Course Overview

    Overview

    What's Included

    Course Highlights

    Eligibility Criteria

    Benefits

    Who Can Take

    What Is Quality by Design and Why It Matters in Malta

    Building Quality in, Not Testing It Out

    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 Malta

    Who Can Enrol?

    Why Quality by Design Skills Are Worth It

    Practical Value from Day One

    Who Should Take Quality by Design Training in Malta?

    • Process Engineers

    • QC Analysts

    • Engineering Teams

    • Technical Staff

    • Production Managers

    • Distribution Managers

    • Regulatory Affairs Specialists

    • Quality Assurance Professionals

    QbD Career Paths in Malta's Pharma Sector

    Roles 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.

    Why Malta's Pharma Employers Value QbD Skills

    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.

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

    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 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.

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    The QbD Skills You Will Build

    Practical 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.

    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 300

    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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    Your Quality by Design Training in Malta, Delivered by Experts

    Expert-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

    12+

    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 Malta

    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 Malta

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

    Quality by Design Training Location in Malta

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

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    Corporate QbD Training

    Build Team Capability at Scale

    • 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

    Trusted by Leading Enterprises in Malta

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

    Enquire with us now

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

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

    Quality by Design Training Course in Sliema / St. Julian'sQuality by Design Training Course in Valletta

    Frequently Asked Questions

    Here'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.