Quality by Design Training in the UK

Build Quality into Every Product

Master the ICH-aligned Quality by Design approach used across UK pharma and biotech. This instructor-led course equips formulation, process, analytical, quality and CMC regulatory professionals to build quality into products from the design stage using QTPP, CQAs, risk assessment, DoE, the design space and control strategy.

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Hours

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Master Quality by Design and Lead Excellence in United Kingdom

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GBP 430

What Is Quality by Design in Pharmaceutical Development?Design Quality in from Day One

The Quality by Design Training in the UK teaches you to design quality into pharmaceutical and biopharmaceutical products from the very start, rather than testing for it at the end. Quality by Design (QbD) is a systematic, science-based approach mandated by the ICH Q8(R2), Q9, Q10 and Q11 guidelines and expected by regulators including the MHRA, EMA and FDA in modern development and manufacturing submissions.

Over one intensive 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 the methods transfer straight to your projects.

The course suits formulation, process development, analytical, quality assurance and CMC regulatory professionals across the UK's pharma, biotech, API and CDMO sectors. Build the process understanding employers now expect and start applying QbD with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the United Kingdom 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 United Kingdom 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 United Kingdom

Instructor-led training formats available for individual learners and corporate teams across the United Kingdom
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 United Kingdom
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 United Kingdom 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 United KingdomWho 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 On-The-Job Value of Learning QbDReal Gains for You and Your Team

For Individuals

Quality by Design training helps pharmaceutical professionals replace empirical, test-and-fix development with a systematic approach that builds quality in from the outset. You gain a practical command of the QTPP, CQAs, risk assessment, DoE, the design space and control strategy that modern development demands. Whether you work in formulation, process development, analytical science, quality assurance or CMC regulatory affairs, the training gives you tools you can apply to real products the very next week.

If you want to stand out in the UK's competitive life sciences market, QbD fluency is a clear differentiator. You leave able to construct a QTPP, lead CQA identification, facilitate FMEA risk assessments, plan DoE studies, define a design space and shape a control strategy for submission.

Learn to build quality into products from the design stage, cutting deviations and rework
Apply QTPP, CQA and design space tools directly to your live development projects
Speak the ICH QbD language that MHRA, EMA and FDA reviewers expect in submissions
Move from trial-and-error development to mechanistic, science-based process understanding
Facilitate risk assessments with Ishikawa diagrams and FMEA with confidence
Plan and interpret Design of Experiments to define robust design spaces
Strengthen your value across formulation, process, analytical, QA and CMC roles
Earn a course completion certificate from Invensis Learning to evidence your CPD

For Organizations

Quality by Design group training helps pharmaceutical and biopharmaceutical organisations embed a consistent, science-based development approach across their teams. Training a formulation, process, analytical, quality and regulatory group together creates a shared language for building quality in. For organisations under pressure to cut deviations, steady supply and satisfy regulators, QbD capability is a scalable, practical investment.

If your teams still rely on end-product testing to catch problems, QbD group training gives them the tools to predict and control quality upstream. The result is fewer post-approval changes, stronger submissions and more consistent products for patients.

Upskill a cross-functional development team in one shared QbD framework
Standardise QTPP, CQA, risk assessment and design space practice across sites
Reduce manufacturing deviations, out-of-specification results and costly changes
Build submission-ready process understanding for CTD Section 3.2.P.2
Apply QbD to your own live products during onsite corporate sessions
Strengthen regulatory relationships through robust control strategies
Develop in-house capability instead of relying on external consultants
Deliver training flexibly via live virtual, classroom or onsite formats

QbD Career Scope and Demand in the UKRoles, Sectors and Pay Outlook

Quality by Design skills are in growing demand across the UK's pharmaceutical and life sciences sector, where the government's Life Sciences Sector Plan and new manufacturing funding are drawing biomanufacturing investment. QbD expertise maps to roles from analytical and formulation scientist through process development, CMC regulatory affairs and pharmaceutical quality assurance manager. As the MHRA reinforces QbD-aligned expectations, employers increasingly value professionals who can build quality into products and evidence process understanding, and here is what the market is telling us now.

