Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters in MaltaUntitledBuilding Quality in, Not Testing It Out

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical product and process development that builds quality into a medicine from the design stage rather than testing it in at the end. This Quality by Design Training in Malta gives pharmaceutical, biopharmaceutical and API professionals a working command of the ICH Q8, Q9, Q10 and Q11 framework that regulators such as the FDA and EMA now expect in modern development submissions. Across Malta's generics and API manufacturing base, employers value people who can turn regulatory expectation into practice: defining the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), running structured risk assessment and Design of Experiments (DoE), mapping a design space and building a robust control strategy. Delivered by Invensis Learning in live virtual, classroom and corporate formats, the one-day programme is practical from the first hour, with hands-on QbD tool exercises on realistic development scenarios. If you develop, test or submit pharmaceutical products, this training turns QbD from a compliance phrase into a repeatable way of working.

    What Is Quality by Design and Why It Matters in MaltaBuilding Quality in, Not Testing It Out

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical product and process development that builds quality into a medicine from the design stage rather than testing it in at the end. This Quality by Design Training in Malta gives pharmaceutical, biopharmaceutical and API professionals a working command of the ICH Q8, Q9, Q10 and Q11 framework that regulators such as the FDA and EMA now expect in modern development submissions.

    Across Malta's generics and API manufacturing base, employers value people who can turn regulatory expectation into practice: defining the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), running structured risk assessment and Design of Experiments (DoE), mapping a design space and building a robust control strategy.

    Delivered by Invensis Learning in live virtual, classroom and corporate formats, the one-day programme is practical from the first hour, with hands-on QbD tool exercises on realistic development scenarios. If you develop, test or submit pharmaceutical products, this training turns QbD from a compliance phrase into a repeatable way of working.

    Certification Badge

    Key Highlightsof the Quality by Design Training Course

    End-to-End Skill Development

    • Structured Quality by Design training in the Malta 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 Malta 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 Malta

    • Instructor-led training formats available for individual learners and corporate teams across the Malta
    • 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 Malta
    • 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 Malta 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 MaltaWho 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 Quality by Design Skills Are Worth ItPractical Value from Day One

    For Individuals

    For Individuals

    Quality by Design skills make you the person on the team who can design a robust product first time, not troubleshoot a failing one later. You learn to work the way ICH Q8 to Q11 and modern regulators expect, from the QTPP through to the control strategy. Whether you are a formulation scientist, analytical chemist, process engineer, QA professional or regulatory affairs specialist in Malta's pharma sector, these tools apply directly to your live development projects.

    If you want to move from empirical trial and error to a structured, science-based approach that stands up in a CTD dossier, this training gives you the QbD toolkit and the confidence to use it at work.

    • Design robust pharmaceutical products from the start using a structured QbD workflow
    • Build a Quality Target Product Profile (QTPP) from clinical and patient needs
    • Identify and classify Critical Quality Attributes with confidence
    • Run risk assessments using Ishikawa diagrams and FMEA with RPN scoring
    • Plan and interpret Design of Experiments to define a design space
    • Develop a control strategy that supports EMA and FDA submissions
    • Apply your new skills immediately to live development projects
    For Organizations

    For Organizations

    Quality by Design group training helps pharmaceutical and biopharmaceutical organisations build development capability across a whole cross-functional team. When formulation, analytical, process, QA and regulatory colleagues share one QbD language, development is faster and dossiers are stronger. For sites in Malta competing in the generics and API market, QbD is a practical route to fewer deviations, more efficient development and smoother regulatory interaction.

    If your teams still rely on end-product testing and trial-and-error scale-up, corporate QbD training creates a shared, science-based approach to product and process design that pays back in quality and consistency.

    • Builds a shared QbD language across formulation, analytical, process, QA and regulatory teams
    • Reduces batch deviations and out-of-specification results through process understanding
    • Speeds product and process development with Design of Experiments
    • Strengthens CTD dossiers with QTPP, design space and control strategy evidence
    • Supports ICH Q8 to Q11 alignment expected by the EMA and FDA
    • Tailored, on-site or live virtual delivery around production schedules
    • Builds in-house capability that reduces reliance on external consultants

    QbD Career Paths in Malta's Pharma SectorRoles These Skills Open Up

    Quality by Design has become a core capability across Malta's pharmaceutical sector, a mature EU base for generics and API manufacturing where more than 15 producers develop products for global markets. Employers value professionals who have completed Quality by Design training and can apply the ICH QbD framework to design robust products and build regulator-ready dossiers. Demand spans formulation, analytical, process development, QA and CMC regulatory roles, and here is what the local market is telling us right now.

