Quality by Design Training in Canada

Build Quality into Every Product

Give your pharmaceutical and biopharma teams in Canada a systematic, ICH-aligned way to design quality into products from the very first stage. This instructor-led QbD course turns the Q8 to Q11 framework into practical tools your scientists, QA and regulatory colleagues can apply on live development projects from day one.

Flexible

Duration

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Mode

Hours

13.3K+ already enrolled

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Want to Train Your Team?

Master Quality by Design and Lead Excellence in Canada

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CAD 640

What Is Quality by Design and Why It Matters in PharmaA Science-Based Route to Consistent Quality

Quality by Design (QbD) Training in Canada gives pharmaceutical and biopharmaceutical professionals a systematic, science-based way to build quality into products from the design stage, rather than testing it in at the end. It is grounded in the ICH Q8(R2), Q9, Q10 and Q11 guidelines that Health Canada, the FDA and the EMA expect to see in modern development and manufacturing submissions.

Over one focused day you learn to apply the full QbD toolkit: 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. Hands-on exercises use realistic development scenarios, so you leave able to apply the ICH framework on your own projects.

Whether you work in formulation, process development, analytical science, quality assurance or CMC regulatory affairs, this is a practical route to the design-stage capability Canadian employers increasingly expect. Start building QbD skills with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the Canada 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 Canada 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 Canada

Instructor-led training formats available for individual learners and corporate teams across the Canada
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 Canada
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 Canada 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 CanadaWho 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 QbD Capability Delivers at WorkValue for Individuals and Organisations

For Individuals

QbD training helps pharmaceutical professionals move from empirical, test-and-fix development to a structured, science-based approach. You learn to design quality into products using QTPP, CQAs, risk assessment, DoE and the control strategy. Whether you are a formulation scientist, process engineer, analytical scientist, QA professional or regulatory specialist, the course builds skills you can apply immediately on live development projects.

If you want to strengthen how your organisation develops and defends products, QbD is a practical, immediately usable skill set. You gain the tools, the ICH context and the workshop practice to lead design-stage quality with confidence.

Apply the ICH QbD framework to real formulation and process development work
Build a QTPP and identify Critical Quality Attributes with confidence
Lead risk assessments using Ishikawa diagrams and FMEA with RPN scoring
Plan and interpret Design of Experiments to define a robust design space
Develop control strategies that support smoother regulatory submissions
Speak the QbD language shared by formulation, QA and CMC regulatory teams
Position yourself for QbD-focused roles across Canada's pharma sector

For Organizations

QbD group training equips cross-functional teams with a consistent, ICH-aligned approach to designing quality into pharmaceutical products. It can be delivered for R&D groups, manufacturing sites, QA functions or regulatory teams. For organisations wanting fewer deviations, stronger submissions and more predictable scale-up, this training provides a scalable, flexible way to build in-house QbD capability.

If your teams still rely on end-product testing and trial-and-error development, QbD group training creates a common framework for design-stage quality. Teams gain a standardised approach to QTPP, risk assessment, design space and control strategy.

Builds a shared QbD language across formulation, process, QA and regulatory teams
Strengthens ICH Q8 to Q11 alignment in development and manufacturing submissions
Reduces manufacturing deviations through better process understanding
Improves right-first-time development and cuts costly late-stage rework
Supports smoother post-approval change management under a defined design space
Enables customised delivery for cross-functional development teams
Raises the QbD capability CDMOs and sponsors increasingly expect

Where QbD Skills Take Your Pharma Career in CanadaIn-Demand Roles

Quality by Design capability is increasingly valued across Canada's pharmaceutical and biomanufacturing sector, from generic and API manufacturers to biopharma innovators and CDMOs. As Health Canada, the FDA and the EMA expect ICH-aligned QbD evidence in submissions, and federal strategy expands domestic capacity, employers want scientists and quality professionals who can design quality in, not test it later. This is driving growing demand for Quality by Design training across the sector. Here is what the market is telling us right now.

C$2.2B

Federal life sciences investment

Biomanufacturing and Life Sciences Strategy, Government of Canada

3,800+

Life sciences companies in Canada

Invest in Canada, 2026

10,000+

New pharma and biotech jobs

added over five years, Invest in Canada

C$106K

CMC Regulatory Affairs Manager pay

average per year, Glassdoor Canada 2026

SECTORS HIRING

—Pharmaceutical Manufacturing and Generics
—Biopharmaceuticals and Biotechnology
—Contract Development and Manufacturing (CDMOs)
—Active Pharmaceutical Ingredient (API) Production
—Regulatory Affairs and CMC
—Medical Devices and Vaccines

GROWTH TRENDS

—Federal Biomanufacturing and Life Sciences Strategy scaling capacity
—Canadian Critical Drug Initiative expanding domestic production
—Cell and gene therapy and precision medicine growth
—Health Canada, FDA and EMA expecting ICH-aligned QbD submissions
—AstraZeneca and Roche expansions across Ontario
—Strong generic and CDMO manufacturing base seeking QbD skills

Sources: Invest in Canada; Government of Canada (Biomanufacturing and Life Sciences Strategy); Glassdoor, SalaryExpert, PayScale (Canada) 2026.

