Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Quality by Design Means for Modern Pharma DevelopmentUntitledBuilding Quality in, Not Testing It Out

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This one-day Quality by Design training in Germany gives scientists, engineers and quality professionals the tools to apply QbD on live development projects. Grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH Q9, Q10 and Q11 framework, the course shows you how to define a Quality Target Product Profile, identify Critical Quality Attributes, run risk assessment and Design of Experiments, and build a robust Control Strategy that regulators such as the EMA and FDA increasingly expect. Germany is the second-largest producer of biopharmaceuticals in the EU, and employers from Bayer and Boehringer Ingelheim to BioNTech and a fast-growing CDMO base value professionals who can design quality in from the outset. Start building that capability with Invensis Learning.

    What Quality by Design Means for Modern Pharma DevelopmentBuilding Quality in, Not Testing It Out

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical and biopharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. This one-day Quality by Design training in Germany gives scientists, engineers and quality professionals the tools to apply QbD on live development projects.

    Grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH Q9, Q10 and Q11 framework, the course shows you how to define a Quality Target Product Profile, identify Critical Quality Attributes, run risk assessment and Design of Experiments, and build a robust Control Strategy that regulators such as the EMA and FDA increasingly expect.

    Germany is the second-largest producer of biopharmaceuticals in the EU, and employers from Bayer and Boehringer Ingelheim to BioNTech and a fast-growing CDMO base value professionals who can design quality in from the outset. Start building that capability with Invensis Learning.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Germany 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 Germany 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 Germany

    • Instructor-led training formats available for individual learners and corporate teams across the Germany
    • 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 Germany
    • 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 Germany 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 GermanyWho 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

    Why This QbD Training Pays off on the JobSkills You Can Apply from Day One

    For Individuals

    For Individuals

    This QbD training helps pharmaceutical and biopharmaceutical professionals turn regulatory theory into everyday practice. It suits formulation scientists, process development engineers, analytical scientists, regulatory affairs (CMC) specialists and quality assurance professionals who want to build quality in from the start. Whether you are moving into development, strengthening your submissions, or working on small molecules or biologics, the course builds capability that maps directly to what German employers are hiring for.

    If you want to move from testing quality at the end to designing it in from the outset, QbD is the skill that gets you there. You leave with practical tools, worked pharmaceutical examples and the confidence to lead QbD work in your own organisation.

    • Design quality into products using QTPP, CQAs and a defined design space
    • Replace trial-and-error development with structured, science-based methods
    • Run risk assessment with FMEA and Ishikawa diagrams to focus your effort
    • Plan and interpret Design of Experiments to understand your process
    • Build Control Strategies that hold up in EMA and FDA submissions
    • Speak the shared QbD language of formulation, analytics, process and QA teams
    • Stand out for in-demand roles across German pharma and biopharma
    • Apply ICH Q8, Q9, Q10 and Q11 thinking to your own live projects
    For Organizations

    For Organizations

    QbD group training helps pharmaceutical and biopharmaceutical organisations equip cross-functional development teams with a common, regulator-aligned approach to quality. The training can be delivered for R&D groups, process development, analytical and quality functions together. For companies scaling biologics, adopting continuous manufacturing, or preparing QbD-based submissions, this training provides a practical, flexible way to build capability across the organisation.

    If your teams still rely on end-product testing and empirical development, QbD training gives them a shared framework for designing quality in. Cross-functional groups gain a standard approach to QTPP, CQA identification, risk assessment, DoE and Control Strategy.

    • Builds a shared QbD approach across formulation, analytics, process and QA
    • Reduces manufacturing deviations through stronger process understanding
    • Strengthens EMA and FDA submissions with defensible design spaces
    • Lowers post-approval change burden by working within approved ranges
    • Speeds development by focusing effort on the highest-risk variables
    • Enables customised training mapped to your product pipeline
    • Standardises risk assessment and DoE practice across sites
    • Builds in-house QbD capability that scales with your teams

    What QbD Skills Unlock in German PharmaQuality and Development Careers

    Quality by Design has moved from a regulatory nice-to-have to a core capability across German pharma and biopharma. As EMA and FDA increasingly expect QbD evidence in submissions and manufacturers pour investment into biologics and continuous manufacturing, employers from Bayer and Boehringer Ingelheim to BioNTech and a fast-growing CDMO base want scientists, engineers and quality professionals who can design quality in. Here is what the German market looks like right now.

