teams
Scalable delivery for local, regional, or global workforces

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

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

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Quality by Design Focused 1-to-1 Training

One-to-one instructor attention
Customized learning plans and objectives
Flexible scheduling based on availability
Personalized feedback and coaching
Additional focus on challenging topics
Targeted practice and revision support
Faster clarification of questions and concepts
Learning pace is adapted to individual needs

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

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

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Quality by Design 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

Please Note: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.

Loading schedules…

Why Choose Invensis Learning for QbD Training in AustraliaExpert-Led, Practical and Flexible

Invensis Learning delivers structured QbD training for pharmaceutical and biopharmaceutical professionals and organisations that want to build quality into their products from the design stage. Our programmes combine experienced trainers, a curriculum grounded in the ICH Q8 to Q11 guidelines, flexible delivery formats and practical, scenario-based exercises. Whether you enrol as an individual or plan corporate training for your team, Invensis Learning stands out as a trusted Quality by Design training company in Australia, providing a professional learning experience focused on real-world application, so you leave able to use QbD tools on live development projects across Australia's medicines-manufacturing sector.

Experienced trainers with real pharmaceutical and quality management expertise
ISO 9001:2015 certified training with ISO 27001:2022 information security
Flexible delivery through live virtual, classroom and corporate on-site formats
Hands-on exercises using realistic QbD development scenarios
Curriculum grounded in the ICH Q8 to Q11 QbD framework
Course completion certificate from Invensis Learning
Dedicated learner support before, during and after the programme
Corporate training tailored to your team's live development projects

Flexible Learning Modes

98%

First-Attempt Pass Rate

5000+

Accredited Trainers Globally

4.7/5

Rated by Learners Worldwide

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 AustraliaAll our classroom training is now available online at your convenience

Quality by Design in Australia

Park Hyatt Sydney, 7 Hickson Rd, The Rocks NSW 2000, Australia

Quality by Design in Australia

Gilligan’s, 57/89 Grafton St, Cairns City QLD 4870, Australia

Quality by Design in Australia

Park Hyatt Sydney, 7 Hickson Rd, The Rocks NSW 2000, Australia

Quality by Design in Australia

Gilligan’s, 57/89 Grafton St, Cairns City QLD 4870, Australia

Corporate QbD Training in AustraliaUpskill Your Whole Team

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Train your whole development team on one consistent QbD framework
Flexible onsite, live virtual or blended delivery around your schedule
Sessions built around your own live pharmaceutical development projects
Experienced trainers with pharmaceutical and quality management expertise
Standardise QTPP, risk assessment and control strategy practice across sites
Scalable delivery for teams in Melbourne, Sydney and across Australia
Dedicated coordination and post-training support for corporate groups

What Our Learners Say

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From Theory to a Real Design Space

"The QbD training finally made the ICH Q8 to Q11 framework click for me. I went straight back to a formulation project and built a proper QTPP and CQA list with the team. The DoE and design space sessions were the most useful part."

Emily Nguyen

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Practical QbD Tools I Use Weekly

"Very practical and well paced for a one-day programme. The risk assessment exercises with Ishikawa and FMEA gave me a clear way to prioritise process parameters before we plan experiments. I use the RPN approach in every review now."

Daniel Costa

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Made QbD Submissions Make Sense

"As a regulatory affairs associate, I needed to understand how QbD evidence fits the CTD. The session on control strategy and Section 3.2.P.2 gave me exactly that. I can now review development reports with much more confidence."

Priya Sharma

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Aligned Our Whole Development Team

"We ran this as an onsite programme for our cross-functional team. Having formulation, analytical, quality and regulatory people learn the same QbD language in one room has already reduced friction on our scale-up projects."

Mark Henderson

Pharmaceutical Manufacturing

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Tailored and Directly Relevant

"Invensis Learning tailored the case studies to our biologics pipeline, which made the design space and PAT content directly relevant. A well-run corporate session that lifted our team's process understanding quickly."

Sarah Whitfield

Biopharmaceutical Sector

0/0

4.6

Ratings

100K+

Happy Learners

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Locations Worldwide

99%

Training Satisfaction

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

Quality by Design training is a one-day, non-certification programme that teaches the QbD approach to pharmaceutical and biopharmaceutical development. You learn to build quality into products from the design stage using the ICH Q8 to Q11 framework, QTPP, CQAs, risk assessment, DoE, design space and control strategy.

General

What is Quality by Design (QbD) training?

Is QbD training worth it for my career?

Yes. QbD is increasingly expected across Australia's growing medicines-manufacturing sector, where sovereign manufacturing investment, the Moderna mRNA facility and CSL's expansion are driving demand. The practical skills apply directly to formulation, process, quality and CMC regulatory roles that TGA-regulated employers are hiring for.

Who should attend the QbD training?

