Course Overview

    Overview

    Course Highlights

    Eligibility Criteria

    Benefits

    What Is Quality by Design and Why It Matters in TunisiaA Science-Based Route to Better Medicines

    Quality by Design Training in Tunisia is a practical programme that teaches pharmaceutical and biopharmaceutical professionals how to build quality into products from the development stage, rather than testing it in at the end. Quality by Design (QbD) is the systematic, science-based approach set out in the ICH Q8, Q9, Q10 and Q11 guidelines and increasingly expected by regulators such as the FDA and EMA. The course suits formulation scientists, process development engineers, analytical scientists, quality assurance teams and regulatory affairs professionals across Tunisia's growing pharmaceutical sector. You learn the structured QbD toolkit, from the Quality Target Product Profile and Critical Quality Attributes through to risk assessment, Design of Experiments, the design space and the control strategy. With Tunisian manufacturers exporting to more than 20 countries and upgrading facilities to European and WHO GMP standards, QbD skills are now central to winning and defending international product registrations. Build capability you can apply the very next day with Invensis Learning.

    What Is Quality by Design and Why It Matters in TunisiaA Science-Based Route to Better Medicines

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    Key Highlightsof the Quality by Design Training Course

    Quality by Design Training Eligibility in the TunisiaWho Can Enroll?

    How QbD Skills Pay off in Your Daily WorkPractical Value for Individuals and Teams

    Your QbD Career Path in TunisiaRoles and Sectors Hiring Now

    Quality by Design skills are increasingly sought across Tunisia's pharmaceutical and biopharmaceutical employers, from generic manufacturers and API producers to CDMOs and regulatory consultancies. As Tunisian firms export to more than 20 markets and upgrade to European GMP standards, professionals who can run QbD in development and manufacturing stand out. Quality by Design training equips them to step into exactly these roles. Demand spans formulation scientists, process development engineers, QA specialists and regulatory affairs leads, and here is what the market shows right now.

    Market Pressures Making QbD Essential in Tunisia

    QbD is more than a compliance box. It is the capability Tunisia's pharmaceutical sector needs to compete on exports and quality. Build practical QbD skills your teams can apply immediately. Start your journey today.

    Your Tunisia QbD Career Shift

    From Testing Quality to Designing It In,

    The Shift QbD Delivers for Your Career

    Tunisia's pharmaceutical sector is scaling exports and upgrading to European GMP standards, and employers increasingly separate professionals who can design quality in from those who only test for it. Here is which side of that line QbD training puts you on.

    Sources: Paylab, worldsalaries.com, FIPA Tunisia 2024-2026.

    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 Tunisia 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 BuildTools You Apply on Real Projects

    By the end of this QbD programme you will be able to apply the full Quality by Design toolkit to real pharmaceutical development work. The course builds practical capability across the QTPP, Critical Quality Attributes, risk assessment, Design of Experiments, the design space, PAT and the control strategy, aligned to the ICH Q8, Q9, Q10 and Q11 guidelines.

    Define the Quality Target Product Profile

    Translate patient and clinical needs into a QTPP that sets the design specification for the whole development programme, covering dosage form, strength, delivery and quality standards.

    Identify Critical Quality Attributes

    Determine which physical, chemical, biological and microbiological properties are critical to product quality, safety and efficacy, and classify them with confidence for both small molecules and biologics.

    Run QbD Risk Assessments

    Use Ishikawa (fishbone) diagrams and FMEA with RPN scoring to link material attributes and process parameters to each CQA, and prioritise the relationships that need experimental study.

    Design and Interpret Experiments (DoE)

    Plan screening and response-surface designs, interpret the statistical model output, and use it to define the design space, Normal Operating Ranges and Proven Acceptable Ranges.

    Apply PAT and Build a Control Strategy

    Use Process Analytical Technology and combine material, process and in-process controls into a risk-proportionate control strategy that keeps production within the design space.

    Document QbD for Regulatory Submission

    Structure the QTPP, risk assessment, design space and control strategy evidence for the pharmaceutical development section of a CTD submission to the FDA, EMA and ANMPS.

    Who Should TakeQuality by Design Training in Tunisia?

    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

    USD 395

    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

    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

    USD 395

    Please Note: Attend fully interactive weekday Quality by Design training sessions from anywhere while benefiting from real-time instructor guidance and collaborative learning experiences.

