Quality by Design Training in France

Build Quality into Every Product

Designed for pharmaceutical and biopharmaceutical professionals in France, this instructor-led QbD training shows you how to design quality into products using the ICH Q8, Q9, Q10 and Q11 toolkit, from the QTPP and CQAs to DoE, the design space and the control strategy.

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Hours

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Master Quality by Design and Lead Excellence in France

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Designing Quality into Pharmaceutical ProductsA Practical Introduction to QbD

The Quality by Design Training in France is a practical, one-day programme that teaches pharmaceutical and biopharmaceutical professionals how to build quality into a product from the design stage instead of testing it in 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 increasingly expected by regulators such as the EMA and FDA.

Across a single eight-hour session you learn the full QbD toolkit: the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment with Ishikawa 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 can apply each tool at work the next day.

The training suits formulation scientists, process and analytical scientists, regulatory affairs (CMC) specialists and quality professionals across France's pharma, biotech, API and CDMO sites. With France reshoring essential medicine production and scaling biologics, QbD-literate teams are in strong demand. Start building this capability with Invensis Learning.

Key Highlightsof the Quality by Design Training Course

End-to-End Skill Development

Structured Quality by Design training in the France 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 France 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 France

Instructor-led training formats available for individual learners and corporate teams across the France
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 France
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 France 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 FranceWho Can Enroll?

No formal prerequisites are required to enroll in the Quality by Design training program
Basic familiarity with quality assurance concepts is helpful but not mandatory for enrollment
Professionals from pharmaceutical, biotechnology, healthcare, and manufacturing industries are well-suited for this training
Individuals and corporate teams seeking to build QbD knowledge and apply regulatory-aligned product development principles are eligible to enroll
Learners with backgrounds in quality, regulatory affairs, process engineering, and production management will find the content directly applicable to their roles

What You Gain from QbD TrainingSkills You Apply Immediately

For Individuals

QbD training helps pharmaceutical and biopharmaceutical professionals design quality into products from the outset and apply the ICH-based toolkit at work. It suits formulation, analytical and process scientists, regulatory affairs specialists and quality professionals. Whether you are moving from trial-and-error development to a systematic approach, preparing QbD evidence for a submission, or supporting a new French production site, this training builds capability that employers value.

If you want a practical, science-based way to design and control pharmaceutical quality, QbD is a clear step forward. You gain hands-on experience with the QTPP, CQAs, DoE and the control strategy, plus a course completion record from Invensis Learning.

Build quality into products from the design stage, not through end-product testing
Apply QTPP, CQA identification, risk assessment and DoE with confidence
Define a design space and control strategy aligned to ICH Q8, Q9, Q10 and Q11
Speak the QbD language regulators expect in EMA and FDA submissions
Stand out for roles at France's reshoring, biologics and CDMO sites
Help reduce manufacturing deviations and costly post-approval changes
Contribute across formulation, analytics, process and quality teams
Gain skills you can apply to live development projects immediately

For Organizations

QbD group training helps pharmaceutical organisations build development and quality capability by equipping cross-functional teams with a common, science-based method. It can be delivered for R&D, manufacturing, quality or regulatory groups. For organisations scaling biologics, reshoring production or preparing QbD submissions, this training offers a scalable, flexible way to raise the whole team's capability.

If your teams still rely on end-product testing and trial-and-error development, QbD group training creates a shared approach to designing and controlling quality. Teams gain a consistent way to run QTPP, risk assessment, DoE and control-strategy work.

Build a shared QbD language across formulation, process, analytics and quality
Strengthen ICH Q8, Q9, Q10 and Q11 readiness for regulatory submissions
Reduce deviations, rework and post-approval changes through process understanding
Support QbD adoption at new and reshored production sites in France
Upskill cross-functional development teams together on live projects
Standardise risk assessment, DoE and control-strategy practice
Choose flexible onsite, live virtual or blended delivery for your teams
Strengthen in-house capability for biologics and continuous manufacturing

Where QbD Skills Take Your Career in FranceRoles, Demand and Employers

Quality by Design skills have become a practical marker of capability across France's pharmaceutical and biopharmaceutical sector, valued by manufacturers, biotech firms, API producers and CDMOs that must design and control quality to ICH standards. As France reshores essential medicine production and scales biologics, employers increasingly want teams who can apply QbD from development through to submission. Quality by Design training is how professionals build exactly that capability. Roles span formulation, analytical and process science, regulatory affairs and quality, and here is what the French market is telling us right now.

