Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    Designing Quality into Pharmaceutical Products

    A Practical Introduction to QbD

    Quality by Design course badge

    What's Included in Your Quality by Design Training

    • One-day course spanning ten structured modules

    • 8 PDUs on completion of the training

    • Copy of course material and SME-prepared study guide

    • Case studies and practical applications module

    • Course completion certificate from Invensis Learning

    Key Highlights

    of the Quality by Design Training Course

    Quality by Design Training Eligibility in the France

    Who Can Enrol?

    What You Gain from QbD Training

    Skills You Apply Immediately

    Who Should Take Quality by Design Training in France?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    Where QbD Skills Take Your Career in France

    Roles, 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 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 optimisation
    • 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 Curriculum

    of 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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    The Practical QbD Skills You Will Build

    QTPP, 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.

    Quality by Design Training Modes

    for 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

    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

    • Customised training aligned to organisational 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, standardise knowledge, and support workforce development through customised 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

    • Customised 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 340

    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.

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    Why Choose Invensis Learning for Quality by Design Training in France

    Practical 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 France

    Instructor-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

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    Corporate Quality by Design Training

    For 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

    Trusted by Leading Enterprises in France

    SanofiServierPierre FabreIpsenGuerbetLFB

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    What Our Learners Say About Us

    "Shatish Course pace, explanation, examples were great. Learned new terminologies, he is a great lecturer."

    Nompumelelo

    (5.0/5)

    South AfricaTrustpilot

    "The 1st day was good. But not very satisfied with the 2nd day. "

    DIPANKAR BISWAS

    (3.0/5)

    "My instructor Amol was great! I appreciated the real life examples he was able to share that made the framework and tools relevant."

    Charlene

    (5.0/5)

    "The Training from Alex was helpful for the Six Sigma learning and process improvement"

    CARL KRUGER

    (5.0/5)

    "I recently completed the Quality By Design Training Course with Invensis Learning, and it has significantly enhanced my skills as a Distribution Manager. The interactive sessions and expert trainers provided practical insights that I can apply directly to my work. I highly recommend this training to anyone looking to improve their quality management practices. Thank you, Invensis Learning, for an outstanding experience! - Kritsada Kham"

    Kritsada Kham

    (5.0/5)

    "It was great interactive session."

    narayan_PANDAYYAHOO.COM

    (4.0/5)

    Saudi ArabiaTrustpilot

    "The instructor was Pritesh and the trainning was very clear and as someone who never heard this subject before I was able to understand the topics"

    Ildy Tenjua

    (5.0/5)

    PortugalTrustpilot

    "Sathish conducted the training exceptionally well. He explained concepts thoroughly."

    Nyaradzo

    (5.0/5)

    NetherlandsTrustpilot


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    Ratings

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    Happy Learners

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    Training Satisfaction

    We also deliver Quality by Design Training across multiple cities in France

    Quality by Design training for individuals and teams. Select a city in France to view upcoming dates, formats and pricing.

    Quality by Design Training Course in Paris

    Frequently Asked Questions

    Here'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.

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