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

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    Why Choose Invensis Learning for Quality by Design Training in TunisiaExpert-Led, Flexible and Practical

    Invensis Learning delivers practical Quality by Design training for pharmaceutical professionals and organisations across Tunisia and worldwide. Our programmes combine experienced practitioner trainers, ICH-aligned courseware, flexible delivery formats and learner-focused support. Whether you enrol as an individual or arrange corporate training for your team, we focus on real understanding and workplace application, backed by ISO 9001:2015 and ISO 27001:2022 certified processes.

    • Experienced practitioner trainers in pharmaceutical quality and development
    • Live virtual, classroom and onsite delivery to fit working schedules
    • Hands-on exercises using realistic pharmaceutical development scenarios
    • ISO 9001:2015 certified quality and ISO 27001:2022 certified information security
    • Structured, ICH-aligned courseware focused on workplace application
    • Dedicated learner support before, during and after training
    • Customised corporate delivery for pharmaceutical teams in Tunisia
    • Global training provider trusted across more than 100 countries

    5000+

    Accredited Trainers Globally

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    Rated by Learners Worldwide

    500+

    Corporate Clients

    15+

    Years of Training Excellence

    ISO 9001:2015 Certified

    ISO 9001:2015 Certified

    ISO 27001:2022 Certified

    ISO 27001:2022 Certified

    Secure SSL Encryption

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    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 TunisiaInstructor-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 Tunisia

    Mövenpick Hotel Du Lac Tunis, Great Salt Lake Pass, lakeside, lake, El Khadra delegation, Tunisia, Tunis Governorate, 1053, Tunisia

    Quality by Design Training Location in Tunisia

    Sheraton Tunis Hotel, Tunisia

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    Corporate QbD Training for Pharma TeamsAcross Tunisia

    • Tailored QbD content mapped to your live development projects
    • Onsite, live virtual or blended delivery for teams
    • Schedules aligned to your production and project calendar
    • Cross-functional training across formulation, process, QA and regulatory
    • Experienced trainers with pharmaceutical industry expertise
    • Progress tracking and dedicated coordination for group training
    • Scalable delivery for single-site or multi-site organisations

    Leading Pharmaceutical Employers

    MediSAdwyaSIPHATOpalia PharmaUnimedSaiph

    What Our Learners Say

    A Practical New Way to Develop Products

    "The QbD course completely changed how I approach formulation. I now start every project with a clear QTPP and CQA list, and the risk assessment tools helped me cut trial-and-error work on my last development batch."

    Sana Ben Salah

    Formulation Scientist

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    Finally Understand DoE and Design Space

    "The Design of Experiments and design space sessions were exactly what I needed. I can now plan a screening study and read the response surface properly, instead of changing one factor at a time."

    Yassine Trabelsi

    Process Development Engineer

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    Clearer View of QbD in Submissions

    "As a regulatory professional, the module on documenting QbD for the CTD was very useful. I understand far better what reviewers expect in the pharmaceutical development section and how the control strategy ties it together."

    Mariem Gharbi

    Regulatory Affairs Specialist

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    Aligned Our Whole Team on QbD

    "We booked this as onsite training for our development and quality teams. Everyone now shares the same QbD language, which has made our risk assessments and design reviews much faster and more consistent."

    Khaled Bouazizi

    Head of Quality Assurance, Generic Manufacturer

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    Relevant, Tailored and High Impact

    "The trainer tailored the case studies to our biosimilar work, which made the content immediately relevant. Our people came away able to apply CQA identification and DoE to real projects. Strong return on the investment."

    Ines Hammami

    Learning and Development Lead, Biopharmaceutical Company

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

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

    Quality by Design training is a practical course that teaches pharmaceutical professionals to build quality into products from the development stage. It covers the QbD approach set out in the ICH Q8, Q9, Q10 and Q11 guidelines, including the QTPP, Critical Quality Attributes, risk assessment, Design of Experiments, the design space and the control strategy.

    General

    What is Quality by Design training?

    Quality by Design training is a practical course that teaches pharmaceutical professionals to build quality into products from the development stage. It covers the QbD approach set out in the ICH Q8, Q9, Q10 and Q11 guidelines, including the QTPP, Critical Quality Attributes, risk assessment, Design of Experiments, the design space and the control strategy.

    Is QbD training worth it for professionals in Tunisia?

    Yes. As Tunisian manufacturers export to more than 20 markets and upgrade to European and WHO GMP standards, QbD skills are increasingly expected in development, quality and regulatory roles. The training gives you tools you can apply immediately to real pharmaceutical projects.