£67,700

Pharma QA manager pay, UK

average, PayScale 2026

£40k-£68k

CMC regulatory affairs pay, UK

officer to manager, industry data 2026

£520m

UK life sciences manufacturing fund

LSIMF, GOV.UK 2026

8% CAGR

UK biomanufacturing growth

2026-2035 forecast, IndexBox

SECTORS HIRING

—Pharmaceutical Manufacturing and Development
—Biopharmaceutical and Biotechnology
—Contract Development and Manufacturing (CDMOs)
—Active Pharmaceutical Ingredient (API) Manufacturing
—Cell and Gene Therapy
—CMC Regulatory Affairs and Consulting

GROWTH TRENDS

—Life Sciences Sector Plan and 520m manufacturing fund (LSIMF)
—MHRA modernising QbD-aligned regulatory expectations
—Biomanufacturing expansion at Fujifilm and new UK CDMO sites
—Cell and gene therapy scale-up demanding tighter process control
—Shift to continuous manufacturing and real-time release testing
—Skills shortage in QbD tools and process understanding

Sources: GOV.UK Life Sciences Sector Plan 2026; PayScale, Glassdoor (UK) 2026; IndexBox UK biomanufacturing forecast 2026.

Designation

Quality by Design Professionals in United Kingdom : Salary Insights and Trends

Hiring Companies in United Kingdom

£30K

Min

£40K

Average

£52K

Max

Glassdoor · Check-a-Salary (UK) 2026

AstraZenecaGSKFujifilm BiotechnologiesCatalent

Source: AstraZeneca · GSK · Fujifilm Biotechnologies · Catalent

Industry Pressures Driving QbD Demand in UK Pharma

Regulatory Expectations Are Rising

The MHRA, EMA and FDA increasingly expect QbD evidence in submissions, so teams that cannot show process understanding face delays and costly deficiencies.

QbD builds ICH-aligned submission skills

Test-And-Fix Development Wastes Time

Empirical, trial-and-error development drives deviations, out-of-specification batches and rework. QbD replaces it with mechanistic understanding of the process.

QbD builds process-understanding skills

Biologics and Advanced Therapies Are Complex

The UK's growing cell, gene and biologics pipeline needs QbD to control critical quality attributes such as glycosylation and aggregation at scale.

QbD builds CQA control skills

Continuous Manufacturing Needs Control

As UK sites move from batch to continuous processing and real-time release, robust design spaces and control strategies become essential rather than optional.

QbD builds design space and control strategy skills

QbD Talent Is Scarce

Biomanufacturing investment is outpacing the supply of professionals fluent in QTPP, DoE and design space, leaving UK employers competing for skilled talent.

QbD makes skilled practitioners stand out

Post-Approval Changes Are Expensive

Poorly understood processes trigger frequent post-approval change filings. A well-designed control strategy reduces that regulatory and cost burden.

QbD builds lifecycle and change skills

Sources: GOV.UK Life Sciences Sector Plan 2026; MHRA guidance; European Pharmaceutical Manufacturer 2026.

Quality by Design is fast becoming the baseline for UK pharmaceutical development. Build the process understanding that employers and regulators now expect, and apply it from day one. Start your QbD journey today.

Your UK QbD Transformation

From Test-And-Fix to Built-In Quality,

The Shift QbD Delivers

The UK's pharmaceutical and biopharmaceutical sector is shifting from testing quality in to designing it in, and employers increasingly separate teams that understand QbD from those that do not. Here is the change this training delivers.

