Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    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.

    Designing Quality into Pharmaceutical ProductsA Practical Introduction to QbD

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    Quality by Design Training Eligibility in the FranceWho Can Enroll?

    What You Gain from QbD TrainingSkills You Apply Immediately

    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.

    Market Forces Making QbD a Must-Have Skill in France

    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.

    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.

    image

    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 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.

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

    Quality by Design Classroom Training

    • Instructor-led classroom sessions

    • Interactive discussions and group activities

    • Real-world examples and practical exercises

    • Structured learning with fixed schedules

    • Opportunities for peer networking and collaboration

    • Practice assessments and knowledge checks

    • Dedicated Q&A and concept clarification

    • Immediate trainer feedback and support

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

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

    Quality by Design Corporate Group Training

    • Customized training aligned to organizational goals

    • Flexible delivery: onsite, virtual, hybrid, or blended

    • Scheduling tailored to business availability

    • Role-based examples and industry-relevant discussions

    • Progress tracking and learner assessments where applicable

    • Dedicated coordination and administrative support

    • Consistent learning experiences across teams

    • Scalable delivery for local, regional, or global workforces

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

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

    Quality by Design Focused 1-to-1 Training

    • One-to-one instructor attention

    • Customized learning plans and objectives

    • Flexible scheduling based on availability

    • Personalized feedback and coaching

    • Additional focus on challenging topics

    • Targeted practice and revision support

    • Faster clarification of questions and concepts

    • Learning pace is adapted to individual needs

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

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

    Quality by Design Live Virtual Training

    Quality by Design Live Virtual Training

    Live online instructor-led sessions

    Interactive discussions and virtual activities

    Expert guidance from experienced trainers

    Practice assessments and revision support

    Dedicated Q&A sessions for concept clarification

    Fixed schedules for accountability and momentum

    Small batch sizes for personalized attention

    Access from any location with internet connectivity

    Starts from

    EUR 430

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

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

    Loading schedules…

    Why Choose Invensis Learning for 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 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

    Secure SSL Encryption

    Leaders in Training industry for 12+ years

    Leaders in Training industry for 12+ years

    Over 5000 five star reviews

    Over 5000 five star reviews

    Level AA conformance, W3C WCAG 2.2

    Level AA conformance, W3C WCAG 2.2

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

    Quality by Design Training Location in France

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

    Quality by Design Training Location in France

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

    corporate banner

    Corporate Quality by Design TrainingFor Pharma, Biotech Teams

    • 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

    Pharma Organisations We Support

    SanofiServierPierre FabreIpsenGuerbetLFB

    What Our Learners Say

    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

    Formulation Scientist

    0/0

    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

    Process Development Engineer

    0/0

    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

    Regulatory Affairs (CMC) Specialist

    0/0

    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

    Quality Director, Biopharmaceutical Manufacturer

    0/0

    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

    Head of Learning and Development, Pharmaceutical Group

    0/0



    Trustpilot

    4.6

    Ratings

    100K+

    Happy Learners

    100+

    Locations Worldwide

    99%

    Training Satisfaction

    Enquire with us now

    Drop us a query and our learning consultant will reach out to you shortly

    Get Course Details & Pricing

    Fill out this form and we will respond quickly.

    We also deliver Quality by Design Training across multiple cities

    Invensis Learning delivers industry-leading Quality by Design training solutions tailored for individuals and organizations.

    Paris

    Explore Our Other Course Categories

    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)?

    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.

    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.