    €36,700

    Average QA Specialist pay, Malta

    per year, ERI SalaryExpert 2026

    €52,600

    Senior QA Analyst pay, Malta

    average, ERI SalaryExpert 2026

    15+

    Generics makers on the island

    FinanceMalta 2026

    €288m+

    Generic medicine sales, Malta

    annual, FinanceMalta

    SECTORS HIRING

    • —Generics Manufacturing and Finished Dosage Forms
    • —Active Pharmaceutical Ingredient (API) Production
    • —Biopharmaceutical and Biosimilar Development
    • —Regulatory Affairs and CMC Consulting
    • —Contract Development and Manufacturing (CDMOs)
    • —Medical Devices and Analytical Testing

    GROWTH TRENDS

    • —Malta positioned as an EU generics and API hub
    • —EMA and FDA raising QbD expectations in dossiers
    • —Generics cost pressure driving efficient DoE-led development
    • —Small talent pool pushing employers to upskill in-house
    • —ICH Q11 QbD extending to API manufacturing
    • —Growth in biosimilars and complex product development

    Sources: FinanceMalta, US ITA Country Commercial Guide, ERI SalaryExpert, Paylab, PayScale (Malta) 2026.

    Why Malta's Pharma Employers Value QbD Skills

    Generics Development Under Cost Pressure

    Malta is a mature EU generics base, and margin pressure rewards teams that design bioequivalent products efficiently. QbD and DoE cut wasted experiments and speed robust development.

    QbD builds efficient, DoE-led development skills

    Rising EMA and FDA Dossier Expectations

    Regulators now expect QbD evidence, from the QTPP to the design space, in CTD Section 3.2.P.2. Professionals who can build that evidence keep Maltese submissions on track.

    QbD builds regulator-ready submission skills

    API Manufacturing Complexity

    Malta's API producers work to ICH Q11, which extends QbD to drug substance development. Structured risk assessment and process understanding are essential to control it.

    QbD builds ICH Q11 process understanding

    A Small Island Talent Pool

    With a limited local workforce, Maltese sites upskill existing scientists rather than hire scarce QbD specialists. Practical training builds that capability quickly.

    QbD upskills your existing scientists fast

    The Cost of Batch Deviations

    End-product testing catches problems late and expensively. QbD builds quality in through process understanding, reducing deviations and out-of-specification results.

    QbD builds quality in through process understanding

    Biosimilars and Complex Products

    As Malta moves into biosimilars and complex modalities, QbD gives development teams the tools to characterise variable processes and define reliable control strategies.

    QbD builds control strategies for complex modalities

    Sources: FinanceMalta, US ITA Country Commercial Guide, PharmExec (Malta pharmaceutical sector) 2026.

    Quality by Design is more than compliance. It is a practical, career-building capability for Malta's pharma professionals. Build the skills to design quality in and lead better development. Start today.

    Your Malta Development Career, Levelled Up

    Where You Stand Today

    The Shift QbD Skills Deliver

    Malta's pharmaceutical sector is competing on quality and efficiency in a demanding EU market, and employers increasingly separate teams who can design quality in from those who still test it in. Here is the gap QbD skills close.

    Today

    Your skills sit at end-product QC, with limited development influence

    After QbD

    You lead QTPP, CQA and design-space work across the project

    Today

    Pay tracks a QC or analyst band with little differentiation

    After QbD

    QbD-capable roles in QA, process and CMC sit at stronger Malta pay bands

    Today

    You react to deviations after they happen

    After QbD

    You prevent deviations through process understanding built in by design

    You master QbD

    Before

    Quality is checked by end-product testing after the batch is made

    Now you have

    Quality is designed into the product from the QTPP onwards

    Before

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

    Now you have

    Development is structured with DoE and a defined design space

    Before

    Risk is judged informally, without a clear method

    Now you have

    Risk is ranked with Ishikawa and FMEA to focus effort where it matters

    Before

    Dossier sections are hard to defend to EMA and FDA reviewers

    Now you have

    QbD evidence supports a clear, defensible CTD submission

    "The difference between testing quality and designing it in is increasingly what separates the pharma teams that win in Europe."

    Join professionals who trained with Invensis Learning and changed how they develop products.

    Sources: ERI SalaryExpert, Paylab, PayScale (Malta) 2026; FinanceMalta.

    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 Malta 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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    The QbD Skills You Will BuildPractical Tools for Pharma Development

    This practical programme gives you a working command of the full Quality by Design toolkit, from the Quality Target Product Profile through to the control strategy. By the end you can apply each tool to real pharmaceutical development scenarios.

    Build the Quality Target Product Profile

    Define a QTPP from clinical and patient needs that sets the design target for the whole development programme, linking dosage form, performance and quality standards.

    Identify Critical Quality Attributes

    Classify the physical, chemical, biological and microbiological attributes that drive product quality, safety and efficacy, and distinguish them from non-critical characteristics.