Today

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

After QbD

You design quality in from the QTPP stage and predict it through the process

Today

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

Today

Submissions lack the process understanding MHRA and EMA reviewers expect

After QbD

You produce QbD evidence for CTD Section 3.2.P.2 with a clear control strategy

Today

Submissions lack the process understanding MHRA and EMA reviewers expect

Today

Career limited to a single function with a narrow methodology

After QbD

You are valued across formulation, process, QA and CMC roles that pay well in the UK

Today

Career limited to a single function with a narrow methodology

You apply QbD at work

Before

Quality assured only by end-product testing after the batch is made

Now you have

A design space that keeps every critical quality attribute in specification

Before

Quality assured only by end-product testing after the batch is made

Before

Risk assessed informally, with little traceability to product quality

Now you have

Structured FMEA and Ishikawa risk assessment linking CMAs and CPPs to CQAs

Before

Risk assessed informally, with little traceability to product quality

Before

One-factor-at-a-time experiments that miss critical interactions

Now you have

Design of Experiments that reveal true factor interactions and the design space

Before

One-factor-at-a-time experiments that miss critical interactions

Before

Frequent, costly post-approval changes and recurring deviations

Now you have

A robust control strategy that reduces change burden and steadies supply

Before

Frequent, costly post-approval changes and recurring deviations

"The gap between testing quality in and designing it in is now what separates leading pharmaceutical teams, and UK regulators already expect the difference."

Join the professionals who train with Invensis Learning and build quality in from the start.

Sources: PayScale, Glassdoor (UK) 2026; GOV.UK Life Sciences Sector Plan 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 United Kingdom 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

Skills You Will Build in This QbD CourseApply the Full QbD Toolkit at Work

This Quality by Design course builds practical, job-ready skills across the full QbD workflow. You will learn to define product quality, identify what is critical, assess risk, run experiments, define the design space and control the process, all grounded in the ICH Q8, Q9, Q10 and Q11 framework.

Build a Quality Target Product Profile (QTPP)

Construct a QTPP from clinical and patient needs to set the design specification for an entire development programme, linking dosage form, strength, pharmacokinetic profile and quality standards.

Identify and Classify Critical Quality Attributes

Determine which physical, chemical, biological and microbiological attributes are critical to product quality, safety and efficacy for both small molecules and biologics, and justify each classification.

Run QbD Risk Assessments

Use Ishikawa (fishbone) diagrams and FMEA to map and rank how critical material attributes and process parameters affect CQAs, prioritising the highest-risk relationships for formal study.

Design and Interpret Experiments (DoE)

Select screening, response-surface and mixture designs, then interpret the models to understand factor interactions and define the multidimensional design space, including NOR and PAR.

Apply Process Analytical Technology (PAT)

Use PAT tools such as NIR and Raman spectroscopy to monitor CQAs and CPPs in real time, supporting real-time release testing and tighter in-process control.

Develop a Control Strategy for Submission

Build a risk-proportionate control strategy from your risk assessment and DoE outputs, and structure the QbD evidence for CTD Section 3.2.P.2 regulatory submissions.

Who Should TakeQuality by Design Training in United Kingdom?

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

GBP 430

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 Training in the UKExpert-Led, ICH-Aligned and Practical

As a trusted Quality by Design training company in the United Kingdom, Invensis Learning delivers instructor-led QbD training for pharmaceutical and biopharmaceutical professionals and teams across the UK. Our trainers are experienced quality and process practitioners, and every programme is grounded in the ICH Q8, Q9, Q10 and Q11 framework rather than theory alone. We combine hands-on QbD tool exercises, real pharmaceutical case studies and flexible delivery through online (live virtual), classroom and onsite formats. As an ISO 9001:2015 and ISO 27001:2022 certified provider trusted by professionals worldwide, we help you turn one focused day of training into skills you apply the very next week.