The programme suits formulation scientists, analytical scientists, process development engineers, QA professionals, CMC regulatory specialists and manufacturing technical managers in pharmaceutical, biopharmaceutical, API and CDMO organisations who want to apply QbD in product development and submissions.

Do I need prior experience to take QbD training?

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

Which standards and guidelines does the training follow?

The training is grounded in the ICH Q8(R2) Pharmaceutical Development guideline together with ICH Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Q11 (Drug Substances). These are the guidelines the TGA, FDA and EMA expect to see reflected in modern development and manufacturing submissions.

Pricing

How much does QbD training cost in Australia?

Pricing depends on the delivery format, whether you enrol as an individual or a group, and your location, so the fee is available on request in Australian dollars. Contact a learning advisor for a current quote for live virtual, classroom or corporate training.

What is included in the QbD course fee?

The fee typically covers instructor-led training across all six QbD modules, hands-on tool exercises, case study materials, learner support and a course completion certificate from Invensis Learning. Ask about the exact inclusions for your chosen format.

Do you offer group or corporate pricing?

Yes. Corporate group training is available with schedules and content tailored to your team, and pricing scales with group size. It is ideal for cross-functional development teams. Contact us for a tailored group quote.

Are there any other costs beyond the training fee?

No. Because this is a non-certification skills course, there is no exam fee, awarding-body fee or renewal cost. You pay only for the training itself. Any optional add-ons are confirmed with your advisor before you enrol.

How do I get a quote and enrol?

Request a quote through the Invensis Learning website or speak with a learning advisor, who will confirm pricing in Australian dollars, available dates and your preferred format. You can then complete enrolment and receive your joining details.

Assessment

Is there an exam for the QbD training?

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

Do I receive a certificate after the training?

You receive a course completion certificate from Invensis Learning. No formal certification or credential is awarded by an external body, because this is a practical skills programme. The tools you learn are immediately applicable to your development projects.

How is learning assessed during the course?

There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, risk assessment and design space interpretation to realistic development scenarios throughout the day, so you practise the skills directly rather than sitting a test.

Will I be able to apply QbD at work afterwards?

Yes. After the programme you can construct a QTPP, identify and classify CQAs, run Ishikawa and FMEA risk assessments, plan and interpret DoE, define a design space with NOR and PAR, and develop a control strategy for CTD submissions.

Is the training relevant to both small molecules and biologics?

Yes. The course covers QbD principles for small molecule drug products such as tablets and injectables and for biopharmaceutical products such as monoclonal antibodies and vaccines, with case study examples drawn from both to show how the tools apply across modalities.

Course Content

What topics does the QbD training cover?

The training covers six modules: QbD principles and the ICH framework; QTPP and CQAs; risk assessment; DoE and design space; PAT and control strategy; and QbD in practice, including case studies, CTD submissions and lifecycle management, with hands-on exercises throughout.

What will I learn about Design of Experiments?

You will learn why DoE replaces one-factor-at-a-time testing, the design types used in QbD such as screening and response surface designs, how to run and interpret a study, and how DoE results define the design space that underpins the control strategy.

Does the course include hands-on exercises?

Yes. Hands-on QbD tool exercises run throughout the day, covering QTPP construction, CQA identification and criticality assessment, Ishikawa diagrams, DoE design selection and design space interpretation, all applied to realistic pharmaceutical development scenarios.

How long is the QbD training programme?

The programme runs for one day, totalling eight hours. It can also be delivered as two half-day sessions. The format covers all six modules with concept explanations, the ICH regulatory context, case study examples and hands-on tool exercises.

Is the curriculum aligned with current regulatory expectations?

Yes. The curriculum reflects the current ICH Q8(R2), Q9, Q10 and Q11 guidelines and related FDA and EMA guidance, so the QbD tools and submission approach you learn match what the TGA and other regulators expect in modern pharmaceutical development.

Enrollment

How do I enrol in the QbD course?

You can enrol through the Invensis Learning website. Choose your preferred format, confirm your date, and you will receive joining instructions and access to learning resources. A learning advisor can help you pick the right option for your goals.

What training formats are available?

QbD training is available as online (live virtual) instructor-led sessions, in-person classroom training, and customised corporate on-site programmes for teams. Choose the format that best fits your schedule and whether you are learning individually or as a group.

Can the training be delivered on-site for our team?

Yes. Corporate on-site delivery is available for pharmaceutical and biopharmaceutical teams across Australia. It works especially well when participants apply the QbD tools to their own live development projects during the session. Contact us to arrange a group programme.

When can I start the QbD training?

Public sessions run on a regular schedule, and corporate groups can arrange dates that suit the team. Speak with a learning advisor to see upcoming batches for your preferred format and secure your place in the next available programme.

Can I reschedule my enrolment if needed?

Yes. Flexible options let you reschedule to another batch where needed, subject to our published policy. Contact learner support ahead of your session and the team will help you move to a date that works for you.