    Which ICH guidelines does QbD training cover?

    The course is aligned to the ICH quality guidelines: Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and Q11 for drug substances. These form the regulatory foundation of Quality by Design worldwide.

    Who should attend QbD training?

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

    Do I need prior QbD experience to attend?

    No. The course has no formal prerequisites and introduces QbD from first principles. Familiarity with pharmaceutical development or GMP is helpful but not required.

    Pricing

    How much does QbD training cost in Tunisia?

    Pricing depends on the delivery format (live virtual, classroom or corporate onsite) and group size. Fees include instructor-led training, ICH-aligned courseware, hands-on exercises and a course completion record. Contact us for current Tunisia pricing or request a group quote.

    What is included in the course fee?

    The fee typically includes live instructor-led training across all six QbD modules, ICH-aligned courseware, hands-on tool exercises, worked pharmaceutical case studies and a course completion record from Invensis Learning.

    Do you offer corporate or group pricing?

    Yes. We offer volume-based corporate pricing for pharmaceutical teams, with customised schedules and content mapped to your projects. Request a tailored quote for your organisation.

    Are there discounts for training several team members?

    Group and corporate rates are available when you train several team members together. Speak with a learning advisor to find the best option for your team.

    What payment options are available?

    We accept major credit and debit cards and bank transfers, with invoicing available for corporate bookings. Talk to our team to arrange payment for your enrolment.

    Assessment

    Is there an exam for QbD training?

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

    What do I receive on completion?

    You receive a course completion record from Invensis Learning confirming you have completed the Quality by Design programme. The skills are immediately applicable and do not expire.

    How is learning checked during the course?

    There is no formal assessment. Instead, you apply QbD tools such as the QTPP, CQA identification, risk assessment and design space interpretation to realistic development scenarios throughout the course.

    Will I be able to apply QbD at work afterwards?

    Yes. After the course you can construct a QTPP, identify and classify CQAs, run Ishikawa and FMEA risk assessments, plan DoE studies, interpret a design space and build a control strategy for submission.

    Is QbD relevant to both small molecules and biologics?

    Yes. The course covers QbD for small molecule drug products and for biopharmaceuticals such as monoclonal antibodies and biosimilars, with case examples drawn from both.

    Course Content

    What topics does QbD training cover?

    The course covers six modules: QbD principles and the ICH framework; the QTPP and Critical Quality Attributes; risk assessment; Design of Experiments and the design space; Process Analytical Technology and the control strategy; and QbD in practice, including CTD submission and lifecycle management.

    How long is the QbD training?

    The programme runs for one day (8 hours), and can also be delivered as two half-day sessions. It covers the full QbD framework with hands-on exercises throughout.

    Are there hands-on exercises?

    Yes. You practise building a QTPP, identifying CQAs, constructing Ishikawa diagrams, selecting a DoE design and interpreting a design space, all using realistic pharmaceutical development scenarios.

    What learning materials are provided?

    You receive ICH-aligned courseware, worked pharmaceutical and biopharmaceutical case studies, QbD tool templates and reference material covering the ICH Q8, Q9, Q10 and Q11 guidelines.

    Is the course aligned to current regulatory expectations?

    Yes. The content reflects the ICH Q8(R2), Q9, Q10 and Q11 guidelines and current FDA and EMA expectations for QbD-based pharmaceutical development and control strategy.

    Enrollment

    How do I enrol in QbD training in Tunisia?

    You can enrol through the Invensis Learning website or by contacting our team. Choose your preferred format, complete booking, and you will receive schedules, courseware and joining details. Talk to a learning advisor to pick a batch.

    What delivery formats are available?

    The course is available as live virtual (online) instructor-led training, in-person classroom training, and corporate onsite delivery for teams across Tunisia. Choose the format that suits your schedule.

    Can the course be delivered onsite for my team?

    Yes. We deliver corporate onsite QbD training at your premises, tailored to your live development projects, so cross-functional teams can learn and apply the tools together. Request a group quote to arrange this.

    When are the next sessions scheduled?

    New public and corporate sessions are scheduled regularly. Contact us or view upcoming schedules to find a date that fits, or arrange a dedicated session for your team.

    Can I reschedule my booking?

    Yes. Flexible options let you reschedule to another session where needed. Contact our support team to arrange this for your enrolment.