    €57,600

    Average pharmaceutical scientist salary, Germany

    per year, SalaryExpert 2026

    €90,400

    Average QA manager salary, Germany

    per year, SalaryExpert 2026

    No. 2

    Germany biopharma rank in the EU

    second-largest EU producer, GTAI

    $73bn+

    Germany pharma market size

    2026 estimate, Mordor Intelligence

    SECTORS HIRING

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

    GROWTH TRENDS

    • —Second-largest biopharmaceutical producer in the EU
    • —Major biologics capacity investment in Alzey, Darmstadt and Halle
    • —mRNA and cell-and-gene platforms scaling in the Rhein-Main hub
    • —EMA and FDA expecting QbD evidence in submissions
    • —Continuous manufacturing adoption spreading across sites
    • —CDMO growth drawing global development work to Germany

    Sources: SalaryExpert, PayScale, Glassdoor (Germany) 2026; Germany Trade & Invest (GTAI); Mordor Intelligence.

    Why German Pharma Needs QbD Capability Now

    Regulatory Pressure for QbD Evidence

    EMA and FDA increasingly expect QbD-based dossiers with a justified design space and control strategy. Teams without QbD fluency face slower, weaker submissions.

    QbD training builds submission-ready skills

    Biologics Complexity

    Germany's biologics boom in mRNA, monoclonal antibodies and biosimilars demands deep process understanding that only structured QbD methods can deliver.

    QbD training builds design-space understanding

    Shift to Continuous Manufacturing

    Moving from batch to continuous manufacturing needs QbD process understanding and PAT to control quality in real time across the production line.

    QbD training supports process control

    Design of Experiments Skills Gap

    Many teams still develop products one factor at a time. Scientists who can plan and interpret Design of Experiments to map a design space remain scarce.

    QbD training builds DoE capability

    Post-Approval Change Burden

    Without a defined design space, every process change can trigger a costly regulatory variation. QbD lets manufacturers flex within approved ranges.

    QbD training builds design-space flexibility

    CDMO Competitiveness

    Germany's growing CDMO base wins global work by offering QbD expertise. Providers that can design quality in stand out to pharmaceutical clients.

    QbD training strengthens CDMO capability

    Sources: Germany Trade & Invest (GTAI); Mordor Intelligence; Glassdoor, LinkedIn (Germany) 2026.

    QbD is more than a regulatory expectation. It is the skill German pharma employers are hiring for. Join professionals who design quality in and lead development with confidence. Start your journey today.

    Your German Pharma Career Transformation

    Your Development Practice Before and After QbD

    A Clear Capability Upgrade

    German pharma and biopharma employers increasingly separate scientists who can design quality in from those who still rely on end-product testing. Here is which side of that line QbD skills put you on.

    Today

    Development runs on trial and error and end-product testing

    After QbD

    You design quality in with a QTPP, CQAs and a defined design space

    Today

    Every process change risks a costly regulatory variation

    After QbD

    A justified design space lets you flex within approved ranges

    Today

    Progression capped in general lab roles with limited leverage

    After QbD

    Process development and QA roles in Germany average €76k to €90k

    You master QbD

    Before

    QbD felt like abstract regulatory theory you could not apply

    Now you have

    Practical command of the ICH Q8, Q9, Q10 and Q11 QbD toolset

    Before

    Confined to a single technical function with little wider view

    Now you have

    Cross-functional fluency across formulation, analytics, process and QA

    Before

    Reacting to deviations only after they show up in testing

    Now you have

    The ability to predict and control quality through risk assessment and DoE

    Before

    Recognition tied to one employer, site or product

    Now you have

    Skills valued across German pharma, biotech and the CDMO sector

    "The distance between testing quality and designing it in is exactly what modern pharma employers are hiring for."

    Join professionals who trained with Invensis Learning and made the shift.

    Sources: SalaryExpert, PayScale, Glassdoor (Germany) 2026; Germany Trade & Invest (GTAI).

    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 Germany 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.

    • 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.

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    100% Secure and Safe download

    The QbD Tools You Will MasterFrom QTPP to Control Strategy

    This QbD training builds practical, job-ready skills across the full Quality by Design workflow. By the end of the day you can apply each core QbD tool to real pharmaceutical and biopharmaceutical development scenarios, from the Quality Target Product Profile through to the Control Strategy.

    Build a Quality Target Product Profile

    Construct a QTPP from clinical and patient needs, defining the dosage form, delivery, pharmacokinetic targets and quality standards that anchor the whole QbD programme.

    Identify and Classify Critical Quality Attributes

    Translate the QTPP into Critical Quality Attributes for small molecules and biologics, then link each CQA to the material attributes and process parameters that drive it.

    Run Risk Assessment with FMEA and Ishikawa

    Use Ishikawa diagrams and FMEA with Risk Priority Numbers to prioritise the highest-risk variables, focusing experimental effort where it matters most.

    Design Experiments and Define the Design Space

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

    Apply PAT and Real-Time Release

    Use Process Analytical Technology tools such as NIR and Raman to monitor quality during manufacturing and understand where real-time release testing applies.

    Build and Document a Control Strategy

    Turn risk assessment and DoE results into a holistic Control Strategy, and structure the evidence for CTD Section 3.2.P.2 in regulatory submissions.