Designation

Quality by Design Professionals in Canada : Salary Insights and Trends

Hiring Companies in Canada

C$57K

Min

C$67K

Average

C$93K

Max

Glassdoor · SalaryExpert (Canada) 2026

ApotexPharmascienceBausch HealthSandoz Canada

Source: Apotex · Pharmascience · Bausch Health · Sandoz Canada

Why QbD Talent Is in Demand Across Canada

Rising Regulatory Expectations

Health Canada, the FDA and the EMA increasingly expect QbD evidence in submissions, yet many Canadian teams still lean on end-product testing rather than the ICH Q8 to Q11 approach.

QbD builds ICH-aligned submission skills

Scaling Domestic Manufacturing

Federal strategy is expanding domestic drug and vaccine capacity fast, demanding scientists who can characterise processes, define a design space and transfer them reliably to scale.

QbD builds process understanding skills

Complex Biologics and Cell Therapies

Canada's growth in biologics, cell and gene therapies brings process-defined products where CQA identification, DoE and control strategy are essential to consistent quality.

QbD builds CQA and DoE skills

Deviations and Costly Rework

Weak process understanding drives batch deviations, out-of-specification results and late-stage rework. QbD risk assessment and design space work reduce that cost at the source.

QbD builds risk-assessment skills

QbD Talent Shortage

The talent pool is deep in GMP and analytical skills but thinner in applied QbD. Professionals who can run QTPP, DoE and control strategy work are rare and sought after.

QbD makes skilled professionals stand out

CDMO Competitiveness

Canada's contract manufacturers win work by demonstrating QbD maturity to sponsors, making design-stage quality skills a real commercial differentiator for their teams.

QbD builds differentiating capability

Sources: Invest in Canada; Government of Canada (Biomanufacturing and Life Sciences Strategy, Canadian Critical Drug Initiative); ICH Q8 to Q11 guidelines, 2026.

QbD is more than a compliance box. It is the capability that separates strong pharmaceutical teams from the rest. Join professionals who design quality into products from the start. Begin your QbD journey today.

Your Canada QbD Skills Journey

Your QbD Skills, Before and After This Training,

A Practical Capability Upgrade

Canada's pharmaceutical and biomanufacturing sector is scaling fast, and employers increasingly separate teams who can apply Quality by Design from those who cannot. Here is the shift this training makes.

Today

You know GMP but have not applied the full ICH QbD toolkit

After training

You can run QTPP, CQA, risk assessment and design-space work end to end

Today

You know GMP but have not applied the full ICH QbD toolkit

Today

Overlooked for the QbD-focused roles Canadian employers now list

After training

Ready for formulation, process, QA and CMC roles that expect QbD

Today

Overlooked for the QbD-focused roles Canadian employers now list

Today

Design-stage quality still feels theoretical rather than practical

After training

You apply QbD tools to live development projects with confidence

Today

Design-stage quality still feels theoretical rather than practical

You build QbD capability

Before

Quality is checked mainly by end-product testing after manufacture

Now you have

Quality is designed in from the QTPP and CQAs at the start

Before

Quality is checked mainly by end-product testing after manufacture

Before

Development runs on empirical, one-factor-at-a-time trial and error

Now you have

Development is driven by DoE and mechanistic process understanding

Before

Development runs on empirical, one-factor-at-a-time trial and error

Before

Process limits are fixed with little room to flex at scale

Now you have

A defined design space gives justified, flexible operating ranges

Before

Process limits are fixed with little room to flex at scale

Before

Submissions rely on tight, hard-to-change specifications

Now you have

A risk-based control strategy supports smoother regulatory change

Before

Submissions rely on tight, hard-to-change specifications

"The distance between running GMP checks and truly designing quality into a product is a defined set of skills, and Canadian employers already know it."

Join 50,000+ professionals who trained with Invensis Learning and built the capability.

Sources: Glassdoor, SalaryExpert, PayScale (Canada) 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 Canada 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 Apply on Real ProjectsFrom Principles to Practice

This programme builds hands-on command of the full Quality by Design toolkit, from QTPP and CQAs through risk assessment, DoE and the design space to PAT and the control strategy. By the end you can apply these tools to realistic pharmaceutical development scenarios.

QbD Principles and the ICH Framework

Understand how QbD replaces test-and-fix development and how ICH Q8(R2), Q9, Q10 and Q11 shape what Health Canada, the FDA and the EMA expect in modern pharmaceutical submissions.