Experienced quality and process practitioners as trainers, not theorists
Every session grounded in the ICH Q8, Q9, Q10 and Q11 QbD framework
Hands-on QTPP, CQA, risk assessment and DoE exercises using real scenarios
Flexible online (live virtual), classroom and onsite delivery across the UK
Practical focus so you apply QbD tools at work the very next week
ISO 9001:2015 and ISO 27001:2022 certified training provider
Course completion certificate from Invensis Learning to evidence CPD
Trusted by pharmaceutical professionals and teams worldwide

50+

Industries Served

1-to-1

Doubt-Clearing Sessions

60+

Global Course Portfolio

100+

Countries Served

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 United KingdomAll our classroom training is now available online at your convenience

Quality by Design in United Kingdom

Le Manoir aux Quat’Saisons, A Belmond Hotel, Oxfordshire Church Rd, Great Milton, Oxford OX44 7PD, United Kingdom

Quality by Design in United Kingdom

The Gleneagles Hotel, Auchterarder PH3 1NF, United Kingdom

Quality by Design in United Kingdom

Le Manoir aux Quat’Saisons, A Belmond Hotel, Oxfordshire Church Rd, Great Milton, Oxford OX44 7PD, United Kingdom

Quality by Design in United Kingdom

The Gleneagles Hotel, Auchterarder PH3 1NF, United Kingdom

Corporate QbD Training for TeamsUpskill Your Whole Team

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Train a cross-functional QbD team together in one shared framework
Customised content mapped to your products and therapeutic areas
Flexible onsite, live virtual or hybrid delivery across UK sites
Apply QbD tools to your own live development projects in-session
Experienced trainers with pharma quality and process expertise
Standardise QTPP, risk assessment and design space practice
Dedicated coordination and learner support for group programmes

What Our Learners Say

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Practical from Day One

"The QbD training finally connected the theory to my day job. I went back and rebuilt our QTPP and CQA justification for a new tablet formulation, and the DoE session changed how I plan experiments. Genuinely practical."

Hannah Clarke

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Clear on PAT and Control Strategy

"The PAT and control strategy modules were exactly what I needed. I now understand how our in-process measurements fit a design space rather than just sitting in a report. The trainer answered every real-world question I had."

Daniel Foster

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Made QbD Submissions Make Sense

"As someone in CMC regulatory affairs, seeing how QTPP, risk assessment and DoE feed Section 3.2.P.2 was really useful. I can now review QbD sections with far more confidence and ask the right questions of the development team."

Priya Sharma

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One Shared QbD Language for Our Teams

"We ran this as an onsite session for our development and quality teams. Everyone now uses the same QbD language for QTPP, CQAs and design space, which has already reduced back-and-forth between functions. Well worth the day."

Mark Thompson

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Tailored Corporate Training That Landed

"Invensis Learning tailored the corporate programme to our small-molecule and biologics work, and the exercises used our kind of scenarios. Coordination was smooth and our scientists came away able to apply the tools immediately."

Elaine Docherty

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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...

Quality by Design training is a one-day course that teaches a systematic, science-based approach to pharmaceutical development, where quality is built into the product from the design stage rather than tested in at the end. It covers the ICH Q8, Q9, Q10 and Q11 framework and tools such as QTPP, CQAs, risk assessment, DoE, the design space, PAT and control strategy.

General

What is Quality by Design (QbD) training?

Is the Quality by Design course worth it?

Yes. QbD is now expected by the MHRA, EMA and FDA in modern submissions, so professionals who can build quality into products and evidence process understanding are increasingly in demand across the UK's pharma, biotech and CDMO sectors. The skills apply immediately to development and manufacturing work.

Who should attend the QbD training?

The course suits formulation, process development and analytical scientists, quality assurance professionals, and CMC regulatory affairs specialists in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations across the UK. It introduces QbD from first principles, so mixed teams can attend together.

Do I need prior QbD experience to attend?

No. There are no formal prerequisites. Familiarity with pharmaceutical development or GMP is helpful but not required, as the course introduces Quality by Design from first principles in a real development context.

Which regulatory guidelines does the course follow?

The training 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 FDA and EMA expectations relevant to UK submissions.

Pricing

How much does the Quality by Design course cost in the UK?

Pricing varies by delivery mode (live online, classroom or corporate), group size and schedule, so it is available on request. Contact a learning advisor for current UK pricing and any group offers.