    Who Should TakeQuality by Design Training in Germany?

    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.

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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 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 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

    Untitled

    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 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 GermanyExpert-Led, ISO-Certified Training

    Invensis Learning delivers practical Quality by Design training for pharmaceutical and biopharmaceutical professionals and teams across Germany. Our programmes combine experienced trainers, hands-on QbD tool exercises and flexible delivery, so you leave able to apply QbD on live development work. Whether you enrol as an individual or arrange training for a cross-functional team, you get a structured, ISO-certified learning experience focused on real workplace application rather than theory. That is the standard we, as a Quality by Design training company in Germany, hold ourselves to on every course.

    • ISO 9001:2015 and ISO 27001:2022 certified training provider
    • Experienced trainers with real pharmaceutical and quality management expertise
    • Live virtual, classroom and onsite delivery for teams across Germany
    • Hands-on QbD tool exercises using realistic development scenarios
    • Content aligned to the ICH Q8, Q9, Q10 and Q11 framework
    • Course completion certificate from Invensis Learning
    • Dedicated learner support before, during and after training
    • Flexible corporate and group training options for organisations

    12M+

    Hours of Training Delivered

    4

    Flexible Learning Modes

    98%

    First-Attempt Pass Rate

    5000+

    Accredited Trainers Globally

    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 GermanyAll our classroom training is now available online at your convenience

    Quality by Design in Germany

    Kastens Hotel Luisenhof, Luisenstraße 1-3, 30159 Hannover, Germany

    Quality by Design in Germany

    Leonardo Dortmund Burgwall 11-13, 44135 Dortmund, Germany

    corporate banner

    Corporate QbD Training for TeamsUpskill Your Quality Teams

    Untitled

    • Tailored QbD curriculum mapped to your product pipeline and processes
    • Flexible onsite, live virtual or hybrid delivery across German sites
    • Train cross-functional development and quality teams together
    • Experienced trainers with pharmaceutical and quality expertise
    • Standardise QbD practice across formulation, analytics, process and QA
    • Progress tracking and dedicated coordination for group training
    • Scalable delivery for teams in Germany and global locations

    Trusted by Life Sciences Teams

    BayerBoehringer IngelheimMerck KGaAFresenius KabiBioNTechSartorius

    What Our Learners Say

    Untitled

    QbD That I Could Apply the Next Week

    "The course finally made QbD practical for me. Building a QTPP and mapping CQAs to process parameters in the exercises changed how I approach formulation work. I now lead risk assessments on our development projects with real confidence."

    Lukas Brandt

    Formulation Scientist

    Untitled

    0/0

    Strong on DoE and PAT

    "As an analytical scientist, the sessions on Design of Experiments and Process Analytical Technology were exactly what I needed. The trainer connected the ICH guidelines to real examples, so it never felt like abstract theory."

    Anna Vogel

    Analytical Scientist

    Untitled

    0/0

    Clearer on Submissions

    "The module on structuring QbD evidence for the CTD was the most useful part for me. I understand the design space and control strategy far better now, which makes preparing our submissions much smoother."

    Julia Hofmann

    Regulatory Affairs Specialist (CMC)

    Untitled

    0/0

    Great Cross-Functional Team Training

    "We ran this as an onsite session for our cross-functional development team. Having formulation, process and QA in the room learning the same QbD language paid off immediately in how we plan our studies."

    Stefan Keller

    Learning and Development Lead, Biopharmaceutical Manufacturer

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    Lifted Our CDMO Capability

    "Our CDMO needed to strengthen its QbD offering for clients. The corporate training gave our process development group a consistent, regulator-aligned approach to design space and control strategy. The coordination was excellent."

    Katharina Reinhardt

    Head of Process Development, Contract Manufacturer

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    Frequently Asked QuestionsHere's everything you may ask...

    Quality by Design (QbD) training is a one-day, practical course on the science-based approach to pharmaceutical development that builds quality into a product from the design stage. It covers the ICH Q8(R2), Q9, Q10 and Q11 framework and the core QbD tools, from the QTPP through to the Control Strategy.

    General

    What is Quality by Design (QbD) training?

    Quality by Design (QbD) training is a one-day, practical course on the science-based approach to pharmaceutical development that builds quality into a product from the design stage. It covers the ICH Q8(R2), Q9, Q10 and Q11 framework and the core QbD tools, from the QTPP through to the Control Strategy.

    Who should attend QbD training in Germany?

    The training suits formulation scientists, process development engineers, analytical scientists, regulatory affairs (CMC) specialists, quality assurance professionals and manufacturing technical managers in pharmaceutical, biopharmaceutical, API, CDMO and medical device organisations across Germany.

    Is QbD training worth it for pharma professionals?