Building the QTPP and Identifying CQAs

Construct a Quality Target Product Profile from clinical and patient needs, then identify and classify the Critical Quality Attributes that determine product safety, efficacy and quality.

Risk Assessment with Ishikawa and FMEA

Map potential sources of variation with Ishikawa diagrams and prioritise them using FMEA and Risk Priority Numbers, so development effort focuses on the highest-impact variables.

Design of Experiments and the Design Space

Plan screening, response-surface and mixture DoE studies, interpret the models, and define a design space with Normal Operating and Proven Acceptable Ranges.

PAT and the Control Strategy

Apply Process Analytical Technology tools such as NIR and Raman, and build a risk-based control strategy that keeps every batch within the design space.

QbD in Submissions and Lifecycle Management

Structure QbD evidence for CTD Section 3.2.P.2, and manage post-approval change and continuous improvement using ICH Q12 across the product lifecycle.

Who Should TakeQuality by Design Training in Canada?

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

CAD 640

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

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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 TrainingPharma Partner in Canada

Invensis Learning delivers structured, practical Quality by Design training for pharmaceutical and biopharma professionals and teams across Canada who want to build design-stage quality capability. Our programmes combine experienced trainers, ICH-aligned content, flexible delivery formats and learner-focused support. As an established Quality by Design training company in Canada, we bring proven delivery experience to every engagement. Whether you enrol as an individual or plan corporate training for a cross-functional team, Invensis Learning provides a professional training experience built around practical understanding, real-world application and measurable learning outcomes.

Experienced trainers with real pharmaceutical development and quality expertise
Practical, ICH-aligned QbD content built around Q8 to Q11 and hands-on exercises
Flexible delivery through live virtual, classroom, onsite and corporate formats
Structured courseware and workshop scenarios drawn from real development work
Customised group training for R&D, manufacturing, QA and regulatory teams
ISO 9001:2015 quality management and ISO 27001:2022 information security certified
Dedicated learner support before, during and after your training
Trusted by professionals and organisations across many industries and regions

200K+

Professionals Trained

12M+

Hours of Training Delivered

Flexible Learning Modes

98%

First-Attempt Pass Rate

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 CanadaAll our classroom training is now available online at your convenience

Quality by Design in Canada

Hotel Nelligan, 106 Saint-Paul St W, Montreal, Quebec H2Y 1Z3

Quality by Design in Canada

Hotel Fairmont Le Manoir Richelieu, 181 Rue Richelieu, La Malbaie, QC G5A 1X7

Quality by Design in Canada

Hotel Nelligan, 106 Saint-Paul St W, Montreal, Quebec H2Y 1Z3

Quality by Design in Canada

Hotel Fairmont Le Manoir Richelieu, 181 Rue Richelieu, La Malbaie, QC G5A 1X7

Corporate QbD Training for Pharma TeamsFor Teams in Canada

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Suitable for small, medium and large development and quality teams
Customised schedules aligned with your project and site availability
Flexible delivery through onsite, live virtual, hybrid or blended formats
Trainers with practical pharmaceutical development and QbD experience
Role-based examples for formulation, process, analytical, QA and CMC teams
Applies QbD tools to your own live products and development scenarios
Scalable delivery for teams across Canada and global sites

What Our Learners Say

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From Theory to a Repeatable Method

"The QbD training finally connected the ICH guidelines to day-to-day work. Building a QTPP and running the CQA and FMEA exercises gave me a repeatable way to plan formulation studies instead of guessing."

Melissa Tremblay

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DoE and Design Space Made Clear

"The Design of Experiments and design space sessions were the most useful part for me. I now understand how to set Normal Operating and Proven Acceptable Ranges and defend them in a submission."

Arjun Sharma

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Exactly What a CMC Reviewer Needs

"As a regulatory professional I needed to understand QbD evidence well enough to review it. The control strategy and CTD Section 3.2.P.2 walkthrough was practical and easy to follow."

Claire Bergeron

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A Shared Language Across the Team

"We trained our cross-functional development team together and it created a shared QbD language across formulation, process and QA. Deviations discussions are far more structured now."

David Okonkwo

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Tailored to Our Biologics Pipeline

"Invensis Learning tailored the onsite programme to our biologics pipeline. The trainer used our own process examples for the risk assessment work, which made adoption much faster."

Priya Nair

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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 practical, non-certification course that teaches the Quality by Design approach to pharmaceutical product and process development. You learn to build quality in from the design stage using the ICH Q8(R2), Q9, Q10 and Q11 framework, with tools such as QTPP, CQAs, risk assessment, DoE, design space and control strategy.

General

What is Quality by Design (QbD) training?

Who should attend this QbD course in Canada?

It suits formulation scientists, process development and analytical scientists, quality assurance professionals, CMC regulatory affairs specialists and manufacturing technical managers in pharmaceutical, biopharma, API, CDMO and medical device organisations across Canada who want to apply QbD in their work.

