Quality by Design Training in Malta

Build Quality into Every Product

Master the ICH Q8 to Q11 approach that Malta's generics and API manufacturers rely on. This practical, instructor-led Quality by Design programme equips pharmaceutical, analytical, process and regulatory professionals to build quality into products from the design stage, using QTPP, CQAs, risk assessment, DoE, design space and control strategy on real development scenarios.

Live Virtual

Mode

Hours

13.3K+ already enrolled

4.1 (2330+ Reviews)

12 enrolled this week

Want to Train Your Team?

Master Quality by Design and Lead Excellence in Malta

Starts from

EUR 400

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.

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

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

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.

Designation

Quality by Design Professionals in Malta : Salary Insights and Trends

Hiring Companies in Malta

€27K

Min

€34K

Average

€44K

Max

ERI SalaryExpert · Paylab (Malta) 2026

Aurobindo Pharma (Malta)ActavisAmino ChemicalsCherubino

Source: Aurobindo Pharma · Actavis · Amino Chemicals · Cherubino

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.

100% Secure and Safe download

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

Shifts your thinking from testing quality in at the end to designing it in from the start.

100% Secure and Safe download

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.

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

Quality by Design Classroom Training

Instructor-led classroom sessions
Interactive discussions and group activities
Real-world examples and practical exercises
Structured learning with fixed schedules
Opportunities for peer networking and collaboration
Practice assessments and knowledge checks
Dedicated Q&A and concept clarification
Immediate trainer feedback and support

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

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

Quality by Design Corporate Group Training

Customized training aligned to organizational goals
Flexible delivery: onsite, virtual, hybrid, or blended
Scheduling tailored to business availability
Role-based examples and industry-relevant discussions
Progress tracking and learner assessments where applicable
Dedicated coordination and administrative support
Consistent learning experiences across teams
Scalable delivery for local, regional, or global workforces

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

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

Quality by Design Focused 1-to-1 Training

One-to-one instructor attention
Customized learning plans and objectives
Flexible scheduling based on availability
Personalized feedback and coaching
Additional focus on challenging topics
Targeted practice and revision support
Faster clarification of questions and concepts
Learning pace is adapted to individual needs

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

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

Quality by Design Live Virtual Training

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 27001:2022 Certified

Secure SSL Encryption

Leaders in Training industry for 12+ years

Over 5000 five star reviews

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 QbD TrainingBuild 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

What Our Learners Say

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

0/0

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

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

0/0

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

0/0

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

0/0

4.6

Ratings

100K+

Happy Learners

100+

Locations Worldwide

99%

Training Satisfaction

Enquire with us now

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

Get Course Details & Pricing

Fill out this form and we will respond quickly.

We also deliver Quality by Design Training across multiple cities

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

Valletta

Explore Our Other Course Categories

Agile Certification Training Courses

Project Management Certification Training Courses

IT Service Management Certification Training Courses

DevOps

IT Governance Certification Training Courses

Other Related Courses

Foundation

Kaizen

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)?

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.

Quality by Design Training in Malta

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

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

Key Highlightsof the Quality by Design Training Course

Quality by Design Training Eligibility in the MaltaWho Can Enroll?

Why Quality by Design Skills Are Worth ItPractical Value from Day One

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

SECTORS HIRING

GROWTH TRENDS

Why Malta's Pharma Employers Value QbD Skills

Generics Development Under Cost Pressure

Rising EMA and FDA Dossier Expectations

API Manufacturing Complexity

A Small Island Talent Pool

The Cost of Batch Deviations

Biosimilars and Complex Products

Where You Stand Today

The Shift QbD Skills Deliver

Module 1: Introduction to QbD

Module 2: QbD Tools and Techniques

Module 3: Industry and Regulatory Perspective

Module 4: Quality Target Product Profile (QTPP)

Module 5: Critical Quality Attributes, Critical Material Attributes, and Critical Process Parameters

Module 6: Statistical Design of Experiments

Module 7: Design Space and Process Control

Module 8: Risk Assessment and Management

Module 9: Real-time Release Testing (RTRT)

Module 10: Case Studies and Practical Applications

Course Curriculumof the Quality by Design Training

Module 1: Introduction to QbD

The QbD Skills You Will BuildPractical Tools for Pharma Development

Build the Quality Target Product Profile

Identify Critical Quality Attributes

Run Structured Risk Assessment

Design Experiments and Map the Design Space

Apply Process Analytical Technology

Develop the Control Strategy

Who Should TakeQuality by Design Training in Malta?

Quality by Design Training Modesfor Professionals and Teams

Quality by Design Live Virtual Training

Quality by Design Classroom Training

Quality by Design Corporate Group Training

Quality by Design Focused 1-to-1 Training

Quality by Design Live Virtual Training

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

Quality by Design Training Locations in MaltaAll our classroom training is now available online at your convenience

Corporate QbD TrainingBuild Team Capability at Scale

What Our Learners Say

Enquire with us now

Get Course Details & Pricing

We also deliver Quality by Design Training across multiple cities

Explore Our Other Course Categories

Other Related Courses

Poka Yoke

Lean Six Sigma Yellow Belt

Business Process Management

Six Sigma Awareness

7 QC Tools Training

Lean Six Sigma Black Belt

Quality Function Deployment

Lean IT

Lean Six Sigma Green Belt

Minitab Essentials

Design for Six Sigma

Lean Fundamentals