271

Pharmaceutical production sites in France

French Healthcare 2026

EUR 4bn+

Pharma manufacturing investment since 2023

FiercePharma 2026

~100,000

People employed in French pharma production

French Healthcare 2026

EUR 57k

Avg responsable qualite pharma salary

per year, Indeed 2026

SECTORS HIRING

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

GROWTH TRENDS

—France 2030 reshoring of essential medicines driving new production sites
—Over 4 billion euros of pharma manufacturing investment since 2023
—271 production sites employing nearly 100,000 people nationwide
—Five bio-clusters scaling gene therapy, oncology and immunology
—EMA and regulatory expectations pushing QbD-based submissions
—Shortage of qualified pharmaceutical development talent

Sources: French Healthcare, FiercePharma, France 2030, Indeed and JournalDuNet (France), 2026.

Designation

Quality by Design Professionals in France : Salary Insights and Trends

Hiring Companies in France

EUR30K

Min

EUR40K

Average

EUR52K

Max

SalaryExpert - Talent.com (France)

SanofiServierDelpharmFareva

Source: Sanofi - Servier - Delpharm - Fareva

Market Forces Making QbD a Must-Have Skill in France

Reshoring of Essential Medicines

France 2030 is relocating essential medicine production, with nearly 300 million euros invested across 14 projects. New and reshored sites need teams who can design and control quality from the start.

QbD builds design-stage quality skills

Regulatory Pressure for QbD Evidence

The EMA and FDA increasingly expect QbD-based development in submissions. Teams fluent in ICH Q8, Q9, Q10 and Q11 help avoid queries and speed approval of French-made medicines.

QbD builds ICH submission skills

Scaling Biologics and Advanced Therapies

France's five bio-clusters are scaling gene therapy, oncology and immunology products. Complex biologics demand QbD tools like CQA identification and the design space to keep quality consistent.

QbD builds CQA and design-space skills

Shortage of Development Talent

Industrialists report real difficulty recruiting qualified pharmaceutical profiles. Professionals who apply QbD systematically stand out as French sites ramp up hiring and apprenticeships.

QbD makes your profile stand out

Pressure to Cut Deviations and Cost

Margin and capital discipline push manufacturers to reduce deviations, rework and post-approval changes. QbD process understanding is the proven route to more consistent, lower-cost production.

QbD builds process-understanding skills

Move to Continuous Manufacturing

As French sites adopt continuous and PAT-enabled manufacturing, real-time process understanding becomes essential. QbD provides the design space and control strategy these lines rely on.

QbD builds PAT and control-strategy skills

Sources: France 2030 (economie.gouv.fr), French Healthcare, FiercePharma, Expectra (France), 2026.

QbD is fast becoming a core skill for pharmaceutical teams in France. Build it now and help your organisation design quality into every product. Start your training today.

Your France Career Transformation

From Test-And-Fix to Design-Led Quality

Your QbD Transformation

France is living through its biggest pharmaceutical manufacturing boom in decades, and employers increasingly separate teams that can design quality in from those that still test it in at the end. Here is which side of that line you want to be on.

Today

Limited to a single-discipline development role

After Training

Ready to contribute across formulation, analytics, process and quality

Today

Limited to a single-discipline development role

Today

Fewer options as French sites hire QbD-literate profiles

After Training

Eligible for in-demand roles at reshoring and biologics sites

Today

Fewer options as French sites hire QbD-literate profiles

Today

Confident in the lab, less so in the regulatory context

After Training

Fluent in linking process understanding to ICH-based submissions

Today

Confident in the lab, less so in the regulatory context

You Master QbD

Before

Quality is verified by end-product testing after manufacture

Now You Have

The skill to build quality into the product from the design stage

Before

Quality is verified by end-product testing after manufacture

Before

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

Now You Have

A systematic method using QTPP, CQAs, risk assessment and DoE

Before

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

Before

Process understanding sits with only a few individuals

Now You Have

A design space and control strategy the whole team can follow

Before

Process understanding sits with only a few individuals

Before

Submissions get queried on their process rationale

Now You Have

QbD evidence aligned to ICH Q8, Q9, Q10 and Q11

Before

Submissions get queried on their process rationale

"The gap between testing quality in and designing it in is now a career gap, and the French sites that are hiring already know it."

Join 50,000+ professionals who trained with Invensis Learning and made the shift.

Sources: French Healthcare, FiercePharma, France 2030, Indeed (France), 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 France 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 Practical QbD Skills You Will BuildQTPP, DoE and Control Strategy

This QbD training gives pharmaceutical and biopharmaceutical professionals a complete, hands-on command of the Quality by Design toolkit. By the end of the day you can design quality into a product and control it across development and manufacturing.