    Run Structured Risk Assessment

    Use Ishikawa (fishbone) diagrams and FMEA with Severity, Occurrence and Detectability scoring to rank which material attributes and process parameters need formal study.

    Design Experiments and Map the Design Space

    Plan screening and response-surface DoE, interpret the models, and define the design space, normal operating ranges and proven acceptable ranges.

    Apply Process Analytical Technology

    Understand how PAT tools such as NIR and Raman enable real-time monitoring and release testing, replacing or supplementing traditional end-product testing.

    Develop the Control Strategy

    Turn risk assessment and DoE outputs into a holistic control strategy, and document it for the CTD submission in the way regulators expect.

    Who Should TakeQuality by Design Training in Malta?

    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 400

    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

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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 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 400

    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…

    Your Quality by Design Training in Malta, Delivered by ExpertsExpert-Led, Flexible and Trusted

    Invensis Learning is a trusted Quality by Design training company in Malta, delivering practical training for pharmaceutical professionals and organisations that want to build quality into their products, not test it in. Our programmes combine experienced, industry-practitioner trainers, flexible delivery and organised courseware built around real development scenarios. Whether you enrol as an individual or plan corporate training for a development team in Malta, you get a professional learning experience focused on practical understanding, real-world application and measurable outcomes.

    • Experienced trainers with real pharmaceutical quality and development expertise
    • Live virtual, classroom and on-site delivery to fit your schedule
    • Practical, scenario-based learning with hands-on QbD tool exercises
    • Courseware aligned to the ICH Q8, Q9, Q10 and Q11 framework
    • Flexible corporate and group training for pharma teams
    • Dedicated learner support before, during and after training
    • Globally recognised training provider with ISO-certified processes
    • A course completion certificate from Invensis Learning

    15+

    Years of Training Excellence

    24/7

    Learner Support

    50+

    Industries Served

    1-to-1

    Doubt-Clearing Sessions

    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 MaltaAll our classroom training is now available online at your convenience

    Quality by Design in Malta

    Hilton Malta, Portomaso Avenue, St. Julian's, Eastern Region, STJ 4012, Malta

    Quality by Design in Malta

    InterContinental, St. George Street, St. Julian's, Eastern Region, STJ 3310, Malta

    corporate banner

    Corporate QbD TrainingBuild Team Capability at Scale

    Untitled

    • Suitable for small development teams or whole quality functions
    • Customised schedules built around production and shift patterns
    • On-site, live virtual, hybrid or blended delivery across Malta
    • Trainers with real pharmaceutical development and quality experience
    • Role-based examples for formulation, analytical, process and QA staff
    • Dedicated coordination and support for group programmes
    • Scalable delivery for local sites and global pharma networks

    Pharma Employers in Malta

    Aurobindo Pharma (Malta)Combino Pharm (Malta)ActavisSiegfried MaltaAmino ChemicalsFresenius Kabi

    What Our Learners Say

    Untitled

    From Testing Quality to Designing It In

    "The QbD approach finally connected the dots between our QTPP and the process parameters we actually control. I ran my first proper DoE within weeks of the training and the design space made real sense."

    Maria Borg

    Formulation Scientist

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    A Clear Method for Risk Assessment

    "Risk assessment used to feel like guesswork. Learning to apply Ishikawa diagrams and FMEA with RPN scoring gave me a clear way to decide what needs formal study and what does not."

    Daniel Vella

    Analytical Chemist

    Untitled

    0/0

    Made Our Dossier Easier to Defend

    "The session on building QbD evidence for the CTD made our Section 3.2.P.2 far easier to defend. Very practical, and grounded in real pharmaceutical examples rather than theory."

    Sarah Grech

    Regulatory Affairs Officer

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    One Shared QbD Language Across the Site

    "We trained a cross-functional team together and now share one QbD language across formulation, process and QA. Deviations linked to poor process understanding have dropped noticeably."

    Ronald Camilleri

    Site Quality Manager, Pharmaceutical Manufacturing

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    Robust Products First Time

    "The corporate training was tailored to our generics pipeline. Our scientists now design robust products first time instead of troubleshooting late-stage failures, which has saved real development time."

    Elena Farrugia

    Head of Product Development, Generics

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

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. It uses tools such as the QTPP, Critical Quality Attributes, risk assessment, Design of Experiments and a control strategy, aligned to the ICH Q8 to Q11 guidelines.

    General

    What is Quality by Design (QbD)?

    Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical development that builds quality into a product from the design stage rather than testing it in at the end. It uses tools such as the QTPP, Critical Quality Attributes, risk assessment, Design of Experiments and a control strategy, aligned to the ICH Q8 to Q11 guidelines.

    Who should attend this Quality by Design training?