Is QbD in demand in Canada?

Yes. As federal strategy scales domestic biomanufacturing and Health Canada, the FDA and the EMA expect ICH-aligned QbD evidence in submissions, employers increasingly value professionals who can design quality into products rather than test it in later.

Do I need prior QbD experience to attend?

No. There are no formal prerequisites. Familiarity with pharmaceutical development or GMP is helpful, but the course introduces QbD from first principles in a development context, so newcomers and experienced professionals both benefit.

Which standards and guidelines does the course follow?

The course is grounded in the ICH Quality guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances, along with the FDA PAT framework and ICH Q12 for lifecycle management.

Pricing

How much does the QbD course cost in Canada?

Fees vary by delivery format (live virtual, classroom or corporate onsite) and group size. For current pricing in Canadian dollars and group rates, request a quote and a learning advisor will share the options that fit your needs.

What is included in the training fee?

The fee typically includes instructor-led sessions, structured courseware, hands-on QbD tool exercises, learning resources and post-training support. Confirm the exact inclusions for your chosen format when you request a quote.

Do you offer group or corporate pricing?

Yes. We offer corporate group training with customised schedules and volume-based pricing for development, manufacturing, QA and regulatory teams. Contact us for a tailored group quote for your organisation.

Are there any additional fees beyond the course?

No. This is a skills training course with no examination and no separate credentialing body, so there are no exam or membership fees. You pay for the training only. Ask a learning advisor about payment options.

Is QbD training a worthwhile investment?

QbD skills apply immediately to development and manufacturing work, helping reduce deviations and strengthen submissions, which makes the training a practical, quickly usable investment for individuals and teams. Request a quote to plan your training.

Assessment

Is there an exam for this QbD course?

No. This is a non-certification skills course with no examination. Learning is reinforced through hands-on tool exercises, realistic case scenarios and group discussion throughout the one-day programme.

Will I receive anything on completion?

Yes. On completing the programme you receive a course completion record from Invensis Learning. It recognises your participation and the practical QbD skills you have built, though it is not a formal certification.

How is my learning reinforced without an exam?

Through applied practice. You work through QTPP construction, CQA identification, Ishikawa and FMEA risk assessment, DoE design selection and design space interpretation using realistic development scenarios, so you can apply the tools at work straight away.

Does the course cover both small molecules and biologics?

Yes. The programme covers QbD principles for small molecule drug products such as tablets and injectables, and for biopharmaceuticals such as monoclonal antibodies, with case examples drawn from both product types.

What will I be able to do after the training?

You will be able to build a QTPP, identify and classify CQAs, run risk assessments with Ishikawa and FMEA, plan a DoE for design space work, interpret the results, and develop a control strategy and QbD evidence for submissions.

Course Content

What topics does the QbD training cover?

The course spans QbD principles and the ICH framework, the QTPP and CQAs, risk assessment, Design of Experiments and the design space, Process Analytical Technology and the control strategy, plus QbD in submissions and lifecycle management, with exercises throughout.

How long is the QbD course?

The programme is delivered as one focused day of around eight hours, or as two half-days. It covers the full QbD toolkit with concept explanations, ICH context, real case examples and hands-on tool exercises.

What tools and techniques will I practise?

You practise QTPP construction, CQA identification and criticality assessment, Ishikawa diagrams, FMEA with Risk Priority Numbers, DoE design selection, design space interpretation with NOR and PAR, and control strategy development.

Are the sessions hands-on or lecture based?

Both. Trainers explain concepts and the ICH context, then guide you through hands-on exercises using realistic pharmaceutical development scenarios, so you learn by applying each QbD tool rather than only hearing about it.

How does QbD relate to my regulatory submissions?

QbD outputs such as the QTPP, CQAs, design space and control strategy form the basis of Section 3.2.P.2 Pharmaceutical Development in CTD submissions. The course shows how to structure and justify that evidence for Health Canada, the FDA and the EMA.

Enrollment

How do I enrol in the QbD training?

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

What delivery formats are available in Canada?

The course is available as live virtual instructor-led training, in-person classroom sessions and corporate onsite delivery for teams. Choose the format that best fits your schedule and location across Canada.

Can this be delivered onsite for our team?

Yes. Corporate onsite and live virtual group delivery let you train a cross-functional team together, with content tailored to your products and pipeline. Talk to a learning advisor to arrange a session for your organisation.

How soon can I start?

Public sessions run on a regular schedule, and corporate sessions are arranged around your team's availability. Contact us to see the next available dates and reserve your place.

Can I reschedule after enrolling?

Yes. Rescheduling options are available on selected plans so you can move to another batch if your plans change. Reach out to our support team to arrange the details that apply to your enrolment.