Set the Quality Target Product Profile (QTPP)

In this Quality by Design training you learn to translate patient and clinical needs into a Quality Target Product Profile that defines what the product must achieve, from dosage form and route of administration to the pharmacokinetic and quality targets that guide the whole programme.

Identify and Classify Critical Quality Attributes

Learn to identify the physical, chemical, biological and microbiological properties that are critical to product quality, and classify CQAs for both small molecules and biologics using prior knowledge and structured risk assessment.

Run Risk Assessments with Ishikawa and FMEA

Apply Ishikawa (fishbone) diagrams and FMEA to link material attributes and process parameters to each CQA, and use Risk Priority Numbers to focus experimental work on the highest-impact variables.

Design Experiments and Define the Design Space

Use Design of Experiments to quantify how process parameters and material attributes affect quality, then define the design space, normal operating ranges and proven acceptable ranges from the results.

Apply PAT and Build a Control Strategy

Learn how Process Analytical Technology enables real-time monitoring, and how to build a control strategy that combines material controls, process controls, in-process checks and testing to keep quality consistent.

Present QbD Evidence for Submissions

Structure QbD outputs for regulatory submissions in the CTD format, linking the QTPP, risk assessment, DoE and the control strategy so your evidence aligns with ICH Q8, Q9, Q10 and Q11 expectations.

Who Should TakeQuality by Design Training in France?

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

EUR 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

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 Quality by Design Training in FrancePractical Training for Pharma Teams

Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and organisations that want to design quality into their products and strengthen ICH-based development. Our programmes combine experienced trainers, hands-on exercises, well-structured courseware and learner-focused support. As a trusted Quality by Design training company in France, we focus on capability you can apply straight away. Whether you enrol as an individual or arrange corporate training for your team, Invensis Learning offers a professional experience built around real-world application and measurable learning outcomes across France and worldwide.

Experienced, industry-practitioner trainers with pharmaceutical and quality expertise
Flexible live virtual, classroom and onsite formats for individuals and teams
Hands-on QbD exercises using realistic pharmaceutical development scenarios
Backed by ISO 9001:2015 quality and ISO 27001:2022 information-security standards
Structured, well-organised courseware and practical learning resources
Dedicated learner support before, during and after the training
Customised corporate delivery for French pharma and biotech teams
Trusted by professionals and organisations across more than 100 countries

5000+

Accredited Trainers Globally

4.7/5

Rated by Learners Worldwide

500+

Corporate Clients

15+

Years of Training Excellence

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 FranceAll our classroom training is now available online at your convenience

Quality by Design in France

Four Seasons Hotel George V, Paris 31 Av. George V, 75008 Paris, France

Quality by Design in France

Hôtel Plaza Athénée, 25 Av. Montaigne, 75008 Paris, France

Quality by Design in France

Four Seasons Hotel George V, Paris 31 Av. George V, 75008 Paris, France

Quality by Design in France

Hôtel Plaza Athénée, 25 Av. Montaigne, 75008 Paris, France

Corporate Quality by Design TrainingFor Pharma, Biotech Teams

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Suitable for small, medium and large cross-functional teams
Customised schedules aligned to your project and site availability
Onsite, live virtual, hybrid or blended delivery across France
Trainers with real pharmaceutical development and quality expertise
Role-based QbD scenarios drawn from your own product types
Dedicated coordination and learner support for group programmes
Scalable delivery for local and multi-site French organisations

What Our Learners Say

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A Systematic Way to Design Quality

"The QbD training finally connected the tools I use every day. Building a QTPP and mapping CQAs to process parameters made my formulation work far more systematic, and I applied the risk-assessment approach to a live project the same week."

Camille Laurent

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DoE and Design Space Made Clear

"The Design of Experiments and design-space sessions were exactly what I needed. I now plan studies that explain why quality varies, not just where, which has made our scale-up work much more predictable."

Thomas Moreau

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Stronger on QbD Submissions

"As a regulatory affairs specialist, the module on structuring QbD evidence for CTD submissions was invaluable. I understand far better how the control strategy links back to ICH Q8, Q9, Q10 and Q11."

Nadia Benali

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A Shared QbD Language for Our Teams

"We ran this as an onsite programme for our development and quality teams. It gave everyone a shared QbD language, and our risk assessments and control strategies are noticeably more consistent across projects now."

Elodie Girard

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Tailored and Genuinely Practical

"Invensis Learning tailored the training to our biologics portfolio and delivered it flexibly around our schedules. The practical exercises meant our people could apply QbD to real work rather than just learn the theory."

Julien Faure

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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 is a systematic, science-based approach to pharmaceutical product and process development that builds quality into the product from the design stage rather than testing it in at the end. It is mandated by the ICH Q8(R2), Q9, Q10 and Q11 guidelines and expected by regulators such as the EMA and FDA.