    Yes. QbD is now a core capability in German pharma and biopharma, where EMA and FDA increasingly expect QbD evidence in submissions. Professionals who can design quality in are valued across formulation, process development, quality and regulatory roles at leading employers.

    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 QbD from first principles before moving into the practical tools.

    Which regulatory framework does the course align to?

    The course is grounded in the ICH Q8(R2) Pharmaceutical Development guideline and the wider ICH Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 Drug Substances framework, reflecting the QbD evidence that the EMA and FDA increasingly expect.

    Is QbD relevant for both small molecules and biologics?

    Yes. The training covers QbD for both small molecule drug products, such as tablets and injectables, and biopharmaceuticals such as monoclonal antibodies and biosimilars. Worked examples from both product types are included.

    Pricing

    How much does QbD training cost in Germany?

    Pricing varies by delivery mode, group size and whether you book an individual seat or corporate training. A current quote in euros is available on request. Talk to a learning advisor for the option that fits you.

    What is included in the QbD course fee?

    The fee typically includes instructor-led training across all QbD modules, hands-on tool exercises, worked pharmaceutical case studies, course materials, learner support and a course completion certificate from Invensis Learning.

    Do you offer corporate or group pricing?

    Yes. We offer corporate group training with customised schedules and volume-based pricing for development, quality and regulatory teams. Ask about corporate and group pricing for a tailored quote.

    What payment options are available?

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

    Is there a separate certification exam fee?

    No. This is a non-certification skills course with no examination, so there is no separate exam fee. You pay only the training fee for your chosen delivery format.

    Assessment

    Is there an exam for QbD training?

    No. QbD training is a non-certification course with no examination. Learning is reinforced through hands-on tool exercises, pharmaceutical case studies and group discussion throughout the day.

    Do I receive a certificate after the training?

    Yes. You receive a course completion certificate from Invensis Learning. This is a record of completing the training rather than a formal certification from an external awarding body.

    How is learning assessed during the course?

    There is no formal assessment. Instead, you apply QbD tools such as QTPP construction, CQA identification, risk assessment and design space interpretation to realistic development scenarios, so you practise the methods as you learn them.

    Is QbD an accredited certification?

    No. QbD is a skills-based training course with no awarding body or accreditation. Its value lies in the practical, regulator-aligned capability you build, grounded in the ICH Q8, Q9, Q10 and Q11 guidelines.

    Will the course help with regulatory submissions?

    Yes. You learn how QbD outputs, such as the QTPP, CQAs, risk assessment, design space and control strategy, form the basis of Section 3.2.P.2 in a CTD submission to the EMA, FDA and other authorities.

    Course Content

    What topics does the QbD training cover?

    The course covers QbD principles and the ICH regulatory context, the QTPP and Critical Quality Attributes, risk assessment with Ishikawa and FMEA, Design of Experiments and the design space, Process Analytical Technology and Control Strategy, and QbD case studies.

    What will I be able to do after the course?

    You will be able to construct a QTPP, identify and classify CQAs, run an FMEA-based risk assessment, plan a Design of Experiments strategy, interpret a design space, and build and document a Control Strategy for regulatory submission.

    Does the course cover Design of Experiments (DoE)?

    Yes. DoE is a core module. You learn screening, response surface and mixture designs, how to interpret the models, and how DoE results are used to define the design space and its Normal Operating and Proven Acceptable Ranges.

    Are hands-on exercises included?

    Yes. Practical QbD tool exercises run throughout the day, applying the QTPP, CQA identification, Ishikawa and FMEA risk assessment and design space interpretation to realistic pharmaceutical and biopharmaceutical scenarios.

    How long is the QbD training?

    The programme runs for one full day of eight hours, covering all six QbD modules. It can also be delivered as two half-day sessions to suit team schedules.

    Is the content aligned to the current ICH guidelines?

    Yes. The content reflects the current ICH Q8(R2) Pharmaceutical Development guideline alongside ICH Q9, Q10 and Q11, so you learn QbD as regulators expect it to be applied today.

    Enrollment

    How do I enrol in QbD training in Germany?

    You can enrol through the Invensis Learning website. Choose your preferred format, complete your booking, and you receive access to schedules, course materials and learning resources. See upcoming batches to get started.

    What delivery formats are available?

    The course is available online (live virtual instructor-led), in the classroom, and as onsite corporate training. You can choose the format that best fits your schedule and team.

    Can the course be delivered onsite for my team?

    Yes. We deliver QbD as an onsite or live virtual corporate programme, so a cross-functional team can train together and apply the tools to your own live development projects. Ask about corporate training for a quote.

    Can I reschedule my enrolment to another batch?

    Yes. Flexi options let you reschedule or transfer to another batch on selected plans. Contact our support team to arrange this.

    How soon can I start?

    New batches run regularly in live virtual and classroom formats, and onsite corporate sessions are scheduled to suit your team. Talk to a learning advisor to find the next available date.