What is included in the course fee?

The fee typically includes instructor-led training across all six QbD modules, hands-on tool exercises, pharmaceutical case studies, learning materials and a course completion certificate from Invensis Learning. Request a quote for the full inclusions on your chosen format.

Do you offer corporate or group pricing?

Yes. Group and corporate on-site training is available with tailored pricing for teams, which is often the most cost-effective way to train a cross-functional development group together. Ask about corporate pricing for your team.

Are there any additional costs beyond the training fee?

No. As a non-certification course there is no separate examination or awarding-body fee. The training fee covers the programme itself, so request a quote to confirm exactly what your chosen format includes.

How do I pay and are instalments available?

We accept major cards and bank transfers, and instalment options are available on selected plans. Speak with a learning advisor to choose the payment option that suits you.

Assessment

Is there an exam at the end of the course?

No. Quality by Design training is a non-certification course with no examination. Your understanding is developed through practical QbD tool exercises, realistic case studies and group discussion throughout the day.

What will I receive on completion?

You receive a course completion certificate from Invensis Learning, which you can use to evidence your continuing professional development. No external credential or awarding body is involved, as this is a practical skills course.

How is my learning assessed during the course?

Learning is assessed informally through hands-on activities: building a QTPP, identifying CQAs, running Ishikawa and FMEA risk assessments, and interpreting a design space, all applied to realistic development scenarios rather than a formal test.

Is this a recognised qualification?

This is a practical skills training course, not a formal qualification, and it does not award a certification. It builds job-ready QbD capability aligned to the ICH framework that employers value across the pharmaceutical sector.

Will the skills stay current after the course?

Yes. The ICH Q8, Q9, Q10 and Q11 guidelines that underpin QbD are well established, so the tools and methods you learn remain applicable and require no renewal or maintenance.

Course Content

What topics does the QbD course cover?

The course covers QbD principles and the ICH framework, the QTPP and CQAs, risk assessment with Ishikawa diagrams and FMEA, Design of Experiments and the design space, Process Analytical Technology and control strategy, and QbD in practice through case studies and CTD submissions.

Does the course include hands-on exercises?

Yes. Throughout the day you apply QbD tools to realistic pharmaceutical scenarios: constructing a QTPP, classifying CQAs, running a risk assessment and interpreting a design space, so the methods transfer straight to your work.

Does it cover both small molecules and biologics?

Yes. The course includes QbD case examples for small-molecule drug products such as tablets and for biologics such as monoclonal antibodies, covering critical quality attributes like potency, dissolution, glycosylation and aggregation.

Will I learn Design of Experiments (DoE)?

Yes. You learn how DoE is used within QbD to understand factor interactions and define the design space, including screening, response-surface and mixture designs and how to interpret the resulting models.

How long is the training and how is it delivered?

The programme runs for one day (8 hours) and is available as online (live virtual), classroom or corporate on-site training. The full day covers all six QbD modules with hands-on exercises throughout.

Enrollment

How do I enrol in the Quality by Design course?

You can enrol through the Invensis Learning website. Choose your preferred format and schedule, complete payment, and you will receive joining details, materials and learning resources. Talk to an advisor if you need help choosing dates.

What delivery formats are available in the UK?

The course is offered as online (live virtual) instructor-led training, in-person classroom sessions and corporate on-site delivery, so you can pick the format that fits your schedule and location.

Can this be delivered on-site for our team?

Yes. Corporate on-site delivery lets a cross-functional team train together and apply QbD tools to your own live products. Contact us to arrange an on-site or live virtual group session for your organisation.

How soon can I start?

New live online and classroom sessions run regularly, and corporate sessions are scheduled to suit your team. See upcoming schedules or speak with a learning advisor to find the next available date.

What is the reschedule or cancellation policy?

Rescheduling and cancellation are handled per our published policy, and flexible options are available on selected plans. Reach out to our team for the details that apply to your booking.