General

What is Quality by Design (QbD)?

Is the QbD training worth it for pharma professionals in France?

Yes. QbD is now a core capability in French pharma as the country reshores essential medicine production and scales biologics under France 2030. Professionals who can apply the QbD toolkit are in demand across manufacturing, biotech, API and CDMO sites nationwide.

Who should attend this QbD course?

The training suits formulation scientists, process development engineers, analytical scientists, regulatory affairs (CMC) specialists, quality professionals and manufacturing technical managers in pharmaceutical, biopharmaceutical, API and CDMO organisations who want to apply QbD in development and manufacturing.

Do I need prior QbD knowledge to join?

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

Which standards and guidelines does the training follow?

The training is grounded in the ICH Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 drug substance guidelines. It also covers the FDA PAT framework and EMA regulatory expectations for QbD.

Pricing

How much does the QbD training cost in France?

Pricing varies by delivery format, group size and whether the training is public or corporate, so exact fees are available on request. Request a quote and a learning advisor will share current pricing for your preferred format in France.

What is included in the course fee?

The fee typically includes instructor-led delivery of all six QbD modules, hands-on tool exercises, structured courseware and learning resources, learner support, and a course completion record from Invensis Learning.

Do you offer group or corporate pricing?

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

Are there payment or instalment options?

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

Is the training available online for teams in France?

Yes. The course is available as online (live virtual) instructor-led training as well as classroom and onsite formats, so teams across France can join from any location. Ask about group pricing for live virtual delivery.

Assessment

Is there a test or assessment at the end of the course?

No. This is a practical skills training course with no formal test. Learning is reinforced through hands-on QbD tool exercises, pharmaceutical case studies and team discussion throughout the one-day programme.

Does the QbD training award a formal credential?

No. This is a non-credential skills course with no awarding body. You receive a course completion record from Invensis Learning and immediately applicable QbD skills you can use in development and manufacturing projects.

What do I receive on completing the training?

You receive a course completion record from Invensis Learning, confirming you have completed the one-day QbD programme, along with practical command of the QbD toolkit that you can apply straight away.

How is my learning reinforced during the day?

Through hands-on exercises applied to realistic development scenarios: constructing a QTPP, identifying and classifying CQAs, building Ishikawa diagrams and FMEA risk assessments, and interpreting a design space and control strategy.

Will I be able to apply QbD at work straight away?

Yes. The skills are immediately applicable. After the training you can construct QTPPs, lead CQA identification, facilitate risk assessments, plan and interpret DoE studies, define design spaces and develop control strategies for submissions.

Course Content

What topics does the QbD training cover?

The course covers QbD principles and the ICH framework, the QTPP and CQAs, risk assessment with Ishikawa and FMEA, DoE and the design space, PAT and the control strategy, and QbD in practice through case studies, submissions and lifecycle management.

Does the course cover both small molecules and biologics?

Yes. The training covers QbD for both small molecule drug products, such as tablets, capsules and injectables, and biopharmaceuticals, such as monoclonal antibodies, biosimilars and gene therapies, with case study examples from both.

Is Design of Experiments (DoE) covered practically?

Yes. DoE is covered with hands-on exercises. You learn screening, response surface and mixture designs, how to run and interpret a QbD DoE, and how to derive the design space, normal operating ranges and proven acceptable ranges from the results.

How long is the training and what format is it?

The training is a one-day, eight-hour programme covering all six QbD modules with concept explanations, case studies and hands-on tool exercises. It is delivered in live virtual, classroom and corporate onsite formats.

What materials are provided?

You receive structured courseware covering all six modules, worked pharmaceutical case studies, and practical exercises for the QTPP, CQA identification, risk assessment and design space, so you can apply the tools after the training.

Enrollment

How do I enrol in the QbD training in France?

You can enrol through the Invensis Learning website. Choose your preferred format, complete your booking, and you will receive access to schedules, courseware and learning resources. Talk to a learning advisor if you need help choosing.

What delivery formats are available?

The course is available as online (live virtual) instructor-led training, in-person classroom training, and customised corporate onsite training, so you can pick the format that fits your schedule and team.

Can the course be delivered onsite for our French team?

Yes. We deliver corporate onsite QbD training for teams across France, tailored to your product types and schedules. It is a strong option when you want a cross-functional development team to learn QbD together on live projects.

How soon can I start?

Public sessions run on a regular schedule, and corporate dates are arranged to suit your team. View upcoming schedules or talk to a learning advisor to find the next available date that works for you.

What is the reschedule or cancellation policy?

Rescheduling and cancellations 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.