    The training suits formulation and analytical scientists, process development engineers, QA professionals and CMC regulatory specialists in pharmaceutical, biopharmaceutical, API and medical device organisations. No prior QbD knowledge is required, as the course introduces the approach from first principles.

    Is Quality by Design training worth it for pharma professionals?

    Yes. QbD is expected by the FDA and EMA and is central to modern pharmaceutical development, so the skills apply directly to daily work in Malta's generics and API sector. You leave able to build a QTPP, run risk assessments and DoE, and develop a control strategy. Speak with a learning advisor to plan your training.

    Do I get a certificate after the training?

    Yes. You receive a course completion certificate from Invensis Learning after finishing the one-day programme. This is a practical skills course, so there is no separate examination or external credential to maintain.

    Is this course relevant to generics and API work in Malta?

    Very relevant. Malta is a mature EU base for generics and API manufacturing, where QbD and ICH Q11 underpin efficient development and strong regulatory dossiers. The course uses realistic pharmaceutical scenarios you can map to local development work.

    Pricing

    How much does Quality by Design training cost in Malta?

    Fees are set by delivery mode and group size, so the exact price is shared on request. The fee covers instructor-led training, courseware and hands-on exercises. Contact us for a quote tailored to individual or corporate enrolment.

    What is included in the course fee?

    The fee typically includes live instructor-led training, structured courseware, hands-on QbD tool exercises on realistic scenarios, learner support and a course completion certificate from Invensis Learning. Request a quote for the full inclusions.

    Do you offer group or corporate pricing?

    Yes. We offer corporate and group pricing for pharmaceutical teams, with customised schedules built around your development and quality functions. Contact us for a tailored group quote for your Malta site.

    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 any cost beyond the training fee?

    No. This is a non-certification skills course, so there is no separate examination or awarding-body fee. You pay only the training fee, which is confirmed on request.

    Assessment

    How is learning assessed during the course?

    Learning is reinforced through hands-on QbD tool exercises, worked pharmaceutical case studies and group discussion rather than a formal test. You apply QTPP construction, CQA identification, risk assessment and design-space interpretation to realistic scenarios during the day.

    Will I be able to apply QbD at work after the training?

    Yes. The training is built for immediate application. You leave able to construct a QTPP, identify and classify CQAs, run FMEA-based risk assessments, plan and interpret DoE, and develop a control strategy for your own development projects.

    Do I need prior QbD experience to keep up?

    No prior QbD experience is needed. The course introduces QbD from first principles in a pharmaceutical development context. Familiarity with pharmaceutical development or GMP is helpful but not required.

    What practical exercises are included?

    You work through practical exercises including QTPP construction, CQA and criticality assessment, Ishikawa diagrams for risk mapping, DoE design selection and design-space interpretation, all based on realistic pharmaceutical development scenarios.

    Does the course prepare me for regulatory submissions?

    Yes. The course shows how QbD outputs, from the QTPP to the control strategy, form the basis of Section 3.2.P.2 of a CTD submission, so regulatory affairs and CMC teams can prepare and defend QbD-based dossiers with confidence.

    Course Content

    What topics does the Quality by Design course cover?

    The course covers the full QbD framework: 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 building the control strategy, plus practical case studies.

    Which ICH guidelines does the training follow?

    The training is aligned to the ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Q11 (Development and Manufacture of Drug Substances) guidelines that underpin modern QbD.

    Does it cover both small molecules and biologics?

    Yes. The course addresses QbD for both small molecule drug products, such as tablets and injectables, and biopharmaceutical products, such as monoclonal antibodies and biosimilars, with case study examples from both.

    Is Design of Experiments (DoE) covered?

    Yes. DoE is central to the course. You learn screening and response-surface designs, how to interpret the models, and how to define a design space with normal operating ranges and proven acceptable ranges.

    What learning materials are provided?

    You receive structured courseware, worked case studies, QbD tool templates and exercise materials aligned to the ICH framework, supporting both the session and later application at work.

    Enrollment

    How do I enrol in the Quality by Design course?

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

    What training formats are available?

    The course is available as live virtual instructor-led training, classroom training and customised corporate on-site delivery, so you can choose the format that fits your schedule and team.

    How long is the training?

    The programme runs for one day (8 hours), covering all QbD modules from principles and the ICH framework through QTPP, CQAs, risk assessment, DoE, PAT and the control strategy, with hands-on exercises throughout.

    Can I book corporate training for my team in Malta?

    Yes. We deliver corporate Quality by Design training for pharmaceutical teams across Malta, on-site or live virtual, with schedules built around your operations. Request a group quote to get started.

    Can I reschedule my booking?

    Yes. Flexible options let you reschedule or transfer to another session where needed. Contact our support team to arrange a change to your booking.